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"title": "FDA OKs Pfizer COVID-19 Vaccine For Ages 12-15",
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"content": "\u003cp>The Food and Drug Administration says children 12 to 15 years old are now eligible to receive a key COVID-19 vaccine, as the agency on Monday \u003ca href=\"https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use\">expanded its emergency use authorization\u003c/a> for the Pfizer/BioNTech vaccine.\u003c/p>\n\u003cp>Dr. Janet Woodcock, the acting FDA commissioner, said the expansion “brings us closer to returning to a sense of normalcy.”\u003c/p>\n\u003cp>“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Woodcock said.\u003c/p>\n\u003cp>Until now, the Pfizer vaccine had been authorized only for people age 16 and older. Pfizer asked the FDA to broaden its emergency use authorization for the vaccine after \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2021/03/31/982983455/pfizer-says-covid-19-vaccine-shows-100-efficacy-in-adolescents\">announcing in late March\u003c/a> that clinical trials found “100% efficacy and robust antibody responses” in study participants who were 12 to 15 years old.\u003c/p>\n\u003cp>The FDA first granted Pfizer’s request for an emergency use authorization, or EUA, for its COVID-19 vaccine \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/11/945366548/fda-authorizes-covid-19-vaccine-for-emergency-use-in-u-s\">in December\u003c/a>. It got federal approval to include children as young as 12 years old in its vaccine trial \u003ca href=\"https://www.npr.org/sections/health-shots/2020/10/13/923248377/will-kids-get-a-covid-19-vaccine-pfizer-to-expand-trial-to-ages-12-and-up\">last October\u003c/a>.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>All three makers of U.S.-authorized vaccines — Pfizer, Moderna and Johnson & Johnson — are studying the safety and effectiveness of their vaccines in children, including as young as 6 months.\u003c/p>\n\u003cp>Johnson & Johnson said last week that its vaccine “will initially be tested in a small number of adolescents, which will be expanded to a larger group in a step-wise approach, if initial data shows an acceptable safety profile.”\u003c/p>\n\u003cp>Those expanded trials started last month, when J&J vaccine shots were given to teens from 16 to 17 years old. If all goes well, the trial will include kids as young as 12, \u003ca href=\"https://www.jnj.com/johnson-johnson-expands-phase-2a-clinical-trial-of-covid-19-vaccine-candidate-to-include-adolescents\">the company says\u003c/a>.\u003c/p>\n\u003cp>Moderna \u003ca href=\"https://investors.modernatx.com/news-releases/news-release-details/moderna-provides-clinical-and-supply-updates-covid-19-vaccine\">said in mid-April\u003c/a> that its vaccine study in adolescents is now fully enrolled, with around 3,000 people age 12 to 17 slated to receive doses. A second phase of the study will follow, including children who are from 6 months to 11 years old.\u003c/p>\n\u003cp>Pfizer says it won’t be ready to ask the FDA for new emergency use authorization expansions for kids younger than 12 until September. One such request would cover children from 2 to 5 years old; a second would apply to ages 5 to 11. A third request, aimed at protecting infants and toddlers, isn’t expected until the fourth quarter of this year.\u003c/p>\n\u003cp>Pfizer and BioNTech say they have the capacity to manufacture up to 2.5 billion vaccine doses in 2021, and to produce at least 3 billion doses in 2022.\u003c/p>\n\u003cp>In another move that could boost COVID-19 vaccine availability, Pfizer recently asked the FDA to approve a change that would allow its vaccine to be stored at common refrigerator temperatures of 2 to 8 degrees Celsius (roughly 36 to 46 degrees Fahrenheit) for up to four weeks. The company says it submitted data about the vaccine’s stability at those temperatures on April 30.\u003c/p>\n\u003cp>In general, Pfizer’s vaccine must be stored at ultra-cold temperatures of around -70 degrees Celsius (-94 degrees Fahrenheit). The company \u003ca href=\"https://www.npr.org/sections/goatsandsoda/2021/02/24/965835993/what-is-a-cold-chain-and-why-do-so-many-vaccines-need-it\">loosened that requirement\u003c/a> a bit in February, however, saying the shots, which use messenger RNA, could safely be kept at typical home freezer temperatures, -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit), for up to two weeks.\u003c/p>\n\u003cp>The COVID-19 vaccine’s success has brought billions of dollars to Pfizer. In the first quarter of 2021 alone, the vaccine added $3.5 billion in global revenue, Pfizer chairman and CEO Albert Bourla \u003ca href=\"https://s21.q4cdn.com/317678438/files/doc_financials/2021/q1/Q1-2021-Earnings-Conference-Call-Prepared-Remarks-FINAL.pdf\">told investors\u003c/a> in a conference call last Tuesday. Over the entire year, Pfizer could bring in around $26 billion based on the vaccine, Bourla said.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The company and BioNTech, its development and revenue-sharing partner, have shipped some 430 million doses to 91 countries and territories, Bourla said last week.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2021 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=FDA+OKs+Pfizer+COVID-19+Vaccine+For+12-15+Age+Group&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration says children 12 to 15 years old are now eligible to receive a key COVID-19 vaccine, as the agency on Monday \u003ca href=\"https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use\">expanded its emergency use authorization\u003c/a> for the Pfizer/BioNTech vaccine.\u003c/p>\n\u003cp>Dr. Janet Woodcock, the acting FDA commissioner, said the expansion “brings us closer to returning to a sense of normalcy.”\u003c/p>\n\u003cp>“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Woodcock said.\u003c/p>\n\u003cp>Until now, the Pfizer vaccine had been authorized only for people age 16 and older. Pfizer asked the FDA to broaden its emergency use authorization for the vaccine after \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2021/03/31/982983455/pfizer-says-covid-19-vaccine-shows-100-efficacy-in-adolescents\">announcing in late March\u003c/a> that clinical trials found “100% efficacy and robust antibody responses” in study participants who were 12 to 15 years old.\u003c/p>\n\u003cp>The FDA first granted Pfizer’s request for an emergency use authorization, or EUA, for its COVID-19 vaccine \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/11/945366548/fda-authorizes-covid-19-vaccine-for-emergency-use-in-u-s\">in December\u003c/a>. It got federal approval to include children as young as 12 years old in its vaccine trial \u003ca href=\"https://www.npr.org/sections/health-shots/2020/10/13/923248377/will-kids-get-a-covid-19-vaccine-pfizer-to-expand-trial-to-ages-12-and-up\">last October\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>All three makers of U.S.-authorized vaccines — Pfizer, Moderna and Johnson & Johnson — are studying the safety and effectiveness of their vaccines in children, including as young as 6 months.\u003c/p>\n\u003cp>Johnson & Johnson said last week that its vaccine “will initially be tested in a small number of adolescents, which will be expanded to a larger group in a step-wise approach, if initial data shows an acceptable safety profile.”\u003c/p>\n\u003cp>Those expanded trials started last month, when J&J vaccine shots were given to teens from 16 to 17 years old. If all goes well, the trial will include kids as young as 12, \u003ca href=\"https://www.jnj.com/johnson-johnson-expands-phase-2a-clinical-trial-of-covid-19-vaccine-candidate-to-include-adolescents\">the company says\u003c/a>.\u003c/p>\n\u003cp>Moderna \u003ca href=\"https://investors.modernatx.com/news-releases/news-release-details/moderna-provides-clinical-and-supply-updates-covid-19-vaccine\">said in mid-April\u003c/a> that its vaccine study in adolescents is now fully enrolled, with around 3,000 people age 12 to 17 slated to receive doses. A second phase of the study will follow, including children who are from 6 months to 11 years old.\u003c/p>\n\u003cp>Pfizer says it won’t be ready to ask the FDA for new emergency use authorization expansions for kids younger than 12 until September. One such request would cover children from 2 to 5 years old; a second would apply to ages 5 to 11. A third request, aimed at protecting infants and toddlers, isn’t expected until the fourth quarter of this year.\u003c/p>\n\u003cp>Pfizer and BioNTech say they have the capacity to manufacture up to 2.5 billion vaccine doses in 2021, and to produce at least 3 billion doses in 2022.\u003c/p>\n\u003cp>In another move that could boost COVID-19 vaccine availability, Pfizer recently asked the FDA to approve a change that would allow its vaccine to be stored at common refrigerator temperatures of 2 to 8 degrees Celsius (roughly 36 to 46 degrees Fahrenheit) for up to four weeks. The company says it submitted data about the vaccine’s stability at those temperatures on April 30.\u003c/p>\n\u003cp>In general, Pfizer’s vaccine must be stored at ultra-cold temperatures of around -70 degrees Celsius (-94 degrees Fahrenheit). The company \u003ca href=\"https://www.npr.org/sections/goatsandsoda/2021/02/24/965835993/what-is-a-cold-chain-and-why-do-so-many-vaccines-need-it\">loosened that requirement\u003c/a> a bit in February, however, saying the shots, which use messenger RNA, could safely be kept at typical home freezer temperatures, -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit), for up to two weeks.\u003c/p>\n\u003cp>The COVID-19 vaccine’s success has brought billions of dollars to Pfizer. In the first quarter of 2021 alone, the vaccine added $3.5 billion in global revenue, Pfizer chairman and CEO Albert Bourla \u003ca href=\"https://s21.q4cdn.com/317678438/files/doc_financials/2021/q1/Q1-2021-Earnings-Conference-Call-Prepared-Remarks-FINAL.pdf\">told investors\u003c/a> in a conference call last Tuesday. Over the entire year, Pfizer could bring in around $26 billion based on the vaccine, Bourla said.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The company and BioNTech, its development and revenue-sharing partner, have shipped some 430 million doses to 91 countries and territories, Bourla said last week.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2021 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=FDA+OKs+Pfizer+COVID-19+Vaccine+For+12-15+Age+Group&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp class=\"p2\">Eloise LaCour clutches her dolly as a nurse takes her blood pressure, then swabs the 3-year-old’s delicate arm with alcohol.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p2\">“Tickle Tickle,” says Eloise’s mom Angelica LaCour. She’s trying to get a smile. “Mommy’s going to hug you, OK?”\u003c/p>\n\u003cp class=\"p2\">The nurse, carefully, gives Eloise her shot. Here at a Stanford University medical facility, she is one of 144 children in the country who are part of a phase one clinical trial to test Pfizer-BioNTech COVID vaccines in the most adorable of study cohorts — those 5 and under.\u003c/p>\n\u003cp class=\"p2\">“That’s it!” exclaims nurse manager Richard Brotherton, pulling the needle out of Eloise’s arm.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p2\">Eloise barely flinches. In fact, under her mask it looks like she’s smiling.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“Look at you brave kid,” beams her mom.\u003c/p>\n\u003cp class=\"p2\">The next day, Eloise has yet to complain of any side effects — not even an ouch in her arm where the needle went in.\u003c/p>\n\u003cp class=\"p3\">While an unfortunate number of people are still hesitating about the remarkably effective vaccines, let alone enrolling their kids in clinical trials, Angelica LaCour speaks of the importance of getting children inoculated.\u003c/p>\n\u003cp>“I think it’s just really important to highlight that we’re not going to get to herd immunity as a country if children are not vaccinated,” she said. “We don’t know the long-term impacts of the virus. And we know that this is a well-tolerated vaccine that’s saving people’s lives. And it’s important that our children get that as well. ”\u003c/p>\n\u003cp>Still, the family was initially nervous about enrolling their only daughter in the early trial. But they’ weren’t sure they’d be any less so in six months, a year, or whenever the official rollout of vaccines for the youngest Americans takes place.\u003c/p>\n\u003cp>And while Eloise is healthy, “We know that there’s a lot of other families with kids with vulnerabilities where COVID is potentially life-threatening,” LaCour said. “And so being part of making this a reality for those families is something that is really meaningful to us.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">\u003cb>Second Dose\u003c/b>\u003c/p>\n\u003cp class=\"p3\">After three weeks it’s time for Eloise’s second poke. She has decided to dress up as her favorite character from the Pixar movie “Brave.” This time, she squirms a little more but still doesn’t cry.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">That night she complains her head hurts a little and that her arm is sore. Nothing that can’t be solved with a low dose of Tylenol, says her mom. Otherwise she’s running around\u003c/p>\n\u003cp class=\"p3\">“Lots of energy,” LaCour says.\u003c/p>\n\u003cp class=\"p3\">Now, a couple of days before her father has gotten his second shot, Eloise is one of a small number of children in the country to be fully vaccinated.\u003c/p>\n\u003cp class=\"p3\">Soon the family will start planning a summer vacation.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">Stanford scientists will track Eloise for the next two years to make sure all goes well. The next phases will involve enrolling many more children, eventually thousands, to study accurate dosage, vaccine safety, immune response and efficacy.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">\u003cb>Kids Rollout Could Begin Next Fall\u003c/b>\u003c/p>\n\u003cp class=\"p3\">\u003cspan class=\"s1\">Pfizer\u003c/span> is planning to apply to the Food and Drug Administration in September for emergency authorization of the vaccine for children age 2 to 11. Meanwhile, the company is expected to receive permission any day now to vaccinate 12- to 15-year-olds. \u003ca href=\"https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-dosed-phase-23-study-0\">\u003cspan class=\"s2\">Moderna\u003c/span>\u003c/a> is also conducting clinical trials in kids for its vaccine.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">This science would not be possible without children and parents who are willing to go first, which is why Dr. Yvonne Maldonado, a pediatric infectious disease expert at Stanford Medicine who is leading the trial, lauds the family’s courage.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">“If we didn’t have clinical trials, we’d have zero vaccines for children,” she said. “And we save 3 million lives a year from death due to vaccine-preventable diseases as well.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">Last week the Kaiser Family Foundation released a \u003ca href=\"https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/\">\u003cspan class=\"s2\">survey\u003c/span>\u003c/a> showing fewer than a third of parents reporting plans to get their kids COVID shots as soon as it’s possible. \u003cspan class=\"s3\">Another 32% said they would “wait and see.”\u003c/span>\u003c/p>\n\u003cp class=\"p4\">\u003cspan class=\"s4\">Health officials hope the hesitation eases over time, as it did for adult vaccines. \u003c/span>The current survey percentages are similar to what U.S. adults expressed in a KFF September \u003ca href=\"https://www.kff.org/report-section/kff-the-undefeated-survey-on-race-and-health-main-findings/#COVID-19Vaccine\">\u003cspan class=\"s2\">survey\u003c/span>\u003c/a>, in which 34% of adults said they would get a vaccine “right away,” with 29% in the wait-and-see camp.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p4\">Getting parents on board is critical to stamping out the virus and reaching herd immunity, that by now almost mythical juncture\u003cspan class=\"s5\"> when the vast majority of a population will be protected from COVID-19.\u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp class=\"p5\">“We need to make sure that we can limit transmission,” said Maldonado. “And if we can reach children, that really gets to a fairly large segment of the U.S. population.”\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"p2\">Eloise LaCour clutches her dolly as a nurse takes her blood pressure, then swabs the 3-year-old’s delicate arm with alcohol.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p2\">“Tickle Tickle,” says Eloise’s mom Angelica LaCour. She’s trying to get a smile. “Mommy’s going to hug you, OK?”\u003c/p>\n\u003cp class=\"p2\">The nurse, carefully, gives Eloise her shot. Here at a Stanford University medical facility, she is one of 144 children in the country who are part of a phase one clinical trial to test Pfizer-BioNTech COVID vaccines in the most adorable of study cohorts — those 5 and under.\u003c/p>\n\u003cp class=\"p2\">“That’s it!” exclaims nurse manager Richard Brotherton, pulling the needle out of Eloise’s arm.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p2\">Eloise barely flinches. In fact, under her mask it looks like she’s smiling.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“Look at you brave kid,” beams her mom.\u003c/p>\n\u003cp class=\"p2\">The next day, Eloise has yet to complain of any side effects — not even an ouch in her arm where the needle went in.\u003c/p>\n\u003cp class=\"p3\">While an unfortunate number of people are still hesitating about the remarkably effective vaccines, let alone enrolling their kids in clinical trials, Angelica LaCour speaks of the importance of getting children inoculated.\u003c/p>\n\u003cp>“I think it’s just really important to highlight that we’re not going to get to herd immunity as a country if children are not vaccinated,” she said. “We don’t know the long-term impacts of the virus. And we know that this is a well-tolerated vaccine that’s saving people’s lives. And it’s important that our children get that as well. ”\u003c/p>\n\u003cp>Still, the family was initially nervous about enrolling their only daughter in the early trial. But they’ weren’t sure they’d be any less so in six months, a year, or whenever the official rollout of vaccines for the youngest Americans takes place.\u003c/p>\n\u003cp>And while Eloise is healthy, “We know that there’s a lot of other families with kids with vulnerabilities where COVID is potentially life-threatening,” LaCour said. “And so being part of making this a reality for those families is something that is really meaningful to us.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">\u003cb>Second Dose\u003c/b>\u003c/p>\n\u003cp class=\"p3\">After three weeks it’s time for Eloise’s second poke. She has decided to dress up as her favorite character from the Pixar movie “Brave.” This time, she squirms a little more but still doesn’t cry.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">That night she complains her head hurts a little and that her arm is sore. Nothing that can’t be solved with a low dose of Tylenol, says her mom. Otherwise she’s running around\u003c/p>\n\u003cp class=\"p3\">“Lots of energy,” LaCour says.\u003c/p>\n\u003cp class=\"p3\">Now, a couple of days before her father has gotten his second shot, Eloise is one of a small number of children in the country to be fully vaccinated.\u003c/p>\n\u003cp class=\"p3\">Soon the family will start planning a summer vacation.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">Stanford scientists will track Eloise for the next two years to make sure all goes well. The next phases will involve enrolling many more children, eventually thousands, to study accurate dosage, vaccine safety, immune response and efficacy.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">\u003cb>Kids Rollout Could Begin Next Fall\u003c/b>\u003c/p>\n\u003cp class=\"p3\">\u003cspan class=\"s1\">Pfizer\u003c/span> is planning to apply to the Food and Drug Administration in September for emergency authorization of the vaccine for children age 2 to 11. Meanwhile, the company is expected to receive permission any day now to vaccinate 12- to 15-year-olds. \u003ca href=\"https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-dosed-phase-23-study-0\">\u003cspan class=\"s2\">Moderna\u003c/span>\u003c/a> is also conducting clinical trials in kids for its vaccine.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">This science would not be possible without children and parents who are willing to go first, which is why Dr. Yvonne Maldonado, a pediatric infectious disease expert at Stanford Medicine who is leading the trial, lauds the family’s courage.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">“If we didn’t have clinical trials, we’d have zero vaccines for children,” she said. “And we save 3 million lives a year from death due to vaccine-preventable diseases as well.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">Last week the Kaiser Family Foundation released a \u003ca href=\"https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/\">\u003cspan class=\"s2\">survey\u003c/span>\u003c/a> showing fewer than a third of parents reporting plans to get their kids COVID shots as soon as it’s possible. \u003cspan class=\"s3\">Another 32% said they would “wait and see.”\u003c/span>\u003c/p>\n\u003cp class=\"p4\">\u003cspan class=\"s4\">Health officials hope the hesitation eases over time, as it did for adult vaccines. \u003c/span>The current survey percentages are similar to what U.S. adults expressed in a KFF September \u003ca href=\"https://www.kff.org/report-section/kff-the-undefeated-survey-on-race-and-health-main-findings/#COVID-19Vaccine\">\u003cspan class=\"s2\">survey\u003c/span>\u003c/a>, in which 34% of adults said they would get a vaccine “right away,” with 29% in the wait-and-see camp.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p4\">Getting parents on board is critical to stamping out the virus and reaching herd immunity, that by now almost mythical juncture\u003cspan class=\"s5\"> when the vast majority of a population will be protected from COVID-19.\u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp class=\"p5\">“We need to make sure that we can limit transmission,” said Maldonado. “And if we can reach children, that really gets to a fairly large segment of the U.S. population.”\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">R\u003c/span>\u003c/span>egeneron Pharmaceuticals said Monday that a single administration of its monoclonal antibody cocktail reduced the risk that volunteers exposed to COVID-19 would develop the disease by 81%.\u003c/p>\n\u003cp>The study enrolled 1,500 healthy volunteers, each of whom shared a home with someone who tested positive for SARS-CoV-2, and randomized them to receive a single dose of its antibody treatment, given subcutaneously as four shots, or placebo. After 29 days, 11 patients in the treatment group developed COVID-19 compared to 59 on placebo. And for the subjects who got COVID-19 despite treatment, their symptoms resolved after one week, compared to three weeks for those on placebo. In 204 patients who had already tested positive for the SARS-CoV-2 virus at the study’s outset, the injection reduced their chances of progressing to symptomatic COVID-19 by 31%.\u003c/p>\n\u003cp>The results were made public in a press release and will be published in a scientific journal or presented at a medical meeting at a later date.\u003c/p>\n\u003cp>Those results mirror similar results seen in a study conducted by Eli Lilly of its monoclonal antibody in nursing homes. One key difference: While in previous studies by both Lilly and Regeneron, antibodies had to be given intravenously, in this one Regeneron used a formulation that could be given with an under-the-skin injection. Lilly is also exploring a subcutaneous injection of its antibodies.\u003c/p>\n\u003cp>That’s “a really, really big deal,” said Myron Cohen, director of the Institute for Global Health and Infectious Diseases at the University of North Carolina and one of the study’s lead investigators. He said that having to start an IV is “unequivocally” one of the barriers to using the antibodies either for treatment or prevention. The other barrier? Awareness.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“In order for these antibodies to be used for treatment and prevention and for treatment as prevention, we need the patients or their families familiar with the opportunity,” Cohen said. “We need health providers to be familiar with these drugs and comfortable administering them.”\u003c/p>\n\u003cp>And why do we need antibodies when there are already vaccines? Dan Barouch, the director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a key figure in the development of the J&J vaccine and another investigator in Regeneron’s study, said that the approaches are “complementary.”\u003c/p>\n\u003cp>“As of now, there are still substantial numbers of people who are not fully vaccinated,” Barouch said. What’s more, some people, including those with compromised immune systems, might not generate enough antibodies one their own — and could benefit from antibodies that are injected into their bodies.\u003c/p>\n\u003cp>In some circumstances, say, an outbreak at a nursing home, the monoclonal antibodies, which start working immediately, could be the better approach.\u003c/p>\n\u003cp>Adverse events occurred in 20% of those who received the antibody cocktail and 29% of those who received placebo. None of the antibody cocktail recipients were hospitalized, but four volunteers in the placebo group were. Injection site reactions occurred in 4% of those who received the antibody and 2% of those who received placebo.\u003c/p>\n\u003cp>Regeneron said 35% of study volunteers were Latinx and 5% were Black. About a third had at least one risk factor that would put them at high risk if they developed COVID-19. A third were obese, and 38% were over 50.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2021/04/12/regeneron-antibody-cocktail-covid-simple-injection/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">R\u003c/span>\u003c/span>egeneron Pharmaceuticals said Monday that a single administration of its monoclonal antibody cocktail reduced the risk that volunteers exposed to COVID-19 would develop the disease by 81%.\u003c/p>\n\u003cp>The study enrolled 1,500 healthy volunteers, each of whom shared a home with someone who tested positive for SARS-CoV-2, and randomized them to receive a single dose of its antibody treatment, given subcutaneously as four shots, or placebo. After 29 days, 11 patients in the treatment group developed COVID-19 compared to 59 on placebo. And for the subjects who got COVID-19 despite treatment, their symptoms resolved after one week, compared to three weeks for those on placebo. In 204 patients who had already tested positive for the SARS-CoV-2 virus at the study’s outset, the injection reduced their chances of progressing to symptomatic COVID-19 by 31%.\u003c/p>\n\u003cp>The results were made public in a press release and will be published in a scientific journal or presented at a medical meeting at a later date.\u003c/p>\n\u003cp>Those results mirror similar results seen in a study conducted by Eli Lilly of its monoclonal antibody in nursing homes. One key difference: While in previous studies by both Lilly and Regeneron, antibodies had to be given intravenously, in this one Regeneron used a formulation that could be given with an under-the-skin injection. Lilly is also exploring a subcutaneous injection of its antibodies.\u003c/p>\n\u003cp>That’s “a really, really big deal,” said Myron Cohen, director of the Institute for Global Health and Infectious Diseases at the University of North Carolina and one of the study’s lead investigators. He said that having to start an IV is “unequivocally” one of the barriers to using the antibodies either for treatment or prevention. The other barrier? Awareness.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“In order for these antibodies to be used for treatment and prevention and for treatment as prevention, we need the patients or their families familiar with the opportunity,” Cohen said. “We need health providers to be familiar with these drugs and comfortable administering them.”\u003c/p>\n\u003cp>And why do we need antibodies when there are already vaccines? Dan Barouch, the director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a key figure in the development of the J&J vaccine and another investigator in Regeneron’s study, said that the approaches are “complementary.”\u003c/p>\n\u003cp>“As of now, there are still substantial numbers of people who are not fully vaccinated,” Barouch said. What’s more, some people, including those with compromised immune systems, might not generate enough antibodies one their own — and could benefit from antibodies that are injected into their bodies.\u003c/p>\n\u003cp>In some circumstances, say, an outbreak at a nursing home, the monoclonal antibodies, which start working immediately, could be the better approach.\u003c/p>\n\u003cp>Adverse events occurred in 20% of those who received the antibody cocktail and 29% of those who received placebo. None of the antibody cocktail recipients were hospitalized, but four volunteers in the placebo group were. Injection site reactions occurred in 4% of those who received the antibody and 2% of those who received placebo.\u003c/p>\n\u003cp>Regeneron said 35% of study volunteers were Latinx and 5% were Black. About a third had at least one risk factor that would put them at high risk if they developed COVID-19. A third were obese, and 38% were over 50.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2021/04/12/regeneron-antibody-cocktail-covid-simple-injection/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>If you’ve been following the coronavirus headlines lately, you’ve likely been hearing a lot about new coronavirus variants. As a result, you may be freaking out, experiencing pandemic fatigue or be just plain confused.\u003c/p>\n\u003cp>[pullquote size='medium' align='right' citation='Dr. Robert Siegel, Stanford University']‘The vaccines are so wildly effective, they produce such a strong immune response that the variants that exist now, even the ones that are slightly better at spreading, they all seem to be susceptible to the vaccine.’[/pullquote]Doctors have called some coronavirus variants highly concerning — but there are things you can do to protect yourself against infection, like getting the vaccine when you’re eligible and doubling down on your masking and distancing habits.\u003c/p>\n\u003cp>We consulted medical experts Dr. Robert Siegel, professor of microbiology and immunology at Stanford, and Dr. Peter Chin-Hong, professor of medicine and infectious disease specialist at UCSF, as well as CDC guidance, on what you need to know about variants.\u003c/p>\n\u003cp>\u003cstrong>What is a variant?\u003c/strong>\u003c/p>\n\u003cp>Viruses are constantly changing. When a virus hijacks a host cell and replicates, \u003ca href=\"https://www.nytimes.com/interactive/2021/health/coronavirus-variant-tracker.html\" target=\"_blank\" rel=\"noopener noreferrer\">mistakes occur\u003c/a> so that the genetic makeup of the copies isn’t exactly the same as the original. These errors are called mutations.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“The more times that the virus copies itself, the more viruses that are made, the more mistakes that are made,” Siegel said. “Variants are just [viruses with] collections of mutations. So they inevitably arise as long as there’s lots of people that are infected making virus.”\u003c/p>\n\u003cp>Scientists can track variants by looking for a distinct set of inherited mutations. In addition to an alphanumeric string, coronavirus variants are often referred to by the part of the world where they were first observed.\u003c/p>\n\u003cp>Siegel says the emergence of variants is “basically normal for all viruses.”\u003c/p>\n\u003cp>\u003cstrong>Do variants change the way the virus behaves?\u003c/strong>\u003c/p>\n\u003cp>Many variants have no effect on the behavior of a virus. But as mutations accumulate, errors can occur in parts of the virus’s genetic material that alter its physical properties and behavior.\u003c/p>\n\u003cp>These changes may affect where and how strongly a virus binds to host cells, its ability to evade an immune response, how fast it can copy itself or how easy it is for someone to transmit the virus to another person.\u003c/p>\n\u003cp>Thus, some variants may persist longer, become more infectious or be more resistant to antibodies or vaccines than others. If you think about it, we’re all familiar with this basic truth about viruses because it’s why the annual flu vaccine is more effective one year and less in another year.\u003c/p>\n\u003cp>Like all viruses, those that cause the flu change constantly — in fact, says Siegel, influenza makes far more mistakes when it copies than the coronavirus. The more errors a virus makes, the more mutations and the more variants.\u003c/p>\n\u003cp>Each year, scientists around the world \u003ca href=\"https://www.cdc.gov/flu/prevent/vaccine-selection.htm\" target=\"_blank\" rel=\"noopener noreferrer\">track them\u003c/a> to see which influenza viruses are making people sick, how quickly or widely they’re spreading, and how well the previous year’s vaccine works against them. More than 100 countries participate in this work, tracking thousands of test samples of the virus.\u003c/p>\n\u003cp>Every February, the WHO gathers representatives from its own and the world’s top labs and national academies and recommends which viruses should be included in the annual flu vaccine. Each country then makes its own final decision. But it’s difficult to predict the spread and timing of flu viruses, so each year’s flu vaccine is more or less effective depending on factors such as what influenza virus shows up and when.\u003c/p>\n\u003cp>\u003cstrong>Are coronavirus variants more dangerous than the original virus?\u003c/strong>\u003c/p>\n\u003cp>In short, it depends on the variant.\u003c/p>\n\u003cp>Siegel says the vast majority of coronavirus variants don’t increase the virus’s ability to spread. Some, like the British \u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e2.htm\" target=\"_blank\" rel=\"noopener noreferrer\">B.1.1.7 variant\u003c/a>, have been shown to be more contagious than the original coronavirus. Others, like the \u003ca href=\"https://www.krisp.org.za/publications.php?pubid=316\" target=\"_blank\" rel=\"noopener noreferrer\">South African\u003c/a> and \u003ca href=\"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00183-5/fulltext\" target=\"_blank\" rel=\"noopener noreferrer\">Brazilian\u003c/a> variants, have mutations that research suggests make them somewhat more resistant to some treatments or vaccines.\u003c/p>\n\u003cp>More transmissible variants, Dr. Siegel says, are potentially of greater concern because of how rapidly they can spread through the population.\u003c/p>\n\u003cp>For a virus, he said, “Winning the game is not necessarily making a variant that is more dangerous, it’s just making a variant that can spread more.”\u003c/p>\n\u003cp>Vaccines used in the U.S. appear to protect against all known coronavirus variants — even more antibody-resistant variants — and the key to ending the pandemic is controlling the spread.\u003c/p>\n\u003cp>Chin-Hong says the British variant is probably the most troubling of the variants out there. “It seems to be the bulldog of the variants,” he says. “Wherever it goes, it sets up shop and it bullies all the other variants.”\u003c/p>\n\u003cp>Scientists are still studying why, but Chin-Hong says one hypothesis is that people infected with the B.1.1.7 variant appear to shed the virus for longer and have more copies of the virus.\u003c/p>\n\u003cp>\u003cstrong>Do vaccines work well against variants?\u003c/strong>\u003c/p>\n\u003cp>In short, yes.\u003c/p>\n\u003cp>“The vaccines are so wildly effective,” Siegel said. “They produce such a strong immune response that the variants that exist now, even the ones that are slightly better at spreading, they all seem to be susceptible to the vaccine.”\u003c/p>\n\u003cp>While a handful of variants, particularly the South African variant, appear to be somewhat more resistant, \u003ca href=\"https://investors.modernatx.com/news-releases/news-release-details/moderna-covid-19-vaccine-retains-neutralizing-activity-against\" target=\"_blank\" rel=\"noopener noreferrer\">data suggest\u003c/a> vaccines authorized for use in the U.S. are still effective at preventing serious illness and death.\u003c/p>\n\u003cp>“They still seem to be able to keep people out of the ICU,” Siegel said, “still seem to be able to keep people from dying.”\u003c/p>\n\u003cp>Chin-Hong adds that two vaccines not authorized for use in the U.S., AstraZeneca and Novavax, may be less effective against some variants.\u003c/p>\n\u003cp>\u003cstrong>Overall, how concerned are health experts about new variants? What can I do to protect myself?\u003c/strong>\u003c/p>\n\u003cp>The CDC \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant.html\" target=\"_blank\" rel=\"noopener noreferrer\">classifies coronavirus variants\u003c/a> into three categories: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC). There are currently no VOHC and five VOCs in the United States.\u003c/p>\n\u003cp>The variant that he’s most worried about, Siegel says, “is the variant that we haven’t seen yet.” He says that’s because we’re only now at the point with vaccine and infection rates that an immune resistant variant could emerge from the rest. Scientists call these “escape variants.”\u003c/p>\n\u003cp>He adds that with less than half the population vaccinated, there’s still a real risk for unvaccinated people to get the coronavirus unless they continue to protect themselves with masking and social distancing.\u003c/p>\n\u003cp>“Not only do they have to be just as safe as they were,” he said. “They actually have to be safer because they might encounter a strain that’s more contagious.”\u003c/p>\n\u003cp>With more transmissible variants like B.1.1.7 out there, Chin-Hong said that compared to a year ago, a person in their 30s is more likely to catch the virus from an infected person if you share an elevator. Unless, that is, you’re vaccinated.\u003c/p>\n\u003cp>“Silver lining number one is the vaccines will work,” Chin-Hong said. “Silver lining number two is we know what to do even if we don’t have a vaccine.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>“With the finish line so close at hand in terms of if you’re going to get vaccinated in two weeks,” Siegel added, “You don’t want to get infected now.”\u003c/p>\n\n",
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"excerpt": "The three vaccines approved in the U.S. -- Pfizer, Moderna, and Johnson & Johnson -- are all effective against the coronavirus variants. As the virus mutates, it's a race against time to stop the spread of the pandemic.",
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"description": "The three vaccines approved in the U.S. -- Pfizer, Moderna, and Johnson & Johnson -- are all effective against the coronavirus variants. As the virus mutates, it's a race against time to stop the spread of the pandemic.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>If you’ve been following the coronavirus headlines lately, you’ve likely been hearing a lot about new coronavirus variants. As a result, you may be freaking out, experiencing pandemic fatigue or be just plain confused.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "‘The vaccines are so wildly effective, they produce such a strong immune response that the variants that exist now, even the ones that are slightly better at spreading, they all seem to be susceptible to the vaccine.’",
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"content": "\u003cdiv class=\"post-body\">\u003cp>Doctors have called some coronavirus variants highly concerning — but there are things you can do to protect yourself against infection, like getting the vaccine when you’re eligible and doubling down on your masking and distancing habits.\u003c/p>\n\u003cp>We consulted medical experts Dr. Robert Siegel, professor of microbiology and immunology at Stanford, and Dr. Peter Chin-Hong, professor of medicine and infectious disease specialist at UCSF, as well as CDC guidance, on what you need to know about variants.\u003c/p>\n\u003cp>\u003cstrong>What is a variant?\u003c/strong>\u003c/p>\n\u003cp>Viruses are constantly changing. When a virus hijacks a host cell and replicates, \u003ca href=\"https://www.nytimes.com/interactive/2021/health/coronavirus-variant-tracker.html\" target=\"_blank\" rel=\"noopener noreferrer\">mistakes occur\u003c/a> so that the genetic makeup of the copies isn’t exactly the same as the original. These errors are called mutations.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“The more times that the virus copies itself, the more viruses that are made, the more mistakes that are made,” Siegel said. “Variants are just [viruses with] collections of mutations. So they inevitably arise as long as there’s lots of people that are infected making virus.”\u003c/p>\n\u003cp>Scientists can track variants by looking for a distinct set of inherited mutations. In addition to an alphanumeric string, coronavirus variants are often referred to by the part of the world where they were first observed.\u003c/p>\n\u003cp>Siegel says the emergence of variants is “basically normal for all viruses.”\u003c/p>\n\u003cp>\u003cstrong>Do variants change the way the virus behaves?\u003c/strong>\u003c/p>\n\u003cp>Many variants have no effect on the behavior of a virus. But as mutations accumulate, errors can occur in parts of the virus’s genetic material that alter its physical properties and behavior.\u003c/p>\n\u003cp>These changes may affect where and how strongly a virus binds to host cells, its ability to evade an immune response, how fast it can copy itself or how easy it is for someone to transmit the virus to another person.\u003c/p>\n\u003cp>Thus, some variants may persist longer, become more infectious or be more resistant to antibodies or vaccines than others. If you think about it, we’re all familiar with this basic truth about viruses because it’s why the annual flu vaccine is more effective one year and less in another year.\u003c/p>\n\u003cp>Like all viruses, those that cause the flu change constantly — in fact, says Siegel, influenza makes far more mistakes when it copies than the coronavirus. The more errors a virus makes, the more mutations and the more variants.\u003c/p>\n\u003cp>Each year, scientists around the world \u003ca href=\"https://www.cdc.gov/flu/prevent/vaccine-selection.htm\" target=\"_blank\" rel=\"noopener noreferrer\">track them\u003c/a> to see which influenza viruses are making people sick, how quickly or widely they’re spreading, and how well the previous year’s vaccine works against them. More than 100 countries participate in this work, tracking thousands of test samples of the virus.\u003c/p>\n\u003cp>Every February, the WHO gathers representatives from its own and the world’s top labs and national academies and recommends which viruses should be included in the annual flu vaccine. Each country then makes its own final decision. But it’s difficult to predict the spread and timing of flu viruses, so each year’s flu vaccine is more or less effective depending on factors such as what influenza virus shows up and when.\u003c/p>\n\u003cp>\u003cstrong>Are coronavirus variants more dangerous than the original virus?\u003c/strong>\u003c/p>\n\u003cp>In short, it depends on the variant.\u003c/p>\n\u003cp>Siegel says the vast majority of coronavirus variants don’t increase the virus’s ability to spread. Some, like the British \u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e2.htm\" target=\"_blank\" rel=\"noopener noreferrer\">B.1.1.7 variant\u003c/a>, have been shown to be more contagious than the original coronavirus. Others, like the \u003ca href=\"https://www.krisp.org.za/publications.php?pubid=316\" target=\"_blank\" rel=\"noopener noreferrer\">South African\u003c/a> and \u003ca href=\"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00183-5/fulltext\" target=\"_blank\" rel=\"noopener noreferrer\">Brazilian\u003c/a> variants, have mutations that research suggests make them somewhat more resistant to some treatments or vaccines.\u003c/p>\n\u003cp>More transmissible variants, Dr. Siegel says, are potentially of greater concern because of how rapidly they can spread through the population.\u003c/p>\n\u003cp>For a virus, he said, “Winning the game is not necessarily making a variant that is more dangerous, it’s just making a variant that can spread more.”\u003c/p>\n\u003cp>Vaccines used in the U.S. appear to protect against all known coronavirus variants — even more antibody-resistant variants — and the key to ending the pandemic is controlling the spread.\u003c/p>\n\u003cp>Chin-Hong says the British variant is probably the most troubling of the variants out there. “It seems to be the bulldog of the variants,” he says. “Wherever it goes, it sets up shop and it bullies all the other variants.”\u003c/p>\n\u003cp>Scientists are still studying why, but Chin-Hong says one hypothesis is that people infected with the B.1.1.7 variant appear to shed the virus for longer and have more copies of the virus.\u003c/p>\n\u003cp>\u003cstrong>Do vaccines work well against variants?\u003c/strong>\u003c/p>\n\u003cp>In short, yes.\u003c/p>\n\u003cp>“The vaccines are so wildly effective,” Siegel said. “They produce such a strong immune response that the variants that exist now, even the ones that are slightly better at spreading, they all seem to be susceptible to the vaccine.”\u003c/p>\n\u003cp>While a handful of variants, particularly the South African variant, appear to be somewhat more resistant, \u003ca href=\"https://investors.modernatx.com/news-releases/news-release-details/moderna-covid-19-vaccine-retains-neutralizing-activity-against\" target=\"_blank\" rel=\"noopener noreferrer\">data suggest\u003c/a> vaccines authorized for use in the U.S. are still effective at preventing serious illness and death.\u003c/p>\n\u003cp>“They still seem to be able to keep people out of the ICU,” Siegel said, “still seem to be able to keep people from dying.”\u003c/p>\n\u003cp>Chin-Hong adds that two vaccines not authorized for use in the U.S., AstraZeneca and Novavax, may be less effective against some variants.\u003c/p>\n\u003cp>\u003cstrong>Overall, how concerned are health experts about new variants? What can I do to protect myself?\u003c/strong>\u003c/p>\n\u003cp>The CDC \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant.html\" target=\"_blank\" rel=\"noopener noreferrer\">classifies coronavirus variants\u003c/a> into three categories: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC). There are currently no VOHC and five VOCs in the United States.\u003c/p>\n\u003cp>The variant that he’s most worried about, Siegel says, “is the variant that we haven’t seen yet.” He says that’s because we’re only now at the point with vaccine and infection rates that an immune resistant variant could emerge from the rest. Scientists call these “escape variants.”\u003c/p>\n\u003cp>He adds that with less than half the population vaccinated, there’s still a real risk for unvaccinated people to get the coronavirus unless they continue to protect themselves with masking and social distancing.\u003c/p>\n\u003cp>“Not only do they have to be just as safe as they were,” he said. “They actually have to be safer because they might encounter a strain that’s more contagious.”\u003c/p>\n\u003cp>With more transmissible variants like B.1.1.7 out there, Chin-Hong said that compared to a year ago, a person in their 30s is more likely to catch the virus from an infected person if you share an elevator. Unless, that is, you’re vaccinated.\u003c/p>\n\u003cp>“Silver lining number one is the vaccines will work,” Chin-Hong said. “Silver lining number two is we know what to do even if we don’t have a vaccine.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“With the finish line so close at hand in terms of if you’re going to get vaccinated in two weeks,” Siegel added, “You don’t want to get infected now.”\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "JAMA and Other Medical Journals Under Fire After Disastrous Podcast on Racism in Medicine",
"headTitle": "JAMA and Other Medical Journals Under Fire After Disastrous Podcast on Racism in Medicine | KQED",
"content": "\u003cp>Weeks after it was scrubbed from the \u003cem>Journal of the American Medical Association’s\u003c/em> website, a disastrous podcast — whose host, a white editor and physician, questioned whether racism even exists in medicine — is surfacing complaints that JAMA and other elite medical journals have routinely excluded, minimized, and mishandled issues of race.\u003c/p>\n\u003cp>Recent examples include research blaming higher death rates from COVID-19 in African Americans on a single gene in their nasal passages; a letter claiming structural racism doesn’t play a role in pulse oximeters working less well on patients with dark skin because machines can’t exhibit bias; and an article claiming that students of programs designed to increase diversity in medicine won’t make good doctors.\u003c/p>\n\u003cp>Critics say such ideas, published in powerful journals that doctors look to for leadership and education, are serving to perpetuate and entrench health inequities that have long harmed and \u003ca href=\"https://www.cdc.gov/mmwr/volumes/66/wr/mm6617e1.htm\" target=\"_blank\" rel=\"noopener noreferrer\">shortened the lives\u003c/a> of many people of color.\u003c/p>\n\u003cp>“It’s the voice of medicine. They set the priorities,” said Brittani James, an assistant professor of clinical family medicine at the University of Illinois College of Medicine and co-founder of the Institute for Antiracism in Medicine. She helped start a petition calling for widespread change at JAMA that has attracted nearly 8,000 signatures.\u003c/p>\n\u003cp>While the podcast sparked the petition drive, James said the problem goes far beyond a single podcast or a single journal. The episode at JAMA, she said, merely exposed a culture of racism that runs rife though medicine. “It’s the tip of the racist iceberg,” she said of the podcast. That listeners of the podcast were offered continuing medical education credit, she added, only rubs salt in the wound.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The February podcast involved two white doctors — Ed Livingston, JAMA’s deputy editor for clinical content, and Mitchell Katz, an editor at \u003cem>JAMA Internal Medicine\u003c/em> and CEO of NYC Health + Hospitals — who are not experts in structural racism, broadcasting a conversation about that topic on JAMA’s huge and powerful platform that came across as deeply offensive.\u003c/p>\n\u003cp>Livingston questioned whether racism could be embedded in society \u003ca href=\"https://static1.squarespace.com/static/5d7d985bfc6bb40f1dfae872/t/6061d1425689961a044a3ac0/1617023298545/Transcript+-+Structural+Racism+for+Doctors.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">because it is “illegal”\u003c/a> and said he did not consider himself a racist because he grew up in a Jewish family and was taught never to hate. He asked whether the term racism “might be hurting us” and whether there might be a better word because “the term racism invokes feelings amongst people.” Katz repeatedly affirmed his belief that structural racism exists but was later criticized by some for coddling Livingston. Katz has since condemned the podcast and said he was not involved in its production and firmly believes structural racism exists in medicine. Livingston has not commented publicly.\u003c/p>\n\u003cp>The uproar over the podcast led the journal to ask Livingston to resign. Howard Bauchner, JAMA’s editor-in-chief, apologized but was then put on administrative leave. He and other editors at JAMA have refused to comment, pending the outcome of an investigation of the matter by outside counsel. The journal is owned by the American Medical Association, the nation’s leading physicians organization, but has editorial independence.\u003c/p>\n\u003cp>Critics say problems at \u003cem>JAMA\u003c/em> and its network of medical journals include limiting publication of scholarship on how racism affects health and suggesting papers involving racism be submitted not as research articles, which have the most clinical impact, but as opinion pieces or “Perspectives,” a series in \u003cem>JAMA Internal Medicine\u003c/em> featuring “stories about the joys and challenges of practicing general medicine and truths discovered along the way.”\u003c/p>\n\u003cp>Other problems they cite include editors asking authors to scrub the term racism from their manuscripts even as they publish other manuscripts that include outdated and racist notions, such as the idea that genetic and not social factors may explain the higher rates of COVID-19 death and hospitalization among people of color.\u003c/p>\n\u003cp>Problematic articles have appeared recently and steadily in \u003cem>JAMA\u003c/em> and other prominent medical journals, even as discussions of racism in medicine have taken center stage during the pandemic and as journals and medical associations have publicly affirmed the Black Lives Matter movement and \u003ca href=\"https://www.ama-assn.org/about/board-trustees/ama-board-trustees-pledges-action-against-racism-and-police-brutality\" target=\"_blank\" rel=\"noopener noreferrer\">their own commitment to racial equality\u003c/a>.\u003c/p>\n\u003cp>A \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770682\" target=\"_blank\" rel=\"noopener noreferrer\">September \u003cem>JAMA\u003c/em> paper\u003c/a> suggested African Americans may have higher rates of COVID-19 because of differences in the expression of a certain gene in the nasal epithelium, despite the fact that the clinical relevance of that gene’s expression is unknown and Hispanic people, who also have higher death rates from COVID-19, do not have a higher rate of expression of the gene. “That’s biomedical racism to a T,” James said.\u003c/p>\n\u003cp>Critics say \u003ca href=\"https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2767260\" target=\"_blank\" rel=\"noopener noreferrer\">an October \u003cem>JAMA\u003c/em> paper\u003c/a> on the association between air pollution and poor birth outcomes failed to examine the role racism plays in environmental exposure to poorer air. And an article about the high rates of hospitalization among people of color with COVID-19 in California, \u003ca href=\"https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.00598\" target=\"_blank\" rel=\"noopener noreferrer\">published online in \u003cem>Health Affairs\u003c/em>\u003c/a> in May, initially questioned whether there could be “some unknown or unmeasured genetic or biological factors that increase the severity of this illness for African Americans.” In response to criticism, the paper was later revised to remove this language.\u003c/p>\n\u003cp>An article published in August in the \u003cem>Journal of the American Heart Association\u003c/em>, arguing that students of educational programs intended to increase diversity would \u003ca href=\"https://www.ahajournals.org/doi/10.1161/JAHA.120.015959\" target=\"_blank\" rel=\"noopener noreferrer\">make poorer clinicians\u003c/a>, was retracted after many physicians questioned how the article — \u003ca href=\"https://www.ahajournals.org/doi/10.1161/JAHA.119.014602\" target=\"_blank\" rel=\"noopener noreferrer\">rife with stereotypes and errors\u003c/a> — made it past reviewers.\u003c/p>\n\u003cp>And a letter published just last week in the\u003cem> New England Journal of Medicine\u003c/em> \u003ca href=\"https://www.nejm.org/doi/10.1056/NEJMc2101321\">disputed\u003c/a> use of the phrase “structural racism” when discussing the fact that pulse oximeters — oxygen sensors that are critical tools for COVID-19 care and were developed and tested largely on people with white skin — \u003ca href=\"https://www.statnews.com/2021/02/10/pulse-oximeters-racial-disparities/\">work less well on people with Black skin.\u003c/a> “Medical devices such as pulse oximeters are blind to color and cannot exhibit such a bias,” the author wrote.\u003c/p>\n\u003cp>Months before the recent podcast, Rhea Boyd, a pediatrician and public health advocate in Palo Alto, California, had taken to Twitter to call out JAMA’s poor record on studies involving race. With colleagues Edwin Lindo, Lachelle Weeks and Monica McLemore, she wrote a piece in \u003cem>Health Affairs\u003c/em> in July \u003ca href=\"https://www.healthaffairs.org/do/10.1377/hblog20200630.939347/full/\">calling for a higher standard\u003c/a> for publishing on racial health inequities. “The bar hasn’t been high enough,” she told STAT. “We don’t treat scholarship around race the same way we do other health issues. When we do that, we sell this field short.”\u003c/p>\n\u003cp>Boyd said researchers need to do a better job of defining race, specifying the reason they use it in studies, refraining from using genetic definitions of race that are not grounded in science, and citing experts who have rigorously studied the effects of racism. She said journals should reject articles on health inequities that don’t examine racism, use reviewers who are experienced in the scholarship of racism, and consider compensating reviewers, particularly those of color, who are increasingly being asked to share their expertise for free.\u003c/p>\n\u003cp>Crucially, she said, scholars and journal editors must openly use the term racism, something many have clearly been uncomfortable with. “In doing this, we obscure ways that racism drives health inequities,” said Boyd.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"excerpt": "Weeks after it was scrubbed from the Journal of the American Medical Association's website, a disastrous podcast whose host questioned whether racism exists in medicine is surfacing complaints that elite medical journals have routinely excluded, minimized and mishandled issues of race.",
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"description": "Weeks after it was scrubbed from the Journal of the American Medical Association's website, a disastrous podcast whose host questioned whether racism exists in medicine is surfacing complaints that elite medical journals have routinely excluded, minimized and mishandled issues of race.",
"title": "JAMA and Other Medical Journals Under Fire After Disastrous Podcast on Racism in Medicine | KQED",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Weeks after it was scrubbed from the \u003cem>Journal of the American Medical Association’s\u003c/em> website, a disastrous podcast — whose host, a white editor and physician, questioned whether racism even exists in medicine — is surfacing complaints that JAMA and other elite medical journals have routinely excluded, minimized, and mishandled issues of race.\u003c/p>\n\u003cp>Recent examples include research blaming higher death rates from COVID-19 in African Americans on a single gene in their nasal passages; a letter claiming structural racism doesn’t play a role in pulse oximeters working less well on patients with dark skin because machines can’t exhibit bias; and an article claiming that students of programs designed to increase diversity in medicine won’t make good doctors.\u003c/p>\n\u003cp>Critics say such ideas, published in powerful journals that doctors look to for leadership and education, are serving to perpetuate and entrench health inequities that have long harmed and \u003ca href=\"https://www.cdc.gov/mmwr/volumes/66/wr/mm6617e1.htm\" target=\"_blank\" rel=\"noopener noreferrer\">shortened the lives\u003c/a> of many people of color.\u003c/p>\n\u003cp>“It’s the voice of medicine. They set the priorities,” said Brittani James, an assistant professor of clinical family medicine at the University of Illinois College of Medicine and co-founder of the Institute for Antiracism in Medicine. She helped start a petition calling for widespread change at JAMA that has attracted nearly 8,000 signatures.\u003c/p>\n\u003cp>While the podcast sparked the petition drive, James said the problem goes far beyond a single podcast or a single journal. The episode at JAMA, she said, merely exposed a culture of racism that runs rife though medicine. “It’s the tip of the racist iceberg,” she said of the podcast. That listeners of the podcast were offered continuing medical education credit, she added, only rubs salt in the wound.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The February podcast involved two white doctors — Ed Livingston, JAMA’s deputy editor for clinical content, and Mitchell Katz, an editor at \u003cem>JAMA Internal Medicine\u003c/em> and CEO of NYC Health + Hospitals — who are not experts in structural racism, broadcasting a conversation about that topic on JAMA’s huge and powerful platform that came across as deeply offensive.\u003c/p>\n\u003cp>Livingston questioned whether racism could be embedded in society \u003ca href=\"https://static1.squarespace.com/static/5d7d985bfc6bb40f1dfae872/t/6061d1425689961a044a3ac0/1617023298545/Transcript+-+Structural+Racism+for+Doctors.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">because it is “illegal”\u003c/a> and said he did not consider himself a racist because he grew up in a Jewish family and was taught never to hate. He asked whether the term racism “might be hurting us” and whether there might be a better word because “the term racism invokes feelings amongst people.” Katz repeatedly affirmed his belief that structural racism exists but was later criticized by some for coddling Livingston. Katz has since condemned the podcast and said he was not involved in its production and firmly believes structural racism exists in medicine. Livingston has not commented publicly.\u003c/p>\n\u003cp>The uproar over the podcast led the journal to ask Livingston to resign. Howard Bauchner, JAMA’s editor-in-chief, apologized but was then put on administrative leave. He and other editors at JAMA have refused to comment, pending the outcome of an investigation of the matter by outside counsel. The journal is owned by the American Medical Association, the nation’s leading physicians organization, but has editorial independence.\u003c/p>\n\u003cp>Critics say problems at \u003cem>JAMA\u003c/em> and its network of medical journals include limiting publication of scholarship on how racism affects health and suggesting papers involving racism be submitted not as research articles, which have the most clinical impact, but as opinion pieces or “Perspectives,” a series in \u003cem>JAMA Internal Medicine\u003c/em> featuring “stories about the joys and challenges of practicing general medicine and truths discovered along the way.”\u003c/p>\n\u003cp>Other problems they cite include editors asking authors to scrub the term racism from their manuscripts even as they publish other manuscripts that include outdated and racist notions, such as the idea that genetic and not social factors may explain the higher rates of COVID-19 death and hospitalization among people of color.\u003c/p>\n\u003cp>Problematic articles have appeared recently and steadily in \u003cem>JAMA\u003c/em> and other prominent medical journals, even as discussions of racism in medicine have taken center stage during the pandemic and as journals and medical associations have publicly affirmed the Black Lives Matter movement and \u003ca href=\"https://www.ama-assn.org/about/board-trustees/ama-board-trustees-pledges-action-against-racism-and-police-brutality\" target=\"_blank\" rel=\"noopener noreferrer\">their own commitment to racial equality\u003c/a>.\u003c/p>\n\u003cp>A \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770682\" target=\"_blank\" rel=\"noopener noreferrer\">September \u003cem>JAMA\u003c/em> paper\u003c/a> suggested African Americans may have higher rates of COVID-19 because of differences in the expression of a certain gene in the nasal epithelium, despite the fact that the clinical relevance of that gene’s expression is unknown and Hispanic people, who also have higher death rates from COVID-19, do not have a higher rate of expression of the gene. “That’s biomedical racism to a T,” James said.\u003c/p>\n\u003cp>Critics say \u003ca href=\"https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2767260\" target=\"_blank\" rel=\"noopener noreferrer\">an October \u003cem>JAMA\u003c/em> paper\u003c/a> on the association between air pollution and poor birth outcomes failed to examine the role racism plays in environmental exposure to poorer air. And an article about the high rates of hospitalization among people of color with COVID-19 in California, \u003ca href=\"https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.00598\" target=\"_blank\" rel=\"noopener noreferrer\">published online in \u003cem>Health Affairs\u003c/em>\u003c/a> in May, initially questioned whether there could be “some unknown or unmeasured genetic or biological factors that increase the severity of this illness for African Americans.” In response to criticism, the paper was later revised to remove this language.\u003c/p>\n\u003cp>An article published in August in the \u003cem>Journal of the American Heart Association\u003c/em>, arguing that students of educational programs intended to increase diversity would \u003ca href=\"https://www.ahajournals.org/doi/10.1161/JAHA.120.015959\" target=\"_blank\" rel=\"noopener noreferrer\">make poorer clinicians\u003c/a>, was retracted after many physicians questioned how the article — \u003ca href=\"https://www.ahajournals.org/doi/10.1161/JAHA.119.014602\" target=\"_blank\" rel=\"noopener noreferrer\">rife with stereotypes and errors\u003c/a> — made it past reviewers.\u003c/p>\n\u003cp>And a letter published just last week in the\u003cem> New England Journal of Medicine\u003c/em> \u003ca href=\"https://www.nejm.org/doi/10.1056/NEJMc2101321\">disputed\u003c/a> use of the phrase “structural racism” when discussing the fact that pulse oximeters — oxygen sensors that are critical tools for COVID-19 care and were developed and tested largely on people with white skin — \u003ca href=\"https://www.statnews.com/2021/02/10/pulse-oximeters-racial-disparities/\">work less well on people with Black skin.\u003c/a> “Medical devices such as pulse oximeters are blind to color and cannot exhibit such a bias,” the author wrote.\u003c/p>\n\u003cp>Months before the recent podcast, Rhea Boyd, a pediatrician and public health advocate in Palo Alto, California, had taken to Twitter to call out JAMA’s poor record on studies involving race. With colleagues Edwin Lindo, Lachelle Weeks and Monica McLemore, she wrote a piece in \u003cem>Health Affairs\u003c/em> in July \u003ca href=\"https://www.healthaffairs.org/do/10.1377/hblog20200630.939347/full/\">calling for a higher standard\u003c/a> for publishing on racial health inequities. “The bar hasn’t been high enough,” she told STAT. “We don’t treat scholarship around race the same way we do other health issues. When we do that, we sell this field short.”\u003c/p>\n\u003cp>Boyd said researchers need to do a better job of defining race, specifying the reason they use it in studies, refraining from using genetic definitions of race that are not grounded in science, and citing experts who have rigorously studied the effects of racism. She said journals should reject articles on health inequities that don’t examine racism, use reviewers who are experienced in the scholarship of racism, and consider compensating reviewers, particularly those of color, who are increasingly being asked to share their expertise for free.\u003c/p>\n\u003cp>Crucially, she said, scholars and journal editors must openly use the term racism, something many have clearly been uncomfortable with. “In doing this, we obscure ways that racism drives health inequities,” said Boyd.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "Your COVID-19 Vaccine Questions, From Side Effects to Safety",
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"headTitle": "Your COVID-19 Vaccine Questions, From Side Effects to Safety | KQED",
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"content": "\u003cp>\u003cem>Updated April 26, 2021, 5:53 p.m.\u003c/em>\u003c/p>\n\u003cp>On Friday, the Centers for Disease Control and Prevention and the Food and Drug Administration \u003ca href=\"https://www.kqed.org/news/11870973/cdc-vaccine-committee-votes-to-recommend-jj-vaccine-use-again\" target=\"_blank\" rel=\"noopener noreferrer\">lifted a 10-day pause\u003c/a> of Johnson & Johnson’s coronavirus vaccine. Bay Area counties followed suit, announcing they would resume using the single-dose shot.\u003c/p>\n\u003cp>Federal officials\u003ca href=\"https://www.nytimes.com/live/2021/04/13/world/johnson-vaccine-blood-clots\" target=\"_blank\" rel=\"noopener noreferrer\"> halted\u003c/a> the use of the Johnson & Johnson vaccine on April 13 “out of an abundance of caution” after a rare type of \u003ca href=\"https://www.scientificamerican.com/article/blood-clots-and-the-johnson-johnson-vaccine-what-we-know-so-far/\" target=\"_blank\" rel=\"noopener noreferrer\">blood clot\u003c/a> showed up in 6 women within about two weeks of receiving the vaccination.\u003c/p>\n\u003cp>“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work — identifying even these small number of cases,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement. “We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts.”\u003c/p>\n\u003cp>On Friday, the CDC updated the total to 15 women, ages 18 to 59, who experienced a combination of rare blood clots and low platelets between 6 and 15 days after vaccination. Over the weekend, UCSF announced that it was treating a male patient in his 30s for the condition, which is known as vaccine-induced thrombotic thrombocytopenia (VITT).\u003c/p>\n\u003cp>[aside postID=news_11869210]In the U.S., roughly eight million people have received the Johnson & Johnson vaccine.\u003c/p>\n\u003cp>“The relative risk is really, really low for these severe blood clots,” said Dr. Catherine Blish, infectious disease specialist at Stanford Medicine. If you develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of receiving the vaccine, seek medical treatment with your health care provider or an urgent care clinic or hospital emergency room, and let the provider know you received the Johnson & Johnson vaccine.\u003c/p>\n\u003cp>The CDC said in a statement earlier this month that one purpose of the pause was to let health care providers know what to do. The usual treatment for blood clots, a blood-thinning medication called heparin, can be dangerous used for this type of clot, and the CDC is alerting health providers to be prepared to offer alternate treatments.\u003c/p>\n\u003cp>[aside postID=news_11855623,news_11861322]We’ve searched for and compiled answers to some of the most frequently asked questions about the vaccine. Our answers come from a \u003ca href=\"https://www.exploratorium.edu/visit/calendar/after-dark-online-covid-catchup?utm_source=Twitter&utm_medium=Social&UTM_campaign=FY21AfterDark\" target=\"_blank\" rel=\"noopener noreferrer\">live Q&A\u003c/a> with the \u003ca href=\"https://www.exploratorium.edu/\" target=\"_blank\" rel=\"noopener noreferrer\">Exploratorium\u003c/a> featuring Dr. Bob Wachter, chair of the UCSF Department of Medicine, and Dr. Kirsten Bibbins-Domingo, chair of the UCSF Department of Epidemiology and Biostatistics. We also consulted the Centers for Disease Control and Prevention, the Food and Drug Administration, the World Health Organization and various other medical associations and journal articles. For those of you who want to dig deeper, we’ve linked to some of those.\u003cbr>\n\u003ca id=\"backtotop\">\u003c/a>\u003cbr>\n\u003cstrong>Jump to a question:\u003c/strong>\u003c/p>\n\u003cul>\n\u003cli>\u003ca href=\"#question1\">How were the vaccines developed so quickly?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question2\">How do people know the vaccines are safe and effective?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question3\">What are the possible side effects of getting a vaccine?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question4\">But the FDA approved this vaccine after two months of observation; isn’t there a chance a really bad side effect could show up much later?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question11\">Why do you need multiple doses and how long does your immunity last?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question5\">Do the vaccines give me the virus?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question6\">Do the vaccines work against the variants?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question7\">Can you still get and transmit COVID-19 if you’ve been vaccinated?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question8\">Should you get vaccinated if you’re pregnant or breastfeeding?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question9\">Were the vaccines tested on racially and ethnically diverse populations? Were they effective for a range of races/ethnicities?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question10\">What are the differences between the vaccines? Is one better than the others?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question12\">Are the vaccines safe for all ages? When will children be eligible?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question13\">Why should people in their 20s and 30s get vaccinated?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question14\">Should I get vaccinated if I already had COVID-19? And how long should I wait after I’ve had COVID-19 to get it?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question15\">If I’m vaccinated, can I stop wearing a mask and get close to people again?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question16\">I am immunosuppressed, should I still get the vaccine?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question17\">Do the COVID-19 vaccines cause infertility?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question18\">Does the vaccine allow any authority to track me?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question19\">How do I get the vaccine?\u003c/a>\u003c/li>\n\u003c/ul>\n\u003cp>\u003ca id=\"question1\">\u003c/a>\u003cstrong>Q: How were the vaccines developed so quickly?\u003c/strong>\u003c/p>\n\u003cp>U.S. government agencies and private companies collaborated on a project called \u003ca href=\"https://www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/\" target=\"_blank\" rel=\"noopener noreferrer\">Operation Warp Speed\u003c/a> to fast-track the coronavirus vaccine. This accelerated timeline doesn’t mean any steps were skipped in the testing stages for the vaccines. The shortcuts related to funding and to dialogue and planning, which went quickly since everyone had the same goal.\u003c/p>\n\u003cp>Normally, companies hesitate to manufacture a vaccine until they’re in the FDA approval process. It’s a big risk to invest a lot of money in manufacturing without knowing whether the vaccine will be approved. But under Operation Warp Speed, governments pre-paid for the vaccines to eliminate the financial risk for the companies involved. This allowed them to manufacture the vaccine at the same time they were doing the testing. So when the testing was complete, a lot of doses were already available to distribute.\u003c/p>\n\u003cp>Another reason for how quickly these vaccines were developed is that the processes used for making the vaccines aren’t new. mRNA had already been studied for years, and and was being developed for other infectious diseases. Because of this, researchers already knew how to make an mRNA vaccine and could customize development and testing for SARS-CoV-2. Adenovirus vaccines, the method used by Johnson & Johnson, are common.\u003c/p>\n\u003cp>The FDA authorized the emergency use of the Johnson & Johnson vaccine in February.\u003c/p>\n\u003cp>“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for theauthorization of a vaccine for emergency use,” Peter Marks, M.D., Ph.D. and director of the FDA’s Center for Biologics Evaluation and Research said at the time.\u003c/p>\n\u003cp>The FDA paused the use of the Johnson & Johnson vaccine on April 13 to investigate 6 cases in which a rare blood clot developed, out of the roughly 7 million people who’d received the vaccine in the U.S. to that point. Medical experts say that the risk of developing a blood clot from COVID-19 is \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/33254369/\" target=\"_blank\" rel=\"noopener noreferrer\">50 times higher\u003c/a>.\u003c/p>\n\u003cp>The halt on Johnson & Johnson’s Janssen coronavirus vaccine was lifted 10 days later on April 23 after a review of the initial six cases and 9 additional cases by the FDA and CDC.\u003c/p>\n\u003cp>“We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement. “We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider.”\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003ca id=\"question2\">\u003c/a>\u003cstrong>Q: How do people know the vaccines are safe and effective?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine\" target=\"_blank\" rel=\"noopener noreferrer\">Pfizer\u003c/a>, \u003ca href=\"https://www.modernatx.com/sites/default/files/content_documents/mRNA-1273-Update-11-16-20-Final.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Moderna\u003c/a> and \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine\" target=\"_blank\" rel=\"noopener noreferrer\">Johnson & Johnson\u003c/a> conducted full trials and \u003ca href=\"https://www.fda.gov/media/143890/download\" target=\"_blank\" rel=\"noopener noreferrer\">didn’t skip any steps\u003c/a> in the stages of testing for the vaccines’ safety and efficacy. The \u003ca href=\"https://media.defense.gov/2020/Aug/13/2002476369/-1/-1/0/200813-D-ZZ999-100.JPG\" target=\"_blank\" rel=\"noopener noreferrer\">stages\u003c/a> included testing in animals and an application for FDA approval to test in humans. Then the drug companies tested the vaccine in a small number of individuals before conducting tests in tens of thousands of people.\u003c/p>\n\u003cp>The only part of this process that was shorter than usual was in how long drug companies observed people for long-term side effects before requesting FDA authorization to distribute the vaccine.\u003c/p>\n\u003cp>“They would normally wait, let’s say, six months after testing of the vaccine,” Wachter said. “They waited two months, and why? Because this was an absolute emergency and a catastrophe. And so in waiting extra months, there would have been hundreds of thousands of people that would have died.”\u003c/p>\n\u003cp>The FDA recently resumed the rollout of the Johnson & Johnson vaccine after a short pause to investigate incidents of a rare blood clot showing up in a small percentage of people in the U.S. who received this vaccine.\u003c/p>\n\u003cp>Experts say a pause like this is normal when a new medication or vaccine becomes available to the public, and does not indicate that the Johnson & Johnson vaccine is dangerous.\u003c/p>\n\u003cp>“The relative risk is really, really low for these severe blood clots,” said Dr. Catherine Blish, infectious disease specialist at Stanford Medicine after the initial reports. “So we’ve had the six cases out of almost seven million vaccines delivered, which is about one in a million. And while this has been hugely controversial, the birth control pills are associated with about one in 1000-100 rate of blood clots.”\u003c/p>\n\u003cp>The FDA was asking for a minimum of 50% efficacy against the coronavirus. After two doses, Pfizer-BioNTech’s vaccine is 95% effective at preventing the symptoms of COVID-19 and Moderna’s is a little over 94%.\u003c/p>\n\u003cp>Johnson & Johnson’s vaccine is about 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.\u003c/p>\n\u003cp>Those results and the safety records are why the FDA \u003ca href=\"https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained#:~:text=An%20Emergency%20Use%20Authorization%20(EUA)%20is%20a%20mechanism%20to%20facilitate,the%20current%20COVID%2D19%20pandemic.\" target=\"_blank\" rel=\"noopener noreferrer\">authorized\u003c/a> the emergency use of these vaccines.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question3\">\u003c/a>\u003cstrong>Q: What are the possible side effects of getting a vaccine?\u003c/strong>\u003c/p>\n\u003cp>The possible short-term side effects for all the vaccines include pain, swelling and redness at the injection site, as well as tiredness, chills and headaches. If you get side effects, they would typically start within a day or two of injection and last a few days. The side effects, experts note, are your immune system telling you the vaccine is working and your body is creating antibodies.\u003c/p>\n\u003cp>If you find yourself experiencing these side effects, consult your doctor before taking over-the-counter medication such as ibuprofen, aspirin, antihistamines or acetaminophen. Also, don’t take these medications before you get the vaccine.\u003c/p>\n\u003cp>The CDC reports that a December study found that a small fraction of people — 11.1 recipients per million doses administered — had a severe allergic reaction called anaphylaxis, which can be lethal. The CDC has listed a few allergies that could \u003ca href=\"https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html\" target=\"_blank\" rel=\"noopener noreferrer\">prevent\u003c/a> someone from getting the vaccine. The agency also recommends people get screened for allergies before receiving the vaccine, and that vaccine sites have epinephrine injections available. If you have allergies, you may wish to consult your doctor about the vaccine.\u003c/p>\n\u003cp>There are two systems that allow you or your doctor to report any unusual side effects to officials at the CDC and elsewhere: \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html\" target=\"_blank\" rel=\"noopener noreferrer\">V-safe\u003c/a> and \u003ca href=\"https://vaers.hhs.gov/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">VAERS\u003c/a>.\u003c/p>\n\u003cp>In the 15 cases confirmed by the CDC in which blood clots developed, it happened within three weeks after receiving the Johnson & Johnson vaccine. If you develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of receiving the vaccine, seek medical treatment with your health care provider or an urgent care clinic or hospital emergency room, and let the provider know you received the Johnson & Johnson vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question4\">\u003c/a>\u003cstrong>Q: But the FDA approved this vaccine after two months of observation; isn’t there a chance a really bad side effect could show up much later?\u003c/strong>\u003c/p>\n\u003cp>According to experts, says Wachter, in the history of vaccines there have been no instances of a serious, worrisome side effect that didn’t show up in the first two months. So while no one is saying it’s impossible for a long-term side effect to emerge later, both Wachter and Bibbins-Domingo say the risk of that is not even close to the risk of contracting COVID-19 and dying or ending up with long-term physical problems.\u003c/p>\n\u003cp>“It’s certainly not a close call, especially when you look at the surge in California, and also when you look at how much we really are still learning about how much the coronavirus affects the body,” said Bibbins-Domingo. “People should talk to their doctors, they should ask questions, but really the balance is in favor of getting this vaccine.”\u003c/p>\n\u003cp>While regulators don’t yet know whether there’s a link between the vaccine and the extremely rare cases of blood clots. \u003cem>If there is\u003c/em>, it could be an example of the kind of thing that only occurs one in a million times. This type of case, then, typically only shows up once the number of vaccinated people rises above one million.\u003c/p>\n\u003cp>Overall, \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/23640658/\" target=\"_blank\" rel=\"noopener noreferrer\">many medications\u003c/a> including birth control pills, carry a higher risk for blood clots. And the risk of developing a blood clot from COVID-19 is \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/33254369/\" target=\"_blank\" rel=\"noopener noreferrer\">50 times higher\u003c/a> than if you get the Johnson and Johnson vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question11\">\u003c/a>\u003cstrong>Q: Why do you need multiple doses for some of the vaccines and how long does your immunity last?\u003c/strong>\u003c/p>\n\u003cp>For the Moderna and Pfizer-BioNTech vaccines, the first dose gives you most of the protection against severe disease, and the second dose takes you all the way there. Plus experts think the second dose may extend how long the vaccine lasts.\u003c/p>\n\u003cp>Fourteen days after your first dose of either vaccine, you are 80% protected on average, says Wachter. In case that makes you think about skipping the second dose, remember that the vaccine trials were two doses, so what we know about how well the vaccine works depends on two doses.\u003c/p>\n\u003cp>Researchers still don’t know exactly how long your immunity will last after receiving both doses. Only a few months of data on the vaccines exist so far. But, says Bibbins-Domingo, there are indications they will provide longer-term immunity.\u003c/p>\n\u003cp>For people who received the Johnson & Johnson single dose vaccine before the FDA halted its use, it becomes more effective after 28 days at preventing severe or critical illness, at 85%; overall protection stays about the same, at 66% after 14 days.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question5\">\u003c/a>\u003cstrong>Q: Do the vaccines give me the coronavirus?\u003c/strong>\u003c/p>\n\u003cp>No. None of the vaccines contain live coronavirus or synthetic coronavirus. \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html\" target=\"_blank\" rel=\"noopener noreferrer\">They train\u003c/a> your immune system to make antibodies against the coronavirus and then disappears. You cannot get COVID-19 from the vaccine. Also, mRNA vaccines do not interact with your DNA because the mRNA does not enter the cell nucleus.\u003c/p>\n\u003cp>The antibodies your immune system creates protect you from the symptoms of COVID-19, especially severe symptoms. It’s important to keep in mind, however, that the time between getting the vaccine and producing these antibodies is \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html\" target=\"_blank\" rel=\"noopener noreferrer\">several weeks\u003c/a>.\u003c/p>\n\u003cp>The mRNA vaccine is the newer technology; Marla Broadfoot, a Ph.D. geneticist who’s also an independent journalist, likes to compare mRNA to scratch paper on which you write a note then throw away when you’re done.\u003c/p>\n\u003cp>“mRNA is a kind of molecular scratch paper that carries these instructions around the cell where they can be used to construct proteins,” she \u003ca href=\"https://healthjournalism.org/blog/2021/02/when-writing-about-sars-cov-2-variants-utilize-metaphors/\" target=\"_blank\" rel=\"noopener noreferrer\">told\u003c/a> the \u003ca href=\"https://healthjournalism.org/\" target=\"_blank\" rel=\"noopener noreferrer\">Association of Health Care Journalists\u003c/a>. “In the case of the COVID-19 vaccines, the mRNA is giving our cells instructions for making the spike protein, a harmless bit of the coronavirus. Our cells recognize the protein as foreign and make antibodies against it and against the virus. In the meantime, the mRNA scratch paper disintegrates.”\u003c/p>\n\u003cp>The Johnson & Johnson vaccine uses a common virus, engineered so it cannot infect you, to prompt your body to make the spike protein and the antibodies against it.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question6\">\u003c/a>\u003cstrong>Q: Do the vaccines work against the variants?\u003c/strong>\u003c/p>\n\u003cp>Yes. You may have heard otherwise, but the important point is that the vaccines are highly effective against the variants in preventing severe disease — that is, preventing hospitalizations and deaths. It’s true the vaccines were less \u003cem>potent \u003c/em>against the variants in lab tests, meaning they generated fewer antibodies. However, the vaccines trigger a range of immune responses in addition to antibodies, and the immune response is so robust that it can lose a good bit of potency and still be effective.\u003c/p>\n\u003cp>Experts think a vaccinated person who contracts a variant of the coronavirus may experience mild or moderate symptoms a little more than they would with the original coronavirus.\u003c/p>\n\u003cp>It’s normal for viruses to mutate, and scientists expected it. The important point is that every infection the vaccines prevent denies the coronavirus a chance to mutate further.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question7\">\u003c/a>\u003cstrong>Q: Can you still get and transmit COVID-19 if you’ve been vaccinated?\u003c/strong>\u003c/p>\n\u003cp>Initial trials tested vaccines on how effective they are at preventing severe disease. These studies did not examine whether the vaccines prevent infection or transmission of that infection.\u003c/p>\n\u003cp>Early evidence suggests that the Pfizer-BioNTech and Moderna vaccines may be able prevent SARS-CoV-2 infection. A \u003ca href=\"https://www.cdc.gov/media/releases/2021/p0329-COVID-19-Vaccines.html\">recent CDC study\u003c/a> with roughly 4,000 participants showed that mRNA vaccines were effective at preventing coronavirus infections in real-world conditions. Results showed that after partial vaccination, the risk of infection was reduced by 80 percent. Two weeks or more following the second dose of the vaccine, the risk of infection was reduced by 90 percent. More research is needed to confirm these results.\u003c/p>\n\u003cp>Bibbins-Domingo says that all indications are that vaccines have the ability to prevent infection, but this is still being studied. The uncertainty about this is why people who’ve had the vaccine are advised to continue to wear masks and socially distance.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question8\">\u003c/a>\u003cstrong>Q: Should you get vaccinated if you’re pregnant or breastfeeding?\u003c/strong>\u003c/p>\n\u003cp>The vaccines were not studied in pregnant and nursing women. Based on the review of the data on how the mRNA vaccines work and on the side effects, says Bibbins-Domingo, medical authorities say pregnant and nursing women should consider getting the vaccine.\u003c/p>\n\u003cp>Pregnant women are at \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html\" target=\"_blank\" rel=\"noopener noreferrer\">higher risk\u003c/a> than other women of having severe illness if they contract COVID-19, according to the CDC, and might be at higher risk of preterm birth or other complications.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.who.int/news-room/feature-stories/detail/the-moderna-covid-19-mrna-1273-vaccine-what-you-need-to-know\" target=\"_blank\" rel=\"noopener noreferrer\">World Health Organization\u003c/a> says women who are at high risk of exposure or who have underlying health conditions may receive the vaccine.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19\" target=\"_blank\" rel=\"noopener noreferrer\">American College of Obstetricians and Gynecologists\u003c/a> and the \u003ca href=\"https://s3.amazonaws.com/cdn.smfm.org/media/2591/SMFM_Vaccine_Statement_12-1-20_(final).pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Society for Maternal-Fetal Medicine \u003c/a>say the vaccine should not be withheld from pregnant women who wish to receive it. Both organizations objected to excluding pregnant and lactating women from the vaccine trials, and they are pressing for future trials to include these groups.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question9\">\u003c/a>\u003cstrong>Q: Were the vaccines tested on racially and ethnically diverse populations? Were they effective for a range of races/ethnicities?\u003c/strong>\u003c/p>\n\u003cp>Yes. And yes.\u003c/p>\n\u003cp>The drug companies gathered demographic information from participants in the study. Both of the vaccine clinical trials included a smaller percentage of Blacks and Asians than in the U.S. population and a roughly similar percentage of Latinos. Here’s where you can find the demographic information for \u003ca href=\"https://www.nejm.org/doi/10.1056/NEJMoa2035389\" target=\"_blank\" rel=\"noopener noreferrer\">Moderna’s\u003c/a> vaccine, and for \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMoa2034577\" target=\"_blank\" rel=\"noopener noreferrer\">Pfizer-BioNTech’s\u003c/a>. And here’s the \u003ca href=\"https://www.census.gov/quickfacts/fact/table/US/PST045219\" target=\"_blank\" rel=\"noopener noreferrer\">U.S. population\u003c/a> from the census as of 2019.\u003c/p>\n\u003cp>The coronavirus has hit certain populations much harder: Black, Latino, Indigenous and lower-income people are suffering high rates of COVID-19 and are among the most important groups to be vaccinated. At the same time, says Bibbins-Domingo, they may have serious questions about the vaccines.\u003c/p>\n\u003cp>“Oftentimes these same communities have very legitimate concerns about trusting government, trusting the medical establishment, trusting science, because of historical instances where, really, there is basis for that mistrust,” said Bibbins-Domingo.”\u003c/p>\n\u003cp>The United States’ history of medical exploitation, especially of minorities, includes incidents like the widely condemned \u003ca href=\"https://www.bbc.co.uk/programmes/p013281q\" target=\"_blank\" rel=\"noopener noreferrer\">Tuskegee experiment\u003c/a> on Black men with syphilis, from 1932-1972, and the forced sterilization of \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449330/\" target=\"_blank\" rel=\"noopener noreferrer\">Latina\u003c/a>, \u003ca href=\"https://ihpi.umich.edu/news/forced-sterilization-policies-us-targeted-minorities-and-those-disabilities-and-lasted-21st\" target=\"_blank\" rel=\"noopener noreferrer\">African American\u003c/a> and \u003ca href=\"https://www.tandfonline.com/doi/abs/10.1080/09612025.2015.1083229?journalCode=rwhr20\" target=\"_blank\" rel=\"noopener noreferrer\">Native American\u003c/a> women as late as the \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449330/\">1970s\u003c/a>.\u003c/p>\n\u003cp>While there are many examples of racist treatment throughout the history of health care, there are also \u003ca href=\"https://www.kqed.org/news/11861322/were-learning-the-wrong-lessons-from-the-tuskegee-experiment\" target=\"_blank\" rel=\"noopener noreferrer\">failures\u003c/a> in America’s current health care system that reinforce structures of racism and drive distrust. And the country’s immigration debate can also show \u003ca href=\"https://www.theatlantic.com/politics/archive/2010/04/why-can-t-i-micro-chip-an-illegal/340979/\" target=\"_blank\" rel=\"noopener noreferrer\">why it’s hard\u003c/a> for people of color to trust government health projects.\u003c/p>\n\u003cp>Bibbins-Domingo encourages people to seek answers to their questions, particularly from doctors or organizations they trust.\u003c/p>\n\u003cp>Bay Area organizations such as \u003ca href=\"https://rootsclinic.org/\" target=\"_blank\" rel=\"noopener noreferrer\">Roots Community Health Center\u003c/a>, \u003ca href=\"https://chaaweb.org/\" target=\"_blank\" rel=\"noopener noreferrer\">Community Health for Asian Americans\u003c/a>, \u003ca href=\"https://thelatinacenter.org/\" target=\"_blank\" rel=\"noopener noreferrer\">The Latina Center\u003c/a>, and the \u003ca href=\"https://www.nativehealth.org/\" target=\"_blank\" rel=\"noopener noreferrer\">Native American Health Center\u003c/a> serve their communities and understand the historical factors and current struggles that influence perceptions of the health care system.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question11\">\u003c/a>\u003cstrong>Q: What are the differences between the vaccines? Is one better than the others?\u003c/strong>\u003c/p>\n\u003cp>The Pfizer-BioNTech and Moderna vaccines are essentially the same; they are both mRNA vaccines, with the same side effects and the same effectiveness. The way they prompt your immune system to respond and make antibodies is the same. The main difference is which fat globule they use to get the mRNA into the cell. Both require two doses.\u003c/p>\n\u003cp>The Johnson & Johnson vaccine uses a different delivery system involving \u003ca href=\"https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html\" target=\"_blank\" rel=\"noopener noreferrer\">a disabled adenovirus\u003c/a> to trigger your immune system to make antibodies against the coronavirus. It requires only on shot. Its use was halted on April 13, 2021, as the CDC and FDA review 6 cases of women who developed blood clots within a couple of weeks of receiving the vaccine.\u003c/p>\n\u003cp>\u003ca href=\"https://www.sccgov.org/sites/covid19/Pages/press-release-03-15-2021-Bay-Area-health-officers-statement-COVID19-vaccine.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">A joint statement\u003c/a> signed by all of the Bay Area’s health officers in March noted that the vaccines are “100 percent effective in preventing deaths from COVID-19. Our collective medical advice is this: the best vaccine is the one you can get the soonest.”\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question12\">\u003c/a>\u003cstrong>Q: Are the vaccines safe for all ages? When will children be eligible?\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cp>Pfizer-BioNTech’s vaccine was tested and found safe for ages 16 and up. The Moderna vaccine was authorized for ages 18 and up. Before the FDA halted its use, the Johnson & Johnson vaccine was authorized for ages 18 and up.\u003c/p>\n\u003cp>Drug companies have to test the vaccine in an age group before they can show it’s safe for those ages. Pfizer-BioNTech and Moderna are currently testing the vaccine in both young children and adolescents.\u003c/p>\n\u003cp>Pfizer-BioNTech recently announced \u003ca href=\"https://www.businesswire.com/news/home/20210331005503/en/\" target=\"_blank\" rel=\"noopener noreferrer\">results of a Phase 3 clinical trial\u003c/a> that showed the vaccine was effective and well-tolerated in adolescents aged 12-15. However, the vaccine has not yet been authorized by the FDA for use in adolescents.\u003c/p>\n\u003cp>\u003ca href=\"https://www.scientificamerican.com/article/when-will-kids-get-covid-vaccines/\" target=\"_blank\" rel=\"noopener noreferrer\">Some health experts\u003c/a> say vaccines could be authorized for adolescents this summer and for young children in early 2022.\u003c/p>\n\u003cp>For people 65 and older, the risk from COVID-19 is much higher than the risk of the vaccine. Very elderly and frail people with underlying health conditions should be evaluated before receiving the vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question13\">\u003c/a>\u003cstrong>Q: Why should people in their 20s and 30s get vaccinated?\u003c/strong>\u003c/p>\n\u003cp>While young people are less likely to get really sick from COVID-19, they can still get and spread the virus. Also, many young people are in contact with parents, grandparents and others who are older and more at risk. Finally, while the likelihood of a young person getting a serious case requiring hospitalization is lower, some have become seriously ill or died.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question14\">\u003c/a>\u003cstrong>Q: Should I get vaccinated if I already had COVID-19? And how long should I wait after I’ve had COVID-19 to get it?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html\" target=\"_blank\" rel=\"noopener noreferrer\">Yes.\u003c/a> The level of protection you receive from the vaccine is higher than what you get from having had COVID-19.\u003c/p>\n\u003cp>According to the \u003ca href=\"https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html\" target=\"_blank\" rel=\"noopener noreferrer\">CDC\u003c/a>, once you’ve recovered and completed your isolation requirements, you can get the vaccine. However, the \u003ca href=\"https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html\" target=\"_blank\" rel=\"noopener noreferrer\">CDC says\u003c/a> people who were treated for COVID-19 with monoclonal antibodies or convalescent plasma should wait 90 days before getting the vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question15\">\u003c/a>\u003cstrong>Q: If I’m vaccinated, can I stop wearing a mask and get close to people again?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html\" target=\"_blank\" rel=\"noopener noreferrer\">No\u003c/a>. Even if you’re vaccinated, you can still get and transmit the disease. Remember, the trials only thoroughly tested how well the vaccine protects against the symptoms of COVID-19. Researchers are still studying whether the vaccine prevents infection and transmission.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question16\">\u003c/a>\u003cstrong>Q: I am immunosuppressed; should I still get the vaccine?\u003c/strong>\u003c/p>\n\u003cp>Immunocompromised people are at a higher risk for severe COVID-19. While there is no data on mRNA vaccines in people who are immunocompromised, the \u003ca href=\"https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html\" target=\"_blank\" rel=\"noopener noreferrer\">CDC\u003c/a> does not recommend against it, but does recommend people be counseled.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question17\">\u003c/a>\u003cstrong>Q: Do the COVID-19 vaccines cause infertility?\u003c/strong>\u003c/p>\n\u003cp>No. There’s \u003ca href=\"https://www.nytimes.com/2020/12/10/technology/pfizer-vaccine-infertility-disinformation.html\" target=\"_blank\" rel=\"noopener noreferrer\">no evidence\u003c/a> that COVID-19 vaccines cause infertility. In early December, an internet post spread a false rumor about this, but it was proven \u003ca href=\"https://www.politifact.com/factchecks/2020/dec/10/blog-posting/no-pfizers-head-research-didnt-say-covid-19-vaccin/\" target=\"_blank\" rel=\"noopener noreferrer\">to be untrue\u003c/a>.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question18\">\u003c/a>\u003cstrong>Q: Does the vaccine allow any authority to track me?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://www.reuters.com/article/uk-factcheck-microchip-not-injected-covi/fact-check-covid-19-vaccine-labels-would-not-microchip-or-track-individuals-but-serve-logistical-purpose-idUSKBN28O1TM\" target=\"_blank\" rel=\"noopener noreferrer\">No\u003c/a>. There is a microchip on the syringe’s label (not inside the actual vaccine) that tracks the vaccine’s expiration date and whether it has been used. It does not track who receives the vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question19\">\u003c/a>\u003cstrong>Q: How do I get the vaccine?\u003c/strong>\u003c/p>\n\u003cp>See KQED’s “\u003ca href=\"https://www.kqed.org/news/11855623/where-can-i-get-a-covid-19-vaccine-in-the-bay-area-your-questions-answered\" target=\"_blank\" rel=\"noopener noreferrer\">Where Can I Get a COVID-19 Vaccine in the Bay Area? \u003c/a>” post.\u003c/p>\n\u003cp>California’s \u003ca href=\"https://myturn.ca.gov/\" target=\"_blank\" rel=\"noopener noreferrer\">MyTurn\u003c/a> website will tell you if you’re eligible for the vaccine and when appointments are available. If you’re not eligible, you can register to receive a notification when you become eligible.\u003c/p>\n\u003cp>\u003cstrong>*If you are wondering whether you should get a vaccine, contact your health provider.\u003c/strong>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n",
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"excerpt": "Answers to some of the most frequently asked questions health experts are hearing.",
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"title": "Your COVID-19 Vaccine Questions, From Side Effects to Safety | KQED",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cem>Updated April 26, 2021, 5:53 p.m.\u003c/em>\u003c/p>\n\u003cp>On Friday, the Centers for Disease Control and Prevention and the Food and Drug Administration \u003ca href=\"https://www.kqed.org/news/11870973/cdc-vaccine-committee-votes-to-recommend-jj-vaccine-use-again\" target=\"_blank\" rel=\"noopener noreferrer\">lifted a 10-day pause\u003c/a> of Johnson & Johnson’s coronavirus vaccine. Bay Area counties followed suit, announcing they would resume using the single-dose shot.\u003c/p>\n\u003cp>Federal officials\u003ca href=\"https://www.nytimes.com/live/2021/04/13/world/johnson-vaccine-blood-clots\" target=\"_blank\" rel=\"noopener noreferrer\"> halted\u003c/a> the use of the Johnson & Johnson vaccine on April 13 “out of an abundance of caution” after a rare type of \u003ca href=\"https://www.scientificamerican.com/article/blood-clots-and-the-johnson-johnson-vaccine-what-we-know-so-far/\" target=\"_blank\" rel=\"noopener noreferrer\">blood clot\u003c/a> showed up in 6 women within about two weeks of receiving the vaccination.\u003c/p>\n\u003cp>“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work — identifying even these small number of cases,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement. “We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts.”\u003c/p>\n\u003cp>On Friday, the CDC updated the total to 15 women, ages 18 to 59, who experienced a combination of rare blood clots and low platelets between 6 and 15 days after vaccination. Over the weekend, UCSF announced that it was treating a male patient in his 30s for the condition, which is known as vaccine-induced thrombotic thrombocytopenia (VITT).\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>In the U.S., roughly eight million people have received the Johnson & Johnson vaccine.\u003c/p>\n\u003cp>“The relative risk is really, really low for these severe blood clots,” said Dr. Catherine Blish, infectious disease specialist at Stanford Medicine. If you develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of receiving the vaccine, seek medical treatment with your health care provider or an urgent care clinic or hospital emergency room, and let the provider know you received the Johnson & Johnson vaccine.\u003c/p>\n\u003cp>The CDC said in a statement earlier this month that one purpose of the pause was to let health care providers know what to do. The usual treatment for blood clots, a blood-thinning medication called heparin, can be dangerous used for this type of clot, and the CDC is alerting health providers to be prepared to offer alternate treatments.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>We’ve searched for and compiled answers to some of the most frequently asked questions about the vaccine. Our answers come from a \u003ca href=\"https://www.exploratorium.edu/visit/calendar/after-dark-online-covid-catchup?utm_source=Twitter&utm_medium=Social&UTM_campaign=FY21AfterDark\" target=\"_blank\" rel=\"noopener noreferrer\">live Q&A\u003c/a> with the \u003ca href=\"https://www.exploratorium.edu/\" target=\"_blank\" rel=\"noopener noreferrer\">Exploratorium\u003c/a> featuring Dr. Bob Wachter, chair of the UCSF Department of Medicine, and Dr. Kirsten Bibbins-Domingo, chair of the UCSF Department of Epidemiology and Biostatistics. We also consulted the Centers for Disease Control and Prevention, the Food and Drug Administration, the World Health Organization and various other medical associations and journal articles. For those of you who want to dig deeper, we’ve linked to some of those.\u003cbr>\n\u003ca id=\"backtotop\">\u003c/a>\u003cbr>\n\u003cstrong>Jump to a question:\u003c/strong>\u003c/p>\n\u003cul>\n\u003cli>\u003ca href=\"#question1\">How were the vaccines developed so quickly?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question2\">How do people know the vaccines are safe and effective?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question3\">What are the possible side effects of getting a vaccine?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question4\">But the FDA approved this vaccine after two months of observation; isn’t there a chance a really bad side effect could show up much later?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question11\">Why do you need multiple doses and how long does your immunity last?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question5\">Do the vaccines give me the virus?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question6\">Do the vaccines work against the variants?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question7\">Can you still get and transmit COVID-19 if you’ve been vaccinated?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question8\">Should you get vaccinated if you’re pregnant or breastfeeding?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question9\">Were the vaccines tested on racially and ethnically diverse populations? Were they effective for a range of races/ethnicities?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question10\">What are the differences between the vaccines? Is one better than the others?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question12\">Are the vaccines safe for all ages? When will children be eligible?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question13\">Why should people in their 20s and 30s get vaccinated?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question14\">Should I get vaccinated if I already had COVID-19? And how long should I wait after I’ve had COVID-19 to get it?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question15\">If I’m vaccinated, can I stop wearing a mask and get close to people again?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question16\">I am immunosuppressed, should I still get the vaccine?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question17\">Do the COVID-19 vaccines cause infertility?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question18\">Does the vaccine allow any authority to track me?\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"#question19\">How do I get the vaccine?\u003c/a>\u003c/li>\n\u003c/ul>\n\u003cp>\u003ca id=\"question1\">\u003c/a>\u003cstrong>Q: How were the vaccines developed so quickly?\u003c/strong>\u003c/p>\n\u003cp>U.S. government agencies and private companies collaborated on a project called \u003ca href=\"https://www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/\" target=\"_blank\" rel=\"noopener noreferrer\">Operation Warp Speed\u003c/a> to fast-track the coronavirus vaccine. This accelerated timeline doesn’t mean any steps were skipped in the testing stages for the vaccines. The shortcuts related to funding and to dialogue and planning, which went quickly since everyone had the same goal.\u003c/p>\n\u003cp>Normally, companies hesitate to manufacture a vaccine until they’re in the FDA approval process. It’s a big risk to invest a lot of money in manufacturing without knowing whether the vaccine will be approved. But under Operation Warp Speed, governments pre-paid for the vaccines to eliminate the financial risk for the companies involved. This allowed them to manufacture the vaccine at the same time they were doing the testing. So when the testing was complete, a lot of doses were already available to distribute.\u003c/p>\n\u003cp>Another reason for how quickly these vaccines were developed is that the processes used for making the vaccines aren’t new. mRNA had already been studied for years, and and was being developed for other infectious diseases. Because of this, researchers already knew how to make an mRNA vaccine and could customize development and testing for SARS-CoV-2. Adenovirus vaccines, the method used by Johnson & Johnson, are common.\u003c/p>\n\u003cp>The FDA authorized the emergency use of the Johnson & Johnson vaccine in February.\u003c/p>\n\u003cp>“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for theauthorization of a vaccine for emergency use,” Peter Marks, M.D., Ph.D. and director of the FDA’s Center for Biologics Evaluation and Research said at the time.\u003c/p>\n\u003cp>The FDA paused the use of the Johnson & Johnson vaccine on April 13 to investigate 6 cases in which a rare blood clot developed, out of the roughly 7 million people who’d received the vaccine in the U.S. to that point. Medical experts say that the risk of developing a blood clot from COVID-19 is \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/33254369/\" target=\"_blank\" rel=\"noopener noreferrer\">50 times higher\u003c/a>.\u003c/p>\n\u003cp>The halt on Johnson & Johnson’s Janssen coronavirus vaccine was lifted 10 days later on April 23 after a review of the initial six cases and 9 additional cases by the FDA and CDC.\u003c/p>\n\u003cp>“We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement. “We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider.”\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003ca id=\"question2\">\u003c/a>\u003cstrong>Q: How do people know the vaccines are safe and effective?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine\" target=\"_blank\" rel=\"noopener noreferrer\">Pfizer\u003c/a>, \u003ca href=\"https://www.modernatx.com/sites/default/files/content_documents/mRNA-1273-Update-11-16-20-Final.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Moderna\u003c/a> and \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine\" target=\"_blank\" rel=\"noopener noreferrer\">Johnson & Johnson\u003c/a> conducted full trials and \u003ca href=\"https://www.fda.gov/media/143890/download\" target=\"_blank\" rel=\"noopener noreferrer\">didn’t skip any steps\u003c/a> in the stages of testing for the vaccines’ safety and efficacy. The \u003ca href=\"https://media.defense.gov/2020/Aug/13/2002476369/-1/-1/0/200813-D-ZZ999-100.JPG\" target=\"_blank\" rel=\"noopener noreferrer\">stages\u003c/a> included testing in animals and an application for FDA approval to test in humans. Then the drug companies tested the vaccine in a small number of individuals before conducting tests in tens of thousands of people.\u003c/p>\n\u003cp>The only part of this process that was shorter than usual was in how long drug companies observed people for long-term side effects before requesting FDA authorization to distribute the vaccine.\u003c/p>\n\u003cp>“They would normally wait, let’s say, six months after testing of the vaccine,” Wachter said. “They waited two months, and why? Because this was an absolute emergency and a catastrophe. And so in waiting extra months, there would have been hundreds of thousands of people that would have died.”\u003c/p>\n\u003cp>The FDA recently resumed the rollout of the Johnson & Johnson vaccine after a short pause to investigate incidents of a rare blood clot showing up in a small percentage of people in the U.S. who received this vaccine.\u003c/p>\n\u003cp>Experts say a pause like this is normal when a new medication or vaccine becomes available to the public, and does not indicate that the Johnson & Johnson vaccine is dangerous.\u003c/p>\n\u003cp>“The relative risk is really, really low for these severe blood clots,” said Dr. Catherine Blish, infectious disease specialist at Stanford Medicine after the initial reports. “So we’ve had the six cases out of almost seven million vaccines delivered, which is about one in a million. And while this has been hugely controversial, the birth control pills are associated with about one in 1000-100 rate of blood clots.”\u003c/p>\n\u003cp>The FDA was asking for a minimum of 50% efficacy against the coronavirus. After two doses, Pfizer-BioNTech’s vaccine is 95% effective at preventing the symptoms of COVID-19 and Moderna’s is a little over 94%.\u003c/p>\n\u003cp>Johnson & Johnson’s vaccine is about 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.\u003c/p>\n\u003cp>Those results and the safety records are why the FDA \u003ca href=\"https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained#:~:text=An%20Emergency%20Use%20Authorization%20(EUA)%20is%20a%20mechanism%20to%20facilitate,the%20current%20COVID%2D19%20pandemic.\" target=\"_blank\" rel=\"noopener noreferrer\">authorized\u003c/a> the emergency use of these vaccines.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question3\">\u003c/a>\u003cstrong>Q: What are the possible side effects of getting a vaccine?\u003c/strong>\u003c/p>\n\u003cp>The possible short-term side effects for all the vaccines include pain, swelling and redness at the injection site, as well as tiredness, chills and headaches. If you get side effects, they would typically start within a day or two of injection and last a few days. The side effects, experts note, are your immune system telling you the vaccine is working and your body is creating antibodies.\u003c/p>\n\u003cp>If you find yourself experiencing these side effects, consult your doctor before taking over-the-counter medication such as ibuprofen, aspirin, antihistamines or acetaminophen. Also, don’t take these medications before you get the vaccine.\u003c/p>\n\u003cp>The CDC reports that a December study found that a small fraction of people — 11.1 recipients per million doses administered — had a severe allergic reaction called anaphylaxis, which can be lethal. The CDC has listed a few allergies that could \u003ca href=\"https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html\" target=\"_blank\" rel=\"noopener noreferrer\">prevent\u003c/a> someone from getting the vaccine. The agency also recommends people get screened for allergies before receiving the vaccine, and that vaccine sites have epinephrine injections available. If you have allergies, you may wish to consult your doctor about the vaccine.\u003c/p>\n\u003cp>There are two systems that allow you or your doctor to report any unusual side effects to officials at the CDC and elsewhere: \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html\" target=\"_blank\" rel=\"noopener noreferrer\">V-safe\u003c/a> and \u003ca href=\"https://vaers.hhs.gov/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">VAERS\u003c/a>.\u003c/p>\n\u003cp>In the 15 cases confirmed by the CDC in which blood clots developed, it happened within three weeks after receiving the Johnson & Johnson vaccine. If you develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of receiving the vaccine, seek medical treatment with your health care provider or an urgent care clinic or hospital emergency room, and let the provider know you received the Johnson & Johnson vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question4\">\u003c/a>\u003cstrong>Q: But the FDA approved this vaccine after two months of observation; isn’t there a chance a really bad side effect could show up much later?\u003c/strong>\u003c/p>\n\u003cp>According to experts, says Wachter, in the history of vaccines there have been no instances of a serious, worrisome side effect that didn’t show up in the first two months. So while no one is saying it’s impossible for a long-term side effect to emerge later, both Wachter and Bibbins-Domingo say the risk of that is not even close to the risk of contracting COVID-19 and dying or ending up with long-term physical problems.\u003c/p>\n\u003cp>“It’s certainly not a close call, especially when you look at the surge in California, and also when you look at how much we really are still learning about how much the coronavirus affects the body,” said Bibbins-Domingo. “People should talk to their doctors, they should ask questions, but really the balance is in favor of getting this vaccine.”\u003c/p>\n\u003cp>While regulators don’t yet know whether there’s a link between the vaccine and the extremely rare cases of blood clots. \u003cem>If there is\u003c/em>, it could be an example of the kind of thing that only occurs one in a million times. This type of case, then, typically only shows up once the number of vaccinated people rises above one million.\u003c/p>\n\u003cp>Overall, \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/23640658/\" target=\"_blank\" rel=\"noopener noreferrer\">many medications\u003c/a> including birth control pills, carry a higher risk for blood clots. And the risk of developing a blood clot from COVID-19 is \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/33254369/\" target=\"_blank\" rel=\"noopener noreferrer\">50 times higher\u003c/a> than if you get the Johnson and Johnson vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question11\">\u003c/a>\u003cstrong>Q: Why do you need multiple doses for some of the vaccines and how long does your immunity last?\u003c/strong>\u003c/p>\n\u003cp>For the Moderna and Pfizer-BioNTech vaccines, the first dose gives you most of the protection against severe disease, and the second dose takes you all the way there. Plus experts think the second dose may extend how long the vaccine lasts.\u003c/p>\n\u003cp>Fourteen days after your first dose of either vaccine, you are 80% protected on average, says Wachter. In case that makes you think about skipping the second dose, remember that the vaccine trials were two doses, so what we know about how well the vaccine works depends on two doses.\u003c/p>\n\u003cp>Researchers still don’t know exactly how long your immunity will last after receiving both doses. Only a few months of data on the vaccines exist so far. But, says Bibbins-Domingo, there are indications they will provide longer-term immunity.\u003c/p>\n\u003cp>For people who received the Johnson & Johnson single dose vaccine before the FDA halted its use, it becomes more effective after 28 days at preventing severe or critical illness, at 85%; overall protection stays about the same, at 66% after 14 days.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question5\">\u003c/a>\u003cstrong>Q: Do the vaccines give me the coronavirus?\u003c/strong>\u003c/p>\n\u003cp>No. None of the vaccines contain live coronavirus or synthetic coronavirus. \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html\" target=\"_blank\" rel=\"noopener noreferrer\">They train\u003c/a> your immune system to make antibodies against the coronavirus and then disappears. You cannot get COVID-19 from the vaccine. Also, mRNA vaccines do not interact with your DNA because the mRNA does not enter the cell nucleus.\u003c/p>\n\u003cp>The antibodies your immune system creates protect you from the symptoms of COVID-19, especially severe symptoms. It’s important to keep in mind, however, that the time between getting the vaccine and producing these antibodies is \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html\" target=\"_blank\" rel=\"noopener noreferrer\">several weeks\u003c/a>.\u003c/p>\n\u003cp>The mRNA vaccine is the newer technology; Marla Broadfoot, a Ph.D. geneticist who’s also an independent journalist, likes to compare mRNA to scratch paper on which you write a note then throw away when you’re done.\u003c/p>\n\u003cp>“mRNA is a kind of molecular scratch paper that carries these instructions around the cell where they can be used to construct proteins,” she \u003ca href=\"https://healthjournalism.org/blog/2021/02/when-writing-about-sars-cov-2-variants-utilize-metaphors/\" target=\"_blank\" rel=\"noopener noreferrer\">told\u003c/a> the \u003ca href=\"https://healthjournalism.org/\" target=\"_blank\" rel=\"noopener noreferrer\">Association of Health Care Journalists\u003c/a>. “In the case of the COVID-19 vaccines, the mRNA is giving our cells instructions for making the spike protein, a harmless bit of the coronavirus. Our cells recognize the protein as foreign and make antibodies against it and against the virus. In the meantime, the mRNA scratch paper disintegrates.”\u003c/p>\n\u003cp>The Johnson & Johnson vaccine uses a common virus, engineered so it cannot infect you, to prompt your body to make the spike protein and the antibodies against it.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question6\">\u003c/a>\u003cstrong>Q: Do the vaccines work against the variants?\u003c/strong>\u003c/p>\n\u003cp>Yes. You may have heard otherwise, but the important point is that the vaccines are highly effective against the variants in preventing severe disease — that is, preventing hospitalizations and deaths. It’s true the vaccines were less \u003cem>potent \u003c/em>against the variants in lab tests, meaning they generated fewer antibodies. However, the vaccines trigger a range of immune responses in addition to antibodies, and the immune response is so robust that it can lose a good bit of potency and still be effective.\u003c/p>\n\u003cp>Experts think a vaccinated person who contracts a variant of the coronavirus may experience mild or moderate symptoms a little more than they would with the original coronavirus.\u003c/p>\n\u003cp>It’s normal for viruses to mutate, and scientists expected it. The important point is that every infection the vaccines prevent denies the coronavirus a chance to mutate further.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question7\">\u003c/a>\u003cstrong>Q: Can you still get and transmit COVID-19 if you’ve been vaccinated?\u003c/strong>\u003c/p>\n\u003cp>Initial trials tested vaccines on how effective they are at preventing severe disease. These studies did not examine whether the vaccines prevent infection or transmission of that infection.\u003c/p>\n\u003cp>Early evidence suggests that the Pfizer-BioNTech and Moderna vaccines may be able prevent SARS-CoV-2 infection. A \u003ca href=\"https://www.cdc.gov/media/releases/2021/p0329-COVID-19-Vaccines.html\">recent CDC study\u003c/a> with roughly 4,000 participants showed that mRNA vaccines were effective at preventing coronavirus infections in real-world conditions. Results showed that after partial vaccination, the risk of infection was reduced by 80 percent. Two weeks or more following the second dose of the vaccine, the risk of infection was reduced by 90 percent. More research is needed to confirm these results.\u003c/p>\n\u003cp>Bibbins-Domingo says that all indications are that vaccines have the ability to prevent infection, but this is still being studied. The uncertainty about this is why people who’ve had the vaccine are advised to continue to wear masks and socially distance.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question8\">\u003c/a>\u003cstrong>Q: Should you get vaccinated if you’re pregnant or breastfeeding?\u003c/strong>\u003c/p>\n\u003cp>The vaccines were not studied in pregnant and nursing women. Based on the review of the data on how the mRNA vaccines work and on the side effects, says Bibbins-Domingo, medical authorities say pregnant and nursing women should consider getting the vaccine.\u003c/p>\n\u003cp>Pregnant women are at \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html\" target=\"_blank\" rel=\"noopener noreferrer\">higher risk\u003c/a> than other women of having severe illness if they contract COVID-19, according to the CDC, and might be at higher risk of preterm birth or other complications.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.who.int/news-room/feature-stories/detail/the-moderna-covid-19-mrna-1273-vaccine-what-you-need-to-know\" target=\"_blank\" rel=\"noopener noreferrer\">World Health Organization\u003c/a> says women who are at high risk of exposure or who have underlying health conditions may receive the vaccine.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19\" target=\"_blank\" rel=\"noopener noreferrer\">American College of Obstetricians and Gynecologists\u003c/a> and the \u003ca href=\"https://s3.amazonaws.com/cdn.smfm.org/media/2591/SMFM_Vaccine_Statement_12-1-20_(final).pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Society for Maternal-Fetal Medicine \u003c/a>say the vaccine should not be withheld from pregnant women who wish to receive it. Both organizations objected to excluding pregnant and lactating women from the vaccine trials, and they are pressing for future trials to include these groups.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question9\">\u003c/a>\u003cstrong>Q: Were the vaccines tested on racially and ethnically diverse populations? Were they effective for a range of races/ethnicities?\u003c/strong>\u003c/p>\n\u003cp>Yes. And yes.\u003c/p>\n\u003cp>The drug companies gathered demographic information from participants in the study. Both of the vaccine clinical trials included a smaller percentage of Blacks and Asians than in the U.S. population and a roughly similar percentage of Latinos. Here’s where you can find the demographic information for \u003ca href=\"https://www.nejm.org/doi/10.1056/NEJMoa2035389\" target=\"_blank\" rel=\"noopener noreferrer\">Moderna’s\u003c/a> vaccine, and for \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMoa2034577\" target=\"_blank\" rel=\"noopener noreferrer\">Pfizer-BioNTech’s\u003c/a>. And here’s the \u003ca href=\"https://www.census.gov/quickfacts/fact/table/US/PST045219\" target=\"_blank\" rel=\"noopener noreferrer\">U.S. population\u003c/a> from the census as of 2019.\u003c/p>\n\u003cp>The coronavirus has hit certain populations much harder: Black, Latino, Indigenous and lower-income people are suffering high rates of COVID-19 and are among the most important groups to be vaccinated. At the same time, says Bibbins-Domingo, they may have serious questions about the vaccines.\u003c/p>\n\u003cp>“Oftentimes these same communities have very legitimate concerns about trusting government, trusting the medical establishment, trusting science, because of historical instances where, really, there is basis for that mistrust,” said Bibbins-Domingo.”\u003c/p>\n\u003cp>The United States’ history of medical exploitation, especially of minorities, includes incidents like the widely condemned \u003ca href=\"https://www.bbc.co.uk/programmes/p013281q\" target=\"_blank\" rel=\"noopener noreferrer\">Tuskegee experiment\u003c/a> on Black men with syphilis, from 1932-1972, and the forced sterilization of \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449330/\" target=\"_blank\" rel=\"noopener noreferrer\">Latina\u003c/a>, \u003ca href=\"https://ihpi.umich.edu/news/forced-sterilization-policies-us-targeted-minorities-and-those-disabilities-and-lasted-21st\" target=\"_blank\" rel=\"noopener noreferrer\">African American\u003c/a> and \u003ca href=\"https://www.tandfonline.com/doi/abs/10.1080/09612025.2015.1083229?journalCode=rwhr20\" target=\"_blank\" rel=\"noopener noreferrer\">Native American\u003c/a> women as late as the \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449330/\">1970s\u003c/a>.\u003c/p>\n\u003cp>While there are many examples of racist treatment throughout the history of health care, there are also \u003ca href=\"https://www.kqed.org/news/11861322/were-learning-the-wrong-lessons-from-the-tuskegee-experiment\" target=\"_blank\" rel=\"noopener noreferrer\">failures\u003c/a> in America’s current health care system that reinforce structures of racism and drive distrust. And the country’s immigration debate can also show \u003ca href=\"https://www.theatlantic.com/politics/archive/2010/04/why-can-t-i-micro-chip-an-illegal/340979/\" target=\"_blank\" rel=\"noopener noreferrer\">why it’s hard\u003c/a> for people of color to trust government health projects.\u003c/p>\n\u003cp>Bibbins-Domingo encourages people to seek answers to their questions, particularly from doctors or organizations they trust.\u003c/p>\n\u003cp>Bay Area organizations such as \u003ca href=\"https://rootsclinic.org/\" target=\"_blank\" rel=\"noopener noreferrer\">Roots Community Health Center\u003c/a>, \u003ca href=\"https://chaaweb.org/\" target=\"_blank\" rel=\"noopener noreferrer\">Community Health for Asian Americans\u003c/a>, \u003ca href=\"https://thelatinacenter.org/\" target=\"_blank\" rel=\"noopener noreferrer\">The Latina Center\u003c/a>, and the \u003ca href=\"https://www.nativehealth.org/\" target=\"_blank\" rel=\"noopener noreferrer\">Native American Health Center\u003c/a> serve their communities and understand the historical factors and current struggles that influence perceptions of the health care system.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question11\">\u003c/a>\u003cstrong>Q: What are the differences between the vaccines? Is one better than the others?\u003c/strong>\u003c/p>\n\u003cp>The Pfizer-BioNTech and Moderna vaccines are essentially the same; they are both mRNA vaccines, with the same side effects and the same effectiveness. The way they prompt your immune system to respond and make antibodies is the same. The main difference is which fat globule they use to get the mRNA into the cell. Both require two doses.\u003c/p>\n\u003cp>The Johnson & Johnson vaccine uses a different delivery system involving \u003ca href=\"https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html\" target=\"_blank\" rel=\"noopener noreferrer\">a disabled adenovirus\u003c/a> to trigger your immune system to make antibodies against the coronavirus. It requires only on shot. Its use was halted on April 13, 2021, as the CDC and FDA review 6 cases of women who developed blood clots within a couple of weeks of receiving the vaccine.\u003c/p>\n\u003cp>\u003ca href=\"https://www.sccgov.org/sites/covid19/Pages/press-release-03-15-2021-Bay-Area-health-officers-statement-COVID19-vaccine.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">A joint statement\u003c/a> signed by all of the Bay Area’s health officers in March noted that the vaccines are “100 percent effective in preventing deaths from COVID-19. Our collective medical advice is this: the best vaccine is the one you can get the soonest.”\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question12\">\u003c/a>\u003cstrong>Q: Are the vaccines safe for all ages? When will children be eligible?\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cp>Pfizer-BioNTech’s vaccine was tested and found safe for ages 16 and up. The Moderna vaccine was authorized for ages 18 and up. Before the FDA halted its use, the Johnson & Johnson vaccine was authorized for ages 18 and up.\u003c/p>\n\u003cp>Drug companies have to test the vaccine in an age group before they can show it’s safe for those ages. Pfizer-BioNTech and Moderna are currently testing the vaccine in both young children and adolescents.\u003c/p>\n\u003cp>Pfizer-BioNTech recently announced \u003ca href=\"https://www.businesswire.com/news/home/20210331005503/en/\" target=\"_blank\" rel=\"noopener noreferrer\">results of a Phase 3 clinical trial\u003c/a> that showed the vaccine was effective and well-tolerated in adolescents aged 12-15. However, the vaccine has not yet been authorized by the FDA for use in adolescents.\u003c/p>\n\u003cp>\u003ca href=\"https://www.scientificamerican.com/article/when-will-kids-get-covid-vaccines/\" target=\"_blank\" rel=\"noopener noreferrer\">Some health experts\u003c/a> say vaccines could be authorized for adolescents this summer and for young children in early 2022.\u003c/p>\n\u003cp>For people 65 and older, the risk from COVID-19 is much higher than the risk of the vaccine. Very elderly and frail people with underlying health conditions should be evaluated before receiving the vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question13\">\u003c/a>\u003cstrong>Q: Why should people in their 20s and 30s get vaccinated?\u003c/strong>\u003c/p>\n\u003cp>While young people are less likely to get really sick from COVID-19, they can still get and spread the virus. Also, many young people are in contact with parents, grandparents and others who are older and more at risk. Finally, while the likelihood of a young person getting a serious case requiring hospitalization is lower, some have become seriously ill or died.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question14\">\u003c/a>\u003cstrong>Q: Should I get vaccinated if I already had COVID-19? And how long should I wait after I’ve had COVID-19 to get it?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html\" target=\"_blank\" rel=\"noopener noreferrer\">Yes.\u003c/a> The level of protection you receive from the vaccine is higher than what you get from having had COVID-19.\u003c/p>\n\u003cp>According to the \u003ca href=\"https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html\" target=\"_blank\" rel=\"noopener noreferrer\">CDC\u003c/a>, once you’ve recovered and completed your isolation requirements, you can get the vaccine. However, the \u003ca href=\"https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html\" target=\"_blank\" rel=\"noopener noreferrer\">CDC says\u003c/a> people who were treated for COVID-19 with monoclonal antibodies or convalescent plasma should wait 90 days before getting the vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question15\">\u003c/a>\u003cstrong>Q: If I’m vaccinated, can I stop wearing a mask and get close to people again?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html\" target=\"_blank\" rel=\"noopener noreferrer\">No\u003c/a>. Even if you’re vaccinated, you can still get and transmit the disease. Remember, the trials only thoroughly tested how well the vaccine protects against the symptoms of COVID-19. Researchers are still studying whether the vaccine prevents infection and transmission.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question16\">\u003c/a>\u003cstrong>Q: I am immunosuppressed; should I still get the vaccine?\u003c/strong>\u003c/p>\n\u003cp>Immunocompromised people are at a higher risk for severe COVID-19. While there is no data on mRNA vaccines in people who are immunocompromised, the \u003ca href=\"https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html\" target=\"_blank\" rel=\"noopener noreferrer\">CDC\u003c/a> does not recommend against it, but does recommend people be counseled.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question17\">\u003c/a>\u003cstrong>Q: Do the COVID-19 vaccines cause infertility?\u003c/strong>\u003c/p>\n\u003cp>No. There’s \u003ca href=\"https://www.nytimes.com/2020/12/10/technology/pfizer-vaccine-infertility-disinformation.html\" target=\"_blank\" rel=\"noopener noreferrer\">no evidence\u003c/a> that COVID-19 vaccines cause infertility. In early December, an internet post spread a false rumor about this, but it was proven \u003ca href=\"https://www.politifact.com/factchecks/2020/dec/10/blog-posting/no-pfizers-head-research-didnt-say-covid-19-vaccin/\" target=\"_blank\" rel=\"noopener noreferrer\">to be untrue\u003c/a>.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question18\">\u003c/a>\u003cstrong>Q: Does the vaccine allow any authority to track me?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://www.reuters.com/article/uk-factcheck-microchip-not-injected-covi/fact-check-covid-19-vaccine-labels-would-not-microchip-or-track-individuals-but-serve-logistical-purpose-idUSKBN28O1TM\" target=\"_blank\" rel=\"noopener noreferrer\">No\u003c/a>. There is a microchip on the syringe’s label (not inside the actual vaccine) that tracks the vaccine’s expiration date and whether it has been used. It does not track who receives the vaccine.\u003c/p>\n\u003cp>\u003ca href=\"#backtotop\">Back to top\u003c/a>\u003c/p>\n\u003cp>\u003ca id=\"question19\">\u003c/a>\u003cstrong>Q: How do I get the vaccine?\u003c/strong>\u003c/p>\n\u003cp>See KQED’s “\u003ca href=\"https://www.kqed.org/news/11855623/where-can-i-get-a-covid-19-vaccine-in-the-bay-area-your-questions-answered\" target=\"_blank\" rel=\"noopener noreferrer\">Where Can I Get a COVID-19 Vaccine in the Bay Area? \u003c/a>” post.\u003c/p>\n\u003cp>California’s \u003ca href=\"https://myturn.ca.gov/\" target=\"_blank\" rel=\"noopener noreferrer\">MyTurn\u003c/a> website will tell you if you’re eligible for the vaccine and when appointments are available. If you’re not eligible, you can register to receive a notification when you become eligible.\u003c/p>\n\u003cp>\u003cstrong>*If you are wondering whether you should get a vaccine, contact your health provider.\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "FDA Scientists Endorse Johnson & Johnson Vaccine",
"headTitle": "FDA Scientists Endorse Johnson & Johnson Vaccine | KQED",
"content": "\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">S\u003c/span>\u003c/span>cientists at the Food and Drug Administration said Wednesday that the single-shot COVID-19 vaccine developed by Johnson & Johnson is effective and prevents hospitalizations from the disease.\u003c/p>\n\u003cp>Johnson & Johnson also revealed new, encouraging data showing the vaccine may do a better-than-expected job at protecting patients against new variants of the virus that causes disease. At the same time, FDA experts said the company’s study, results of which were originally made public in a Jan. 29 press release, includes insufficient information to draw conclusions on efficacy in people older than 75.\u003c/p>\n\u003cp>Documents from the FDA scientists, as well as separate documents from Johnson & Johnson, were released ahead of a Friday meeting of an FDA advisory panel in which outside experts will discuss and then vote on the risks and benefits of the new vaccine. The panel, known as the Vaccines and Related Biological Products Advisory Committee, makes recommendations to the FDA; the agency is not required to follow them, but it generally does.\u003c/p>\n\u003cp>The J&J vaccine is the first vaccine to show efficacy given as a single dose. It also does not need to be kept frozen when being shipped, as the vaccines developed by Moderna and the team of Pfizer and BioNTech do. Both of those advantages could be profound when it comes to vaccinating as many people as possible, a key step in slowing the spread of SARS-CoV-2.\u003c/p>\n\u003cp>Overall in the study, the vaccine reduced cases of COVID-19 that were rated as moderate to severe by 66.1% when considering cases occurring at least 28 days after vaccination. There were 193 cases that occurred at least 28 days after vaccination in the placebo group and 66 in the vaccine group. As of Feb. 5, there were seven COVID-19 related deaths in the placebo group and none in the vaccine group.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>FDA researchers conducted a new analysis of how frequently volunteers in the study were hospitalized for COVID-19. When researchers counted cases 28 days after vaccination, there were zero hospitalizations in the vaccine arm and 16 in the placebo arm. For the full analysis set starting with the first dose, there were six hospitalizations for those who received the vaccine and 42 for those who did not.\u003c/p>\n\u003cp>Johnson & Johnson and the National Institutes of Health initially announced interim results of a 44,325 study testing the vaccine’s efficacy on Jan. 29. At the time, they said the 66% efficacy varied by geography. The vaccine was 72% protective in the U.S., compared to 58% in South Africa, where a new variant of SARS-CoV-2 is circulating.\u003c/p>\n\u003cp>In new documents, Johnson & Johnson said that in South Africa, the vaccine reduced severe or critical COVID-19 by 81.7% starting 28 days after vaccination, but that efficacy against more moderate disease was 64%. But the company said that the vaccine efficacy was not affected by the high prevalence of another variant in Brazil.\u003c/p>\n\u003cp>Unexpected side effects occurred at the same rate overall among volunteers who received the vaccine and placebo — about 0.5%. However, some rare conditions appeared more common with the vaccine. Blood clot-related conditions occurred in 15 volunteers who received the vaccine and 10 who received placebo. Tinnitus, a ringing in the ears, occurred in six volunteers who received the vaccine and none who received placebo. The FDA said it will recommend monitoring for thromboembolic events after an EUA is granted.\u003c/p>\n\u003cp>Expected side effects that are related to the vaccine’s effect were common. Nearly half of volunteers reported injection site pain, 38.9% reported headaches, 38.2% fatigue, and 33% reported muscle aches.\u003c/p>\n\u003cp>Johnson & Johnson also conducted an analysis in 2,650 volunteers looking at whether those who received the vaccine were less likely to test positive for the SARS-CoV-2 virus, which causes COVID-19, without having symptoms. There were 50 such cases in the placebo group compared to 18 among those who received the vaccine, a 65.5% reduction.\u003c/p>\n\u003cp>The United States has purchased 100 million doses of the vaccine, with an option to buy an additional 200 million doses. \u003ca href=\"https://www.jnj.com/johnson-johnson-announces-agreement-with-u-s-government-for-100-million-doses-of-investigational-covid-19-vaccine\" target=\"_blank\" rel=\"noopener noreferrer\">The agreement\u003c/a>, announced last August, netted J&J over $1 billion in a contract with the Biomedical Advanced Research and Development Authority and the Department of Defense.\u003c/p>\n\u003cp>That said, the company currently has a limited number of doses to contribute to the effort to step up the country’s vaccine rollout. It will be April before J&J begins to have substantial amounts of vaccine to feed into the distribution pipeline, Moncef Slaoui, former co-chair of Operation Warp Speed, said earlier this year.\u003c/p>\n\u003cp>However, the company and the NIH said the vaccine was 85% effective at preventing severe disease, with no differences seen across the eight countries included in the study.\u003c/p>\n\u003cp>J&J is also conducting a trial in the United States of a two-dose vaccine, with the doses given eight weeks apart. The results from that 30,000 person trial are not expected until sometime in May.\u003c/p>\n\u003cp>The FDA documents represent the first close look at the data released Jan. 29, and are the result of a three-week effort by FDA scientists to independently evaluate the data generated in the trial. Friday’s panel will provide a deeper look at what those data actually mean.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2021/02/24/new-data-shed-light-on-efficacy-of-jjs-single-dose-vaccine-against-covid-19/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">S\u003c/span>\u003c/span>cientists at the Food and Drug Administration said Wednesday that the single-shot COVID-19 vaccine developed by Johnson & Johnson is effective and prevents hospitalizations from the disease.\u003c/p>\n\u003cp>Johnson & Johnson also revealed new, encouraging data showing the vaccine may do a better-than-expected job at protecting patients against new variants of the virus that causes disease. At the same time, FDA experts said the company’s study, results of which were originally made public in a Jan. 29 press release, includes insufficient information to draw conclusions on efficacy in people older than 75.\u003c/p>\n\u003cp>Documents from the FDA scientists, as well as separate documents from Johnson & Johnson, were released ahead of a Friday meeting of an FDA advisory panel in which outside experts will discuss and then vote on the risks and benefits of the new vaccine. The panel, known as the Vaccines and Related Biological Products Advisory Committee, makes recommendations to the FDA; the agency is not required to follow them, but it generally does.\u003c/p>\n\u003cp>The J&J vaccine is the first vaccine to show efficacy given as a single dose. It also does not need to be kept frozen when being shipped, as the vaccines developed by Moderna and the team of Pfizer and BioNTech do. Both of those advantages could be profound when it comes to vaccinating as many people as possible, a key step in slowing the spread of SARS-CoV-2.\u003c/p>\n\u003cp>Overall in the study, the vaccine reduced cases of COVID-19 that were rated as moderate to severe by 66.1% when considering cases occurring at least 28 days after vaccination. There were 193 cases that occurred at least 28 days after vaccination in the placebo group and 66 in the vaccine group. As of Feb. 5, there were seven COVID-19 related deaths in the placebo group and none in the vaccine group.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>FDA researchers conducted a new analysis of how frequently volunteers in the study were hospitalized for COVID-19. When researchers counted cases 28 days after vaccination, there were zero hospitalizations in the vaccine arm and 16 in the placebo arm. For the full analysis set starting with the first dose, there were six hospitalizations for those who received the vaccine and 42 for those who did not.\u003c/p>\n\u003cp>Johnson & Johnson and the National Institutes of Health initially announced interim results of a 44,325 study testing the vaccine’s efficacy on Jan. 29. At the time, they said the 66% efficacy varied by geography. The vaccine was 72% protective in the U.S., compared to 58% in South Africa, where a new variant of SARS-CoV-2 is circulating.\u003c/p>\n\u003cp>In new documents, Johnson & Johnson said that in South Africa, the vaccine reduced severe or critical COVID-19 by 81.7% starting 28 days after vaccination, but that efficacy against more moderate disease was 64%. But the company said that the vaccine efficacy was not affected by the high prevalence of another variant in Brazil.\u003c/p>\n\u003cp>Unexpected side effects occurred at the same rate overall among volunteers who received the vaccine and placebo — about 0.5%. However, some rare conditions appeared more common with the vaccine. Blood clot-related conditions occurred in 15 volunteers who received the vaccine and 10 who received placebo. Tinnitus, a ringing in the ears, occurred in six volunteers who received the vaccine and none who received placebo. The FDA said it will recommend monitoring for thromboembolic events after an EUA is granted.\u003c/p>\n\u003cp>Expected side effects that are related to the vaccine’s effect were common. Nearly half of volunteers reported injection site pain, 38.9% reported headaches, 38.2% fatigue, and 33% reported muscle aches.\u003c/p>\n\u003cp>Johnson & Johnson also conducted an analysis in 2,650 volunteers looking at whether those who received the vaccine were less likely to test positive for the SARS-CoV-2 virus, which causes COVID-19, without having symptoms. There were 50 such cases in the placebo group compared to 18 among those who received the vaccine, a 65.5% reduction.\u003c/p>\n\u003cp>The United States has purchased 100 million doses of the vaccine, with an option to buy an additional 200 million doses. \u003ca href=\"https://www.jnj.com/johnson-johnson-announces-agreement-with-u-s-government-for-100-million-doses-of-investigational-covid-19-vaccine\" target=\"_blank\" rel=\"noopener noreferrer\">The agreement\u003c/a>, announced last August, netted J&J over $1 billion in a contract with the Biomedical Advanced Research and Development Authority and the Department of Defense.\u003c/p>\n\u003cp>That said, the company currently has a limited number of doses to contribute to the effort to step up the country’s vaccine rollout. It will be April before J&J begins to have substantial amounts of vaccine to feed into the distribution pipeline, Moncef Slaoui, former co-chair of Operation Warp Speed, said earlier this year.\u003c/p>\n\u003cp>However, the company and the NIH said the vaccine was 85% effective at preventing severe disease, with no differences seen across the eight countries included in the study.\u003c/p>\n\u003cp>J&J is also conducting a trial in the United States of a two-dose vaccine, with the doses given eight weeks apart. The results from that 30,000 person trial are not expected until sometime in May.\u003c/p>\n\u003cp>The FDA documents represent the first close look at the data released Jan. 29, and are the result of a three-week effort by FDA scientists to independently evaluate the data generated in the trial. Friday’s panel will provide a deeper look at what those data actually mean.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2021/02/24/new-data-shed-light-on-efficacy-of-jjs-single-dose-vaccine-against-covid-19/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "The Differences Between the Pfizer, Moderna, and Johnson & Johnson Coronavirus Vaccines Explained",
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"content": "\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">I\u003c/span>\u003c/span>n an ideal world, a pandemic vaccine could be delivered in a single shot, so supplies could be stretched to cover a lot of people. It would trigger no side effect more significant than a sore arm. And it would be easy to ship and store.\u003c/p>\n\u003cp>Soon, it seems, this ideal of a COVID-19 vaccine will be within reach.\u003c/p>\n\u003cp>Last Friday, Johnson & Johnson announced that a one-dose vaccine being developed by its vaccines division, Janssen Pharmaceuticals, \u003ca href=\"https://www.statnews.com/2021/01/29/jj-one-dose-covid-vaccine-is-66-effective-a-weapon-but-not-a-knockout-punch/\" target=\"_blank\" rel=\"noopener noreferrer\">had been shown to be 66% protective\u003c/a> against moderate to severe COVID infection in a multicountry study. But, importantly, it was 85% effective in protecting against severe disease. And there were no hospitalizations or deaths among people in the vaccine arm of a large clinical trial.\u003c/p>\n\u003cp>Overall efficacy varied a bit geographically, especially in South Africa, where a new variant appears to evade to some degree the immunity induced both by infection and by COVID vaccines, which were designed to target earlier strains of the SARS-CoV-2 virus.\u003c/p>\n\u003cp>Johnson & Johnson said it will apply to the Food and Drug Administration for an emergency use authorization this week. That means sometime later this month or early in March its vaccine will likely start to be used in the United States, though the company is not expected to be able to supply substantial numbers of doses until April.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Earlier, STAT published a head-to-head comparison of the vaccines developed by \u003ca href=\"https://www.statnews.com/2020/12/11/fda-grants-historic-authorization-to-a-covid-19-vaccine-setting-stage-for-rollout/\" target=\"_blank\" rel=\"noopener noreferrer\">Pfizer and its partner, BioNTech\u003c/a>, and by \u003ca href=\"https://www.statnews.com/2020/12/18/fda-eua-moderna-vaccine-covid19/\" target=\"_blank\" rel=\"noopener noreferrer\">Moderna\u003c/a>, which have been in use in the country since December. We’re updating it here with information about the J&J vaccine, with the caveat that some data from this likely new entry to the U.S. vaccination program haven’t yet been made public.\u003c/p>\n\u003cp>Please note that in the initial rollout of vaccine, individuals are unlikely to be offered a choice of which vaccine they want. Supplies are too scarce. The vaccine available at the place where you are being vaccinated is the one you’ll get.\u003c/p>\n\u003cp>\u003cstrong>Vaccine Types\u003c/strong>\u003c/p>\n\u003cp>The Pfizer and Moderna vaccines are made using messenger RNA, or \u003ca href=\"https://www.statnews.com/2020/10/26/mrna-vaccines-face-their-first-test-in-the-fight-against-covid-19-how-do-they-work/\">mRNA\u003c/a>, a technology that delivers a bit of genetic code to cells — in effect, a recipe to make the surface protein (known as spike) on the SARS-2 virus. The proteins made with the mRNA instructions activate the immune system, teaching it to see the spike protein as foreign and develop antibodies and other immunity weapons with which to fight it.\u003c/p>\n\u003cp>The J&J vaccine uses a different approach to instruct human cells to make the SARS-2 spike protein, which then triggers an immune response. It is what’s known as a viral vectored vaccine. A harmless adenovirus — from a large family of viruses, some of which cause common colds — has been engineered to carry the genetic code for the SARS-2 spike protein. Once the adenovirus enters cells, they use that code to make spike proteins. J&J employs this same approach to make an Ebola vaccine that has been authorized for use by the European Medicines Agency.\u003c/p>\n\u003cp>\u003cstrong>Target Population\u003c/strong>\u003c/p>\n\u003cp>The Pfizer vaccine has been authorized for use for people age 16 and older. Moderna’s has been cleared for use in people 18 and older, though the company is now testing its vaccine in 12- to 17-year-olds. J&J’s vaccine has been tested in people 18 and older, so for the time being, this vaccine won’t be available for use in children and teens under 18 either.\u003c/p>\n\u003cp>\u003cstrong>Vaccine Efficacy\u003c/strong>\u003c/p>\n\u003cp>The Pfizer and Moderna vaccines have shown astonishing — and essentially equivalent — degrees of efficacy, at least in the early stages after vaccination.\u003c/p>\n\u003cp>The Pfizer vaccine showed efficacy of 95% at preventing symptomatic COVID infection after two doses. The vaccine appeared to be more or less equally protective across age groups and racial and ethnic groups.\u003c/p>\n\u003cp>The Moderna vaccine was 94.1% effective at preventing symptomatic COVID-19, after the second dose. The vaccine’s efficacy appeared to be slightly lower in people 65 and older, but during a presentation to the Food and Drug Administration’s advisory committee in December, the company explained that the numbers could have been influenced by the fact there were few cases in that age group in the trial. The vaccine appeared to be equally effective across different ethnic and racial groups.\u003c/p>\n\u003cp>But comparing efficacy in those vaccines to the efficacy of Johnson & Johnson’s is challenging because of differences in the designs of the Phase 3 clinical tests — essentially the trials were testing for different outcomes. Pfizer’s and Moderna’s trials were testing for slightly different criteria, with Pfizer counting cases from seven days after receipt of the second dose of vaccine and Moderna waiting till day 14 to start counting cases. Both tested for any symptomatic COVID infection.\u003c/p>\n\u003cp>J&J, by contrast, sought to determine whether one dose of its vaccine protected against moderate to severe COVID illness — defined as a combination of a positive test and at least one symptom such as shortness of breath, beginning from 14 or 28 days after the single shot. (The company collected data for both.)\u003c/p>\n\u003cp>Because of the difference in the trials, making direct comparisons is a bit like comparing apples and oranges. Additionally, Pfizer and Moderna’s vaccines were tested before the emergence of troubling new variants in Britain, South Africa and Brazil. It’s not entirely clear how well they will work against these mutated viruses.\u003c/p>\n\u003cp>The J&J vaccine was still being tested when the variants were making the rounds. Much of the data generated in the South African arm of the J&J trial involved people who were infected with the variant first seen in South Africa, called B.1.351.\u003c/p>\n\u003cp>The J&J one-dose vaccine was shown to be 66% protective against moderate to severe COVID infections overall from 28 days after injection, though there was variability based on geographic locations. The vaccine was 72% protective in the United States, 66% protective in South America, and 57% protective in South Africa.\u003c/p>\n\u003cp>But the vaccine was shown to be 85% protective against severe disease, with no differences across countries (eight) or regions (three) in the study, nor across age groups among trial participants. And there were no hospitalizations or deaths in the vaccine arm of the trial after the 28-day period in which immunity developed.\u003c/p>\n\u003cp>It’s not yet known if any of these vaccines prevent asymptomatic infection with the SARS-CoV-2 virus. Nor is it known if vaccinated people can transmit the virus if they do become infected but don’t show symptoms.\u003c/p>\n\u003cp>\u003cstrong>Number of Doses/Amounts of Vaccine Per Dose\u003c/strong>\u003c/p>\n\u003cp>Both the Moderna and the Pfizer vaccines require two shots: a priming dose, followed by a booster shot. The interval between Moderna doses is 28 days; for the Pfizer vaccine, it’s 21 days.\u003c/p>\n\u003cp>Each dose of Pfizer’s contains 30 micrograms of vaccine. Moderna went with a much larger dose of vaccine, 100 micrograms. It means the company is using a little more than three times as much vaccine per person as Pfizer is. And yet, they aren’t getting better results. The government’s vaccine development program, formerly called Operation Warp Speed, has asked Moderna to test if it could lower the dosage of its vaccine without eroding the vaccine’s protection.\u003c/p>\n\u003cp>The J&J vaccine is, as mentioned, a single-dose vaccine. The company is also testing a two-dose regimen, with the two shots given eight weeks apart. The results from that 30,000-person trial aren’t expected until sometime in May.\u003c/p>\n\u003cp>\u003cstrong>Side-Effect Profile\u003c/strong>\u003c/p>\n\u003cp>In the vernacular of vaccinology, vaccines that trigger a range of transient side effects in a lot of recipients are known as reactogenic.\u003c/p>\n\u003cp>All of these vaccines — in fact, most if not all the COVID-19 vaccines that have reported data so far — fall into the reactogenic category. The Advisory Committee on Immunization Practices, an expert panel that helps the Centers for Disease Control and Prevention set vaccination policies, has advised hospitals they may want to stagger vaccinations among employees — for instance, don’t vaccinate all emergency room staff at the same time — in case some feel too unwell to work the day after being vaccinated.\u003c/p>\n\u003cp>The most common side effects are injection site pain, fatigue, headache, muscle pain, and joint pain. Some people in the clinical trials have reported fever. Side effects are more common after the second dose; younger adults, who have more robust immune systems, reported more side effects than older adults.\u003c/p>\n\u003cp>To be clear: These side effects are a sign of an immune system kicking into gear. They do not signal that the vaccine is unsafe. To date there are no serious, long-term side effects associated with receipt of these vaccines, which will be closely monitored as their use expands.\u003c/p>\n\u003cp>There have been reports of severe allergic reactions to the mRNA vaccines. Both the Pfizer and Moderna vaccines appear, on rare occasions, to \u003ca href=\"https://www.statnews.com/2021/01/22/cdc-reports-rare-allergic-reactions-to-modernas-covid-19-vaccine/\">trigger anaphylaxis\u003c/a>, a severe and potentially life-threatening reaction. People who develop anaphylaxis must be treated with epinephrine — the drug in EpiPens — and may need to be hospitalized to ensure their airways remain open. The CDC says people should be monitored for 15 minutes after getting a COVID-19 shot, and 30 minutes if they have a history of severe allergies.\u003c/p>\n\u003cp>It will take time to come up with a firm estimate of how frequently this side effect occurs. The most recent data from the CDC suggest that anaphylaxis occurs at a rate of about 2.1 cases per one million doses given of the Moderna vaccine, and 6.2 cases per million doses of the Pfizer. Many of the people who have developed anaphylaxis have a history of severe allergies and some have had previous episodes of anaphylaxis.\u003c/p>\n\u003cp>To date the J&J vaccine has not been associated with anaphylactic reactions.\u003c/p>\n\u003cp>\u003cstrong>Safety for Those Who are Pregnant or Lactating\u003c/strong>\u003c/p>\n\u003cp>None of the vaccines has been tested in these two groups.\u003c/p>\n\u003cp>Moderna has completed animal studies the FDA demanded of manufacturers; these studies look for evidence that the vaccine might harm the pregnancy or the developing fetus. The company said it saw no such signals.\u003c/p>\n\u003cp>Pfizer has only interim data from its animal studies, but said it saw no concerning signs either.\u003c/p>\n\u003cp>The CDC \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html\" target=\"_blank\" rel=\"noopener noreferrer\">recommends\u003c/a> until those studies are conducted, the choice of whether to get vaccinated should rest with the person who is pregnant or lactating. This is a more permissive stance than has been taken in some countries, which have said people who are pregnant should not be vaccinated with these vaccines.\u003c/p>\n\u003cp>The J&J vaccine hasn’t yet been through the regulatory process, so it’s too early to say what the FDA and the CDC will recommend. The company plans to include pregnant women in clinical trials in the near future, a spokesman told STAT.\u003c/p>\n\u003cp>\u003cstrong>Storage Requirements\u003c/strong>\u003c/p>\n\u003cp>The mRNA vaccines require an elaborate cold chain, the term used to describe the conditions under which vaccines must be stored during distribution and when they are in the doctors’ offices, pharmacies, or public health clinics where they’ll be administered.\u003c/p>\n\u003cp>The J&J does not, which means this vaccine can be given easily anywhere, once supplies are adequate. Doctors’ offices, pharmacies, mass vaccination sites, public health clinics — this vaccine will be much easier to use. It can be stored for at least three months at the temperature of a regular refrigerator.\u003c/p>\n\u003cp>Of the mRNA vaccines, Moderna’s is far easier to use than Pfizer’s. For starters, Moderna’s must be shipped at -4 Fahrenheit; Pfizer’s must be shipped and stored at -94 Fahrenheit. The former is the temperature of a regular refrigerator freezer; the latter requires special ultracold freezers. Doctors’ offices do not have ultracold freezers; neighborhood pharmacies don’t either.\u003c/p>\n\u003cp>After thawing, a vial of the Pfizer vaccine must be used within five days; Moderna’s is stable at fridge temperature for 30 days and at room temperature for 12 hours. STAT asked J&J how long its vaccine will last once a vial has begun to be used, but so far the company has not provided that information.\u003c/p>\n\u003cp>\u003cstrong>Minimum Purchase Order\u003c/strong>\u003c/p>\n\u003cp>The ultracold storage requirement is not the only challenging aspect of the Pfizer vaccine. The minimum amount of vaccine a location can order is 975 doses. A large teaching hospital might need several of those. But there are plenty of places across the country that don’t need 975 doses to vaccinate the people currently eligible for vaccination — health workers and nursing home residents. This is the vaccine that needs to be kept at -94 F. The minimum order size will limit the locations in which this vaccine can be used.\u003c/p>\n\u003cp>The Moderna vaccine’s minimum order is 100 doses, a much more manageable number.\u003c/p>\n\u003cp>STAT asked J&J what its minimum order will be; it declined to say.\u003c/p>\n\u003cp>The Pfizer vaccine is shipped in six-dose vials. Moderna’s vaccine comes in 10-dose vials. J&J’s vaccine will be packaged in five-dose vials.\u003c/p>\n\u003cp>\u003cstrong>Durability of Protection\u003c/strong>\u003c/p>\n\u003cp>Figuring out how long the protection provided by any of these vaccines will last will take time. It’s going to involve periodic blood draws from some volunteers to see what their antibody levels look like, though a decline in antibody levels doesn’t necessarily equate to loss of protection.\u003c/p>\n\u003cp>But a large part of this work will involve watching for reports that people who were immunized are starting to contract COVID in larger numbers, a development that would probably lead to recommendations to give people booster shots at some yet-to-be-determined interval.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2020/01/26/containing-new-coronavirus-may-not-be-feasible-experts-say/?utm_source=STAT+Newsletters&utm_campaign=b4213b1d3b-MR_COPY_02&utm_medium=email&utm_term=0_8cab1d7961-b4213b1d3b-149648249\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">I\u003c/span>\u003c/span>n an ideal world, a pandemic vaccine could be delivered in a single shot, so supplies could be stretched to cover a lot of people. It would trigger no side effect more significant than a sore arm. And it would be easy to ship and store.\u003c/p>\n\u003cp>Soon, it seems, this ideal of a COVID-19 vaccine will be within reach.\u003c/p>\n\u003cp>Last Friday, Johnson & Johnson announced that a one-dose vaccine being developed by its vaccines division, Janssen Pharmaceuticals, \u003ca href=\"https://www.statnews.com/2021/01/29/jj-one-dose-covid-vaccine-is-66-effective-a-weapon-but-not-a-knockout-punch/\" target=\"_blank\" rel=\"noopener noreferrer\">had been shown to be 66% protective\u003c/a> against moderate to severe COVID infection in a multicountry study. But, importantly, it was 85% effective in protecting against severe disease. And there were no hospitalizations or deaths among people in the vaccine arm of a large clinical trial.\u003c/p>\n\u003cp>Overall efficacy varied a bit geographically, especially in South Africa, where a new variant appears to evade to some degree the immunity induced both by infection and by COVID vaccines, which were designed to target earlier strains of the SARS-CoV-2 virus.\u003c/p>\n\u003cp>Johnson & Johnson said it will apply to the Food and Drug Administration for an emergency use authorization this week. That means sometime later this month or early in March its vaccine will likely start to be used in the United States, though the company is not expected to be able to supply substantial numbers of doses until April.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Earlier, STAT published a head-to-head comparison of the vaccines developed by \u003ca href=\"https://www.statnews.com/2020/12/11/fda-grants-historic-authorization-to-a-covid-19-vaccine-setting-stage-for-rollout/\" target=\"_blank\" rel=\"noopener noreferrer\">Pfizer and its partner, BioNTech\u003c/a>, and by \u003ca href=\"https://www.statnews.com/2020/12/18/fda-eua-moderna-vaccine-covid19/\" target=\"_blank\" rel=\"noopener noreferrer\">Moderna\u003c/a>, which have been in use in the country since December. We’re updating it here with information about the J&J vaccine, with the caveat that some data from this likely new entry to the U.S. vaccination program haven’t yet been made public.\u003c/p>\n\u003cp>Please note that in the initial rollout of vaccine, individuals are unlikely to be offered a choice of which vaccine they want. Supplies are too scarce. The vaccine available at the place where you are being vaccinated is the one you’ll get.\u003c/p>\n\u003cp>\u003cstrong>Vaccine Types\u003c/strong>\u003c/p>\n\u003cp>The Pfizer and Moderna vaccines are made using messenger RNA, or \u003ca href=\"https://www.statnews.com/2020/10/26/mrna-vaccines-face-their-first-test-in-the-fight-against-covid-19-how-do-they-work/\">mRNA\u003c/a>, a technology that delivers a bit of genetic code to cells — in effect, a recipe to make the surface protein (known as spike) on the SARS-2 virus. The proteins made with the mRNA instructions activate the immune system, teaching it to see the spike protein as foreign and develop antibodies and other immunity weapons with which to fight it.\u003c/p>\n\u003cp>The J&J vaccine uses a different approach to instruct human cells to make the SARS-2 spike protein, which then triggers an immune response. It is what’s known as a viral vectored vaccine. A harmless adenovirus — from a large family of viruses, some of which cause common colds — has been engineered to carry the genetic code for the SARS-2 spike protein. Once the adenovirus enters cells, they use that code to make spike proteins. J&J employs this same approach to make an Ebola vaccine that has been authorized for use by the European Medicines Agency.\u003c/p>\n\u003cp>\u003cstrong>Target Population\u003c/strong>\u003c/p>\n\u003cp>The Pfizer vaccine has been authorized for use for people age 16 and older. Moderna’s has been cleared for use in people 18 and older, though the company is now testing its vaccine in 12- to 17-year-olds. J&J’s vaccine has been tested in people 18 and older, so for the time being, this vaccine won’t be available for use in children and teens under 18 either.\u003c/p>\n\u003cp>\u003cstrong>Vaccine Efficacy\u003c/strong>\u003c/p>\n\u003cp>The Pfizer and Moderna vaccines have shown astonishing — and essentially equivalent — degrees of efficacy, at least in the early stages after vaccination.\u003c/p>\n\u003cp>The Pfizer vaccine showed efficacy of 95% at preventing symptomatic COVID infection after two doses. The vaccine appeared to be more or less equally protective across age groups and racial and ethnic groups.\u003c/p>\n\u003cp>The Moderna vaccine was 94.1% effective at preventing symptomatic COVID-19, after the second dose. The vaccine’s efficacy appeared to be slightly lower in people 65 and older, but during a presentation to the Food and Drug Administration’s advisory committee in December, the company explained that the numbers could have been influenced by the fact there were few cases in that age group in the trial. The vaccine appeared to be equally effective across different ethnic and racial groups.\u003c/p>\n\u003cp>But comparing efficacy in those vaccines to the efficacy of Johnson & Johnson’s is challenging because of differences in the designs of the Phase 3 clinical tests — essentially the trials were testing for different outcomes. Pfizer’s and Moderna’s trials were testing for slightly different criteria, with Pfizer counting cases from seven days after receipt of the second dose of vaccine and Moderna waiting till day 14 to start counting cases. Both tested for any symptomatic COVID infection.\u003c/p>\n\u003cp>J&J, by contrast, sought to determine whether one dose of its vaccine protected against moderate to severe COVID illness — defined as a combination of a positive test and at least one symptom such as shortness of breath, beginning from 14 or 28 days after the single shot. (The company collected data for both.)\u003c/p>\n\u003cp>Because of the difference in the trials, making direct comparisons is a bit like comparing apples and oranges. Additionally, Pfizer and Moderna’s vaccines were tested before the emergence of troubling new variants in Britain, South Africa and Brazil. It’s not entirely clear how well they will work against these mutated viruses.\u003c/p>\n\u003cp>The J&J vaccine was still being tested when the variants were making the rounds. Much of the data generated in the South African arm of the J&J trial involved people who were infected with the variant first seen in South Africa, called B.1.351.\u003c/p>\n\u003cp>The J&J one-dose vaccine was shown to be 66% protective against moderate to severe COVID infections overall from 28 days after injection, though there was variability based on geographic locations. The vaccine was 72% protective in the United States, 66% protective in South America, and 57% protective in South Africa.\u003c/p>\n\u003cp>But the vaccine was shown to be 85% protective against severe disease, with no differences across countries (eight) or regions (three) in the study, nor across age groups among trial participants. And there were no hospitalizations or deaths in the vaccine arm of the trial after the 28-day period in which immunity developed.\u003c/p>\n\u003cp>It’s not yet known if any of these vaccines prevent asymptomatic infection with the SARS-CoV-2 virus. Nor is it known if vaccinated people can transmit the virus if they do become infected but don’t show symptoms.\u003c/p>\n\u003cp>\u003cstrong>Number of Doses/Amounts of Vaccine Per Dose\u003c/strong>\u003c/p>\n\u003cp>Both the Moderna and the Pfizer vaccines require two shots: a priming dose, followed by a booster shot. The interval between Moderna doses is 28 days; for the Pfizer vaccine, it’s 21 days.\u003c/p>\n\u003cp>Each dose of Pfizer’s contains 30 micrograms of vaccine. Moderna went with a much larger dose of vaccine, 100 micrograms. It means the company is using a little more than three times as much vaccine per person as Pfizer is. And yet, they aren’t getting better results. The government’s vaccine development program, formerly called Operation Warp Speed, has asked Moderna to test if it could lower the dosage of its vaccine without eroding the vaccine’s protection.\u003c/p>\n\u003cp>The J&J vaccine is, as mentioned, a single-dose vaccine. The company is also testing a two-dose regimen, with the two shots given eight weeks apart. The results from that 30,000-person trial aren’t expected until sometime in May.\u003c/p>\n\u003cp>\u003cstrong>Side-Effect Profile\u003c/strong>\u003c/p>\n\u003cp>In the vernacular of vaccinology, vaccines that trigger a range of transient side effects in a lot of recipients are known as reactogenic.\u003c/p>\n\u003cp>All of these vaccines — in fact, most if not all the COVID-19 vaccines that have reported data so far — fall into the reactogenic category. The Advisory Committee on Immunization Practices, an expert panel that helps the Centers for Disease Control and Prevention set vaccination policies, has advised hospitals they may want to stagger vaccinations among employees — for instance, don’t vaccinate all emergency room staff at the same time — in case some feel too unwell to work the day after being vaccinated.\u003c/p>\n\u003cp>The most common side effects are injection site pain, fatigue, headache, muscle pain, and joint pain. Some people in the clinical trials have reported fever. Side effects are more common after the second dose; younger adults, who have more robust immune systems, reported more side effects than older adults.\u003c/p>\n\u003cp>To be clear: These side effects are a sign of an immune system kicking into gear. They do not signal that the vaccine is unsafe. To date there are no serious, long-term side effects associated with receipt of these vaccines, which will be closely monitored as their use expands.\u003c/p>\n\u003cp>There have been reports of severe allergic reactions to the mRNA vaccines. Both the Pfizer and Moderna vaccines appear, on rare occasions, to \u003ca href=\"https://www.statnews.com/2021/01/22/cdc-reports-rare-allergic-reactions-to-modernas-covid-19-vaccine/\">trigger anaphylaxis\u003c/a>, a severe and potentially life-threatening reaction. People who develop anaphylaxis must be treated with epinephrine — the drug in EpiPens — and may need to be hospitalized to ensure their airways remain open. The CDC says people should be monitored for 15 minutes after getting a COVID-19 shot, and 30 minutes if they have a history of severe allergies.\u003c/p>\n\u003cp>It will take time to come up with a firm estimate of how frequently this side effect occurs. The most recent data from the CDC suggest that anaphylaxis occurs at a rate of about 2.1 cases per one million doses given of the Moderna vaccine, and 6.2 cases per million doses of the Pfizer. Many of the people who have developed anaphylaxis have a history of severe allergies and some have had previous episodes of anaphylaxis.\u003c/p>\n\u003cp>To date the J&J vaccine has not been associated with anaphylactic reactions.\u003c/p>\n\u003cp>\u003cstrong>Safety for Those Who are Pregnant or Lactating\u003c/strong>\u003c/p>\n\u003cp>None of the vaccines has been tested in these two groups.\u003c/p>\n\u003cp>Moderna has completed animal studies the FDA demanded of manufacturers; these studies look for evidence that the vaccine might harm the pregnancy or the developing fetus. The company said it saw no such signals.\u003c/p>\n\u003cp>Pfizer has only interim data from its animal studies, but said it saw no concerning signs either.\u003c/p>\n\u003cp>The CDC \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html\" target=\"_blank\" rel=\"noopener noreferrer\">recommends\u003c/a> until those studies are conducted, the choice of whether to get vaccinated should rest with the person who is pregnant or lactating. This is a more permissive stance than has been taken in some countries, which have said people who are pregnant should not be vaccinated with these vaccines.\u003c/p>\n\u003cp>The J&J vaccine hasn’t yet been through the regulatory process, so it’s too early to say what the FDA and the CDC will recommend. The company plans to include pregnant women in clinical trials in the near future, a spokesman told STAT.\u003c/p>\n\u003cp>\u003cstrong>Storage Requirements\u003c/strong>\u003c/p>\n\u003cp>The mRNA vaccines require an elaborate cold chain, the term used to describe the conditions under which vaccines must be stored during distribution and when they are in the doctors’ offices, pharmacies, or public health clinics where they’ll be administered.\u003c/p>\n\u003cp>The J&J does not, which means this vaccine can be given easily anywhere, once supplies are adequate. Doctors’ offices, pharmacies, mass vaccination sites, public health clinics — this vaccine will be much easier to use. It can be stored for at least three months at the temperature of a regular refrigerator.\u003c/p>\n\u003cp>Of the mRNA vaccines, Moderna’s is far easier to use than Pfizer’s. For starters, Moderna’s must be shipped at -4 Fahrenheit; Pfizer’s must be shipped and stored at -94 Fahrenheit. The former is the temperature of a regular refrigerator freezer; the latter requires special ultracold freezers. Doctors’ offices do not have ultracold freezers; neighborhood pharmacies don’t either.\u003c/p>\n\u003cp>After thawing, a vial of the Pfizer vaccine must be used within five days; Moderna’s is stable at fridge temperature for 30 days and at room temperature for 12 hours. STAT asked J&J how long its vaccine will last once a vial has begun to be used, but so far the company has not provided that information.\u003c/p>\n\u003cp>\u003cstrong>Minimum Purchase Order\u003c/strong>\u003c/p>\n\u003cp>The ultracold storage requirement is not the only challenging aspect of the Pfizer vaccine. The minimum amount of vaccine a location can order is 975 doses. A large teaching hospital might need several of those. But there are plenty of places across the country that don’t need 975 doses to vaccinate the people currently eligible for vaccination — health workers and nursing home residents. This is the vaccine that needs to be kept at -94 F. The minimum order size will limit the locations in which this vaccine can be used.\u003c/p>\n\u003cp>The Moderna vaccine’s minimum order is 100 doses, a much more manageable number.\u003c/p>\n\u003cp>STAT asked J&J what its minimum order will be; it declined to say.\u003c/p>\n\u003cp>The Pfizer vaccine is shipped in six-dose vials. Moderna’s vaccine comes in 10-dose vials. J&J’s vaccine will be packaged in five-dose vials.\u003c/p>\n\u003cp>\u003cstrong>Durability of Protection\u003c/strong>\u003c/p>\n\u003cp>Figuring out how long the protection provided by any of these vaccines will last will take time. It’s going to involve periodic blood draws from some volunteers to see what their antibody levels look like, though a decline in antibody levels doesn’t necessarily equate to loss of protection.\u003c/p>\n\u003cp>But a large part of this work will involve watching for reports that people who were immunized are starting to contract COVID in larger numbers, a development that would probably lead to recommendations to give people booster shots at some yet-to-be-determined interval.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2020/01/26/containing-new-coronavirus-may-not-be-feasible-experts-say/?utm_source=STAT+Newsletters&utm_campaign=b4213b1d3b-MR_COPY_02&utm_medium=email&utm_term=0_8cab1d7961-b4213b1d3b-149648249\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "Johnson & Johnson's Vaccine Could Set Off a New Phase in the Battle Against COVID-19",
"headTitle": "Johnson & Johnson’s Vaccine Could Set Off a New Phase in the Battle Against COVID-19 | KQED",
"content": "\u003cp>Johnson & Johnson said Friday that its single-dose COVID-19 vaccine reduced rates of moderate and severe disease, but the shot appeared less effective in South Africa, where a \u003ca href=\"https://www.statnews.com/2021/01/28/south-carolina-first-cases-of-south-africa-variant/\" target=\"_blank\" rel=\"noopener noreferrer\">new coronavirus variant\u003c/a> has become common.\u003c/p>\n\u003cp>Overall, the vaccine was 66% effective at preventing moderate to severe disease 28 days after vaccination. But efficacy differed depending on geography. The shot was 72% effective among clinical trial volunteers in the U.S, but 66% among those in Latin America, and just 57% among those in South Africa. Though markedly below the levels seen with the first two authorized COVID-19 vaccines, those rates are above the thresholds originally set by the U.S. Food and Drug Administration for a vaccine to be considered useful.\u003c/p>\n\u003cp>The vaccine reduced severe disease alone by 85%, and prevented COVID-related hospitalization or death, Johnson & Johnson said.\u003c/p>\n\u003cp>“In a pandemic, if you can, with a single-dose vaccine, very quickly eliminate the severe consequences of death, hospitalization, and severe disease, that’s what’s important for society,” Paul Stoffels, the company’s chief scientific officer, told STAT.\u003c/p>\n\u003cp>Eric Topol, director and founder of the Scripps Research Translational Institute, called the results “disappointing,” but added that a vaccine that prevents the most serious outcomes, such as hospitalization and death, is still valuable. “It reinforces how lucky we were that the first two were more effective,” he added.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Dr. Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases, cautioned at a press conference against making too much of comparisons to prior vaccines, calling the result “extraordinarily important,” noting that severe disease was reduced across the board, even in regions where new variants of the virus were common.\u003c/p>\n\u003cp>“So this has really important domestic and global public health implications,” Fauci said, “things that we know about this particular candidate that even add to the importance globally, namely the minimal cold chain requirements, the inexpensive nature of it, the fact that it is one shot and that the company can actually produce in a reasonable period of time, billions of doses.”\u003c/p>\n\u003cp>The results set off a new phase in the battle against the SARS-CoV-2 virus, which causes COVID-19. Different vaccines against the virus are proving to have varying levels of efficacy, but also distinct attributes that could make them more — or less — valuable in certain contexts.\u003c/p>\n\u003cp>Results from the first two authorized vaccines, one from partners Pfizer and BioNtech and a second from Moderna, were considerably stronger, reducing symptomatic infection by about 95%. But those vaccines require two doses. They also come with distribution challenges since they are required to stay at ultra-cold temperatures.\u003c/p>\n\u003cp>The new variant of the virus that was first identified in South Africa, B.1.351, throws another monkey wrench into the equation. It appears to make vaccines less effective. Novavax, another vaccine manufacturer, said Thursday that its \u003ca href=\"https://www.statnews.com/2021/01/28/novavax-says-its-covid-19-vaccine-is-90-effective-but-far-less-so-against-one-variant/\" target=\"_blank\" rel=\"noopener noreferrer\">vaccine was 90% effective\u003c/a> in the U.K. but just 49% effective in South Africa. The existence of such a variant raises the possibility that vaccine makers will have to develop booster shots to protect against it. They might even need to do so regularly, as new strains of the coronavirus emerge.\u003c/p>\n\u003cp>The efficacy of authorized vaccines appears to be somewhat lessened by the B.1.351 strain in test-tube experiments, but have not been put to the test against it yet in clinical research.\u003c/p>\n\u003cp>“The policy implications of having different vaccines with different levels of efficacy are huge,” said Carlos del Rio, a professor of infectious diseases at the Emory University School of Medicine. “To deal with this pandemic and stop the spread, I think you use all the tools in the toolbox.”\u003c/p>\n\u003cp>The J&J results are from an interim analysis of a study of 44,325 volunteers in which 468 symptomatic cases of COVID-19 occurred. They are being unveiled Friday morning at a press conference with the National Institutes of Health, which helped run the study as part of the U.S. vaccine effort, known as Operation Warp Speed. Because the study is still ongoing, the data could still change.\u003c/p>\n\u003cp>Unlike the Pfizer/BioNTech and Moderna vaccines, which are based on a new technology called mRNA that uses the body’s own cells to produce a key viral protein, the J&J vaccine uses a type of virus called an adenovirus to deliver genes that produce those same viral proteins. A similar technology was used in the vaccine developed by Oxford University and AstraZeneca.\u003c/p>\n\u003cp>J&J said that the trial did not result in any significant safety concerns about the vaccine. A case of stroke in one volunteer, which prompted researchers to pause the trial this fall, was determined to be unrelated to the vaccine, Stoffels said. Fevers occurred in 9% of those who received the vaccine, and fevers of more than 104 degrees occured in 0.2% of vaccine recipients. Serious adverse events were more common among those who received a placebo than the vaccine.\u003c/p>\n\u003cp>No matter the age of volunteers in the study, the vaccine appeared to have strong efficacy, Stoffels said. There had been concerns its effectiveness might be less robust in older people.\u003c/p>\n\u003cp>Akiko Iwasaki, a virologist at Yale University, said that the results for both the Novavax and J&J vaccines were strong. She noted that it’s difficult to compare the J&J results to those from other trials, because the earlier trials counted cases of mild COVID-19 whereas the J&J study included only sicker ones.\u003c/p>\n\u003cp>Regardless, Iwasaki emphasized the importance of simply vaccinating as many people as possible, because the current lack of immunity in the majority of the population, and the high number of cases, is giving the virus an opportunity to mutate more often.\u003c/p>\n\u003cp>“We’ve got to get the first dose to as many people as possible,” Iwasaki said. “These variants that are more transmissible and potentially even more lethal are on the rise. I think time is really what we’re fighting against.”\u003c/p>\n\u003cp>Kert Viele, a statistician at Berry Consultants, made a similar point. Approving more vaccines, and expanding global supply, could mean communities reach herd immunity, in which enough people are inoculated against a pathogen to halt chains of transmission. “If we can lower global cases,” Viele said, “we will reduce the emergence rate of all of these strains to everyone’s benefit, and thus the need for such reformulations in the future.”\u003c/p>\n\u003cp>One hope is that the efficacy of the Johnson & Johnson vaccine could rise if it is given as a two-dose regimen. Johnson & Johnson is running another large study, enrolling 30,000 patients, testing two doses of the vaccine given 57 days apart. However, Stoffels said, waiting that long between doses will slow results. He expects results of the two-dose study to read out in the summer or fall.\u003c/p>\n\u003cp>The population in the study was “diverse and broad,” J&J said. Patients came from the U.S. (44%), Central and South America (41%) and South Africa (15%). Women made up 45% of the study, and men 55%. Among participants globally, 59% were white, 45% Hispanic or Latinx, 13% were Black, 6% were Asian and 1% were Native American. Volunteers had health conditions including obesity, type 2 diabetes, hypertension, and HIV.\u003c/p>\n\u003cp>The J&J vaccine will be far easier to distribute than the mRNA vaccines made by Moderna and Pfizer/BioNTech. The vaccine will remain stable for two years at -4 degree Fahrenheit, and will remain stable for up to three months if kept at between 36 degrees and 46 degrees Fahrenheit.\u003c/p>\n\u003cp>Johnson & Johnson expects to file with the FDA for an emergency use authorization in early February, and, assuming the vaccine is authorized, will have some product ready to ship immediately after getting a go-ahead. The company declined to give specifics on how much would be available, except to say it expects to make all of its 2021 supply commitments.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003ci>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/2020/08/10/winter-is-coming-as-flu-season-nears-americas-window-of-opportunity-to-beat-back-covid-19-is-narrowing/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/i>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Johnson & Johnson said Friday that its single-dose COVID-19 vaccine reduced rates of moderate and severe disease, but the shot appeared less effective in South Africa, where a \u003ca href=\"https://www.statnews.com/2021/01/28/south-carolina-first-cases-of-south-africa-variant/\" target=\"_blank\" rel=\"noopener noreferrer\">new coronavirus variant\u003c/a> has become common.\u003c/p>\n\u003cp>Overall, the vaccine was 66% effective at preventing moderate to severe disease 28 days after vaccination. But efficacy differed depending on geography. The shot was 72% effective among clinical trial volunteers in the U.S, but 66% among those in Latin America, and just 57% among those in South Africa. Though markedly below the levels seen with the first two authorized COVID-19 vaccines, those rates are above the thresholds originally set by the U.S. Food and Drug Administration for a vaccine to be considered useful.\u003c/p>\n\u003cp>The vaccine reduced severe disease alone by 85%, and prevented COVID-related hospitalization or death, Johnson & Johnson said.\u003c/p>\n\u003cp>“In a pandemic, if you can, with a single-dose vaccine, very quickly eliminate the severe consequences of death, hospitalization, and severe disease, that’s what’s important for society,” Paul Stoffels, the company’s chief scientific officer, told STAT.\u003c/p>\n\u003cp>Eric Topol, director and founder of the Scripps Research Translational Institute, called the results “disappointing,” but added that a vaccine that prevents the most serious outcomes, such as hospitalization and death, is still valuable. “It reinforces how lucky we were that the first two were more effective,” he added.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Dr. Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases, cautioned at a press conference against making too much of comparisons to prior vaccines, calling the result “extraordinarily important,” noting that severe disease was reduced across the board, even in regions where new variants of the virus were common.\u003c/p>\n\u003cp>“So this has really important domestic and global public health implications,” Fauci said, “things that we know about this particular candidate that even add to the importance globally, namely the minimal cold chain requirements, the inexpensive nature of it, the fact that it is one shot and that the company can actually produce in a reasonable period of time, billions of doses.”\u003c/p>\n\u003cp>The results set off a new phase in the battle against the SARS-CoV-2 virus, which causes COVID-19. Different vaccines against the virus are proving to have varying levels of efficacy, but also distinct attributes that could make them more — or less — valuable in certain contexts.\u003c/p>\n\u003cp>Results from the first two authorized vaccines, one from partners Pfizer and BioNtech and a second from Moderna, were considerably stronger, reducing symptomatic infection by about 95%. But those vaccines require two doses. They also come with distribution challenges since they are required to stay at ultra-cold temperatures.\u003c/p>\n\u003cp>The new variant of the virus that was first identified in South Africa, B.1.351, throws another monkey wrench into the equation. It appears to make vaccines less effective. Novavax, another vaccine manufacturer, said Thursday that its \u003ca href=\"https://www.statnews.com/2021/01/28/novavax-says-its-covid-19-vaccine-is-90-effective-but-far-less-so-against-one-variant/\" target=\"_blank\" rel=\"noopener noreferrer\">vaccine was 90% effective\u003c/a> in the U.K. but just 49% effective in South Africa. The existence of such a variant raises the possibility that vaccine makers will have to develop booster shots to protect against it. They might even need to do so regularly, as new strains of the coronavirus emerge.\u003c/p>\n\u003cp>The efficacy of authorized vaccines appears to be somewhat lessened by the B.1.351 strain in test-tube experiments, but have not been put to the test against it yet in clinical research.\u003c/p>\n\u003cp>“The policy implications of having different vaccines with different levels of efficacy are huge,” said Carlos del Rio, a professor of infectious diseases at the Emory University School of Medicine. “To deal with this pandemic and stop the spread, I think you use all the tools in the toolbox.”\u003c/p>\n\u003cp>The J&J results are from an interim analysis of a study of 44,325 volunteers in which 468 symptomatic cases of COVID-19 occurred. They are being unveiled Friday morning at a press conference with the National Institutes of Health, which helped run the study as part of the U.S. vaccine effort, known as Operation Warp Speed. Because the study is still ongoing, the data could still change.\u003c/p>\n\u003cp>Unlike the Pfizer/BioNTech and Moderna vaccines, which are based on a new technology called mRNA that uses the body’s own cells to produce a key viral protein, the J&J vaccine uses a type of virus called an adenovirus to deliver genes that produce those same viral proteins. A similar technology was used in the vaccine developed by Oxford University and AstraZeneca.\u003c/p>\n\u003cp>J&J said that the trial did not result in any significant safety concerns about the vaccine. A case of stroke in one volunteer, which prompted researchers to pause the trial this fall, was determined to be unrelated to the vaccine, Stoffels said. Fevers occurred in 9% of those who received the vaccine, and fevers of more than 104 degrees occured in 0.2% of vaccine recipients. Serious adverse events were more common among those who received a placebo than the vaccine.\u003c/p>\n\u003cp>No matter the age of volunteers in the study, the vaccine appeared to have strong efficacy, Stoffels said. There had been concerns its effectiveness might be less robust in older people.\u003c/p>\n\u003cp>Akiko Iwasaki, a virologist at Yale University, said that the results for both the Novavax and J&J vaccines were strong. She noted that it’s difficult to compare the J&J results to those from other trials, because the earlier trials counted cases of mild COVID-19 whereas the J&J study included only sicker ones.\u003c/p>\n\u003cp>Regardless, Iwasaki emphasized the importance of simply vaccinating as many people as possible, because the current lack of immunity in the majority of the population, and the high number of cases, is giving the virus an opportunity to mutate more often.\u003c/p>\n\u003cp>“We’ve got to get the first dose to as many people as possible,” Iwasaki said. “These variants that are more transmissible and potentially even more lethal are on the rise. I think time is really what we’re fighting against.”\u003c/p>\n\u003cp>Kert Viele, a statistician at Berry Consultants, made a similar point. Approving more vaccines, and expanding global supply, could mean communities reach herd immunity, in which enough people are inoculated against a pathogen to halt chains of transmission. “If we can lower global cases,” Viele said, “we will reduce the emergence rate of all of these strains to everyone’s benefit, and thus the need for such reformulations in the future.”\u003c/p>\n\u003cp>One hope is that the efficacy of the Johnson & Johnson vaccine could rise if it is given as a two-dose regimen. Johnson & Johnson is running another large study, enrolling 30,000 patients, testing two doses of the vaccine given 57 days apart. However, Stoffels said, waiting that long between doses will slow results. He expects results of the two-dose study to read out in the summer or fall.\u003c/p>\n\u003cp>The population in the study was “diverse and broad,” J&J said. Patients came from the U.S. (44%), Central and South America (41%) and South Africa (15%). Women made up 45% of the study, and men 55%. Among participants globally, 59% were white, 45% Hispanic or Latinx, 13% were Black, 6% were Asian and 1% were Native American. Volunteers had health conditions including obesity, type 2 diabetes, hypertension, and HIV.\u003c/p>\n\u003cp>The J&J vaccine will be far easier to distribute than the mRNA vaccines made by Moderna and Pfizer/BioNTech. The vaccine will remain stable for two years at -4 degree Fahrenheit, and will remain stable for up to three months if kept at between 36 degrees and 46 degrees Fahrenheit.\u003c/p>\n\u003cp>Johnson & Johnson expects to file with the FDA for an emergency use authorization in early February, and, assuming the vaccine is authorized, will have some product ready to ship immediately after getting a go-ahead. The company declined to give specifics on how much would be available, except to say it expects to make all of its 2021 supply commitments.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003ci>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/2020/08/10/winter-is-coming-as-flu-season-nears-americas-window-of-opportunity-to-beat-back-covid-19-is-narrowing/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/i>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "What We Know and Don't Know About the Coronavirus Variants",
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"content": "\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">T\u003c/span>\u003c/span>he coronavirus variants are, in a word, confusing.\u003c/p>\n\u003cp>By now, you have likely heard about different variants that first raised trouble in the United Kingdom, South Africa, Brazil, and now maybe California — though the jury is very much out on whether that last one is cause for concern. To make a messy alphabet soup even more jumbled, these variants have unwieldy names, and they each contain mutations with unwieldy names of their own. The result is that people are left trying to differentiate among B.1.1.7 and N501Y and E484K and C-3PO.\u003c/p>\n\u003cp>Wait, sorry, that last one is from “Star Wars.”\u003c/p>\n\u003cp>The point is that all of this is difficult to keep track of, and it will only grow more confusing with more variants likely to turn up. “It’s becoming a mutation-of-the-week game,” said Stephen Goldstein, a coronavirologist at the University of Utah.\u003c/p>\n\u003cp>Below, STAT explains what’s known about the variants, why they’re getting so much attention, and what they mean for the trajectory of the pandemic.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>Why Are Variants Popping Up Now?\u003c/strong>\u003c/p>\n\u003cp>Well, they are and they aren’t.\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2020/12/14/portrait-of-the-coronavirus-at-1/\" target=\"_blank\" rel=\"noopener noreferrer\">SARS-CoV-2\u003c/a>, the virus that causes COVID-19, has been mutating all along; that’s just what viruses do. Many of those mutations don’t change the virus substantively, and some might actually be detrimental to the virus, making that variant likely to die out.\u003c/p>\n\u003cp>But every so often, a mutation or combination of mutations will give rise to a new form of the virus with an evolutionary edge, like being able to infect cells better or spread faster. This new variant can outpace earlier iterations of the virus and become dominant.\u003c/p>\n\u003cp>Early on in the pandemic, a mutation known as D614G seems to have given the virus a boost in its infectiousness, and variants with the mutation became the most prevalent around the world.\u003c/p>\n\u003cp>Beyond the fact that the virus is constantly changing, there are other reasons why these “fitter” variants have started to emerge. In the early days of the pandemic, when just about all of us were vulnerable to COVID-19, any infectious variant had a pretty easy time circulating. But as more people in certain areas have become protected — either after an initial infection or vaccination — pressure on the virus has increased. A so-so spreader might no longer be able to find new hosts (that’s us) to infect, but variants with mutations that help them spread can still transmit, and can take off from there.\u003c/p>\n\u003cp>“We’ve reached a point one year on and in certain parts of the world where the density of natural immunity is sufficient so that the variants that have got a fitness advantage … are more likely to emerge and spread,” said Wendy Barclay, the head of infectious diseases at Imperial College London.\u003c/p>\n\u003cp>From the time SARS-2 got on people’s radars in late 2019, it was already quite well-suited to infecting humans, even compared to SARS and MERS, the other coronaviruses that have caused health emergencies in recent decades. But that’s not to say that SARS-2 didn’t have room to improve.\u003c/p>\n\u003cp>“Compared to SARS or MERS, it was already quite capable, but that doesn’t mean that it couldn’t become more capable,” said Kristian Andersen, an infectious diseases expert at Scripps Research Institute. “And that’s what we’re observing now.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2020/12/21/looming-questions-new-variant-coronavirus/\" target=\"_blank\" rel=\"noopener noreferrer\">The variant that first appeared\u003c/a> in the U.K. — and perhaps others as well — is a bit of a special situation. Most people who have an acute case of COVID-19 will vanquish the virus after a relatively short period of time. But it’s thought that this variant, dubbed B.1.1.7, came from a person who was immunocompromised and had a rare chronic case, essentially providing an incubator for the virus to accrue mutations as it replicated for weeks or months in that person’s body. The virus, the hypothesis goes, then spread from that person to others.\u003c/p>\n\u003cp>\u003cstrong>If the Virus is Changing all the Time, Why are These Variants Setting Off Alarms?\u003c/strong>\u003c/p>\n\u003cp>For now, let’s focus on the variants that emerged first in the U.K., South Africa and Brazil. (There are at least two variants in Brazil scientists are keeping an eye on). These have the most evidence of greater transmissibility or some other characteristic that might be cause for concern. And, what’s more, they share some of the same mutations despite arising independently. To scientists, that’s a clue that the mutations might confer some evolutionary advantage.\u003c/p>\n\u003cp>When scientists assess the impact of a new viral variant, they consider at least three factors: disease severity, protection, and transmissibility.\u003c/p>\n\u003cp>For now, none of the variants seems to change how sick people get with COVID-19.\u003c/p>\n\u003cp>Answering the question of whether people with existing immunity to SARS-2 are still protected — and whether the vaccines still work — is a bit more complicated. Scientists \u003ca href=\"https://www.statnews.com/2021/01/08/pfizer-biontech-vaccine-mutation-contagious/\" target=\"_blank\" rel=\"noopener noreferrer\">are testing vaccines against\u003c/a> the mutations and variants, and results should be available in the coming weeks. But many experts have a fairly optimistic outlook on the vaccine question. The vaccines generate a multipronged immune response that recognizes and targets different parts of the virus; changes caused by one mutation likely won’t make the virus invisible to protective antibodies generated by immunizations. And even if a mutation reduces the vaccines’ effectiveness a bit, the shots have been shown to be so powerful that they should work just fine even if their potency is taken down a notch.\u003c/p>\n\u003cp>Eventually, scientists think, the virus will accumulate the right combination of mutations to warrant updating the vaccines, a not-that-difficult process for vaccine makers. But it doesn’t appear we’re at that point now (though plenty of studies are ongoing, and some are more anxious than others).\u003c/p>\n\u003cp>There are some concerns about people becoming more vulnerable to reinfection with the new variants. In lab experiments, one of the mutations present in the variants identified in South Africa and Brazil, \u003ca href=\"https://www.statnews.com/2021/01/07/coronavirus-mutation-vaccine-strength/\" target=\"_blank\" rel=\"noopener noreferrer\">called E484K\u003c/a>, has helped the virus evade the antibodies generated after an initial infection in some people.\u003c/p>\n\u003cp>On Monday, \u003ca href=\"https://www.youtube.com/watch?v=Ja_tLG8CLAc\" target=\"_blank\" rel=\"noopener noreferrer\">scientists in South Africa\u003c/a> \u003ca href=\"https://www.nicd.ac.za/can-i-be-re-infected-with-the-new-variant-if-ive-had-covid-19/?utm_content=bufferd4649&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer\" target=\"_blank\" rel=\"noopener noreferrer\">reported\u003c/a> that antibodies from some people infected during the country’s first wave failed to recognize the newer variant spreading there now; \u003ca href=\"https://twitter.com/nicd_sa/status/1351210100996845580\" target=\"_blank\" rel=\"noopener noreferrer\">they didn’t have results yet\u003c/a> about its impact on vaccine-elicited antibodies. Separately, in Brazil, surging cases in a region that had already been hit hard by the virus raised worries that a different variant, called P.1, is able to sneak past existing protection and infect people again. (More on that in a second.)\u003c/p>\n\u003cp>When it comes to transmissibility, it seems that these variants do spread more easily — though there are wide-ranging estimates for just how much more infectious they are.\u003c/p>\n\u003cp>\u003cstrong>What Does a More Transmissible Virus Mean?\u003c/strong>\u003c/p>\n\u003cp>Because a more transmissible variant can infect more people more quickly, it leads to more cases overall without mitigation efforts. Even if people individually aren’t likely to get sicker, the result is that there will be \u003ca href=\"https://www.statnews.com/2021/01/14/more-infectious-variants-could-make-things-much-worse/\" target=\"_blank\" rel=\"noopener noreferrer\">more hospitalizations and deaths\u003c/a>. (One caveat: Widespread vaccinations could prevent some of those.)\u003c/p>\n\u003cp>Faster-spreading viruses also require a greater proportion of a population to be protected for herd immunity to be achieved. Vaccine campaigns will have to reach even more people.\u003c/p>\n\u003cp>That also means that more contagious variants can spread in communities that, even if they hadn’t hit herd immunity, had enough immune people to blunt the circulation of SARS-2.\u003c/p>\n\u003cp>The arrival of more transmissible variants is “bad news, because that means some places that had already started to see protective effects become vulnerable again,” said Caitlin Rivers, an infectious diseases epidemiologist at the Johns Hopkins Center for Health Security.\u003c/p>\n\u003cp>\u003cstrong>What’s Happening in Brazil?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://science.sciencemag.org/content/371/6526/288\" target=\"_blank\" rel=\"noopener noreferrer\">A recent study estimated\u003c/a> that three-quarters of residents of the city of Manaus, Brazil had been infected by SARS-2 by October. The hope was that this level of protection might act as a buffer against more transmission. But last month, cases started rising in the city and its state of Amazonas, straining local health systems once again.\u003c/p>\n\u003cp>When researchers dug into the viral sequences, they found many cases involved a new variant, called P.1, as \u003ca href=\"https://virological.org/t/genomic-characterisation-of-an-emergent-sars-cov-2-lineage-in-manaus-preliminary-findings/586\" target=\"_blank\" rel=\"noopener noreferrer\">reported last week\u003c/a>. (P.1. has also been identified in people who traveled from Brazil to Japan.) They warned the mutations it contained (including E484K) are “potentially associated with an increase in transmissibility or propensity for re-infection of individuals.”\u003c/p>\n\u003cp>Scientists suspect there are several potential factors at work in Manaus, which could be playing out together. They’re investigating.\u003c/p>\n\u003cp>Maybe P.1 is indeed able to evade some existing immune protection, leaving people more susceptible to reinfection. \u003ca href=\"https://virological.org/t/sars-cov-2-reinfection-by-the-new-variant-of-concern-voc-p-1-in-amazonas-brazil/596\" target=\"_blank\" rel=\"noopener noreferrer\">Scientists on Sunday confirmed\u003c/a> a case of reinfection caused by P.1 in Amazonas.\u003c/p>\n\u003cp>Or perhaps P.1 is so transmissible that it can spread just fine even in communities with 75% protection.\u003c/p>\n\u003cp>Or what if some people in Amazonas who were infected months ago are just generally becoming susceptible again to any form of reinfection, regardless of variants? Though immune responses vary, it’s thought that most people who fend off the virus will have lasting protection for some time — but that it will wane. Already, some reinfections have been reported around the world, without the involvement of more transmissible variants. (It’s thought that reinfections with SARS-2 will generally be milder for most people than their initial case because they still have some immune memory to the virus, even if their systems couldn’t block infection entirely. Scientists will be looking out to see if that holds with different variants.)\u003c/p>\n\u003cp>\u003cstrong>What are Scientists Doing About all This?\u003c/strong>\u003c/p>\n\u003cp>Studying it from all angles. One line of inquiry is examining the effects of mutations in isolation and in concert with the other changes dotting the virus’ RNA genome. Essentially, a mutation on its own may not have much of an impact, but it can help a virus spread better or replicate faster if it’s paired with certain other mutations.\u003c/p>\n\u003cp>Scientists are also on the lookout for other potential variants of concern as they comb through sequencing data. But there’s a sense among some experts that new variants are being announced without much helpful information. Lots of mutations will be discovered; it can take some time to figure out what, if anything, each one means.\u003c/p>\n\u003cp>In California, for example, officials held a press conference Sunday to discuss the L452R variant, which has grown from accounting for 3.8% of samples sequenced in the state in the first half of December to 25.2% of sequences heading into January. “We do not know whether it’s more infectious yet,” UCSF virologist Charles Chiu said, though he added, “it is concerning that it may potentially be more infectious.”\u003c/p>\n\u003cp>Outside experts were quick to say that more evidence is needed before such a claim can be verified. The variant was first seen in California in May, and hovered at low levels while the state was at low levels of virus overall. Then, it started to increase as the \u003ca href=\"https://www.statnews.com/2021/01/15/los-angeles-ambulances-circle-for-hours-icus-full-is-this-what-covid19-has-in-store-for-rest-of-the-country/\" target=\"_blank\" rel=\"noopener noreferrer\">state was suffering from major outbreaks\u003c/a>. This can create the illusion that the variant — because it’s so much more prevalent — was perhaps driving the cases. But without more data, it’s just as likely the variant didn’t cause the wave, but simply “went along for the ride,” Goldstein said.\u003c/p>\n\u003cp>\u003cstrong>And What Can I Do About It?\u003c/strong>\u003c/p>\n\u003cp>Commit to the same precautions that have been recommended for months, experts say. Perhaps invest in a better mask than a fabric face covering. Get vaccinated when you can.\u003c/p>\n\u003cp>Public health authorities have been stressing that the new variants aren’t solely responsible for the raging epidemics happening around the world. The United States has never really had a handle on its epidemic, and the most recent surge in cases was driven not by a more transmissible iteration of the virus, but because of lax policies and a lack of precautions.\u003c/p>\n\u003cp>“It’s too easy to just lay the blame on the variant and say, it’s the virus that did it,” Mike Ryan, the head of the World Health Organization’s emergencies program, said Friday. “Unfortunately, it’s also what we didn’t do that did it, and we have to be able to accept our share individually and as communities, as governments, our share of the responsibility in this virus getting out of control, while recognizing the variants in the virus make it difficult.”\u003c/p>\n\u003cp>The emergence of the variants has given experts a new line of argument in their regular pleas that people and governments should do all they can to drive down transmission generally. Slowing spread can buy time for more people to get vaccinated before one of the more transmissible variants becomes dominant — which could happen in the United States as soon as March, a model released by the Centers for Disease Control and Prevention \u003ca href=\"https://www.statnews.com/2021/01/15/covid19-b117-variant-cdc/\" target=\"_blank\" rel=\"noopener noreferrer\">last week showed\u003c/a>.\u003c/p>\n\u003cp>And the more the virus spreads, the higher likelihood that even fitter variants will emerge. Evolution is driven not only by the environment the virus finds itself in, but also, as Barclay put it, “the number of times you roll the dice.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Helen Branswell contributed reporting.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">T\u003c/span>\u003c/span>he coronavirus variants are, in a word, confusing.\u003c/p>\n\u003cp>By now, you have likely heard about different variants that first raised trouble in the United Kingdom, South Africa, Brazil, and now maybe California — though the jury is very much out on whether that last one is cause for concern. To make a messy alphabet soup even more jumbled, these variants have unwieldy names, and they each contain mutations with unwieldy names of their own. The result is that people are left trying to differentiate among B.1.1.7 and N501Y and E484K and C-3PO.\u003c/p>\n\u003cp>Wait, sorry, that last one is from “Star Wars.”\u003c/p>\n\u003cp>The point is that all of this is difficult to keep track of, and it will only grow more confusing with more variants likely to turn up. “It’s becoming a mutation-of-the-week game,” said Stephen Goldstein, a coronavirologist at the University of Utah.\u003c/p>\n\u003cp>Below, STAT explains what’s known about the variants, why they’re getting so much attention, and what they mean for the trajectory of the pandemic.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Why Are Variants Popping Up Now?\u003c/strong>\u003c/p>\n\u003cp>Well, they are and they aren’t.\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2020/12/14/portrait-of-the-coronavirus-at-1/\" target=\"_blank\" rel=\"noopener noreferrer\">SARS-CoV-2\u003c/a>, the virus that causes COVID-19, has been mutating all along; that’s just what viruses do. Many of those mutations don’t change the virus substantively, and some might actually be detrimental to the virus, making that variant likely to die out.\u003c/p>\n\u003cp>But every so often, a mutation or combination of mutations will give rise to a new form of the virus with an evolutionary edge, like being able to infect cells better or spread faster. This new variant can outpace earlier iterations of the virus and become dominant.\u003c/p>\n\u003cp>Early on in the pandemic, a mutation known as D614G seems to have given the virus a boost in its infectiousness, and variants with the mutation became the most prevalent around the world.\u003c/p>\n\u003cp>Beyond the fact that the virus is constantly changing, there are other reasons why these “fitter” variants have started to emerge. In the early days of the pandemic, when just about all of us were vulnerable to COVID-19, any infectious variant had a pretty easy time circulating. But as more people in certain areas have become protected — either after an initial infection or vaccination — pressure on the virus has increased. A so-so spreader might no longer be able to find new hosts (that’s us) to infect, but variants with mutations that help them spread can still transmit, and can take off from there.\u003c/p>\n\u003cp>“We’ve reached a point one year on and in certain parts of the world where the density of natural immunity is sufficient so that the variants that have got a fitness advantage … are more likely to emerge and spread,” said Wendy Barclay, the head of infectious diseases at Imperial College London.\u003c/p>\n\u003cp>From the time SARS-2 got on people’s radars in late 2019, it was already quite well-suited to infecting humans, even compared to SARS and MERS, the other coronaviruses that have caused health emergencies in recent decades. But that’s not to say that SARS-2 didn’t have room to improve.\u003c/p>\n\u003cp>“Compared to SARS or MERS, it was already quite capable, but that doesn’t mean that it couldn’t become more capable,” said Kristian Andersen, an infectious diseases expert at Scripps Research Institute. “And that’s what we’re observing now.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2020/12/21/looming-questions-new-variant-coronavirus/\" target=\"_blank\" rel=\"noopener noreferrer\">The variant that first appeared\u003c/a> in the U.K. — and perhaps others as well — is a bit of a special situation. Most people who have an acute case of COVID-19 will vanquish the virus after a relatively short period of time. But it’s thought that this variant, dubbed B.1.1.7, came from a person who was immunocompromised and had a rare chronic case, essentially providing an incubator for the virus to accrue mutations as it replicated for weeks or months in that person’s body. The virus, the hypothesis goes, then spread from that person to others.\u003c/p>\n\u003cp>\u003cstrong>If the Virus is Changing all the Time, Why are These Variants Setting Off Alarms?\u003c/strong>\u003c/p>\n\u003cp>For now, let’s focus on the variants that emerged first in the U.K., South Africa and Brazil. (There are at least two variants in Brazil scientists are keeping an eye on). These have the most evidence of greater transmissibility or some other characteristic that might be cause for concern. And, what’s more, they share some of the same mutations despite arising independently. To scientists, that’s a clue that the mutations might confer some evolutionary advantage.\u003c/p>\n\u003cp>When scientists assess the impact of a new viral variant, they consider at least three factors: disease severity, protection, and transmissibility.\u003c/p>\n\u003cp>For now, none of the variants seems to change how sick people get with COVID-19.\u003c/p>\n\u003cp>Answering the question of whether people with existing immunity to SARS-2 are still protected — and whether the vaccines still work — is a bit more complicated. Scientists \u003ca href=\"https://www.statnews.com/2021/01/08/pfizer-biontech-vaccine-mutation-contagious/\" target=\"_blank\" rel=\"noopener noreferrer\">are testing vaccines against\u003c/a> the mutations and variants, and results should be available in the coming weeks. But many experts have a fairly optimistic outlook on the vaccine question. The vaccines generate a multipronged immune response that recognizes and targets different parts of the virus; changes caused by one mutation likely won’t make the virus invisible to protective antibodies generated by immunizations. And even if a mutation reduces the vaccines’ effectiveness a bit, the shots have been shown to be so powerful that they should work just fine even if their potency is taken down a notch.\u003c/p>\n\u003cp>Eventually, scientists think, the virus will accumulate the right combination of mutations to warrant updating the vaccines, a not-that-difficult process for vaccine makers. But it doesn’t appear we’re at that point now (though plenty of studies are ongoing, and some are more anxious than others).\u003c/p>\n\u003cp>There are some concerns about people becoming more vulnerable to reinfection with the new variants. In lab experiments, one of the mutations present in the variants identified in South Africa and Brazil, \u003ca href=\"https://www.statnews.com/2021/01/07/coronavirus-mutation-vaccine-strength/\" target=\"_blank\" rel=\"noopener noreferrer\">called E484K\u003c/a>, has helped the virus evade the antibodies generated after an initial infection in some people.\u003c/p>\n\u003cp>On Monday, \u003ca href=\"https://www.youtube.com/watch?v=Ja_tLG8CLAc\" target=\"_blank\" rel=\"noopener noreferrer\">scientists in South Africa\u003c/a> \u003ca href=\"https://www.nicd.ac.za/can-i-be-re-infected-with-the-new-variant-if-ive-had-covid-19/?utm_content=bufferd4649&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer\" target=\"_blank\" rel=\"noopener noreferrer\">reported\u003c/a> that antibodies from some people infected during the country’s first wave failed to recognize the newer variant spreading there now; \u003ca href=\"https://twitter.com/nicd_sa/status/1351210100996845580\" target=\"_blank\" rel=\"noopener noreferrer\">they didn’t have results yet\u003c/a> about its impact on vaccine-elicited antibodies. Separately, in Brazil, surging cases in a region that had already been hit hard by the virus raised worries that a different variant, called P.1, is able to sneak past existing protection and infect people again. (More on that in a second.)\u003c/p>\n\u003cp>When it comes to transmissibility, it seems that these variants do spread more easily — though there are wide-ranging estimates for just how much more infectious they are.\u003c/p>\n\u003cp>\u003cstrong>What Does a More Transmissible Virus Mean?\u003c/strong>\u003c/p>\n\u003cp>Because a more transmissible variant can infect more people more quickly, it leads to more cases overall without mitigation efforts. Even if people individually aren’t likely to get sicker, the result is that there will be \u003ca href=\"https://www.statnews.com/2021/01/14/more-infectious-variants-could-make-things-much-worse/\" target=\"_blank\" rel=\"noopener noreferrer\">more hospitalizations and deaths\u003c/a>. (One caveat: Widespread vaccinations could prevent some of those.)\u003c/p>\n\u003cp>Faster-spreading viruses also require a greater proportion of a population to be protected for herd immunity to be achieved. Vaccine campaigns will have to reach even more people.\u003c/p>\n\u003cp>That also means that more contagious variants can spread in communities that, even if they hadn’t hit herd immunity, had enough immune people to blunt the circulation of SARS-2.\u003c/p>\n\u003cp>The arrival of more transmissible variants is “bad news, because that means some places that had already started to see protective effects become vulnerable again,” said Caitlin Rivers, an infectious diseases epidemiologist at the Johns Hopkins Center for Health Security.\u003c/p>\n\u003cp>\u003cstrong>What’s Happening in Brazil?\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"https://science.sciencemag.org/content/371/6526/288\" target=\"_blank\" rel=\"noopener noreferrer\">A recent study estimated\u003c/a> that three-quarters of residents of the city of Manaus, Brazil had been infected by SARS-2 by October. The hope was that this level of protection might act as a buffer against more transmission. But last month, cases started rising in the city and its state of Amazonas, straining local health systems once again.\u003c/p>\n\u003cp>When researchers dug into the viral sequences, they found many cases involved a new variant, called P.1, as \u003ca href=\"https://virological.org/t/genomic-characterisation-of-an-emergent-sars-cov-2-lineage-in-manaus-preliminary-findings/586\" target=\"_blank\" rel=\"noopener noreferrer\">reported last week\u003c/a>. (P.1. has also been identified in people who traveled from Brazil to Japan.) They warned the mutations it contained (including E484K) are “potentially associated with an increase in transmissibility or propensity for re-infection of individuals.”\u003c/p>\n\u003cp>Scientists suspect there are several potential factors at work in Manaus, which could be playing out together. They’re investigating.\u003c/p>\n\u003cp>Maybe P.1 is indeed able to evade some existing immune protection, leaving people more susceptible to reinfection. \u003ca href=\"https://virological.org/t/sars-cov-2-reinfection-by-the-new-variant-of-concern-voc-p-1-in-amazonas-brazil/596\" target=\"_blank\" rel=\"noopener noreferrer\">Scientists on Sunday confirmed\u003c/a> a case of reinfection caused by P.1 in Amazonas.\u003c/p>\n\u003cp>Or perhaps P.1 is so transmissible that it can spread just fine even in communities with 75% protection.\u003c/p>\n\u003cp>Or what if some people in Amazonas who were infected months ago are just generally becoming susceptible again to any form of reinfection, regardless of variants? Though immune responses vary, it’s thought that most people who fend off the virus will have lasting protection for some time — but that it will wane. Already, some reinfections have been reported around the world, without the involvement of more transmissible variants. (It’s thought that reinfections with SARS-2 will generally be milder for most people than their initial case because they still have some immune memory to the virus, even if their systems couldn’t block infection entirely. Scientists will be looking out to see if that holds with different variants.)\u003c/p>\n\u003cp>\u003cstrong>What are Scientists Doing About all This?\u003c/strong>\u003c/p>\n\u003cp>Studying it from all angles. One line of inquiry is examining the effects of mutations in isolation and in concert with the other changes dotting the virus’ RNA genome. Essentially, a mutation on its own may not have much of an impact, but it can help a virus spread better or replicate faster if it’s paired with certain other mutations.\u003c/p>\n\u003cp>Scientists are also on the lookout for other potential variants of concern as they comb through sequencing data. But there’s a sense among some experts that new variants are being announced without much helpful information. Lots of mutations will be discovered; it can take some time to figure out what, if anything, each one means.\u003c/p>\n\u003cp>In California, for example, officials held a press conference Sunday to discuss the L452R variant, which has grown from accounting for 3.8% of samples sequenced in the state in the first half of December to 25.2% of sequences heading into January. “We do not know whether it’s more infectious yet,” UCSF virologist Charles Chiu said, though he added, “it is concerning that it may potentially be more infectious.”\u003c/p>\n\u003cp>Outside experts were quick to say that more evidence is needed before such a claim can be verified. The variant was first seen in California in May, and hovered at low levels while the state was at low levels of virus overall. Then, it started to increase as the \u003ca href=\"https://www.statnews.com/2021/01/15/los-angeles-ambulances-circle-for-hours-icus-full-is-this-what-covid19-has-in-store-for-rest-of-the-country/\" target=\"_blank\" rel=\"noopener noreferrer\">state was suffering from major outbreaks\u003c/a>. This can create the illusion that the variant — because it’s so much more prevalent — was perhaps driving the cases. But without more data, it’s just as likely the variant didn’t cause the wave, but simply “went along for the ride,” Goldstein said.\u003c/p>\n\u003cp>\u003cstrong>And What Can I Do About It?\u003c/strong>\u003c/p>\n\u003cp>Commit to the same precautions that have been recommended for months, experts say. Perhaps invest in a better mask than a fabric face covering. Get vaccinated when you can.\u003c/p>\n\u003cp>Public health authorities have been stressing that the new variants aren’t solely responsible for the raging epidemics happening around the world. The United States has never really had a handle on its epidemic, and the most recent surge in cases was driven not by a more transmissible iteration of the virus, but because of lax policies and a lack of precautions.\u003c/p>\n\u003cp>“It’s too easy to just lay the blame on the variant and say, it’s the virus that did it,” Mike Ryan, the head of the World Health Organization’s emergencies program, said Friday. “Unfortunately, it’s also what we didn’t do that did it, and we have to be able to accept our share individually and as communities, as governments, our share of the responsibility in this virus getting out of control, while recognizing the variants in the virus make it difficult.”\u003c/p>\n\u003cp>The emergence of the variants has given experts a new line of argument in their regular pleas that people and governments should do all they can to drive down transmission generally. Slowing spread can buy time for more people to get vaccinated before one of the more transmissible variants becomes dominant — which could happen in the United States as soon as March, a model released by the Centers for Disease Control and Prevention \u003ca href=\"https://www.statnews.com/2021/01/15/covid19-b117-variant-cdc/\" target=\"_blank\" rel=\"noopener noreferrer\">last week showed\u003c/a>.\u003c/p>\n\u003cp>And the more the virus spreads, the higher likelihood that even fitter variants will emerge. Evolution is driven not only by the environment the virus finds itself in, but also, as Barclay put it, “the number of times you roll the dice.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>Helen Branswell contributed reporting.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "The U.S. Plans to Expand Vaccine Access to Tens of Millions. That Could be a Problem for Biden",
"headTitle": "The U.S. Plans to Expand Vaccine Access to Tens of Millions. That Could be a Problem for Biden | KQED",
"content": "\u003cp>As health authorities across the country struggle to get COVID-19 vaccination programs up and running, outgoing Health and Human Services Secretary Alex Azar threw a new wrench into the works on Tuesday, telling states to expand priority access to tens of millions of additional people immediately.\u003c/p>\n\u003cp>But it will be several months before there is enough vaccine available to meet that kind of demand. The move all but ensures the current narrative around the vaccine rollout — it’s too slow — will shift, but not in a positive direction: The incoming Biden administration will likely face a groundswell of complaints about long lines, failed efforts to find vaccine supplies, and an inequitable distribution system as it tries to live up to its promise of seeing 100 million vaccine doses administered in the new president’s first 100 days in office.\u003c/p>\n\u003cp>Azar’s new instructions put 152 million people — about half of the adult population of the country — at the front of the vaccine line. But Operation Warp Speed, the U.S. effort to fast-track the development and distribution of vaccine, currently estimates it will take until the end of March before it has 200 million doses to distribute. Even if those doses can be manufactured and shipped seamlessly, that’s only enough for 100 million people, given that the currently authorized vaccines require two doses each.\u003c/p>\n\u003cp>The new prioritization scheme pushes everyone 65 and older, as well as people 16 and older with one high-risk medical condition, to the front of the vaccine line, where they join health workers and nursing home residents and staff. (The Centers for Disease Control and Prevention’s list of health conditions that put people at high risk of severe COVID infection is \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html\" target=\"_blank\" rel=\"noopener noreferrer\">here\u003c/a>.)\u003c/p>\n\u003cp>If states follow Azar’s instructions, a 24-year-old smoker who works from home would have the same vaccine priority status as a frail 85-year-old — and would be ahead of non-smoking teachers, municipal bus drivers, meat packing plant employees, and other frontline essential workers whom the CDC had previously recommended should be vaccinated in Phase 1b.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>States, lacking sufficient federal funding and coping with limited supplies, have struggled to complete the vaccination of people in Phase 1a, which includes health workers plus the residents and staff of long-term care facilities — a population of about 24 million people. Federal officials believe the efforts will get easier as more supply becomes available, but to date only about \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#vaccinations\" target=\"_blank\" rel=\"noopener noreferrer\">9.3 million people\u003c/a> have received their first dose of vaccine, according to the CDC.\u003c/p>\n\u003cp>The initial prioritization schedule was drawn up by the Advisory Committee on Immunization Practices, an expert panel that provided recommendations to the CDC. ACIP envisioned frontline essential workers and adults 75 and older being included in the second phase of the vaccine rollout. There are an estimated 49 million people in those two groups, a more manageable figure in a time of vaccine scarcity.\u003c/p>\n\u003cp>In upending the prioritization schedule, Azar has pushed to the front of the line people he wanted to see there in the first place. When the ACIP recommended health workers and nursing home residents for Phase 1a, he pressed for changing the first group to people 65 and older, \u003ca href=\"https://www.statnews.com/2020/11/30/divisions-emerge-among-u-s-officials-over-when-first-covid-19-vaccine-doses-will-be-available-and-for-whom/\">STAT reported in November\u003c/a>. But CDC Director Robert Redfield had already signed off on the recommendation.\u003c/p>\n\u003cp>The ACIP plan had its critics, too, with some experts questioning how workable it would be to require pharmacists or people working in a vaccine clinic to determine who qualified as a frontline essential worker.\u003c/p>\n\u003cp>“Who’s supposed to be the gatekeeper for that? I mean, you can’t go to Rite Aid and Walgreens and ask the pharmacist to be the gatekeeper, which is essentially what you’d have to do,” Peter Hotez, co-director of the Texas Children’s Center for Vaccine Development, said in an interview.\u003c/p>\n\u003cp>Hotez, who published \u003ca href=\"https://www.washingtonpost.com/outlook/2021/01/11/vaccine-distribution-how-fix/\" target=\"_blank\" rel=\"noopener noreferrer\">an opinion piece\u003c/a> in the Washington Post on Monday urging changes to the vaccination rollout, said the stages outlined by the ACIP were too complex and were slowing down the program. “So my view is to toss ’em at this point.”\u003c/p>\n\u003cp>Beth Bell, a global health professor at the University of Washington who chaired a working group that devised the ACIP’s recommendations, expressed dismay at Azar’s instruction to the states.\u003c/p>\n\u003cp>“We all want the most effective and efficient vaccination program. But I’m quite concerned this approach … is not the best way to get us there,” Bell said.\u003c/p>\n\u003cp>The outgoing HHS secretary blamed states for the slow pace of the rollout, saying some are hewing so closely to prioritization schedules that they are not using the doses they have been allotted. “Some states’ heavy-handed, micromanagement of this process has stood in the way of vaccines reaching a broader swath of the vulnerable population more quickly,” Azar said.\u003c/p>\n\u003cp>He also put states on warning that those that don’t rapidly use their doses will see their supplies diminished in the future. Vaccination allocation so far has been based strictly on a population basis; beginning in two weeks, states that rapidly use their doses will get a larger allocation.\u003c/p>\n\u003cp>But in two weeks’ time, Azar will not be the HHS secretary, meaning it’s unclear if the plan will hold.\u003c/p>\n\u003cp>If states follow Azar’s instructions, efforts to protect frontline essential workers — people who cannot work from home and whose work puts them at greater risk of contracting COVID — will tumble further back in the prioritization scheme.\u003c/p>\n\u003cp>“By opening things up … there would be some gains in efficiency, but there would be significant losses as it relates to equity, racial justice, and the ability to … prevent morbidity and mortality in a high-risk group,” said Kristen Ehresmann, director of infectious disease epidemiology, prevention, and control for the Minnesota Department of Health.\u003c/p>\n\u003cp>“You gain something and you lose some things,” she said. “And I think many of the things you lose are really important things.”\u003c/p>\n\u003cp>Saad Omer, director of Yale University’s Institute of Global Health, supported prioritizing adults over the age of 65. But Omer, who was on a National Academy of Medicine panel that recommended vaccine priority groups and who worked on a priority schedule for the World Health Organization, said changing the advice at this point will come at a cost. State and local public health authorities will have to junk some plans and draft others.\u003c/p>\n\u003cp>“There’s been whiplash at the state level,” said Omer, who noted these decisions should have been made months ago. “And all the community-based partners are thoroughly confused.”\u003c/p>\n\u003cp>Azar on Tuesday also announced that Operation Warp Speed will no longer hold back half of vaccine supplies, a move it took to ensure that when people need to get their booster dose, there was enough available to give them a second, matching vaccine in the timeframe required — 21 days for the vaccine developed by Pfizer and BioNTech, and 28 days for the one developed by Moderna. The incoming Biden administration previously said it planned to rescind the policy.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Tom Frieden, former director of the CDC, was among the people who criticized the original decision to hold back the second dose. “You need to flood the zone with the vaccine that’s available, anticipating that the manufacturers will not fail,” said Frieden, who is now president and CEO of the global health initiative Resolve to Save Lives.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>As health authorities across the country struggle to get COVID-19 vaccination programs up and running, outgoing Health and Human Services Secretary Alex Azar threw a new wrench into the works on Tuesday, telling states to expand priority access to tens of millions of additional people immediately.\u003c/p>\n\u003cp>But it will be several months before there is enough vaccine available to meet that kind of demand. The move all but ensures the current narrative around the vaccine rollout — it’s too slow — will shift, but not in a positive direction: The incoming Biden administration will likely face a groundswell of complaints about long lines, failed efforts to find vaccine supplies, and an inequitable distribution system as it tries to live up to its promise of seeing 100 million vaccine doses administered in the new president’s first 100 days in office.\u003c/p>\n\u003cp>Azar’s new instructions put 152 million people — about half of the adult population of the country — at the front of the vaccine line. But Operation Warp Speed, the U.S. effort to fast-track the development and distribution of vaccine, currently estimates it will take until the end of March before it has 200 million doses to distribute. Even if those doses can be manufactured and shipped seamlessly, that’s only enough for 100 million people, given that the currently authorized vaccines require two doses each.\u003c/p>\n\u003cp>The new prioritization scheme pushes everyone 65 and older, as well as people 16 and older with one high-risk medical condition, to the front of the vaccine line, where they join health workers and nursing home residents and staff. (The Centers for Disease Control and Prevention’s list of health conditions that put people at high risk of severe COVID infection is \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html\" target=\"_blank\" rel=\"noopener noreferrer\">here\u003c/a>.)\u003c/p>\n\u003cp>If states follow Azar’s instructions, a 24-year-old smoker who works from home would have the same vaccine priority status as a frail 85-year-old — and would be ahead of non-smoking teachers, municipal bus drivers, meat packing plant employees, and other frontline essential workers whom the CDC had previously recommended should be vaccinated in Phase 1b.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>States, lacking sufficient federal funding and coping with limited supplies, have struggled to complete the vaccination of people in Phase 1a, which includes health workers plus the residents and staff of long-term care facilities — a population of about 24 million people. Federal officials believe the efforts will get easier as more supply becomes available, but to date only about \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#vaccinations\" target=\"_blank\" rel=\"noopener noreferrer\">9.3 million people\u003c/a> have received their first dose of vaccine, according to the CDC.\u003c/p>\n\u003cp>The initial prioritization schedule was drawn up by the Advisory Committee on Immunization Practices, an expert panel that provided recommendations to the CDC. ACIP envisioned frontline essential workers and adults 75 and older being included in the second phase of the vaccine rollout. There are an estimated 49 million people in those two groups, a more manageable figure in a time of vaccine scarcity.\u003c/p>\n\u003cp>In upending the prioritization schedule, Azar has pushed to the front of the line people he wanted to see there in the first place. When the ACIP recommended health workers and nursing home residents for Phase 1a, he pressed for changing the first group to people 65 and older, \u003ca href=\"https://www.statnews.com/2020/11/30/divisions-emerge-among-u-s-officials-over-when-first-covid-19-vaccine-doses-will-be-available-and-for-whom/\">STAT reported in November\u003c/a>. But CDC Director Robert Redfield had already signed off on the recommendation.\u003c/p>\n\u003cp>The ACIP plan had its critics, too, with some experts questioning how workable it would be to require pharmacists or people working in a vaccine clinic to determine who qualified as a frontline essential worker.\u003c/p>\n\u003cp>“Who’s supposed to be the gatekeeper for that? I mean, you can’t go to Rite Aid and Walgreens and ask the pharmacist to be the gatekeeper, which is essentially what you’d have to do,” Peter Hotez, co-director of the Texas Children’s Center for Vaccine Development, said in an interview.\u003c/p>\n\u003cp>Hotez, who published \u003ca href=\"https://www.washingtonpost.com/outlook/2021/01/11/vaccine-distribution-how-fix/\" target=\"_blank\" rel=\"noopener noreferrer\">an opinion piece\u003c/a> in the Washington Post on Monday urging changes to the vaccination rollout, said the stages outlined by the ACIP were too complex and were slowing down the program. “So my view is to toss ’em at this point.”\u003c/p>\n\u003cp>Beth Bell, a global health professor at the University of Washington who chaired a working group that devised the ACIP’s recommendations, expressed dismay at Azar’s instruction to the states.\u003c/p>\n\u003cp>“We all want the most effective and efficient vaccination program. But I’m quite concerned this approach … is not the best way to get us there,” Bell said.\u003c/p>\n\u003cp>The outgoing HHS secretary blamed states for the slow pace of the rollout, saying some are hewing so closely to prioritization schedules that they are not using the doses they have been allotted. “Some states’ heavy-handed, micromanagement of this process has stood in the way of vaccines reaching a broader swath of the vulnerable population more quickly,” Azar said.\u003c/p>\n\u003cp>He also put states on warning that those that don’t rapidly use their doses will see their supplies diminished in the future. Vaccination allocation so far has been based strictly on a population basis; beginning in two weeks, states that rapidly use their doses will get a larger allocation.\u003c/p>\n\u003cp>But in two weeks’ time, Azar will not be the HHS secretary, meaning it’s unclear if the plan will hold.\u003c/p>\n\u003cp>If states follow Azar’s instructions, efforts to protect frontline essential workers — people who cannot work from home and whose work puts them at greater risk of contracting COVID — will tumble further back in the prioritization scheme.\u003c/p>\n\u003cp>“By opening things up … there would be some gains in efficiency, but there would be significant losses as it relates to equity, racial justice, and the ability to … prevent morbidity and mortality in a high-risk group,” said Kristen Ehresmann, director of infectious disease epidemiology, prevention, and control for the Minnesota Department of Health.\u003c/p>\n\u003cp>“You gain something and you lose some things,” she said. “And I think many of the things you lose are really important things.”\u003c/p>\n\u003cp>Saad Omer, director of Yale University’s Institute of Global Health, supported prioritizing adults over the age of 65. But Omer, who was on a National Academy of Medicine panel that recommended vaccine priority groups and who worked on a priority schedule for the World Health Organization, said changing the advice at this point will come at a cost. State and local public health authorities will have to junk some plans and draft others.\u003c/p>\n\u003cp>“There’s been whiplash at the state level,” said Omer, who noted these decisions should have been made months ago. “And all the community-based partners are thoroughly confused.”\u003c/p>\n\u003cp>Azar on Tuesday also announced that Operation Warp Speed will no longer hold back half of vaccine supplies, a move it took to ensure that when people need to get their booster dose, there was enough available to give them a second, matching vaccine in the timeframe required — 21 days for the vaccine developed by Pfizer and BioNTech, and 28 days for the one developed by Moderna. The incoming Biden administration previously said it planned to rescind the policy.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Tom Frieden, former director of the CDC, was among the people who criticized the original decision to hold back the second dose. “You need to flood the zone with the vaccine that’s available, anticipating that the manufacturers will not fail,” said Frieden, who is now president and CEO of the global health initiative Resolve to Save Lives.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "FDA Authorizes Moderna's Coronavirus Vaccine",
"headTitle": "FDA Authorizes Moderna’s Coronavirus Vaccine | KQED",
"content": "\u003cp>Health care workers across the U.S. are getting a new arrow in their quiver.\u003c/p>\n\u003cp>On Friday, just one week after Pfizer and BioNTech’s COVID-19 vaccine \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/11/945366548/fda-authorizes-covid-19-vaccine-for-emergency-use-in-u-s\">received a federal green light\u003c/a>, the Food and Drug Administration formally authorized a second vaccine for emergency use — this one developed by Moderna. The \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/17/947628608/how-will-moderna-meet-the-demand-for-its-covid-19-vaccine\">biotech upstart\u003c/a> won authorization for use in adults following extensive federal analysis of the vaccine, which the FDA found to be\u003ca href=\"https://www.npr.org/sections/health-shots/2020/11/16/935239294/modernas-covid-19-vaccine-shines-in-clinical-trial\"> 94% effective\u003c/a> at preventing the disease.\u003c/p>\n\u003cp>“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid\">said a statement\u003c/a> by FDA Commissioner Stephen M. Hahn, M.D.\u003c/p>\n\u003cp>The FDA decision represents another leap forward in the effort to combat the coronavirus, which has already killed \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/14/946045921/how-do-we-grieve-300-000-lives-lost\">more than 300,000 people\u003c/a> in the U.S. alone. Since the Pfizer vaccine’s authorization last week, health and defense officials have launched a \u003ca href=\"https://www.npr.org/2020/12/12/945792399/warp-speed-official-1st-shipments-of-covid-19-vaccine-will-be-delivered-on-monda\">vast effort\u003c/a> to distribute \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/14/946372287/millions-more-covid-19-vaccine-doses-are-on-the-way-u-s-officials-say\">millions of doses\u003c/a> across the country. Health care workers and older adults were first in line for the inoculations when providers \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/14/946232462/incredibly-hopeful-u-s-starts-vaccinating-people-against-covid-19\">began administering\u003c/a> them Monday.\u003c/p>\n\u003cp>In a push to inspire public confidence in the vaccine, Vice President Mike Pence on Friday became the country’s highest-ranking official so far to have it administered. Pence, his wife, Karen, and Surgeon General Jerome Adams all received their shots during a \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/18/947744956/i-didnt-feel-a-thing-pence-gets-coronavirus-vaccine-in-public-event\">televised event\u003c/a> at the White House.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Amid the flurry surrounding the Pfizer vaccine’s rollout, Moderna’s alternative was making steady headway in its own push toward authorization. The FDA released a \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/15/946554638/fda-analysis-of-moderna-covid-19-vaccine-finds-it-effective-and-safe\">glowing analysis\u003c/a> of the vaccine on Tuesday, finding “no specific safety concerns.” On Thursday, an outside panel of health care experts from across the U.S. \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/17/947264730/fda-panel-weighs-modernas-covid-19-vaccine\">unanimously recommended\u003c/a> the vaccine with one abstention.\u003c/p>\n\u003cp>“The question that’s being asked us is, ‘Do we have enough evidence in hand to say that the benefits of this vaccine outweigh what at the moment, as far as severe safety issues go, are theoretical risks?'” \u003ca href=\"https://www.chop.edu/doctors/offit-paul-a\">Dr. Paul Offit\u003c/a>, panel member and vaccine researcher at the Children’s Hospital of Philadelphia, said during the hourslong recorded meeting.\u003c/p>\n\u003cp>“I think the answer to that question is clearly yes. I mean, the question is never ‘When do you know everything?’ It’s ‘When do you know enough?'”\u003c/p>\n\u003cp>Offit’s point also gets at a crucial challenge faced by the federal regulators who have been tasked with evaluating these vaccines more quickly than they normally would. In an effort to expedite the process, the FDA — and other health regulators around the world — have loosened their usual approval procedures and adopted a more urgent mechanism known as \u003ca href=\"https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained\">emergency use authorization\u003c/a>.\u003c/p>\n\u003cp>Moderna \u003ca href=\"https://investors.modernatx.com/news-releases/news-release-details/us-government-exercises-1st-option-additional-100-million-doses\">said it that it will deliver about 20 million doses\u003c/a> by the end of December under its federal supply contract.\u003c/p>\n\u003cp>Now, attentions are turning to the Moderna vaccine’s distribution. Like the Pfizer vaccine, the Moderna product uses messenger RNA technology — which, \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html\">in the FDA’s words\u003c/a>, teaches the body’s cells “how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies.”\u003c/p>\n\u003cp>“That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies,” the agency says.\u003c/p>\n\u003cp>Unlike the Pfizer vaccine, though, Moderna’s product does not need to be stored at \u003ca href=\"https://www.npr.org/sections/health-shots/2020/11/17/935563377/why-does-pfizers-covid-19-vaccine-need-to-be-kept-colder-than-antarctica\">extremely low temperatures\u003c/a>, potentially making it accessible for more communities. Balanced against that is the fact that the smaller biotech firm, in contrast with the pharmaceutical giant Pfizer, may \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/17/947628608/how-will-moderna-meet-the-demand-for-its-covid-19-vaccine\">face some steeper challenges\u003c/a> meeting the extraordinary demand for inoculations.\u003c/p>\n\u003cp>But Dr. Anthony Fauci says he is hopeful that initial distribution will happen quickly.\u003c/p>\n\u003cp>“I would anticipate that we likely will see shots in the arm by the very early part of next week,” the director of the National Institute of Allergy and Infectious Diseases \u003ca href=\"https://www.today.com/video/dr-fauci-anticipates-moderna-vaccine-will-be-administered-by-early-next-week-97983045529\">told NBC’s “\u003c/a>Today” show on Friday in advance of the FDA’s authorization. “I would hope Monday or Tuesday.”\u003c/p>\n\u003cp>Fauci’s institute was instrumental in the development of the Moderna vaccine — from some of the basic science to bankrolling clinical testing. In August, the institute \u003ca href=\"https://www.npr.org/sections/health-shots/2020/08/06/899869278/prices-for-covid-19-vaccines-are-starting-to-come-into-focus\">told NPR\u003c/a> its contributions to the studies of the Moderna vaccine would cost taxpayers more than $400 million.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Operation Warp Speed, the crash federal project for vaccine development, poured in $955 million to support development of the Moderna vaccine, including the expanded phase 3 study that provided the data that made possible the emergency use authorization.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2020 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Moderna%27s+COVID-19+Vaccine+Becomes+2nd+To+Earn+FDA+Authorization&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Health care workers across the U.S. are getting a new arrow in their quiver.\u003c/p>\n\u003cp>On Friday, just one week after Pfizer and BioNTech’s COVID-19 vaccine \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/11/945366548/fda-authorizes-covid-19-vaccine-for-emergency-use-in-u-s\">received a federal green light\u003c/a>, the Food and Drug Administration formally authorized a second vaccine for emergency use — this one developed by Moderna. The \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/17/947628608/how-will-moderna-meet-the-demand-for-its-covid-19-vaccine\">biotech upstart\u003c/a> won authorization for use in adults following extensive federal analysis of the vaccine, which the FDA found to be\u003ca href=\"https://www.npr.org/sections/health-shots/2020/11/16/935239294/modernas-covid-19-vaccine-shines-in-clinical-trial\"> 94% effective\u003c/a> at preventing the disease.\u003c/p>\n\u003cp>“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid\">said a statement\u003c/a> by FDA Commissioner Stephen M. Hahn, M.D.\u003c/p>\n\u003cp>The FDA decision represents another leap forward in the effort to combat the coronavirus, which has already killed \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/14/946045921/how-do-we-grieve-300-000-lives-lost\">more than 300,000 people\u003c/a> in the U.S. alone. Since the Pfizer vaccine’s authorization last week, health and defense officials have launched a \u003ca href=\"https://www.npr.org/2020/12/12/945792399/warp-speed-official-1st-shipments-of-covid-19-vaccine-will-be-delivered-on-monda\">vast effort\u003c/a> to distribute \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/14/946372287/millions-more-covid-19-vaccine-doses-are-on-the-way-u-s-officials-say\">millions of doses\u003c/a> across the country. Health care workers and older adults were first in line for the inoculations when providers \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/14/946232462/incredibly-hopeful-u-s-starts-vaccinating-people-against-covid-19\">began administering\u003c/a> them Monday.\u003c/p>\n\u003cp>In a push to inspire public confidence in the vaccine, Vice President Mike Pence on Friday became the country’s highest-ranking official so far to have it administered. Pence, his wife, Karen, and Surgeon General Jerome Adams all received their shots during a \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/12/18/947744956/i-didnt-feel-a-thing-pence-gets-coronavirus-vaccine-in-public-event\">televised event\u003c/a> at the White House.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Amid the flurry surrounding the Pfizer vaccine’s rollout, Moderna’s alternative was making steady headway in its own push toward authorization. The FDA released a \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/15/946554638/fda-analysis-of-moderna-covid-19-vaccine-finds-it-effective-and-safe\">glowing analysis\u003c/a> of the vaccine on Tuesday, finding “no specific safety concerns.” On Thursday, an outside panel of health care experts from across the U.S. \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/17/947264730/fda-panel-weighs-modernas-covid-19-vaccine\">unanimously recommended\u003c/a> the vaccine with one abstention.\u003c/p>\n\u003cp>“The question that’s being asked us is, ‘Do we have enough evidence in hand to say that the benefits of this vaccine outweigh what at the moment, as far as severe safety issues go, are theoretical risks?'” \u003ca href=\"https://www.chop.edu/doctors/offit-paul-a\">Dr. Paul Offit\u003c/a>, panel member and vaccine researcher at the Children’s Hospital of Philadelphia, said during the hourslong recorded meeting.\u003c/p>\n\u003cp>“I think the answer to that question is clearly yes. I mean, the question is never ‘When do you know everything?’ It’s ‘When do you know enough?'”\u003c/p>\n\u003cp>Offit’s point also gets at a crucial challenge faced by the federal regulators who have been tasked with evaluating these vaccines more quickly than they normally would. In an effort to expedite the process, the FDA — and other health regulators around the world — have loosened their usual approval procedures and adopted a more urgent mechanism known as \u003ca href=\"https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained\">emergency use authorization\u003c/a>.\u003c/p>\n\u003cp>Moderna \u003ca href=\"https://investors.modernatx.com/news-releases/news-release-details/us-government-exercises-1st-option-additional-100-million-doses\">said it that it will deliver about 20 million doses\u003c/a> by the end of December under its federal supply contract.\u003c/p>\n\u003cp>Now, attentions are turning to the Moderna vaccine’s distribution. Like the Pfizer vaccine, the Moderna product uses messenger RNA technology — which, \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html\">in the FDA’s words\u003c/a>, teaches the body’s cells “how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies.”\u003c/p>\n\u003cp>“That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies,” the agency says.\u003c/p>\n\u003cp>Unlike the Pfizer vaccine, though, Moderna’s product does not need to be stored at \u003ca href=\"https://www.npr.org/sections/health-shots/2020/11/17/935563377/why-does-pfizers-covid-19-vaccine-need-to-be-kept-colder-than-antarctica\">extremely low temperatures\u003c/a>, potentially making it accessible for more communities. Balanced against that is the fact that the smaller biotech firm, in contrast with the pharmaceutical giant Pfizer, may \u003ca href=\"https://www.npr.org/sections/health-shots/2020/12/17/947628608/how-will-moderna-meet-the-demand-for-its-covid-19-vaccine\">face some steeper challenges\u003c/a> meeting the extraordinary demand for inoculations.\u003c/p>\n\u003cp>But Dr. Anthony Fauci says he is hopeful that initial distribution will happen quickly.\u003c/p>\n\u003cp>“I would anticipate that we likely will see shots in the arm by the very early part of next week,” the director of the National Institute of Allergy and Infectious Diseases \u003ca href=\"https://www.today.com/video/dr-fauci-anticipates-moderna-vaccine-will-be-administered-by-early-next-week-97983045529\">told NBC’s “\u003c/a>Today” show on Friday in advance of the FDA’s authorization. “I would hope Monday or Tuesday.”\u003c/p>\n\u003cp>Fauci’s institute was instrumental in the development of the Moderna vaccine — from some of the basic science to bankrolling clinical testing. In August, the institute \u003ca href=\"https://www.npr.org/sections/health-shots/2020/08/06/899869278/prices-for-covid-19-vaccines-are-starting-to-come-into-focus\">told NPR\u003c/a> its contributions to the studies of the Moderna vaccine would cost taxpayers more than $400 million.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Operation Warp Speed, the crash federal project for vaccine development, poured in $955 million to support development of the Moderna vaccine, including the expanded phase 3 study that provided the data that made possible the emergency use authorization.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2020 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Moderna%27s+COVID-19+Vaccine+Becomes+2nd+To+Earn+FDA+Authorization&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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