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"content": "\u003cp>The \u003ca href=\"https://www.statnews.com/2021/10/01/mercks-antiviral-pill-reduces-hospitalization-of-covid-patients-a-possible-game-changer-for-treatment/\" target=\"_blank\" rel=\"noopener noreferrer\">announcement\u003c/a> that a pill from Merck and partner Ridgeback Biotherapeutics kept COVID-19 patients out of the hospital made headlines and moved stocks. But as is so often true when data are released by press release, there are still many questions left unanswered.\u003c/p>\n\u003cp>Doctors are excited about the medicine, molnupiravir, because a regimen of pills, even one that involves taking several pills twice a day for five days, should be far easier to deliver to patients than current antiviral COVID-19 treatments, which must be given intravenously. But it’s still unclear how widely this treatment will be used. There will also be debate among financial analysts at investment banks regarding exactly how many billions of dollars in sales the new drug will generate.\u003c/p>\n\u003cp>The drugmaker \u003ca href=\"https://www.npr.org/2021/10/11/1045005513/merck-asks-fda-to-authorize-promising-anti-covid-pill\" target=\"_blank\" rel=\"noopener noreferrer\">asked\u003c/a> U.S. regulators Monday to authorize its pill against COVID-19 in what could add an easy-to-use weapon to the world’s arsenal against the pandemic.\u003c/p>\n\u003cp>Here are some things to keep in mind as we learn more about molnupiravir and about other COVID-19 fighting pills in development at other companies.\u003c/p>\n\u003ch3>How many other anti-COVID pills will end up proving effective?\u003c/h3>\n\u003cp>One of the reasons that the success of molnupiravir is such a big deal is that there were questions as to whether an antiviral pill could help COVID-19 patients if given early enough. This medicine certainly did, reducing hospitalizations by 50%; it also appeared to have an impact on whether patients survived. That makes it a game-changer. Its success also ups the odds that other medicines will prove effective, too.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Results for other drugs are likely to be released by the end of the year. That includes data about a similar pill, also given as a five-day course, from Atea Pharmaceuticals and Roche, and about a pill developed by Pfizer that is from a different drug class and might be combined with molnupiravir.\u003c/p>\n\u003cp>Another positive note for all these drugs: remdesivir, the intravenous antiviral made by Gilead Sciences, also showed positive results when used for three days after onset of symptoms. That’s not practical — it had to be given via IV for three days — but bodes well for antiviral pills showing some efficacy. It’s even possible those pills might be combined.\u003c/p>\n\u003ch3>How safe is molnupiravir?\u003c/h3>\n\u003cp>Obviously, a drug given early in COVID needs a clean safety profile. So far, the data included in the press release look very good. Patients in the placebo arm were three times more likely to withdraw from the study due to apparent side effects than those who actually received molnupiravir. That likely means the side effects of COVID were worse than those of the drug.\u003c/p>\n\u003cp>But only so much can be seen from that kind of data. Molnupiravir works by messing up the way the virus copies RNA, its genetic material, preventing viral replication. There is some concern it could be mutagenic, meaning that it could cause mutations. One result could be that it causes birth defects. In the clinical trial, both women and men were told to either abstain from sexual intercourse or to use contraception while they were taking the drug and for at least four days after. Women of childbearing age also needed a negative pregnancy test to start taking the medicine.\u003c/p>\n\u003ch3>Could there be other effects?\u003c/h3>\n\u003cp>In a conference call with reporters, Daria Hazuda, a top Merck virologist, said that Merck and Ridgeback had studied the mutagenic potential of the drug in both cell lines and in animal models that are routinely used in drug development and which are accepted by regulatory agencies.\u003c/p>\n\u003cp>“I would say that in all of the models where we have looked, we have seen no evidence of the potential for mutagenicity for this agent,” Hazuda said. “We’re very comfortable that the drug will be safe if used as intended and at the concentrations where we have looked and in the concentrations which we are achieving in patients.”\u003c/p>\n\u003ch2>Will molnupiravir be used only in unvaccinated patients?\u003c/h2>\n\u003cp>Merck’s trial was conducted entirely in patients who had not been vaccinated. That made it much easier to show that the medicine can reduce hospitalization and death — because patients who have not previously been vaccinated are more likely to be hospitalized or die.\u003c/p>\n\u003cp>But does that mean that, in practice, the drug will only be used in unvaccinated patients, or will it be used in cases of breakthrough infections? It’s hard to say. Patients with breakthrough infections are at lower risk of hospitalization, which could change the risk-benefit calculus around the medicine.\u003c/p>\n\u003ch3>So how big will the market be?\u003c/h3>\n\u003cp>Daina Graybosch, an analyst at SVB Leerink, forecast in a note to investors that molnupiravir sales will peak near $5 billion a year in 2022.\u003c/p>\n\u003cp>Built into this are a number of assumptions, among them that the first-mover advantage will mean that Merck and Ridgeback will be used more than the other pills in development and that vaccinated patients with breakthrough infections will be eligible to receive the drug, too.\u003c/p>\n\u003cp>Timothy Anderson of Wolfe Research, a standalone equities research firm, takes the other side, essentially saying it is too soon to put a number on molnupiravir sales, in part because data from competing firms are not available but also because other questions remain.\u003c/p>\n\u003cp>“Vaccination rates continue to rise in the US and other developed markets, meaning the cohort of patients who would qualify for molnupiravir (i.e. mostly those who are unvaccinated, at higher risk) will shrink over time,” Anderson wrote in a note to clients.\u003c/p>\n\u003cp>Successfully using the drug, he pointed out, will also require that patients get tested early in their disease course. If people start to skip getting tested, they won’t receive molnupiravir.\u003c/p>\n\u003ch3>What will it cost and who will pay?\u003c/h3>\n\u003cp>Most analysts are basing the cost of molnupiravir on the $1.2 billion the U.S. government spent to lock up 1.7 million courses of the medicine, which works out to $700 per five day course. But Anderson points out that the cost for a new pill to treat influenza developed by Roche is just $150 per course. Will the $700 price hold up?\u003c/p>\n\u003cp>Questions about payment and distribution could play a big role in how big the market for molnupiravir gets. Anderson assumes in his note to clients that, in the U.S., insurance companies will be paying for the drug through traditional channels. He expects that at $700, insurers will restrict use of the drug to those who are unvaccinated and have multiple risk factors for disease — basically similar profiles to those who are in the trials.\u003c/p>\n\u003cp>But it’s also possible that sales in the U.S. might be mostly to the government. This is how things have worked with both remdesivir, used in hospitalized patients, and the monoclonal antibodies developed by Regeneron and Eli Lilly. Will the government handle the distribution of a pill granted an emergency use authorization in the same way that it has handled the monoclonals?\u003c/p>\n\u003ch3>How will the availability of COVID pills affect vaccines and other treatments?\u003c/h3>\n\u003cp>It doesn’t make any sense to forego a COVID vaccine because a pill to treat the disease exists. The benefits are additive, and someone who got a breakthrough infection and then the pill has a much lower risk of hospitalization than someone who just relied on the pill.\u003c/p>\n\u003cp>But it seems likely that some people will feel less urgency to get vaccinated as a result of molnupiravir’s existence, and shares in Pfizer, BioNTech, and Moderna all fell on Friday. The latter two are down again Monday morning.\u003c/p>\n\u003cp>Shares in Regeneron also fell, as oral drugs create uncertainty for its monoclonal antibody treatment for COVID. The landscape there is uncertain, with other companies coming forward with antibodies that may have advantages. One small firm, Adagio Therapeutics, recently presented early data on an antibody it thinks could be given as a single shot.\u003c/p>\n\u003ch3>How does this treatment relate to ivermectin?\u003c/h3>\n\u003cp>This is simple: it doesn’t. But it’s worth taking a look at what data are available for each.\u003c/p>\n\u003cp>Ivermectin, ironically, is another Merck drug. The company’s donation of the medicine to be used to combat a parasitic disease called river blindness is one of the great examples of pharmaceutical philanthropy. It’s also used as a veterinary drug to treat heartworm.\u003c/p>\n\u003cp>Early in the pandemic, there were studies in cell cultures that showed that ivermectin and another drug, hydroxychloroquine, might be worth testing as COVID-19 treatments. Multiple studies have failed to show a benefit for hydroxychloroquine, but the picture is murkier for ivermectin. Still, one of the largest studies showing a benefit was \u003ca href=\"https://www.nature.com/articles/d41586-021-02081-w\" target=\"_blank\" rel=\"noopener noreferrer\">withdrawn due to widespread flaws\u003c/a>.\u003c/p>\n\u003cp>There is a study conducted in Brazil, the Together Trial, that tested a three-day course of ivermectin compared to placebo and showed there \u003ca href=\"https://elemental.medium.com/ivermectin-for-covid-19-an-update-5e913bb49483\" target=\"_blank\" rel=\"noopener noreferrer\">was no benefit on hospitalizations and ER visits\u003c/a>. That would make it unlikely that ivermectin, an old antiparasitic, would have efficacy approaching this newer antiviral.\u003c/p>\n\u003cp>Drug companies are unlikely to conduct large, rigorous studies of older generic medicines — although Novartis did begin, then stop, a hydroxychloroquine study. But right now it is unlikely that ivermectin is the oral COVID medicine the world needs. Molnupiravir, on the other hand, might be.\u003c/p>\n\u003caside class=\"read-more donate\">\u003c/aside>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\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/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The \u003ca href=\"https://www.statnews.com/2021/10/01/mercks-antiviral-pill-reduces-hospitalization-of-covid-patients-a-possible-game-changer-for-treatment/\" target=\"_blank\" rel=\"noopener noreferrer\">announcement\u003c/a> that a pill from Merck and partner Ridgeback Biotherapeutics kept COVID-19 patients out of the hospital made headlines and moved stocks. But as is so often true when data are released by press release, there are still many questions left unanswered.\u003c/p>\n\u003cp>Doctors are excited about the medicine, molnupiravir, because a regimen of pills, even one that involves taking several pills twice a day for five days, should be far easier to deliver to patients than current antiviral COVID-19 treatments, which must be given intravenously. But it’s still unclear how widely this treatment will be used. There will also be debate among financial analysts at investment banks regarding exactly how many billions of dollars in sales the new drug will generate.\u003c/p>\n\u003cp>The drugmaker \u003ca href=\"https://www.npr.org/2021/10/11/1045005513/merck-asks-fda-to-authorize-promising-anti-covid-pill\" target=\"_blank\" rel=\"noopener noreferrer\">asked\u003c/a> U.S. regulators Monday to authorize its pill against COVID-19 in what could add an easy-to-use weapon to the world’s arsenal against the pandemic.\u003c/p>\n\u003cp>Here are some things to keep in mind as we learn more about molnupiravir and about other COVID-19 fighting pills in development at other companies.\u003c/p>\n\u003ch3>How many other anti-COVID pills will end up proving effective?\u003c/h3>\n\u003cp>One of the reasons that the success of molnupiravir is such a big deal is that there were questions as to whether an antiviral pill could help COVID-19 patients if given early enough. This medicine certainly did, reducing hospitalizations by 50%; it also appeared to have an impact on whether patients survived. That makes it a game-changer. Its success also ups the odds that other medicines will prove effective, too.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Results for other drugs are likely to be released by the end of the year. That includes data about a similar pill, also given as a five-day course, from Atea Pharmaceuticals and Roche, and about a pill developed by Pfizer that is from a different drug class and might be combined with molnupiravir.\u003c/p>\n\u003cp>Another positive note for all these drugs: remdesivir, the intravenous antiviral made by Gilead Sciences, also showed positive results when used for three days after onset of symptoms. That’s not practical — it had to be given via IV for three days — but bodes well for antiviral pills showing some efficacy. It’s even possible those pills might be combined.\u003c/p>\n\u003ch3>How safe is molnupiravir?\u003c/h3>\n\u003cp>Obviously, a drug given early in COVID needs a clean safety profile. So far, the data included in the press release look very good. Patients in the placebo arm were three times more likely to withdraw from the study due to apparent side effects than those who actually received molnupiravir. That likely means the side effects of COVID were worse than those of the drug.\u003c/p>\n\u003cp>But only so much can be seen from that kind of data. Molnupiravir works by messing up the way the virus copies RNA, its genetic material, preventing viral replication. There is some concern it could be mutagenic, meaning that it could cause mutations. One result could be that it causes birth defects. In the clinical trial, both women and men were told to either abstain from sexual intercourse or to use contraception while they were taking the drug and for at least four days after. Women of childbearing age also needed a negative pregnancy test to start taking the medicine.\u003c/p>\n\u003ch3>Could there be other effects?\u003c/h3>\n\u003cp>In a conference call with reporters, Daria Hazuda, a top Merck virologist, said that Merck and Ridgeback had studied the mutagenic potential of the drug in both cell lines and in animal models that are routinely used in drug development and which are accepted by regulatory agencies.\u003c/p>\n\u003cp>“I would say that in all of the models where we have looked, we have seen no evidence of the potential for mutagenicity for this agent,” Hazuda said. “We’re very comfortable that the drug will be safe if used as intended and at the concentrations where we have looked and in the concentrations which we are achieving in patients.”\u003c/p>\n\u003ch2>Will molnupiravir be used only in unvaccinated patients?\u003c/h2>\n\u003cp>Merck’s trial was conducted entirely in patients who had not been vaccinated. That made it much easier to show that the medicine can reduce hospitalization and death — because patients who have not previously been vaccinated are more likely to be hospitalized or die.\u003c/p>\n\u003cp>But does that mean that, in practice, the drug will only be used in unvaccinated patients, or will it be used in cases of breakthrough infections? It’s hard to say. Patients with breakthrough infections are at lower risk of hospitalization, which could change the risk-benefit calculus around the medicine.\u003c/p>\n\u003ch3>So how big will the market be?\u003c/h3>\n\u003cp>Daina Graybosch, an analyst at SVB Leerink, forecast in a note to investors that molnupiravir sales will peak near $5 billion a year in 2022.\u003c/p>\n\u003cp>Built into this are a number of assumptions, among them that the first-mover advantage will mean that Merck and Ridgeback will be used more than the other pills in development and that vaccinated patients with breakthrough infections will be eligible to receive the drug, too.\u003c/p>\n\u003cp>Timothy Anderson of Wolfe Research, a standalone equities research firm, takes the other side, essentially saying it is too soon to put a number on molnupiravir sales, in part because data from competing firms are not available but also because other questions remain.\u003c/p>\n\u003cp>“Vaccination rates continue to rise in the US and other developed markets, meaning the cohort of patients who would qualify for molnupiravir (i.e. mostly those who are unvaccinated, at higher risk) will shrink over time,” Anderson wrote in a note to clients.\u003c/p>\n\u003cp>Successfully using the drug, he pointed out, will also require that patients get tested early in their disease course. If people start to skip getting tested, they won’t receive molnupiravir.\u003c/p>\n\u003ch3>What will it cost and who will pay?\u003c/h3>\n\u003cp>Most analysts are basing the cost of molnupiravir on the $1.2 billion the U.S. government spent to lock up 1.7 million courses of the medicine, which works out to $700 per five day course. But Anderson points out that the cost for a new pill to treat influenza developed by Roche is just $150 per course. Will the $700 price hold up?\u003c/p>\n\u003cp>Questions about payment and distribution could play a big role in how big the market for molnupiravir gets. Anderson assumes in his note to clients that, in the U.S., insurance companies will be paying for the drug through traditional channels. He expects that at $700, insurers will restrict use of the drug to those who are unvaccinated and have multiple risk factors for disease — basically similar profiles to those who are in the trials.\u003c/p>\n\u003cp>But it’s also possible that sales in the U.S. might be mostly to the government. This is how things have worked with both remdesivir, used in hospitalized patients, and the monoclonal antibodies developed by Regeneron and Eli Lilly. Will the government handle the distribution of a pill granted an emergency use authorization in the same way that it has handled the monoclonals?\u003c/p>\n\u003ch3>How will the availability of COVID pills affect vaccines and other treatments?\u003c/h3>\n\u003cp>It doesn’t make any sense to forego a COVID vaccine because a pill to treat the disease exists. The benefits are additive, and someone who got a breakthrough infection and then the pill has a much lower risk of hospitalization than someone who just relied on the pill.\u003c/p>\n\u003cp>But it seems likely that some people will feel less urgency to get vaccinated as a result of molnupiravir’s existence, and shares in Pfizer, BioNTech, and Moderna all fell on Friday. The latter two are down again Monday morning.\u003c/p>\n\u003cp>Shares in Regeneron also fell, as oral drugs create uncertainty for its monoclonal antibody treatment for COVID. The landscape there is uncertain, with other companies coming forward with antibodies that may have advantages. One small firm, Adagio Therapeutics, recently presented early data on an antibody it thinks could be given as a single shot.\u003c/p>\n\u003ch3>How does this treatment relate to ivermectin?\u003c/h3>\n\u003cp>This is simple: it doesn’t. But it’s worth taking a look at what data are available for each.\u003c/p>\n\u003cp>Ivermectin, ironically, is another Merck drug. The company’s donation of the medicine to be used to combat a parasitic disease called river blindness is one of the great examples of pharmaceutical philanthropy. It’s also used as a veterinary drug to treat heartworm.\u003c/p>\n\u003cp>Early in the pandemic, there were studies in cell cultures that showed that ivermectin and another drug, hydroxychloroquine, might be worth testing as COVID-19 treatments. Multiple studies have failed to show a benefit for hydroxychloroquine, but the picture is murkier for ivermectin. Still, one of the largest studies showing a benefit was \u003ca href=\"https://www.nature.com/articles/d41586-021-02081-w\" target=\"_blank\" rel=\"noopener noreferrer\">withdrawn due to widespread flaws\u003c/a>.\u003c/p>\n\u003cp>There is a study conducted in Brazil, the Together Trial, that tested a three-day course of ivermectin compared to placebo and showed there \u003ca href=\"https://elemental.medium.com/ivermectin-for-covid-19-an-update-5e913bb49483\" target=\"_blank\" rel=\"noopener noreferrer\">was no benefit on hospitalizations and ER visits\u003c/a>. That would make it unlikely that ivermectin, an old antiparasitic, would have efficacy approaching this newer antiviral.\u003c/p>\n\u003cp>Drug companies are unlikely to conduct large, rigorous studies of older generic medicines — although Novartis did begin, then stop, a hydroxychloroquine study. But right now it is unlikely that ivermectin is the oral COVID medicine the world needs. Molnupiravir, on the other hand, might be.\u003c/p>\n\u003caside class=\"read-more donate\">\u003c/aside>\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/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/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>The first results from the highly anticipated trial studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children ages 5 to 11 showed promising results.\u003c/p>\n\u003cp>The pharmaceutical companies said early results of their trial indicate the vaccine is safe for children and establishes a strong antibody response against the virus.\u003c/p>\n\u003cp>Giving a two-dose regimen of 10 μg (micrograms) administered 21 days apart for children between 5 and 11 years old was well tolerated, according to Pfizer and BioNTech. Side effects were also generally comparable to those of people between the ages of 16 and 25 years old who received the vaccine.\u003c/p>\n\u003cp>This trial used a smaller vaccine dosage, 10 micrograms, rather than the 30 microgram dose used for people 12 and older. The dosage was selected as the preferred dose for safety and effectiveness in young children.\u003c/p>\n\u003cp>News of the results come as pediatric cases of COVID-19 are increasing amid a nationwide surge of infections.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” said Albert Bourla, the chairman and CEO for Pfizer.\u003c/p>\n\u003cp>“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Bourla said in a statement.\u003c/p>\n\u003cp>Despite the strong results, it will be some time before the general public can see an official rollout of vaccines for children ages 5 to 11. Once analysis of the trial is completed, Pfizer and BioNTech will submit the results “in the near term” to the Food and Drug Administration for review and possible emergency use authorization.\u003c/p>\n\u003cp>And even if the FDA grants that authorization, Dr. Francis Collins, director of the National Institutes of Health, recently told NPR that parents and caregivers will likely have to wait until the end of 2021 before a COVID-19 vaccine is fully approved for young children ages 5 to 11.\u003c/p>\n\u003cp>Trial results for children under 5 years of age could come later this year, the pharmaceutical companies said.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“Already in March 2021, we have started the study to evaluate the immunization of younger children. Our objective was to generate and submit the data for schoolkids to regulatory authorities around the world before the winter season begins,” BioNTech CEO and co-founder Ugur Sahin said.\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=COVID+Vaccine+For+Kids+Ages+5+To+11+Is+Safe+And+Effective%2C+Pfizer+Says&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The first results from the highly anticipated trial studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children ages 5 to 11 showed promising results.\u003c/p>\n\u003cp>The pharmaceutical companies said early results of their trial indicate the vaccine is safe for children and establishes a strong antibody response against the virus.\u003c/p>\n\u003cp>Giving a two-dose regimen of 10 μg (micrograms) administered 21 days apart for children between 5 and 11 years old was well tolerated, according to Pfizer and BioNTech. Side effects were also generally comparable to those of people between the ages of 16 and 25 years old who received the vaccine.\u003c/p>\n\u003cp>This trial used a smaller vaccine dosage, 10 micrograms, rather than the 30 microgram dose used for people 12 and older. The dosage was selected as the preferred dose for safety and effectiveness in young children.\u003c/p>\n\u003cp>News of the results come as pediatric cases of COVID-19 are increasing amid a nationwide surge of infections.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” said Albert Bourla, the chairman and CEO for Pfizer.\u003c/p>\n\u003cp>“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Bourla said in a statement.\u003c/p>\n\u003cp>Despite the strong results, it will be some time before the general public can see an official rollout of vaccines for children ages 5 to 11. Once analysis of the trial is completed, Pfizer and BioNTech will submit the results “in the near term” to the Food and Drug Administration for review and possible emergency use authorization.\u003c/p>\n\u003cp>And even if the FDA grants that authorization, Dr. Francis Collins, director of the National Institutes of Health, recently told NPR that parents and caregivers will likely have to wait until the end of 2021 before a COVID-19 vaccine is fully approved for young children ages 5 to 11.\u003c/p>\n\u003cp>Trial results for children under 5 years of age could come later this year, the pharmaceutical companies said.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“Already in March 2021, we have started the study to evaluate the immunization of younger children. Our objective was to generate and submit the data for schoolkids to regulatory authorities around the world before the winter season begins,” BioNTech CEO and co-founder Ugur Sahin said.\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=COVID+Vaccine+For+Kids+Ages+5+To+11+Is+Safe+And+Effective%2C+Pfizer+Says&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"title": "Long COVID and Breakthrough Infections: What We Know Now",
"headTitle": "Long COVID and Breakthrough Infections: What We Know Now | KQED",
"content": "\u003cp>Like millions of others, Kathleen Hipps thought she was safe from COVID-19 after she got two shots of the Moderna vaccine last spring. So she figured she just had a summer cold when she got the sniffles in July. But then she opened some Vicks VapoRub.\u003c/p>\n\u003cp>“Anyone who’s ever smelled Vicks VapoRub knows how pungent of a smell it is. And I couldn’t smell it. And that’s how I knew I had COVID,” says Hipps, 40, a Los Angeles lawyer who has two young sons.\u003c/p>\n\u003cp>And sure enough, Hipps tested positive. “I got very sick. I was very tired, very congested — could barely get out of bed. I couldn’t work at all. I had to find colleagues to cover my work for me. And I just spent the next week basically in bed, completely isolated from my family,” she says.\u003c/p>\n\u003cp>Hipps never ran a fever, though, and did not have bad headaches or body aches. She started feeling better after about a week, tested negative and went back to working from home and caring for her family. She thought she was fully recovered.\u003c/p>\n\u003cp>“And I was in my mom’s new car and all of a sudden I felt burning. And I thought there was something wrong with her car,” she says.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Wherever she moved her foot, she could still feel the burning sensation. And then her other foot started burning, too. It felt like she was walking on hot coals, she says.\u003c/p>\n\u003cp>“I’ve learned that this is neuropathy, and this a common symptom of long COVID,” Hipps says.\u003c/p>\n\u003ch3>Some patients’ symptoms last for weeks or months\u003c/h3>\n\u003cp>\u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects.html\" target=\"_blank\" rel=\"noopener noreferrer\">Long COVID\u003c/a> is a poorly defined, poorly understood condition that occurs when COVID-19 patients’ symptoms won’t go away\u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7992371/\" target=\"_blank\" rel=\"noopener noreferrer\"> for weeks or months,\u003c/a> or new ones emerge just when they think they’re all better.\u003c/p>\n\u003cp>More than six weeks after it started, Hipps still experiences the burning sensation every day, as well as tingling and numbness in her hands.\u003c/p>\n\u003cp>Sometimes the numbness is so bad she can’t push her baby’s stroller. Her periods are really heavy. And work tires her out so fast now that she has to take lots of breaks.\u003c/p>\n\u003cp>“I’m really scared. I mean I’m really scared that there are things that are going on with me that I’m going to have to deal with for the rest of my life,” Hipps says.\u003c/p>\n\u003cp>Now it’s really important to stress that the COVID-19 vaccines are still highly effective at protecting people from getting really sick or dying, and are still quite good at keeping most people from even catching the virus or getting mildly ill.\u003c/p>\n\u003cp>But breakthrough infections can happen, especially with the delta variant. And it’s becoming increasingly clear that unvaccinated people can develop long COVID symptoms, even from mild cases.\u003c/p>\n\u003cp>“We’ve seen that with the infection itself in the unvaccinated individuals about 30% of those individuals continue to have these long-haul COVID symptoms,” says Dr.\u003ca href=\"https://irp.nih.gov/pi/avindra-nath\" target=\"_blank\" rel=\"noopener noreferrer\"> Avindra Nath\u003c/a>, who is studying long COVID at the National Institutes of Health.\u003c/p>\n\u003cp>So the concern is whether vaccinated people who get infected may be at risk for long COVID too, Nath says.\u003c/p>\n\u003cp>“I think that’s a good question,” he says.\u003c/p>\n\u003ch3>Studies look for answers about long COVID\u003c/h3>\n\u003cp>A small\u003ca href=\"https://www.npr.org/transcripts/1021888033\" target=\"_blank\" rel=\"noopener noreferrer\"> Israeli study\u003c/a> recently provided the first evidence that breakthrough infections could lead to long COVID symptoms, although the numbers are small. Out of about 1,500 vaccinated health care workers, 39 got infected, and seven reported symptoms that lasted more than six weeks.\u003c/p>\n\u003cp>And a \u003ca href=\"http://www.thelancet-press.com/embargo/vaxeffectiveness.pdf\">large British study\u003c/a> subsequently found about 5% of people who got infected — even though they were fully vaccinated — experienced persistent symptoms, although the study also found that the odds of having symptoms for 28 days or more were halved by having two vaccine doses.\u003c/p>\n\u003cp>“I think it’s a reasonable concern. But it’s too early. I think we need to follow these patients. It’s quite recent that they’ve been recognized. So at the moment we don’t have that answer,” Nath says, adding that if there is a risk, he suspects it’s probably very low.\u003c/p>\n\u003ch3>But the experts don’t all agree\u003c/h3>\n\u003cp>Some infectious disease experts remain highly skeptical that long COVID from breakthrough infections is a big problem.\u003c/p>\n\u003cp>“Pathophysiologically, it’s quite unlikely to get long COVID from a breakthrough infection,” says Dr.\u003ca href=\"https://profiles.ucsf.edu/monica.gandhi\" target=\"_blank\" rel=\"noopener noreferrer\"> Monica Gandhi\u003c/a>, an infectious disease researcher at UCSF.\u003c/p>\n\u003cp>That’s because the immune response generated by the vaccine would prevent the virus from taking hold in the body or triggering a harmful overreaction by the immune system, Gandhi says.\u003c/p>\n\u003cp>“I think it is absolutely not impossible, but pathophysiologically it is less likely,” she says.\u003c/p>\n\u003cp>Other researchers are convinced the problem is real.\u003c/p>\n\u003cp>“Categorically I can say that we have already seen a handful of cases of long COVID from breakthrough infection,” says\u003ca href=\"https://www.putrinolab.net/\"> David Putrino\u003c/a>, who studies long COVID at Mount Sinai.\u003c/p>\n\u003cp>“We need to behave as though there is the same chance as always of developing long COVID from a mild-to-asymptomatic infection because once you have it you can’t unring that bell and you’re looking at months to years of illness,” Putrino says. Putrino is working with\u003ca href=\"https://medicine.yale.edu/profile/akiko_iwasaki/\"> Akiko Iwasaki\u003c/a>, an immunologist at Yale University, to try to understand how breakthrough infections can lead to persistent symptoms.\u003c/p>\n\u003cp>Iwasaki says some people may experience long COVID because the virus is still hiding in the body. In others, it may be that their immune systems overreact to the virus — a so-called autoimmune response.\u003c/p>\n\u003cp>“We know that the vaccine induces a robust immune response to quickly clear the virus during breakthrough infections,” Iwasaki says. “And that suggests to me that autoimmunity may be the culprit there.”\u003c/p>\n\u003cp>Even if breakthrough infections can lead to long COVID, others say there are also plenty of other reasons vaccinated people should continue to keep being careful to avoid catching the virus.\u003c/p>\n\u003cp>“At the end of the day, my biggest concern honestly is not that I’m going to get long COVID,” says Dr.\u003ca href=\"https://vaccines.emory.edu/faculty-evc/primary-faculty/delrio_carlos.html\" target=\"_blank\" rel=\"noopener noreferrer\"> Carlos del Rio\u003c/a>, an infectious disease researcher at Emory University. “It’s that I’m going to bring COVID and give it to someone else. I mean, I have a young granddaughter. If I get infected, I could give it to her. I’m more concerned that people who are vaccinated can get infected and transmit to others.”\u003c/p>\n\u003cp>For her part, Hipps hopes her symptoms don’t plague her for months or even years.\u003c/p>\n\u003cp>“It’s scary because there’s obviously a lot of things we don’t know about this virus and I’m scared about these long-term implications on my body.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Still, she is glad she got the vaccine. She knows it probably kept her out of the hospital and kept her alive.\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=What+We+Know+About+Breakthrough+Infections+And+Long+COVID&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Wherever she moved her foot, she could still feel the burning sensation. And then her other foot started burning, too. It felt like she was walking on hot coals, she says.\u003c/p>\n\u003cp>“I’ve learned that this is neuropathy, and this a common symptom of long COVID,” Hipps says.\u003c/p>\n\u003ch3>Some patients’ symptoms last for weeks or months\u003c/h3>\n\u003cp>\u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects.html\" target=\"_blank\" rel=\"noopener noreferrer\">Long COVID\u003c/a> is a poorly defined, poorly understood condition that occurs when COVID-19 patients’ symptoms won’t go away\u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7992371/\" target=\"_blank\" rel=\"noopener noreferrer\"> for weeks or months,\u003c/a> or new ones emerge just when they think they’re all better.\u003c/p>\n\u003cp>More than six weeks after it started, Hipps still experiences the burning sensation every day, as well as tingling and numbness in her hands.\u003c/p>\n\u003cp>Sometimes the numbness is so bad she can’t push her baby’s stroller. Her periods are really heavy. And work tires her out so fast now that she has to take lots of breaks.\u003c/p>\n\u003cp>“I’m really scared. I mean I’m really scared that there are things that are going on with me that I’m going to have to deal with for the rest of my life,” Hipps says.\u003c/p>\n\u003cp>Now it’s really important to stress that the COVID-19 vaccines are still highly effective at protecting people from getting really sick or dying, and are still quite good at keeping most people from even catching the virus or getting mildly ill.\u003c/p>\n\u003cp>But breakthrough infections can happen, especially with the delta variant. And it’s becoming increasingly clear that unvaccinated people can develop long COVID symptoms, even from mild cases.\u003c/p>\n\u003cp>“We’ve seen that with the infection itself in the unvaccinated individuals about 30% of those individuals continue to have these long-haul COVID symptoms,” says Dr.\u003ca href=\"https://irp.nih.gov/pi/avindra-nath\" target=\"_blank\" rel=\"noopener noreferrer\"> Avindra Nath\u003c/a>, who is studying long COVID at the National Institutes of Health.\u003c/p>\n\u003cp>So the concern is whether vaccinated people who get infected may be at risk for long COVID too, Nath says.\u003c/p>\n\u003cp>“I think that’s a good question,” he says.\u003c/p>\n\u003ch3>Studies look for answers about long COVID\u003c/h3>\n\u003cp>A small\u003ca href=\"https://www.npr.org/transcripts/1021888033\" target=\"_blank\" rel=\"noopener noreferrer\"> Israeli study\u003c/a> recently provided the first evidence that breakthrough infections could lead to long COVID symptoms, although the numbers are small. Out of about 1,500 vaccinated health care workers, 39 got infected, and seven reported symptoms that lasted more than six weeks.\u003c/p>\n\u003cp>And a \u003ca href=\"http://www.thelancet-press.com/embargo/vaxeffectiveness.pdf\">large British study\u003c/a> subsequently found about 5% of people who got infected — even though they were fully vaccinated — experienced persistent symptoms, although the study also found that the odds of having symptoms for 28 days or more were halved by having two vaccine doses.\u003c/p>\n\u003cp>“I think it’s a reasonable concern. But it’s too early. I think we need to follow these patients. It’s quite recent that they’ve been recognized. So at the moment we don’t have that answer,” Nath says, adding that if there is a risk, he suspects it’s probably very low.\u003c/p>\n\u003ch3>But the experts don’t all agree\u003c/h3>\n\u003cp>Some infectious disease experts remain highly skeptical that long COVID from breakthrough infections is a big problem.\u003c/p>\n\u003cp>“Pathophysiologically, it’s quite unlikely to get long COVID from a breakthrough infection,” says Dr.\u003ca href=\"https://profiles.ucsf.edu/monica.gandhi\" target=\"_blank\" rel=\"noopener noreferrer\"> Monica Gandhi\u003c/a>, an infectious disease researcher at UCSF.\u003c/p>\n\u003cp>That’s because the immune response generated by the vaccine would prevent the virus from taking hold in the body or triggering a harmful overreaction by the immune system, Gandhi says.\u003c/p>\n\u003cp>“I think it is absolutely not impossible, but pathophysiologically it is less likely,” she says.\u003c/p>\n\u003cp>Other researchers are convinced the problem is real.\u003c/p>\n\u003cp>“Categorically I can say that we have already seen a handful of cases of long COVID from breakthrough infection,” says\u003ca href=\"https://www.putrinolab.net/\"> David Putrino\u003c/a>, who studies long COVID at Mount Sinai.\u003c/p>\n\u003cp>“We need to behave as though there is the same chance as always of developing long COVID from a mild-to-asymptomatic infection because once you have it you can’t unring that bell and you’re looking at months to years of illness,” Putrino says. Putrino is working with\u003ca href=\"https://medicine.yale.edu/profile/akiko_iwasaki/\"> Akiko Iwasaki\u003c/a>, an immunologist at Yale University, to try to understand how breakthrough infections can lead to persistent symptoms.\u003c/p>\n\u003cp>Iwasaki says some people may experience long COVID because the virus is still hiding in the body. In others, it may be that their immune systems overreact to the virus — a so-called autoimmune response.\u003c/p>\n\u003cp>“We know that the vaccine induces a robust immune response to quickly clear the virus during breakthrough infections,” Iwasaki says. “And that suggests to me that autoimmunity may be the culprit there.”\u003c/p>\n\u003cp>Even if breakthrough infections can lead to long COVID, others say there are also plenty of other reasons vaccinated people should continue to keep being careful to avoid catching the virus.\u003c/p>\n\u003cp>“At the end of the day, my biggest concern honestly is not that I’m going to get long COVID,” says Dr.\u003ca href=\"https://vaccines.emory.edu/faculty-evc/primary-faculty/delrio_carlos.html\" target=\"_blank\" rel=\"noopener noreferrer\"> Carlos del Rio\u003c/a>, an infectious disease researcher at Emory University. “It’s that I’m going to bring COVID and give it to someone else. I mean, I have a young granddaughter. If I get infected, I could give it to her. I’m more concerned that people who are vaccinated can get infected and transmit to others.”\u003c/p>\n\u003cp>For her part, Hipps hopes her symptoms don’t plague her for months or even years.\u003c/p>\n\u003cp>“It’s scary because there’s obviously a lot of things we don’t know about this virus and I’m scared about these long-term implications on my body.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Still, she is glad she got the vaccine. She knows it probably kept her out of the hospital and kept her alive.\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=What+We+Know+About+Breakthrough+Infections+And+Long+COVID&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"title": "What I Learned From My 'Mild' Breakthrough Case of COVID",
"headTitle": "What I Learned From My ‘Mild’ Breakthrough Case of COVID | KQED",
"content": "\u003cp>The test results that hot day in early August shouldn’t have surprised me — all the symptoms were there. A few days earlier, fatigue had enveloped me like a weighted blanket. I chalked it up to my weekend of travel. Next, a headache clamped down on the back of my skull. Then my eyeballs started to ache. And soon enough, everything tasted like nothing.\u003c/p>\n\u003cp>As a reporter who’s covered the coronavirus since the first confirmed U.S. case landed in Seattle, where I live, I should have known what was coming, but there was some part of me that couldn’t quite believe it. I had a breakthrough case of COVID-19 — despite my two shots of the Pfizer vaccine, the second one in April.\u003c/p>\n\u003cp>I was just one more example of our country’s tug and pull between fantasies of a post-COVID-19 summer and the realities of our still-raging pandemic, where even the vaccinated can get sick.\u003c/p>\n\u003cp>Not only was I sick, but I’d brought the virus home and exposed my 67-year-old father and extended family during my first trip back to the East Coast since the start of the pandemic. It was just the scenario I had tried to avoid for a year and a half. And it definitely was not the summer vacation I had anticipated.\u003c/p>\n\u003cp>Where did I get it? Who knows. Like so many Americans, I had loosened up with wearing masks and social distancing after getting fully vaccinated. We had flown across the country, seen friends, stayed at a hotel, eaten indoors and, yes, even went to a long-delayed wedding with other vaccinated people.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>I ended up in quarantine at my father’s house. \u003ca href=\"https://www.npr.org/2021/09/04/1034281124/more-people-are-relying-on-covid-19-tests-but-experts-say-theyre-not-foolproof\" target=\"_blank\" rel=\"noopener noreferrer\">Two rapid antigen tests \u003c/a>(taken a day apart) came back negative, but I could tell I was starting to feel sick. After my second negative test, the nurse leveled with me. “Don’t hang your hat on this,” she said of the results. Sure enough, a few days later the results of a PCR test for the coronavirus (this one sent to a lab) confirmed what had become obvious by then.\u003c/p>\n\u003cp>It was a miserable five days. My legs and arms ached, my fever crept up to 103 and every few hours of sleep would leave my sheets drenched in sweat. I’d drop into bed exhausted after a quick trip down to the kitchen. To sum it up, I’d put my breakthrough case of COVID-19 right up there with my worst bouts of flu. Even after my fever cleared up, I spent the next few weeks feeling low.\u003c/p>\n\u003cp>Of course, I am very lucky. I didn’t go up against the virus with a naive immune system, like millions of Americans did until vaccines were widely available. And, in much of the world, vaccines are \u003cem>still \u003c/em>a distant promise.\u003c/p>\n\u003cp>“You probably would have gotten much sicker if you had not been vaccinated,” \u003ca href=\"https://providers.ucsd.edu/details/11556/infectious-diseases-hiv/aids\">Francesca Torriani\u003c/a>, an infectious disease physician at the University of California, San Diego, explained to me recently.\u003c/p>\n\u003cp>As I shuffled around my room checking my fever, it was also reassuring to know that my chances of ending up in the hospital were slim, even with the delta variant. And now, about a month later, I’ve made a full recovery.\u003c/p>\n\u003cp>The reality is breakthrough cases are becoming more common. Here’s what you should know about getting a breakthrough case — and what I wish I’d known when those first symptoms laid me low:\u003c/p>\n\u003ch3>Is it time for a reality check about what the vaccines can — and can’t do?\u003c/h3>\n\u003cp>The vaccines aren’t a force field that ward off all things COVID-19. They were given the greenlight because they greatly lower your chance of getting seriously ill or dying.\u003c/p>\n\u003cp>But it was easy for me — and I’m not the only one — to grab onto the idea that, after so many months of trying not to get COVID-19, that the vaccine was, more or less, the finish line. And that made getting sick from the virus unnerving.\u003c/p>\n\u003cp>After all, there were reassuring findings\u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm\"> earlier this year\u003c/a> that the vaccine was remarkably good at stopping any infection, even mild ones. This was a kind of bonus, we were told. And then in May the Centers for Disease Control and Prevention said go ahead and shed your mask if you’re vaccinated.\u003c/p>\n\u003cp>“There was so much initial euphoria about how well these vaccines work,” says \u003ca href=\"https://kingcounty.gov/depts/health/about-us/health-officer.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">Jeff Duchin\u003c/a>, an infectious disease physician and the public health officer for Seattle and King County. “I think we — in the public health community, in the medical community — facilitated the impression that these vaccines are bulletproof.”\u003c/p>\n\u003cp>It’s hard to keep dialing up and down your risk calculations. So if you’d hoped to avoid getting sick at all, even slightly, it may be time for a “reset,” Duchin says. This isn’t to be alarmist but to clear away expectations that COVID-19 is out of your life, and keep up your vigilance about common-sense precautions.\u003c/p>\n\u003cp>With more people vaccinated, the total number of breakthrough infections will rise, and that’s not unexpected, he says. “I don’t think our goal should be to achieve zero risk, because that’s unrealistic.”\u003c/p>\n\u003ch3>How high are my chances of getting a breakthrough case these days?\u003c/h3>\n\u003cp>It used to be quite rare, but the rise of delta has changed the odds.\u003c/p>\n\u003cp>“It’s a totally different ballgame with this delta phase,” says \u003ca href=\"https://www.scripps.edu/faculty/topol/\">Dr. Eric Topol\u003c/a>, a professor of molecular medicine at the Scripps Research Translational Institute in La Jolla, Calif. “I think the chance of having a symptomatic infection has gone up substantially.”\u003c/p>\n\u003cp>But he adds, “Quantifying that in the U.S. is very challenging” because our “data is so shoddy.”\u003c/p>\n\u003cp>The vaccinated still have a considerably lower chance of getting infected than those who aren’t protected that way. Look at data collected from Los Angeles County over the summer as the delta variant started to surge in Southern California: Unvaccinated people were \u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e5.htm\">five times more likely to test positive\u003c/a> than those who were vaccinated.\u003c/p>\n\u003cp>Recent research has tried to pin down how well the vaccines are working against preventing any breakthrough cases during the delta surge, but much of that comes from other countries and estimates vary significantly.\u003c/p>\n\u003cp>In the U.S., a study published recently in \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMc2112981\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cem>The New England Journal of Medicine\u003c/em>\u003c/a> concluded that vaccine effectiveness “against any symptomatic disease is considerably lower against the delta variant,” dropping from over 90% earlier in the year before delta was the predominant strain to only about 65% in July. Research on breakthrough infections over the summer in New York found the vaccines were still overall \u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e1.htm\" target=\"_blank\" rel=\"noopener noreferrer\">about 80% effective against any infection\u003c/a>. Each study has its limits.\u003c/p>\n\u003cp>It’s hard to disentangle what’s most responsible for the rise in breakthrough infections this summer — whether it’s the delta variant itself, waning immunity in some people or that much of the U.S. dropped public health precautions such as masking.\u003c/p>\n\u003cp>“We don’t have good evidence of what’s the cause, but we do know all of these things coming together are associated with more breakthroughs,” says\u003ca href=\"https://www.hsph.harvard.edu/community-safety/people/rachael-piltch-loeb-phd/\"> Rachael Piltch-Loeb\u003c/a>, a public health researcher at the Harvard T.H. Chan School of Public Health.\u003c/p>\n\u003ch3>How careful do I need to be if I want to avoid a breakthrough?\u003c/h3>\n\u003cp>Looking back, I wish I’d taken some more precautions.\u003c/p>\n\u003cp>And my advice is different now when friends and family tell me they want to avoid having a breakthrough case such as mine: Don’t leave it all up to the vaccine. Wear masks, stay away from big gatherings with unvaccinated people, cut down on travel, at least until things calm down.\u003c/p>\n\u003cp>The U.S. \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html\">is averaging more than 130,000\u003c/a> coronavirus infections a day (about twice what it was when I fell sick), hospitals are being crushed and the White House has proposed booster shots. Scientists are still making sense of what’s happening with breakthrough cases.\u003c/p>\n\u003cp>What’s clear is that in many parts of the U.S., we’re all more likely to run into the virus than we were in the spring. “Your risk is going to be different if you are in a place that’s very highly vaccinated, with very low level of community spread,” says \u003ca href=\"https://www.uofmhealth.org/profile/922/preeti-n-malani-md\">Preeti Malani\u003c/a>, an infectious disease specialist at the University of Michigan. “The piece that’s important is what’s happening in your community.”\u003c/p>\n\u003cp>Even with delta, the goal is not to go back to a lockdown mindset though, Malani says. “My hope is that people who are fully vaccinated should really feel like this risk is manageable.”\u003c/p>\n\u003cp>She says, “Feel good about spending time with your friends or having a small dinner party, but make sure everyone is vaccinated.”\u003c/p>\n\u003ch3>What does a “mild” case of COVID-19 feel like?\u003c/h3>\n\u003cp>In my case, it was worse than expected, but in the parlance of public health, it was “mild,” meaning I didn’t end up in the hospital or require oxygen.\u003c/p>\n\u003cp>This mild category is essentially a catchall, says \u003ca href=\"https://profiles.ucsf.edu/robert.wachter\" target=\"_blank\" rel=\"noopener noreferrer\">Dr. Bob Wachter\u003c/a>, who chairs the Department of Medicine at the UCSF. “Mild” can be “a day of feeling crummy to being completely laid up in bed for a week, all of your bones hurt and your brain isn’t working well.”\u003c/p>\n\u003cp>“So even if we call them mild cases, as you’ve seen, sometimes these are ones you really don’t want to have if you can avoid it,” he says.\u003c/p>\n\u003cp>There’s not great data on the details of these mild breakthrough infections, but so far it appears that “you do way better than those who are not vaccinated,” says\u003ca href=\"https://healthcare.utah.edu/fad/mddetail.php?physicianID=u1074771&name=sarang-k-yoon\"> Dr. Sarang Yoon\u003c/a>, an occupational medicine specialist at the University of Utah Rocky Mountain Center for Occupational Environmental Health who was part of a nationwide CDC study on breakthrough infections. “In general, in terms of symptom duration, it’s much shorter.”\u003c/p>\n\u003cp>Yoon’s study, published in June with data collected before the delta surge, offers some reassurance: The presence of fever was cut in half, and the days spent in bed reduced by 60% among people with breakthrough infections, compared with unvaccinated people who got sick. “These are meaningful decreases,” says \u003ca href=\"https://medicine.utah.edu/faculty/mddetail.php?facultyID=u0067419\">Matt Thiese\u003c/a>, an epidemiologist and colleague of Yoon’s who worked on the study. “It can be the difference between having a fever for almost nine days and having a fever for just under three days.”\u003c/p>\n\u003cp>A recent study from the U.K. also shows that if you’re sick because of a breakthrough case, it’s generally not as bad, and people have fewer symptoms. In fact, the \u003ca href=\"https://covid.joinzoe.com/post/new-top-5-covid-symptoms\" target=\"_blank\" rel=\"noopener noreferrer\">top five symptoms\u003c/a> for people with a breakthrough infection were headache, sneezing, runny nose, sore throat and loss of smell. Notably absent: fever and persistent cough, which are in the top five for unvaccinated people, according to the data compiled by the U.K. researchers.\u003c/p>\n\u003ch3>If I get a breakthrough infection, how sick could I get?\u003c/h3>\n\u003cp>Even with delta, the chance of getting a case of COVID-19 that’s bad enough to send you to the hospital is still rare.\u003c/p>\n\u003cp>If you’re vaccinated, the\u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e2.htm?s_cid=mm7037e2_w\" target=\"_blank\" rel=\"noopener noreferrer\"> risk of being hospitalized is 10 times lower\u003c/a> than if you weren’t vaccinated, according to the latest data from the CDC. Those who get severely and critically ill with a breakthrough case tend to be older — in one study done before delta, \u003ca href=\"https://news.yale.edu/2021/09/07/study-examines-severe-breakthrough-cases-covid-19\">the median age was 80\u003c/a> — with underlying medical conditions such as cardiovascular disease.\u003c/p>\n\u003cp>When I was sick, one thing was in the back of my mind as I monitored my symptoms: Would I have problems catching my breath?\u003c/p>\n\u003cp>Thankfully, when you get exposed, the vaccine has already set you up with antibodies, a first line of defense, that will neutralize parts of the virus that attach to the mucosal surfaces of your upper respiratory tract, says Torriani at UC San Diego.\u003c/p>\n\u003cp>“That initial moment when our body is attacked by the virus, that \u003cem>can\u003c/em> lead to some disease,” she says. It’s a bit of a race.\u003c/p>\n\u003cp>The virus may cause you to get a cold, but, in most people, your immune system will “get its act together and thwart that infection from going down into your lungs,” Wachter says.\u003c/p>\n\u003cp>That later stage of COVID-19 also seems to trigger the immune system to get “overly exuberant” and attack your own body, causing severe respiratory problems such as shortness of breath and destructive inflammation. “So if you can prevent that sort of second stage from happening,” Wachter says, “you can prevent a lot of the severe illness from COVID.” Other parts of your immune system, such as T-cells, are also ready to kick into action if you get sick.\u003c/p>\n\u003cp>If you’re concerned, you can keep an eye on your oxygen levels with a pulse oximeter. That’s much more important than your temperature or symptoms, he says.\u003c/p>\n\u003ch3>Can I spread it to others, and do I need to isolate?\u003c/h3>\n\u003cp>Unfortunately, you still have COVID-19 and need to act like it.\u003c/p>\n\u003cp>Even though my first two tests were negative, I started wearing a mask at my house and keeping my distance from my vaccinated family members. I’m glad I did: No one else got sick.\u003c/p>\n\u003cp>The delta variant is more than two times as contagious as the original strain of the virus and can build up quickly in your upper respiratory tract, as was shown in \u003ca href=\"https://www.npr.org/sections/health-shots/2021/08/06/1025553638/how-a-gay-community-helped-the-cdc-spot-a-covid-outbreak-and-learn-more-about-de\" target=\"_blank\" rel=\"noopener noreferrer\">a cluster of breakthrough infections linked to Provincetown, Mass\u003c/a>., over the summer.\u003c/p>\n\u003cp>“Even in fully vaccinated, asymptomatic individuals, they can have enough virus to transmit it,” says \u003ca href=\"https://www.rockefeller.edu/our-scientists/heads-of-laboratories/952-robert-b-darnell/\">Robert Darnell\u003c/a>, a physician scientist at the Rockefeller University. “Delta is very good at replicating, attaching and inserting itself into cells.”\u003c/p>\n\u003cp>The science isn’t settled about just how likely vaccinated people are to spread the virus, and it does appear that \u003ca href=\"https://www.nature.com/articles/s41591-021-01316-7\" target=\"_blank\" rel=\"noopener noreferrer\">the amount of virus in the nose decreases\u003c/a> faster in people who are vaccinated.\u003c/p>\n\u003cp>Even so, wearing masks and staying isolated from others if you test positive or have symptoms is absolutely critical, Darnell says. He also advises getting tested if you are exposed to someone who has COVID-19, even if you’ve been vaccinated, “because you could very well get infected or ill, and you want to protect those around you, including all the children who aren’t vaccinated.”\u003c/p>\n\u003ch3>Could I get long COVID-19 after a breakthrough infection?\u003c/h3>\n\u003cp>The chance I \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects.html\">might go on to develop long COVID-19\u003c/a> was front and center in my mind when I had a breakthrough case.\u003c/p>\n\u003cp>While there’s not a lot of data yet, research does show that breakthrough infections can lead to the kind of persistent symptoms that characterize long COVID-19, including brain fog, fatigue and headaches. “Hopefully that number is low. Hopefully it doesn’t last as long and it’s not as severe, but it’s just too early to know these things,” Topol says.\u003c/p>\n\u003cp>Recent research from the U.K. \u003ca href=\"https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00460-6/fulltext\" target=\"_blank\" rel=\"noopener noreferrer\">suggests that vaccinated people\u003c/a> are about 50% less likely to develop long COVID-19 than those who are unvaccinated. The underlying cause of long COVID-19 is still not yet known, so it complicates the picture for researchers even more, but this early evidence offers some reassurance.\u003c/p>\n\u003cp>“There may be some symptoms like fatigue [that linger], but studies appear to show that vaccination might also decrease the chances of getting long COVID symptoms,” Torriani says.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>This is not true for everyone, and it’s a compelling reason to avoid getting infected altogether, Wachter says. “Some of those mild cases will go on to be long COVID, so you have to factor that in,” he says.\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=I+Got+A+%27Mild%27+Breakthrough+Case.+Here%27s+What+I+Wish+I%27d+Known&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"excerpt": "After a year and a half of being COVID-cautious, a fully vaccinated health journalist thought he could finally travel and socialize this summer. The resulting illness didn't feel \"mild\" at all.",
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"description": "After a year and a half of being COVID-cautious, a fully vaccinated health journalist thought he could finally travel and socialize this summer. The resulting illness didn't feel "mild" at all.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The test results that hot day in early August shouldn’t have surprised me — all the symptoms were there. A few days earlier, fatigue had enveloped me like a weighted blanket. I chalked it up to my weekend of travel. Next, a headache clamped down on the back of my skull. Then my eyeballs started to ache. And soon enough, everything tasted like nothing.\u003c/p>\n\u003cp>As a reporter who’s covered the coronavirus since the first confirmed U.S. case landed in Seattle, where I live, I should have known what was coming, but there was some part of me that couldn’t quite believe it. I had a breakthrough case of COVID-19 — despite my two shots of the Pfizer vaccine, the second one in April.\u003c/p>\n\u003cp>I was just one more example of our country’s tug and pull between fantasies of a post-COVID-19 summer and the realities of our still-raging pandemic, where even the vaccinated can get sick.\u003c/p>\n\u003cp>Not only was I sick, but I’d brought the virus home and exposed my 67-year-old father and extended family during my first trip back to the East Coast since the start of the pandemic. It was just the scenario I had tried to avoid for a year and a half. And it definitely was not the summer vacation I had anticipated.\u003c/p>\n\u003cp>Where did I get it? Who knows. Like so many Americans, I had loosened up with wearing masks and social distancing after getting fully vaccinated. We had flown across the country, seen friends, stayed at a hotel, eaten indoors and, yes, even went to a long-delayed wedding with other vaccinated people.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>I ended up in quarantine at my father’s house. \u003ca href=\"https://www.npr.org/2021/09/04/1034281124/more-people-are-relying-on-covid-19-tests-but-experts-say-theyre-not-foolproof\" target=\"_blank\" rel=\"noopener noreferrer\">Two rapid antigen tests \u003c/a>(taken a day apart) came back negative, but I could tell I was starting to feel sick. After my second negative test, the nurse leveled with me. “Don’t hang your hat on this,” she said of the results. Sure enough, a few days later the results of a PCR test for the coronavirus (this one sent to a lab) confirmed what had become obvious by then.\u003c/p>\n\u003cp>It was a miserable five days. My legs and arms ached, my fever crept up to 103 and every few hours of sleep would leave my sheets drenched in sweat. I’d drop into bed exhausted after a quick trip down to the kitchen. To sum it up, I’d put my breakthrough case of COVID-19 right up there with my worst bouts of flu. Even after my fever cleared up, I spent the next few weeks feeling low.\u003c/p>\n\u003cp>Of course, I am very lucky. I didn’t go up against the virus with a naive immune system, like millions of Americans did until vaccines were widely available. And, in much of the world, vaccines are \u003cem>still \u003c/em>a distant promise.\u003c/p>\n\u003cp>“You probably would have gotten much sicker if you had not been vaccinated,” \u003ca href=\"https://providers.ucsd.edu/details/11556/infectious-diseases-hiv/aids\">Francesca Torriani\u003c/a>, an infectious disease physician at the University of California, San Diego, explained to me recently.\u003c/p>\n\u003cp>As I shuffled around my room checking my fever, it was also reassuring to know that my chances of ending up in the hospital were slim, even with the delta variant. And now, about a month later, I’ve made a full recovery.\u003c/p>\n\u003cp>The reality is breakthrough cases are becoming more common. Here’s what you should know about getting a breakthrough case — and what I wish I’d known when those first symptoms laid me low:\u003c/p>\n\u003ch3>Is it time for a reality check about what the vaccines can — and can’t do?\u003c/h3>\n\u003cp>The vaccines aren’t a force field that ward off all things COVID-19. They were given the greenlight because they greatly lower your chance of getting seriously ill or dying.\u003c/p>\n\u003cp>But it was easy for me — and I’m not the only one — to grab onto the idea that, after so many months of trying not to get COVID-19, that the vaccine was, more or less, the finish line. And that made getting sick from the virus unnerving.\u003c/p>\n\u003cp>After all, there were reassuring findings\u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm\"> earlier this year\u003c/a> that the vaccine was remarkably good at stopping any infection, even mild ones. This was a kind of bonus, we were told. And then in May the Centers for Disease Control and Prevention said go ahead and shed your mask if you’re vaccinated.\u003c/p>\n\u003cp>“There was so much initial euphoria about how well these vaccines work,” says \u003ca href=\"https://kingcounty.gov/depts/health/about-us/health-officer.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">Jeff Duchin\u003c/a>, an infectious disease physician and the public health officer for Seattle and King County. “I think we — in the public health community, in the medical community — facilitated the impression that these vaccines are bulletproof.”\u003c/p>\n\u003cp>It’s hard to keep dialing up and down your risk calculations. So if you’d hoped to avoid getting sick at all, even slightly, it may be time for a “reset,” Duchin says. This isn’t to be alarmist but to clear away expectations that COVID-19 is out of your life, and keep up your vigilance about common-sense precautions.\u003c/p>\n\u003cp>With more people vaccinated, the total number of breakthrough infections will rise, and that’s not unexpected, he says. “I don’t think our goal should be to achieve zero risk, because that’s unrealistic.”\u003c/p>\n\u003ch3>How high are my chances of getting a breakthrough case these days?\u003c/h3>\n\u003cp>It used to be quite rare, but the rise of delta has changed the odds.\u003c/p>\n\u003cp>“It’s a totally different ballgame with this delta phase,” says \u003ca href=\"https://www.scripps.edu/faculty/topol/\">Dr. Eric Topol\u003c/a>, a professor of molecular medicine at the Scripps Research Translational Institute in La Jolla, Calif. “I think the chance of having a symptomatic infection has gone up substantially.”\u003c/p>\n\u003cp>But he adds, “Quantifying that in the U.S. is very challenging” because our “data is so shoddy.”\u003c/p>\n\u003cp>The vaccinated still have a considerably lower chance of getting infected than those who aren’t protected that way. Look at data collected from Los Angeles County over the summer as the delta variant started to surge in Southern California: Unvaccinated people were \u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e5.htm\">five times more likely to test positive\u003c/a> than those who were vaccinated.\u003c/p>\n\u003cp>Recent research has tried to pin down how well the vaccines are working against preventing any breakthrough cases during the delta surge, but much of that comes from other countries and estimates vary significantly.\u003c/p>\n\u003cp>In the U.S., a study published recently in \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMc2112981\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cem>The New England Journal of Medicine\u003c/em>\u003c/a> concluded that vaccine effectiveness “against any symptomatic disease is considerably lower against the delta variant,” dropping from over 90% earlier in the year before delta was the predominant strain to only about 65% in July. Research on breakthrough infections over the summer in New York found the vaccines were still overall \u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e1.htm\" target=\"_blank\" rel=\"noopener noreferrer\">about 80% effective against any infection\u003c/a>. Each study has its limits.\u003c/p>\n\u003cp>It’s hard to disentangle what’s most responsible for the rise in breakthrough infections this summer — whether it’s the delta variant itself, waning immunity in some people or that much of the U.S. dropped public health precautions such as masking.\u003c/p>\n\u003cp>“We don’t have good evidence of what’s the cause, but we do know all of these things coming together are associated with more breakthroughs,” says\u003ca href=\"https://www.hsph.harvard.edu/community-safety/people/rachael-piltch-loeb-phd/\"> Rachael Piltch-Loeb\u003c/a>, a public health researcher at the Harvard T.H. Chan School of Public Health.\u003c/p>\n\u003ch3>How careful do I need to be if I want to avoid a breakthrough?\u003c/h3>\n\u003cp>Looking back, I wish I’d taken some more precautions.\u003c/p>\n\u003cp>And my advice is different now when friends and family tell me they want to avoid having a breakthrough case such as mine: Don’t leave it all up to the vaccine. Wear masks, stay away from big gatherings with unvaccinated people, cut down on travel, at least until things calm down.\u003c/p>\n\u003cp>The U.S. \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html\">is averaging more than 130,000\u003c/a> coronavirus infections a day (about twice what it was when I fell sick), hospitals are being crushed and the White House has proposed booster shots. Scientists are still making sense of what’s happening with breakthrough cases.\u003c/p>\n\u003cp>What’s clear is that in many parts of the U.S., we’re all more likely to run into the virus than we were in the spring. “Your risk is going to be different if you are in a place that’s very highly vaccinated, with very low level of community spread,” says \u003ca href=\"https://www.uofmhealth.org/profile/922/preeti-n-malani-md\">Preeti Malani\u003c/a>, an infectious disease specialist at the University of Michigan. “The piece that’s important is what’s happening in your community.”\u003c/p>\n\u003cp>Even with delta, the goal is not to go back to a lockdown mindset though, Malani says. “My hope is that people who are fully vaccinated should really feel like this risk is manageable.”\u003c/p>\n\u003cp>She says, “Feel good about spending time with your friends or having a small dinner party, but make sure everyone is vaccinated.”\u003c/p>\n\u003ch3>What does a “mild” case of COVID-19 feel like?\u003c/h3>\n\u003cp>In my case, it was worse than expected, but in the parlance of public health, it was “mild,” meaning I didn’t end up in the hospital or require oxygen.\u003c/p>\n\u003cp>This mild category is essentially a catchall, says \u003ca href=\"https://profiles.ucsf.edu/robert.wachter\" target=\"_blank\" rel=\"noopener noreferrer\">Dr. Bob Wachter\u003c/a>, who chairs the Department of Medicine at the UCSF. “Mild” can be “a day of feeling crummy to being completely laid up in bed for a week, all of your bones hurt and your brain isn’t working well.”\u003c/p>\n\u003cp>“So even if we call them mild cases, as you’ve seen, sometimes these are ones you really don’t want to have if you can avoid it,” he says.\u003c/p>\n\u003cp>There’s not great data on the details of these mild breakthrough infections, but so far it appears that “you do way better than those who are not vaccinated,” says\u003ca href=\"https://healthcare.utah.edu/fad/mddetail.php?physicianID=u1074771&name=sarang-k-yoon\"> Dr. Sarang Yoon\u003c/a>, an occupational medicine specialist at the University of Utah Rocky Mountain Center for Occupational Environmental Health who was part of a nationwide CDC study on breakthrough infections. “In general, in terms of symptom duration, it’s much shorter.”\u003c/p>\n\u003cp>Yoon’s study, published in June with data collected before the delta surge, offers some reassurance: The presence of fever was cut in half, and the days spent in bed reduced by 60% among people with breakthrough infections, compared with unvaccinated people who got sick. “These are meaningful decreases,” says \u003ca href=\"https://medicine.utah.edu/faculty/mddetail.php?facultyID=u0067419\">Matt Thiese\u003c/a>, an epidemiologist and colleague of Yoon’s who worked on the study. “It can be the difference between having a fever for almost nine days and having a fever for just under three days.”\u003c/p>\n\u003cp>A recent study from the U.K. also shows that if you’re sick because of a breakthrough case, it’s generally not as bad, and people have fewer symptoms. In fact, the \u003ca href=\"https://covid.joinzoe.com/post/new-top-5-covid-symptoms\" target=\"_blank\" rel=\"noopener noreferrer\">top five symptoms\u003c/a> for people with a breakthrough infection were headache, sneezing, runny nose, sore throat and loss of smell. Notably absent: fever and persistent cough, which are in the top five for unvaccinated people, according to the data compiled by the U.K. researchers.\u003c/p>\n\u003ch3>If I get a breakthrough infection, how sick could I get?\u003c/h3>\n\u003cp>Even with delta, the chance of getting a case of COVID-19 that’s bad enough to send you to the hospital is still rare.\u003c/p>\n\u003cp>If you’re vaccinated, the\u003ca href=\"https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e2.htm?s_cid=mm7037e2_w\" target=\"_blank\" rel=\"noopener noreferrer\"> risk of being hospitalized is 10 times lower\u003c/a> than if you weren’t vaccinated, according to the latest data from the CDC. Those who get severely and critically ill with a breakthrough case tend to be older — in one study done before delta, \u003ca href=\"https://news.yale.edu/2021/09/07/study-examines-severe-breakthrough-cases-covid-19\">the median age was 80\u003c/a> — with underlying medical conditions such as cardiovascular disease.\u003c/p>\n\u003cp>When I was sick, one thing was in the back of my mind as I monitored my symptoms: Would I have problems catching my breath?\u003c/p>\n\u003cp>Thankfully, when you get exposed, the vaccine has already set you up with antibodies, a first line of defense, that will neutralize parts of the virus that attach to the mucosal surfaces of your upper respiratory tract, says Torriani at UC San Diego.\u003c/p>\n\u003cp>“That initial moment when our body is attacked by the virus, that \u003cem>can\u003c/em> lead to some disease,” she says. It’s a bit of a race.\u003c/p>\n\u003cp>The virus may cause you to get a cold, but, in most people, your immune system will “get its act together and thwart that infection from going down into your lungs,” Wachter says.\u003c/p>\n\u003cp>That later stage of COVID-19 also seems to trigger the immune system to get “overly exuberant” and attack your own body, causing severe respiratory problems such as shortness of breath and destructive inflammation. “So if you can prevent that sort of second stage from happening,” Wachter says, “you can prevent a lot of the severe illness from COVID.” Other parts of your immune system, such as T-cells, are also ready to kick into action if you get sick.\u003c/p>\n\u003cp>If you’re concerned, you can keep an eye on your oxygen levels with a pulse oximeter. That’s much more important than your temperature or symptoms, he says.\u003c/p>\n\u003ch3>Can I spread it to others, and do I need to isolate?\u003c/h3>\n\u003cp>Unfortunately, you still have COVID-19 and need to act like it.\u003c/p>\n\u003cp>Even though my first two tests were negative, I started wearing a mask at my house and keeping my distance from my vaccinated family members. I’m glad I did: No one else got sick.\u003c/p>\n\u003cp>The delta variant is more than two times as contagious as the original strain of the virus and can build up quickly in your upper respiratory tract, as was shown in \u003ca href=\"https://www.npr.org/sections/health-shots/2021/08/06/1025553638/how-a-gay-community-helped-the-cdc-spot-a-covid-outbreak-and-learn-more-about-de\" target=\"_blank\" rel=\"noopener noreferrer\">a cluster of breakthrough infections linked to Provincetown, Mass\u003c/a>., over the summer.\u003c/p>\n\u003cp>“Even in fully vaccinated, asymptomatic individuals, they can have enough virus to transmit it,” says \u003ca href=\"https://www.rockefeller.edu/our-scientists/heads-of-laboratories/952-robert-b-darnell/\">Robert Darnell\u003c/a>, a physician scientist at the Rockefeller University. “Delta is very good at replicating, attaching and inserting itself into cells.”\u003c/p>\n\u003cp>The science isn’t settled about just how likely vaccinated people are to spread the virus, and it does appear that \u003ca href=\"https://www.nature.com/articles/s41591-021-01316-7\" target=\"_blank\" rel=\"noopener noreferrer\">the amount of virus in the nose decreases\u003c/a> faster in people who are vaccinated.\u003c/p>\n\u003cp>Even so, wearing masks and staying isolated from others if you test positive or have symptoms is absolutely critical, Darnell says. He also advises getting tested if you are exposed to someone who has COVID-19, even if you’ve been vaccinated, “because you could very well get infected or ill, and you want to protect those around you, including all the children who aren’t vaccinated.”\u003c/p>\n\u003ch3>Could I get long COVID-19 after a breakthrough infection?\u003c/h3>\n\u003cp>The chance I \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects.html\">might go on to develop long COVID-19\u003c/a> was front and center in my mind when I had a breakthrough case.\u003c/p>\n\u003cp>While there’s not a lot of data yet, research does show that breakthrough infections can lead to the kind of persistent symptoms that characterize long COVID-19, including brain fog, fatigue and headaches. “Hopefully that number is low. Hopefully it doesn’t last as long and it’s not as severe, but it’s just too early to know these things,” Topol says.\u003c/p>\n\u003cp>Recent research from the U.K. \u003ca href=\"https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00460-6/fulltext\" target=\"_blank\" rel=\"noopener noreferrer\">suggests that vaccinated people\u003c/a> are about 50% less likely to develop long COVID-19 than those who are unvaccinated. The underlying cause of long COVID-19 is still not yet known, so it complicates the picture for researchers even more, but this early evidence offers some reassurance.\u003c/p>\n\u003cp>“There may be some symptoms like fatigue [that linger], but studies appear to show that vaccination might also decrease the chances of getting long COVID symptoms,” Torriani says.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>This is not true for everyone, and it’s a compelling reason to avoid getting infected altogether, Wachter says. “Some of those mild cases will go on to be long COVID, so you have to factor that in,” he says.\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=I+Got+A+%27Mild%27+Breakthrough+Case.+Here%27s+What+I+Wish+I%27d+Known&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"title": "Pfizer's COVID Vaccine Gets Full Approval From The FDA",
"headTitle": "Pfizer’s COVID Vaccine Gets Full Approval From The FDA | KQED",
"content": "\u003cdiv class=\"fullattribution\">\n\u003cp>The Food and Drug Administration has formally approved Pfizer’s COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.\u003c/p>\n\u003cp>This is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.\u003c/p>\n\u003cp>The full approval could make it easier for employers, the military and universities to mandate vaccination and may reassure some people who are hesitant about the vaccine.\u003c/p>\n\u003cp>“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine\">acting FDA Commissioner Janet Woodcock said in a statement\u003c/a>.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">California Gov. Gavin Newsom was quick to issue supportive words Monday morning in a statement emailed to reporters, saying he encourages “all Californians to trust the science and protect themselves and their community by getting vaccinated.”\u003c/span>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400\"> Tomás Aragón, California’s public health officer, said the agency’s official approval of the vaccine “underscores the safety and efficacy of the COVID-19 vaccine and comes at a critical juncture as many of our communities are grappling with increasing cases fueled by the faster spreading Delta variant.”\u003c/span>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400\">“For weeks we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected, especially against severe and long-term illness,” he said in a statement. “We know the vaccines work. We know vaccines are safe. We know they save lives. If you are not vaccinated, let this be the milestone that gets you there. Get vaccinated to protect yourself and help put an end to this deadly pandemic.”\u003c/span>\u003c/p>\n\u003ch3 class=\"edTag\">Approval could lead to more vaccinations\u003c/h3>\n\u003cp>A \u003ca href=\"https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/\">June poll\u003c/a> from the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once one receives full approval from the FDA.\u003c/p>\n\u003cp>“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”\u003c/p>\n\u003cp>The FDA’s full approval applies to people 16 and older. Those between ages 12 and 15 can still receive the vaccine under the existing emergency use authorization.\u003c/p>\n\u003ch3 class=\"edTag\">There is no timeline for children under 12\u003c/h3>\n\u003cp>That authorization does not extend to children under the age of 12. FDA officials have acknowledged the interest in vaccination for children in that age group, but were unable Monday to provide a timeline for a decision on use of the vaccine for those under 12.\u003c/p>\n\u003cp>“Currently there are still trials ongoing here,” Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told reporters. “The agency has to wait for the companies to submit. … Obviously, we will move swiftly, but first the trials have to be finished … and the data need to be submitted to us.”\u003c/p>\n\u003cp>The FDA acted Monday without convening a customary public meeting of expert advisers to vet information about the vaccine and make recommendations to the regulator.\u003c/p>\n\u003cp>As of Sunday, 73%\u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#vaccinations\"> of adults have had at least one dose\u003c/a> of the Pfizer, Moderna or Johnson & Johnson vaccine. Pfizer’s vaccine is most commonly administered, accounting for about 56% of the doses administered overall, according to data from the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Moderna’s COVID-19 vaccine remains under the FDA’s review, but its approval is expected to follow in the near future.\u003c/p>\n\u003cp>\u003cem>KQED’s Kevin Stark contributed to this report. \u003c/em>\u003c/p>\n\u003cp>Copyright 2021 NPR. To see more, visit https://www.npr.org.\u003c/p>\n\u003cp>\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Pfizer%27s+COVID+Vaccine+Gets+Full+Approval+From+The+FDA&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/p>\u003c/div>\n\u003cp>[ad fullwidth]\u003c/p>\u003cp>\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cdiv class=\"fullattribution\">\n\u003cp>The Food and Drug Administration has formally approved Pfizer’s COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.\u003c/p>\n\u003cp>This is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.\u003c/p>\n\u003cp>The full approval could make it easier for employers, the military and universities to mandate vaccination and may reassure some people who are hesitant about the vaccine.\u003c/p>\n\u003cp>“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine\">acting FDA Commissioner Janet Woodcock said in a statement\u003c/a>.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">California Gov. Gavin Newsom was quick to issue supportive words Monday morning in a statement emailed to reporters, saying he encourages “all Californians to trust the science and protect themselves and their community by getting vaccinated.”\u003c/span>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400\"> Tomás Aragón, California’s public health officer, said the agency’s official approval of the vaccine “underscores the safety and efficacy of the COVID-19 vaccine and comes at a critical juncture as many of our communities are grappling with increasing cases fueled by the faster spreading Delta variant.”\u003c/span>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400\">“For weeks we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected, especially against severe and long-term illness,” he said in a statement. “We know the vaccines work. We know vaccines are safe. We know they save lives. If you are not vaccinated, let this be the milestone that gets you there. Get vaccinated to protect yourself and help put an end to this deadly pandemic.”\u003c/span>\u003c/p>\n\u003ch3 class=\"edTag\">Approval could lead to more vaccinations\u003c/h3>\n\u003cp>A \u003ca href=\"https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/\">June poll\u003c/a> from the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once one receives full approval from the FDA.\u003c/p>\n\u003cp>“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”\u003c/p>\n\u003cp>The FDA’s full approval applies to people 16 and older. Those between ages 12 and 15 can still receive the vaccine under the existing emergency use authorization.\u003c/p>\n\u003ch3 class=\"edTag\">There is no timeline for children under 12\u003c/h3>\n\u003cp>That authorization does not extend to children under the age of 12. FDA officials have acknowledged the interest in vaccination for children in that age group, but were unable Monday to provide a timeline for a decision on use of the vaccine for those under 12.\u003c/p>\n\u003cp>“Currently there are still trials ongoing here,” Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told reporters. “The agency has to wait for the companies to submit. … Obviously, we will move swiftly, but first the trials have to be finished … and the data need to be submitted to us.”\u003c/p>\n\u003cp>The FDA acted Monday without convening a customary public meeting of expert advisers to vet information about the vaccine and make recommendations to the regulator.\u003c/p>\n\u003cp>As of Sunday, 73%\u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#vaccinations\"> of adults have had at least one dose\u003c/a> of the Pfizer, Moderna or Johnson & Johnson vaccine. Pfizer’s vaccine is most commonly administered, accounting for about 56% of the doses administered overall, according to data from the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Moderna’s COVID-19 vaccine remains under the FDA’s review, but its approval is expected to follow in the near future.\u003c/p>\n\u003cp>\u003cem>KQED’s Kevin Stark contributed to this report. \u003c/em>\u003c/p>\n\u003cp>Copyright 2021 NPR. To see more, visit https://www.npr.org.\u003c/p>\n\u003cp>\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Pfizer%27s+COVID+Vaccine+Gets+Full+Approval+From+The+FDA&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/p>\u003c/div>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>The Food and Drug Administration on Thursday authorized the administration of an additional dose of one of the messenger RNA COVID-19 vaccines for people who have certain immunocompromising conditions amid growing evidence that they do not get adequate protection from the normal two-dose regimen of the Pfizer-BioNTech or Moderna vaccines.\u003c/p>\n\u003cp>The decision was formally an amendment to the emergency authorization under which the mRNA vaccines are already being used. It does not apply to the one-dose Johnson and Johnson vaccine, which has been used far less in this country than the mRNA products. It is unclear how many immunocompromised Americans would have received the J&J vaccine.\u003c/p>\n\u003cp>“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Acting FDA Commissioner Janet Woodcock said in a statement released shortly before midnight. “As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time.”\u003c/p>\n\u003cp>Patient groups and the physicians who treat them have been advocating for \u003ca href=\"https://www.statnews.com/2021/05/14/uncertain-protection-from-covid-vaccines-leaves-cancer-patients-in-limbo/\" target=\"_blank\" rel=\"noopener noreferrer\">immunocompromised people\u003c/a> — for instance, solid organ \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2779852\" target=\"_blank\" rel=\"noopener noreferrer\">transplant recipients\u003c/a> who take immunosuppressant drugs — to be given an additional dose, especially in the face of the spread of the more transmissible Delta variant. Several countries — France, Germany, Britain, and Israel among them — are or will soon be giving third doses to immunocompromised people.\u003c/p>\n\u003cp>The amended emergency use authorizations say the third doses of vaccine should be given at least 28 days after the second shot in the series. The Pfizer vaccine, which can be given to people 12 years of age and older, is administered in two doses, 21 days apart. The Moderna vaccine, which can be given to people 18 and older, is given in two doses 28 days apart.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The documents do not enumerate in detail who is eligible for an additional vaccine dose. They say people who have had a solid organ transplant or who have been diagnosed with conditions that are “considered to have an equivalent level of immunocompromise” can get a third dose of vaccine.\u003c/p>\n\u003cp>The vaccine advisory panel that makes recommendations to the Centers for Disease Control and Prevention on use of vaccines indicated late last month that it was amenable to recommending a different dosing schedule for immunocompromised patients, but could not do so while the emergency use authorizations under which the vaccines are deployed stipulate only a two-dose or one-dose regimen.\u003c/p>\n\u003cp>“Our hands are really tied with the current regulatory situation,” Camille Kotton, director of the transplant and immunocompromised host infectious diseases clinic at Massachusetts General Hospital, said during the July 22 meeting of the Advisory Committee on Immunization Practices.\u003c/p>\n\u003cp>The group is scheduled to meet on Friday to recommend the changes the FDA’s revision allows. It is expected that CDC Director Rochelle Walensky will sign off on the recommendation later on Friday.\u003c/p>\n\u003cp>If the COVID-19 vaccines were fully licensed, doctors could decide on their own to give an additional dose to some of their patients. So-called off-label use is common medical practice. But the unusual status of these vaccines — they are the first ever to be deployed under emergency use authorizations — precludes that possibility.\u003c/p>\n\u003cp>The confusion about how to proceed has created a bit of a free-for-all, with some immunocompromised people — and some regular people worried by the Delta variant — crossing state lines and using subterfuge to \u003ca href=\"https://www.statnews.com/2021/08/03/people-chasing-covid-19-vaccine-boosters-create-headaches-for-the-health-care-system/\" target=\"_blank\" rel=\"noopener noreferrer\">obtain an additional dose of vaccine\u003c/a>.\u003c/p>\n\u003cp>At least one state, \u003ca href=\"https://www.nbcnews.com/health/health-news/mississippi-offer-covid-vaccine-booster-doses-immunocompromised-people-n1276076\" target=\"_blank\" rel=\"noopener noreferrer\">Mississippi\u003c/a>, decided not to wait for federal action, telling vaccine providers and physicians to assess whether their immunocompromised patients should be given an additional vaccine dose.\u003c/p>\n\u003cp>In a presentation during ACIP’s meeting in July, CDC staff said that immunocompromised people make up about 2.7% of the American population. They include people with cancer who are undergoing some forms of therapy, people with advanced or untreated HIV infection, people born with severe immunodeficiencies, and organ or stem cell transplant patients.\u003c/p>\n\u003cp>People who \u003ca href=\"https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/07-COVID-Oliver-508.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">are immunocompromised\u003c/a> are more likely to get severely ill from COVID-19 and are more likely to have breakthrough infections, the CDC experts said. They are also more likely to have prolonged infections, creating the possibility that they will give rise to troublesome mutations of SARS-CoV-2, the virus that causes the disease.\u003c/p>\n\u003cp>Last week the World Health Organization \u003ca href=\"https://www.statnews.com/2021/08/04/who-calls-for-a-temporary-moratorium-on-administering-booster-shots-of-covid-19-vaccines/\" target=\"_blank\" rel=\"noopener noreferrer\">called for a moratorium\u003c/a> on giving additional doses of vaccine to people who are fully vaccinated in a bid to speed vaccination in lower-income countries where few doses have yet been available. But agency officials made clear they make an exception for immunocompromised people. “There is increasing evidence that there are some populations … who don’t respond to the vaccine as well as the general population does,” said \u003ca href=\"https://www.statnews.com/2021/08/09/who-expert-rush-covid-19-booster-shots-premature/\" target=\"_blank\" rel=\"noopener noreferrer\">Kate O’Brien\u003c/a>, WHO’s director of immunizations, vaccines, and biologics. “We don’t want that to be confused with the policy … of whether booster doses should be given.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2021/08/12/fda-authorizes-additional-dose-of-covid-19-vaccine-for-the-immunocompromised/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"http://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>The Food and Drug Administration on Thursday authorized the administration of an additional dose of one of the messenger RNA COVID-19 vaccines for people who have certain immunocompromising conditions amid growing evidence that they do not get adequate protection from the normal two-dose regimen of the Pfizer-BioNTech or Moderna vaccines.\u003c/p>\n\u003cp>The decision was formally an amendment to the emergency authorization under which the mRNA vaccines are already being used. It does not apply to the one-dose Johnson and Johnson vaccine, which has been used far less in this country than the mRNA products. It is unclear how many immunocompromised Americans would have received the J&J vaccine.\u003c/p>\n\u003cp>“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Acting FDA Commissioner Janet Woodcock said in a statement released shortly before midnight. “As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time.”\u003c/p>\n\u003cp>Patient groups and the physicians who treat them have been advocating for \u003ca href=\"https://www.statnews.com/2021/05/14/uncertain-protection-from-covid-vaccines-leaves-cancer-patients-in-limbo/\" target=\"_blank\" rel=\"noopener noreferrer\">immunocompromised people\u003c/a> — for instance, solid organ \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2779852\" target=\"_blank\" rel=\"noopener noreferrer\">transplant recipients\u003c/a> who take immunosuppressant drugs — to be given an additional dose, especially in the face of the spread of the more transmissible Delta variant. Several countries — France, Germany, Britain, and Israel among them — are or will soon be giving third doses to immunocompromised people.\u003c/p>\n\u003cp>The amended emergency use authorizations say the third doses of vaccine should be given at least 28 days after the second shot in the series. The Pfizer vaccine, which can be given to people 12 years of age and older, is administered in two doses, 21 days apart. The Moderna vaccine, which can be given to people 18 and older, is given in two doses 28 days apart.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The documents do not enumerate in detail who is eligible for an additional vaccine dose. They say people who have had a solid organ transplant or who have been diagnosed with conditions that are “considered to have an equivalent level of immunocompromise” can get a third dose of vaccine.\u003c/p>\n\u003cp>The vaccine advisory panel that makes recommendations to the Centers for Disease Control and Prevention on use of vaccines indicated late last month that it was amenable to recommending a different dosing schedule for immunocompromised patients, but could not do so while the emergency use authorizations under which the vaccines are deployed stipulate only a two-dose or one-dose regimen.\u003c/p>\n\u003cp>“Our hands are really tied with the current regulatory situation,” Camille Kotton, director of the transplant and immunocompromised host infectious diseases clinic at Massachusetts General Hospital, said during the July 22 meeting of the Advisory Committee on Immunization Practices.\u003c/p>\n\u003cp>The group is scheduled to meet on Friday to recommend the changes the FDA’s revision allows. It is expected that CDC Director Rochelle Walensky will sign off on the recommendation later on Friday.\u003c/p>\n\u003cp>If the COVID-19 vaccines were fully licensed, doctors could decide on their own to give an additional dose to some of their patients. So-called off-label use is common medical practice. But the unusual status of these vaccines — they are the first ever to be deployed under emergency use authorizations — precludes that possibility.\u003c/p>\n\u003cp>The confusion about how to proceed has created a bit of a free-for-all, with some immunocompromised people — and some regular people worried by the Delta variant — crossing state lines and using subterfuge to \u003ca href=\"https://www.statnews.com/2021/08/03/people-chasing-covid-19-vaccine-boosters-create-headaches-for-the-health-care-system/\" target=\"_blank\" rel=\"noopener noreferrer\">obtain an additional dose of vaccine\u003c/a>.\u003c/p>\n\u003cp>At least one state, \u003ca href=\"https://www.nbcnews.com/health/health-news/mississippi-offer-covid-vaccine-booster-doses-immunocompromised-people-n1276076\" target=\"_blank\" rel=\"noopener noreferrer\">Mississippi\u003c/a>, decided not to wait for federal action, telling vaccine providers and physicians to assess whether their immunocompromised patients should be given an additional vaccine dose.\u003c/p>\n\u003cp>In a presentation during ACIP’s meeting in July, CDC staff said that immunocompromised people make up about 2.7% of the American population. They include people with cancer who are undergoing some forms of therapy, people with advanced or untreated HIV infection, people born with severe immunodeficiencies, and organ or stem cell transplant patients.\u003c/p>\n\u003cp>People who \u003ca href=\"https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/07-COVID-Oliver-508.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">are immunocompromised\u003c/a> are more likely to get severely ill from COVID-19 and are more likely to have breakthrough infections, the CDC experts said. They are also more likely to have prolonged infections, creating the possibility that they will give rise to troublesome mutations of SARS-CoV-2, the virus that causes the disease.\u003c/p>\n\u003cp>Last week the World Health Organization \u003ca href=\"https://www.statnews.com/2021/08/04/who-calls-for-a-temporary-moratorium-on-administering-booster-shots-of-covid-19-vaccines/\" target=\"_blank\" rel=\"noopener noreferrer\">called for a moratorium\u003c/a> on giving additional doses of vaccine to people who are fully vaccinated in a bid to speed vaccination in lower-income countries where few doses have yet been available. But agency officials made clear they make an exception for immunocompromised people. “There is increasing evidence that there are some populations … who don’t respond to the vaccine as well as the general population does,” said \u003ca href=\"https://www.statnews.com/2021/08/09/who-expert-rush-covid-19-booster-shots-premature/\" target=\"_blank\" rel=\"noopener noreferrer\">Kate O’Brien\u003c/a>, WHO’s director of immunizations, vaccines, and biologics. “We don’t want that to be confused with the policy … of whether booster doses should be given.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2021/08/12/fda-authorizes-additional-dose-of-covid-19-vaccine-for-the-immunocompromised/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"http://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": "CDC Again Recommends Indoor Masking, Even for Some Vaccinated People",
"headTitle": "CDC Again Recommends Indoor Masking, Even for Some Vaccinated People | KQED",
"content": "\u003cp>Federal health officials advised Tuesday that even people who’ve had their COVID-19 shots wear masks in public indoor settings in areas with widespread transmission of the coronavirus, a major setback in the progress in the U.S. epidemic that reflects a surging variant and the country’s ongoing struggles to increase vaccination rates.\u003c/p>\n\u003cp>The reversal to the Centers for Disease Control and Prevention’s earlier guidance comes as the Delta variant — the most transmissible version of the pathogen yet, by far — is igniting outbreaks and driving hospitalizations up in states with low vaccination rates, like Missouri, Arkansas, and Florida. The variant is responsible for \u003ca href=\"https://www.statnews.com/2021/07/23/burning-questions-delta-next-phase-covid-19-pandemic/\" target=\"_blank\" rel=\"noopener noreferrer\">seemingly increasing numbers of breakthrough infections.\u003c/a>\u003c/p>\n\u003cp>The CDC also recommended that schools reopen in the fall with universal indoor masking for all students, teachers, and staff, even among people who are vaccinated — a policy decision that will ultimately be left up to state and local officials.\u003c/p>\n\u003cp>“Children should return to full-time, in-person learning in the fall with proper prevention strategies in place,” CDC Director Rochelle Walensky said during a press briefing.\u003c/p>\n\u003cp>In a statement, President Biden reiterated Walensky’s call that precautions would enable safer resumption of in-person schooling. “Masking students is inconvenient, I know, but will allow them to learn and be with their classmates with the best available protection,” he said.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Just two months ago, the CDC said that fully vaccinated people no longer needed to wear masks indoors, citing evidence that the immunizations prevented many cases entirely and left those who still got infected “less likely to … transmit [the virus] to others.”\u003c/p>\n\u003cp>But in addition to spreading more efficiently, Delta seems to have at least some ability to evade the immune response people generate after being vaccinated. Multiple studies have indicated that immunized people are still broadly protected against severe COVID-19 and death, but there is emerging evidence that Delta can cause breakthrough cases at higher rates than other virus versions — and that in some of those infections, people are still harboring large amounts of virus that could be passed to others.\u003c/p>\n\u003cp>Walensky said that new research indicates that vaccinated people are only contributing a small amount to overall transmission, the vast majority of which is occurring among people who haven’t received immunizations. But the data “unfortunately warrants” the updated recommendations.\u003c/p>\n\u003cp>“In those cases, those rare cases that we have breakthrough infections, we felt it important for people to understand that they have the potential to transmit virus to others,” she said.\u003c/p>\n\u003cp>Walensky called masks “a temporary measure” and urged people to get vaccinated, framing the shots as the tools that can suppress transmission rates in lasting ways.\u003c/p>\n\u003cp>“We really need to work to get these areas in the country that have substantial and high amount of transmission right now down to lower amounts of transmission,” she said.\u003c/p>\n\u003cp>The masking recommendations for vaccinated people applies to communities with “substantial” or “high” transmission rates, which together the CDC defines as 50 cases or more per 100,000 people over the past seven days.\u003c/p>\n\u003cp>Transmission rates in nearly two-thirds of U.S. counties are in those categories, with wide swaths of Nevada, Utah, and many southern states experiencing those levels of spread, \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#county-view\" target=\"_blank\" rel=\"noopener noreferrer\">CDC data show\u003c/a>. Some communities are reporting several hundred new cases per 100,000 people in the past week — what Walensky called “really an extraordinary amount of viral transmission.”\u003c/p>\n\u003cp>Delta’s general transmissibility stems at least in part from changes in its genome that allow it to build up much higher levels of virus in the upper airway, leading to people emitting more virus for longer periods of time, meaning they are more likely to infect others.\u003c/p>\n\u003cp>An administration official, speaking on the condition of anonymity, told STAT that health experts do not have studies proving that fully vaccinated people are transmitting the virus. Rather, the official said, the updated guidance is based on studies showing that vaccinated people who contract the Delta variant have similarly high levels of virus in their airways, which suggested that they may be infectious to others. With other variants, vaccinated people had substantially lower levels of virus in their noses and throats compared to unvaccinated people.\u003c/p>\n\u003cp>The new masking guidelines provide an unwelcome turn in the pandemic. As vaccines started rolling out, it was clear they weren’t just protecting people from getting so sick they needed hospital care or they would die, but that they were also drastically cutting transmission. Experts say vaccines are still limiting transmission even with Delta, but not to the same level as before.\u003c/p>\n\u003cp>It’s taken some time for scientists to tease apart all that Delta can do in vaccinated people. Most concerningly, it has been ripping through unvaccinated populations, leading to another surge in hospitalizations in some states that are almost entirely among people who haven’t been immunized. Experts are still trying to determine if Delta causes more severe disease on average than other variants.\u003c/p>\n\u003cp>Recent infection clusters that included vaccinated people — and that broadly caused mild and asymptomatic cases — raised worries that Delta was potentially spreading among vaccinated people to an extent. Walensky said the CDC was conducting outbreak investigations of the clusters to determine whether and to what extent vaccinated people were passing the virus on to others.\u003c/p>\n\u003cp>If vaccinated people are transmitting the virus, masks could help in cases when people are asymptomatic or in the period when they are infectious but haven’t yet developed symptoms. Under existing CDC guidelines, vaccinated people who were showing symptoms were still urged to isolate.\u003c/p>\n\u003cp>Vaccinated people passing the virus to other vaccinated people isn’t ideal, but given how protective the shots are against the worst outcomes, the bigger concern right now is that vaccinated people could be contributing to the spread of the virus to unvaccinated people. Vaccinated people could also be transmitting the virus to individuals who didn’t mount robust responses to the shots because their immune systems are suppressed, including some with cancer or who have received organ transplants. Children under 12 are also not yet eligible for COVID-19 vaccines.\u003c/p>\n\u003cp>It’s unclear how the new CDC guidelines will land with an American public that \u003ca href=\"https://www.statnews.com/2021/07/22/public-health-officials-have-tools-to-beat-back-covid-again-does-anyone-want-to-use-them/\" target=\"_blank\" rel=\"noopener noreferrer\">seems eager to move on from the pandemic\u003c/a>, even if the pandemic is not done with them. Many people who are vaccinated feel like they’ve done their part and might be unwilling to take a step back. And while health officials hope they can persuade some of the remaining unimmunized people to roll up their sleeves by improving access or addressing concerns, some portion of people have cemented their resistance to the shots.\u003c/p>\n\u003cp>Under the previous guidelines, unvaccinated people were still supposed to wear masks in public indoor settings.\u003c/p>\n\u003cp>The CDC says breakthrough cases still appear to be rare given how many people have been vaccinated, and the vast majority of infections are asymptomatic or mild. It’s also thought that because so many of those cases are so tame, many go undetected. However, many experts argue that breakthrough infections that cause no symptoms shouldn’t really be considered as cases. Mild or asymptomatic breakthrough infections are signs that the vaccines — whose top aim is to stave off death and severe illness — are doing their job, experts stress.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2021/07/27/cdc-recommend-masks-indoors-even-for-those-vaccinated-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>Federal health officials advised Tuesday that even people who’ve had their COVID-19 shots wear masks in public indoor settings in areas with widespread transmission of the coronavirus, a major setback in the progress in the U.S. epidemic that reflects a surging variant and the country’s ongoing struggles to increase vaccination rates.\u003c/p>\n\u003cp>The reversal to the Centers for Disease Control and Prevention’s earlier guidance comes as the Delta variant — the most transmissible version of the pathogen yet, by far — is igniting outbreaks and driving hospitalizations up in states with low vaccination rates, like Missouri, Arkansas, and Florida. The variant is responsible for \u003ca href=\"https://www.statnews.com/2021/07/23/burning-questions-delta-next-phase-covid-19-pandemic/\" target=\"_blank\" rel=\"noopener noreferrer\">seemingly increasing numbers of breakthrough infections.\u003c/a>\u003c/p>\n\u003cp>The CDC also recommended that schools reopen in the fall with universal indoor masking for all students, teachers, and staff, even among people who are vaccinated — a policy decision that will ultimately be left up to state and local officials.\u003c/p>\n\u003cp>“Children should return to full-time, in-person learning in the fall with proper prevention strategies in place,” CDC Director Rochelle Walensky said during a press briefing.\u003c/p>\n\u003cp>In a statement, President Biden reiterated Walensky’s call that precautions would enable safer resumption of in-person schooling. “Masking students is inconvenient, I know, but will allow them to learn and be with their classmates with the best available protection,” he said.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Just two months ago, the CDC said that fully vaccinated people no longer needed to wear masks indoors, citing evidence that the immunizations prevented many cases entirely and left those who still got infected “less likely to … transmit [the virus] to others.”\u003c/p>\n\u003cp>But in addition to spreading more efficiently, Delta seems to have at least some ability to evade the immune response people generate after being vaccinated. Multiple studies have indicated that immunized people are still broadly protected against severe COVID-19 and death, but there is emerging evidence that Delta can cause breakthrough cases at higher rates than other virus versions — and that in some of those infections, people are still harboring large amounts of virus that could be passed to others.\u003c/p>\n\u003cp>Walensky said that new research indicates that vaccinated people are only contributing a small amount to overall transmission, the vast majority of which is occurring among people who haven’t received immunizations. But the data “unfortunately warrants” the updated recommendations.\u003c/p>\n\u003cp>“In those cases, those rare cases that we have breakthrough infections, we felt it important for people to understand that they have the potential to transmit virus to others,” she said.\u003c/p>\n\u003cp>Walensky called masks “a temporary measure” and urged people to get vaccinated, framing the shots as the tools that can suppress transmission rates in lasting ways.\u003c/p>\n\u003cp>“We really need to work to get these areas in the country that have substantial and high amount of transmission right now down to lower amounts of transmission,” she said.\u003c/p>\n\u003cp>The masking recommendations for vaccinated people applies to communities with “substantial” or “high” transmission rates, which together the CDC defines as 50 cases or more per 100,000 people over the past seven days.\u003c/p>\n\u003cp>Transmission rates in nearly two-thirds of U.S. counties are in those categories, with wide swaths of Nevada, Utah, and many southern states experiencing those levels of spread, \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#county-view\" target=\"_blank\" rel=\"noopener noreferrer\">CDC data show\u003c/a>. Some communities are reporting several hundred new cases per 100,000 people in the past week — what Walensky called “really an extraordinary amount of viral transmission.”\u003c/p>\n\u003cp>Delta’s general transmissibility stems at least in part from changes in its genome that allow it to build up much higher levels of virus in the upper airway, leading to people emitting more virus for longer periods of time, meaning they are more likely to infect others.\u003c/p>\n\u003cp>An administration official, speaking on the condition of anonymity, told STAT that health experts do not have studies proving that fully vaccinated people are transmitting the virus. Rather, the official said, the updated guidance is based on studies showing that vaccinated people who contract the Delta variant have similarly high levels of virus in their airways, which suggested that they may be infectious to others. With other variants, vaccinated people had substantially lower levels of virus in their noses and throats compared to unvaccinated people.\u003c/p>\n\u003cp>The new masking guidelines provide an unwelcome turn in the pandemic. As vaccines started rolling out, it was clear they weren’t just protecting people from getting so sick they needed hospital care or they would die, but that they were also drastically cutting transmission. Experts say vaccines are still limiting transmission even with Delta, but not to the same level as before.\u003c/p>\n\u003cp>It’s taken some time for scientists to tease apart all that Delta can do in vaccinated people. Most concerningly, it has been ripping through unvaccinated populations, leading to another surge in hospitalizations in some states that are almost entirely among people who haven’t been immunized. Experts are still trying to determine if Delta causes more severe disease on average than other variants.\u003c/p>\n\u003cp>Recent infection clusters that included vaccinated people — and that broadly caused mild and asymptomatic cases — raised worries that Delta was potentially spreading among vaccinated people to an extent. Walensky said the CDC was conducting outbreak investigations of the clusters to determine whether and to what extent vaccinated people were passing the virus on to others.\u003c/p>\n\u003cp>If vaccinated people are transmitting the virus, masks could help in cases when people are asymptomatic or in the period when they are infectious but haven’t yet developed symptoms. Under existing CDC guidelines, vaccinated people who were showing symptoms were still urged to isolate.\u003c/p>\n\u003cp>Vaccinated people passing the virus to other vaccinated people isn’t ideal, but given how protective the shots are against the worst outcomes, the bigger concern right now is that vaccinated people could be contributing to the spread of the virus to unvaccinated people. Vaccinated people could also be transmitting the virus to individuals who didn’t mount robust responses to the shots because their immune systems are suppressed, including some with cancer or who have received organ transplants. Children under 12 are also not yet eligible for COVID-19 vaccines.\u003c/p>\n\u003cp>It’s unclear how the new CDC guidelines will land with an American public that \u003ca href=\"https://www.statnews.com/2021/07/22/public-health-officials-have-tools-to-beat-back-covid-again-does-anyone-want-to-use-them/\" target=\"_blank\" rel=\"noopener noreferrer\">seems eager to move on from the pandemic\u003c/a>, even if the pandemic is not done with them. Many people who are vaccinated feel like they’ve done their part and might be unwilling to take a step back. And while health officials hope they can persuade some of the remaining unimmunized people to roll up their sleeves by improving access or addressing concerns, some portion of people have cemented their resistance to the shots.\u003c/p>\n\u003cp>Under the previous guidelines, unvaccinated people were still supposed to wear masks in public indoor settings.\u003c/p>\n\u003cp>The CDC says breakthrough cases still appear to be rare given how many people have been vaccinated, and the vast majority of infections are asymptomatic or mild. It’s also thought that because so many of those cases are so tame, many go undetected. However, many experts argue that breakthrough infections that cause no symptoms shouldn’t really be considered as cases. Mild or asymptomatic breakthrough infections are signs that the vaccines — whose top aim is to stave off death and severe illness — are doing their job, experts stress.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "Last Year Saw the Biggest Drop in U.S. Life Expectancy Since WWII",
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"content": "\u003cp>Life expectancy in the United States declined by a year and a half in 2020, according to the Centers for Disease Control and Prevention, which says the coronavirus is largely to blame.\u003c/p>\n\u003cp>COVID-19 contributed to 74% of the\u003ca href=\"https://www.cdc.gov/nchs/data/vsrr/vsrr015-508.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"> decline in life expectancy from 78.8 years in 2019 to 77.3 years in 2020\u003c/a>, according to the CDC’s National Center for Health Statistics.\u003c/p>\n\u003cp>It was the largest one-year decline since World War II, when life expectancy dropped by 2.9 years between 1942 and 1943. Hispanic and Black communities saw the biggest declines.\u003c/p>\n\u003cp>For African Americans, life expectancy dropped by 2.9 years from 74.7 years in 2019 to 71.8 in 2020.\u003c/p>\n\u003cp>U.S. Hispanics — who have a longer life expectancy than non-Hispanic Blacks or whites saw the largest decline in life expectancy during the pandemic, dropping three years from 81.8 years in 2019 to 78.8 years in 2020. Hispanic males saw the biggest decline, with a drop of 3.7 years. COVID-19 was responsible for 90% of the decline among Hispanics.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The increase in drug overdose deaths was also a factor in declining life expectancy. \u003ca href=\"https://www.npr.org/2021/07/14/1016029270/drug-overdoses-killed-a-record-number-of-americans-in-2020-jumping-by-nearly-30\" target=\"_blank\" rel=\"noopener noreferrer\">More than 93,000 people died from drug overdoses in 2020\u003c/a>. That’s the highest number reported in a single year. Other causes of death contributing to the decline were increases in homicide and deaths from diabetes and chronic liver disease.\u003c/p>\n\u003cp>Just last month a study published in the \u003ca href=\"https://www.bmj.com/content/373/bmj.n1343\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cem>British Medical Journal\u003c/em>\u003c/a> looked at life expectancy data for the U.S. and compared it with life expectancy data from 16 other high-income countries. The study found the U.S. decrease in life expectancy from 2018 to 2020 was 8.5 times greater than the average decrease in peer countries. And the U.S. declines were most pronounced among minority groups, specifically Black and Hispanic people.\u003c/p>\n\u003cp>Study author \u003ca href=\"https://medschool.vcu.edu/expertise/detail.html?ID=831\" target=\"_blank\" rel=\"noopener noreferrer\">Steven Woolf of the Virginia Commonwealth University\u003c/a> School of Medicine, told NPR’s Allison Aubrey, “We have not seen a decrease like this since World War II. It’s a horrific decrease in life expectancy.”\u003c/p>\n\u003cp>“It is impossible to look at these findings and not see a reflection of the systemic racism in the U.S.,”\u003ca href=\"https://populationhealth.duke.edu/people/lesley-curtis-phd\" target=\"_blank\" rel=\"noopener noreferrer\"> Lesley Curtis, chair of the Department of Population Health Sciences\u003c/a> at Duke University School of Medicine, told NPR.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“The range of factors that play into this include income inequality, the social safety net, as well as racial inequality and access to health care,” Curtis said.\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=U.S.+Life+Expectancy+Fell+By+1.5+Years+In+2020%2C+The+Biggest+Drop+Since+WWII+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Life expectancy in the United States declined by a year and a half in 2020, according to the Centers for Disease Control and Prevention, which says the coronavirus is largely to blame.\u003c/p>\n\u003cp>COVID-19 contributed to 74% of the\u003ca href=\"https://www.cdc.gov/nchs/data/vsrr/vsrr015-508.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"> decline in life expectancy from 78.8 years in 2019 to 77.3 years in 2020\u003c/a>, according to the CDC’s National Center for Health Statistics.\u003c/p>\n\u003cp>It was the largest one-year decline since World War II, when life expectancy dropped by 2.9 years between 1942 and 1943. Hispanic and Black communities saw the biggest declines.\u003c/p>\n\u003cp>For African Americans, life expectancy dropped by 2.9 years from 74.7 years in 2019 to 71.8 in 2020.\u003c/p>\n\u003cp>U.S. Hispanics — who have a longer life expectancy than non-Hispanic Blacks or whites saw the largest decline in life expectancy during the pandemic, dropping three years from 81.8 years in 2019 to 78.8 years in 2020. Hispanic males saw the biggest decline, with a drop of 3.7 years. COVID-19 was responsible for 90% of the decline among Hispanics.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The increase in drug overdose deaths was also a factor in declining life expectancy. \u003ca href=\"https://www.npr.org/2021/07/14/1016029270/drug-overdoses-killed-a-record-number-of-americans-in-2020-jumping-by-nearly-30\" target=\"_blank\" rel=\"noopener noreferrer\">More than 93,000 people died from drug overdoses in 2020\u003c/a>. That’s the highest number reported in a single year. Other causes of death contributing to the decline were increases in homicide and deaths from diabetes and chronic liver disease.\u003c/p>\n\u003cp>Just last month a study published in the \u003ca href=\"https://www.bmj.com/content/373/bmj.n1343\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cem>British Medical Journal\u003c/em>\u003c/a> looked at life expectancy data for the U.S. and compared it with life expectancy data from 16 other high-income countries. The study found the U.S. decrease in life expectancy from 2018 to 2020 was 8.5 times greater than the average decrease in peer countries. And the U.S. declines were most pronounced among minority groups, specifically Black and Hispanic people.\u003c/p>\n\u003cp>Study author \u003ca href=\"https://medschool.vcu.edu/expertise/detail.html?ID=831\" target=\"_blank\" rel=\"noopener noreferrer\">Steven Woolf of the Virginia Commonwealth University\u003c/a> School of Medicine, told NPR’s Allison Aubrey, “We have not seen a decrease like this since World War II. It’s a horrific decrease in life expectancy.”\u003c/p>\n\u003cp>“It is impossible to look at these findings and not see a reflection of the systemic racism in the U.S.,”\u003ca href=\"https://populationhealth.duke.edu/people/lesley-curtis-phd\" target=\"_blank\" rel=\"noopener noreferrer\"> Lesley Curtis, chair of the Department of Population Health Sciences\u003c/a> at Duke University School of Medicine, told NPR.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“The range of factors that play into this include income inequality, the social safety net, as well as racial inequality and access to health care,” Curtis said.\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=U.S.+Life+Expectancy+Fell+By+1.5+Years+In+2020%2C+The+Biggest+Drop+Since+WWII+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"title": "Experimental Brain Implant Lets Man With Paralysis Turn His Thoughts Into Words",
"headTitle": "Experimental Brain Implant Lets Man With Paralysis Turn His Thoughts Into Words | KQED",
"content": "\u003cp>A man who is unable to move or speak can now generate words and sentences on a computer using only his thoughts.\u003c/p>\n\u003cp>The ability comes from an experimental implanted device that decodes signals in the man’s brain that once controlled his vocal tract, as researchers \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa2027540\" target=\"_blank\" rel=\"noopener noreferrer\">reported\u003c/a> Wednesday in \u003cem>The New England Journal of Medicine\u003c/em>.\u003c/p>\n\u003cp>The man is currently limited to a vocabulary of just 50 words and communicates at a rate of about 15 words per minute, which is much slower than natural speech.\u003c/p>\n\u003cp>“This tells us that it’s possible,” says \u003ca href=\"https://profiles.ucsf.edu/edward.chang\" target=\"_blank\" rel=\"noopener noreferrer\">Edward Chang\u003c/a>, a neurosurgeon at the University of California, San Francisco. “I think there’s a huge runway to make this better over time.”\u003c/p>\n\u003cp>A device that allowed people who can’t speak to communicate using brain circuits previously used for speech would be “more natural, and hopefully effortless compared to current assistive devices,” says \u003ca href=\"https://bme.gatech.edu/bme/faculty/Chethan-Pandarinath\" target=\"_blank\" rel=\"noopener noreferrer\">Chethan Pandarinath\u003c/a>, an assistant professor in the Department of Biomedical Engineering at Emory University and Georgia Tech.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Currently, people with paralysis who have lost the ability to speak usually rely on devices that use eye or head movements to spell out words one letter at a time. Some use a device that allows them to control a computer cursor with thoughts.\u003c/p>\n\u003cp>Chang’s team wanted to find a better solution for the man, identified only as BRAVO1 to protect his privacy. The name refers to his status as the first patient in a study called BRAVO, or Brain-Computer Interface Restoration of Arm and Voice.\u003c/p>\n\u003cp>BRAVO1, who is in his late 30s, has been paralyzed and unable to speak since he had a stroke 15 years ago, Chang says.\u003c/p>\n\u003cp>“The stroke left him nearly completely paralyzed in his arms and legs but also in the muscles of his vocal tract,” Chang says. But the areas of the brain that once issued speech commands are intact.\u003c/p>\n\u003cp>\u003cstrong>Dormant Brain Signals Tapped for Communication\u003c/strong>\u003c/p>\n\u003cp>Previously, Chang’s team had developed a system designed to recognize the brain signals associated with the intention to speak specific words. Tests showed that the system worked in people who were still able to move and speak.\u003c/p>\n\u003cp>But success was far from certain in someone such as BRAVO1, Chang says.\u003c/p>\n\u003cp>“We didn’t know if the speech commands in the brain would still work after 15 years,” he says. “And even if we could revive those dormant brain signals for speech, could we actually translate those into full words?”\u003c/p>\n\u003cp>To find out, the team implanted sensors on the surface of the man’s brain. Then it had a computer study the patterns of electrical activity produced when he attempted to speak 50 different words. The process took months.\u003c/p>\n\u003cp>Once BRAVO1 could reliably generate words on a computer screen, the team began having him form sentences. To help improve accuracy, the team added a program that analyzed the context of each word as it was added.\u003c/p>\n\u003cp>The system is a bit like the texting software on most smartphones. “So, for example, if one word is just not decoded correctly, this autocorrect function can correct it,” Chang says.\u003c/p>\n\u003cp>After months of adjustments to the system, the man was able to generate a word reliably every four seconds, or roughly 15 words per minute.\u003c/p>\n\u003cp>“Normal speech is on the order of 120, 150 words per minute, so there’s a lot of room to improve,” Chang says.\u003c/p>\n\u003cp>A device able to decode words in the brain could eventually help thousands of people who’ve had a stroke or a traumatic brain injury, says \u003ca href=\"https://profiles.stanford.edu/krishna-shenoy\" target=\"_blank\" rel=\"noopener noreferrer\">Krishna Shenoy\u003c/a>, a professor in the School of Engineering at Stanford University.\u003c/p>\n\u003cp>Such a device might also help people with \u003ca href=\"https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet\" target=\"_blank\" rel=\"noopener noreferrer\">amyotrophic lateral sclerosis\u003c/a>, or ALS, a paralyzing disease that eventually makes it impossible to speak, Shenoy says.\u003c/p>\n\u003cp>The ability to recognize even 50 words in the brain is a huge achievement, Shenoy says. “But I think that’s just the tip of the iceberg. I think that could easily become 500 or 5,000 words.”\u003c/p>\n\u003cp>Until that happens though, devices that recognize entire words will be limited to basic communication.\u003c/p>\n\u003cp>\u003cstrong>Keeping Some Thoughts Private and Others Public\u003c/strong>\u003c/p>\n\u003cp>In the meantime, brain implants that allow people to spell out words keep getting better, Shenoy says. Earlier this year, he and a team published results of a \u003ca href=\"https://www.npr.org/sections/health-shots/2021/05/12/996141182/paralyzed-man-communicates-by-imagining-handwriting\">study\u003c/a> showing that people could spell quickly and accurately using a device that decoded the brain signals usually used for handwriting.\u003c/p>\n\u003cp>“We know far more now than 10 years ago or 20 years about how to eavesdrop on those conversations in the brain,” Shenoy says.\u003c/p>\n\u003cp>That sort of eavesdropping could compromise a person’s privacy though, Pandarinath says. That’s because devices wired directly to the brain could make it hard for people to separate private thoughts from those they choose to make public, he says.\u003c/p>\n\u003cp>“We want to make sure the devices we create allow that separation, allow people to be able to think their private thoughts without anything just being broadcast to the world,” he says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>That may be easier with devices that rely on brain signals that control muscles, he says. That’s because these signals generally aren’t sent unless a person makes a conscious attempt at movement.\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=Experimental+Brain+Implant+Lets+Man+With+Paralysis+Turn+His+Thoughts+Into+Words&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>A man who is unable to move or speak can now generate words and sentences on a computer using only his thoughts.\u003c/p>\n\u003cp>The ability comes from an experimental implanted device that decodes signals in the man’s brain that once controlled his vocal tract, as researchers \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa2027540\" target=\"_blank\" rel=\"noopener noreferrer\">reported\u003c/a> Wednesday in \u003cem>The New England Journal of Medicine\u003c/em>.\u003c/p>\n\u003cp>The man is currently limited to a vocabulary of just 50 words and communicates at a rate of about 15 words per minute, which is much slower than natural speech.\u003c/p>\n\u003cp>“This tells us that it’s possible,” says \u003ca href=\"https://profiles.ucsf.edu/edward.chang\" target=\"_blank\" rel=\"noopener noreferrer\">Edward Chang\u003c/a>, a neurosurgeon at the University of California, San Francisco. “I think there’s a huge runway to make this better over time.”\u003c/p>\n\u003cp>A device that allowed people who can’t speak to communicate using brain circuits previously used for speech would be “more natural, and hopefully effortless compared to current assistive devices,” says \u003ca href=\"https://bme.gatech.edu/bme/faculty/Chethan-Pandarinath\" target=\"_blank\" rel=\"noopener noreferrer\">Chethan Pandarinath\u003c/a>, an assistant professor in the Department of Biomedical Engineering at Emory University and Georgia Tech.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Currently, people with paralysis who have lost the ability to speak usually rely on devices that use eye or head movements to spell out words one letter at a time. Some use a device that allows them to control a computer cursor with thoughts.\u003c/p>\n\u003cp>Chang’s team wanted to find a better solution for the man, identified only as BRAVO1 to protect his privacy. The name refers to his status as the first patient in a study called BRAVO, or Brain-Computer Interface Restoration of Arm and Voice.\u003c/p>\n\u003cp>BRAVO1, who is in his late 30s, has been paralyzed and unable to speak since he had a stroke 15 years ago, Chang says.\u003c/p>\n\u003cp>“The stroke left him nearly completely paralyzed in his arms and legs but also in the muscles of his vocal tract,” Chang says. But the areas of the brain that once issued speech commands are intact.\u003c/p>\n\u003cp>\u003cstrong>Dormant Brain Signals Tapped for Communication\u003c/strong>\u003c/p>\n\u003cp>Previously, Chang’s team had developed a system designed to recognize the brain signals associated with the intention to speak specific words. Tests showed that the system worked in people who were still able to move and speak.\u003c/p>\n\u003cp>But success was far from certain in someone such as BRAVO1, Chang says.\u003c/p>\n\u003cp>“We didn’t know if the speech commands in the brain would still work after 15 years,” he says. “And even if we could revive those dormant brain signals for speech, could we actually translate those into full words?”\u003c/p>\n\u003cp>To find out, the team implanted sensors on the surface of the man’s brain. Then it had a computer study the patterns of electrical activity produced when he attempted to speak 50 different words. The process took months.\u003c/p>\n\u003cp>Once BRAVO1 could reliably generate words on a computer screen, the team began having him form sentences. To help improve accuracy, the team added a program that analyzed the context of each word as it was added.\u003c/p>\n\u003cp>The system is a bit like the texting software on most smartphones. “So, for example, if one word is just not decoded correctly, this autocorrect function can correct it,” Chang says.\u003c/p>\n\u003cp>After months of adjustments to the system, the man was able to generate a word reliably every four seconds, or roughly 15 words per minute.\u003c/p>\n\u003cp>“Normal speech is on the order of 120, 150 words per minute, so there’s a lot of room to improve,” Chang says.\u003c/p>\n\u003cp>A device able to decode words in the brain could eventually help thousands of people who’ve had a stroke or a traumatic brain injury, says \u003ca href=\"https://profiles.stanford.edu/krishna-shenoy\" target=\"_blank\" rel=\"noopener noreferrer\">Krishna Shenoy\u003c/a>, a professor in the School of Engineering at Stanford University.\u003c/p>\n\u003cp>Such a device might also help people with \u003ca href=\"https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet\" target=\"_blank\" rel=\"noopener noreferrer\">amyotrophic lateral sclerosis\u003c/a>, or ALS, a paralyzing disease that eventually makes it impossible to speak, Shenoy says.\u003c/p>\n\u003cp>The ability to recognize even 50 words in the brain is a huge achievement, Shenoy says. “But I think that’s just the tip of the iceberg. I think that could easily become 500 or 5,000 words.”\u003c/p>\n\u003cp>Until that happens though, devices that recognize entire words will be limited to basic communication.\u003c/p>\n\u003cp>\u003cstrong>Keeping Some Thoughts Private and Others Public\u003c/strong>\u003c/p>\n\u003cp>In the meantime, brain implants that allow people to spell out words keep getting better, Shenoy says. Earlier this year, he and a team published results of a \u003ca href=\"https://www.npr.org/sections/health-shots/2021/05/12/996141182/paralyzed-man-communicates-by-imagining-handwriting\">study\u003c/a> showing that people could spell quickly and accurately using a device that decoded the brain signals usually used for handwriting.\u003c/p>\n\u003cp>“We know far more now than 10 years ago or 20 years about how to eavesdrop on those conversations in the brain,” Shenoy says.\u003c/p>\n\u003cp>That sort of eavesdropping could compromise a person’s privacy though, Pandarinath says. That’s because devices wired directly to the brain could make it hard for people to separate private thoughts from those they choose to make public, he says.\u003c/p>\n\u003cp>“We want to make sure the devices we create allow that separation, allow people to be able to think their private thoughts without anything just being broadcast to the world,” he says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>That may be easier with devices that rely on brain signals that control muscles, he says. That’s because these signals generally aren’t sent unless a person makes a conscious attempt at movement.\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=Experimental+Brain+Implant+Lets+Man+With+Paralysis+Turn+His+Thoughts+Into+Words&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"title": "Here's What You Need to Know About the More Transmissible Delta Variant",
"headTitle": "Here’s What You Need to Know About the More Transmissible Delta Variant | KQED",
"content": "\u003cp class=\"p1\">\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">I\u003c/span>\u003c/span>t’s getting even riskier to remain unvaccinated.\u003c/p>\n\u003cp class=\"p1\">The United States, as a whole, is still in good shape for the summer of reunions and revived activities. But for those who haven’t been immunized against COVID-19, there is a new concern: the emergence of yet another coronavirus variant, one with a nasty combination of features that makes it even more dangerous than the other strains that have caused global alarms.\u003c/p>\n\u003cp class=\"p1\">The variant, known as Delta, was first spotted in India and helped power that country’s recent explosive outbreaks. Also called B.1.617.2, it seems to be the most transmissible version of the coronavirus seen thus far, but also carries some ability to get around the body’s immune protection generated after vaccination or an initial infection. (There’s also some evidence that it is more likely to cause severe disease, though researchers are still trying to confirm that.)\u003c/p>\n\u003cp class=\"p1\">“It’s really like the worst of both worlds,” said epidemiologist Nathan Grubaugh of the Yale School of Public Health.\u003c/p>\n\u003cp class=\"p1\">Globally, the variant’s march around the world could ignite major epidemics, \u003ca href=\"https://apnews.com/article/uganda-south-africa-cape-town-africa-coronavirus-pandemic-c5d7c2b0f927c8bd4d8d91fbf2cda1ea\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">given vaccine shortages\u003c/span>\u003c/a> in many nations. In unvaccinated populations, experts generally have greater fears about more transmissible variants than ones that are, say, just deadlier, because by causing more cases than would have occurred otherwise, the faster spreading strains can result in greater hospitalizations and deaths overall. Delta appears to be able to do that and more.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“Taken all together, this is something which is really, really anxiety-inducing from a global health perspective,” said epidemiologist William Hanage of Harvard’s T.H. Chan School of Public Health.\u003c/p>\n\u003cp class=\"p1\">In the United States, Delta accounts for just 6% of sequenced cases, federal health officials said this week, though its prevalence is building.\u003c/p>\n\u003cp class=\"p1\">On an individual level, people who have had their full vaccine regimens — a figure that this week in the U.S. \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#vaccinations\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">crossed\u003c/span>\u003c/a> 50% among those 12 and older — don’t need to be particularly worried about Delta. The COVID-19 immunizations retain the large bulk of their effectiveness against the variant, though with different vaccines used in different parts of the world, scientists are still parsing how each of them fare. Experts so far have been particularly impressed with how strongly the two-dose mRNA vaccines from Moderna and Pfizer-BioNTech, which account for the bulk of shots delivered in the U.S., stand up to different versions of the virus.\u003c/p>\n\u003cp class=\"p1\">But it’s not as if the SARS-CoV-2 virus has disappeared from the United States. It’s been clear that it would continue to circulate among unvaccinated people going forward. Now, any clusters that emerge and are driven by Delta will grow bigger and faster. And for those who do contract it — with some evidence from England indicating that people infected with Delta are more likely to be hospitalized — “it’s going to be worse for them,” Hanage said.\u003c/p>\n\u003cp class=\"p1\">With so many people vaccinated, whatever outbreaks occur likely won’t lead to huge spikes that inundate hospitals — but they will lead to some people dying.\u003c/p>\n\u003cp class=\"p1\">Nationwide, cases have plunged from where they were just months ago, though the pace of decline has slowed. Study after study has shown the vaccines aren’t just protecting people from COVID-19, but are blunting transmission.\u003c/p>\n\u003cp class=\"p1\">That wall of protection will benefit people who are unvaccinated as well, as will other factors that could be contributing to lower transmission rates, including immunity levels from natural infection and seasonal factors that seem to put some brake on spread.\u003c/p>\n\u003cp class=\"p1\">But some unvaccinated people remain more vulnerable than others.\u003c/p>\n\u003cp class=\"p1\">The story of the pandemic — both globally and within the United States — has been one of hot spots and areas that are better protected. Now, states where immunization rates are lagging — like Idaho, Wyoming, Louisiana, Alabama, Tennessee and Mississippi — are going to be more susceptible to ongoing outbreaks than states like those in the Northeast, where vaccine uptake has been much higher, particularly as communities slough off remaining countermeasures.\u003c/p>\n\u003cp class=\"p1\">Plus, more transmissible variants like Delta require a higher level of population immunity to be slowed.\u003c/p>\n\u003cp>https://twitter.com/POTUS/status/1402321777200611336?s=20\u003c/p>\n\u003cp class=\"p1\">The silver lining of the appearance of different variants is that, for whatever twists evolution has thrown our way, \u003ca href=\"https://www.statnews.com/2021/05/13/vaccines-work-variants-complicated/\">\u003cspan class=\"s1\">the vaccines have largely been able to withstand them\u003c/span>\u003c/a>. Variants that have some capability to “escape” the immune response elicited by vaccines might cause breakthrough infections at higher rates, and their transmission might not be slowed as quickly. The shots, however, have maintained their incredibly robust ability to prevent sickness and severe outcomes from COVID-19.\u003c/p>\n\u003cp class=\"p1\">But research into Delta has also underscored the importance of getting both shots of the two-dose vaccines. \u003ca href=\"https://www.gov.uk/government/news/vaccines-highly-effective-against-b-1-617-2-variant-after-2-doses\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">A study\u003c/span>\u003c/a> from Public Health England last month showed the Pfizer regimen was 88% effective at protecting against symptomatic illness from the variant, and the AstraZeneca vaccine was 60% effective — just slight drops in performance compared to other forms of the virus. But after just one shot, those figures plummeted to 33% for both vaccines. (The AstraZeneca vaccine has not been authorized in the United States.)\u003c/p>\n\u003cp class=\"p1\">“After the second dose, we see the amount of antibody in a person’s blood is even higher than after the first dose, and therefore more people will be above a threshold,” Wendy Barclay, a virologist at Imperial College London, said at a press briefing Wednesday. “There’s a certain level of antibody and immunity you need to be protected. We know that’s a certain level for the Alpha variant, and there will be a slightly higher level required to protect against Delta variant.”\u003c/p>\n\u003cp class=\"p1\">The Alpha variant Barclay referenced is also known as B.1.1.7 and first appeared last fall in the United Kingdom. Before Delta, it was the most transmissible variant and became dominant in a number of countries, including the United States, but does not have any meaningful immune escape prowess.\u003c/p>\n\u003cp class=\"p1\">Scientists have estimated that Delta is perhaps 60% even more transmissible than Alpha. And in the U.K., it’s overtaken Alpha in frequency — which some experts have speculated could happen in the United States as well. \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#variant-proportions\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">The latest U.S. data\u003c/span>\u003c/a> indicate Alpha accounted for nearly 70% of sequenced cases, but Delta is amassing.\u003c/p>\n\u003cp class=\"p1\">The urgency, then, is to get as many people immunized as quickly as possible, so more people are protected and there are fewer infections overall, as Delta increasingly accounts for more of the country’s cases.\u003c/p>\n\u003cp class=\"p1\">“If you’ve had your first dose, make sure you get that second dose, and for those who have been not vaccinated yet, please, get vaccinated,” Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said at a White House briefing Tuesday, where he highlighted the threat of Delta.\u003c/p>\n\u003cp class=\"p1\">There are several factors that appear to give Delta its transmission boost over Alpha. For one, Delta “can transmit more easily in a vaccinated population than the Alpha variant can,” epidemiologist Neil Ferguson of Imperial College London told reporters Wednesday. That advantage will become particularly noticeable in countries with higher vaccination coverage, like the United Kingdom and the United States, because Alpha will encounter greater barriers as it tries to spread. (It’s not that Delta can run rampant through vaccinated populations; it’s a matter that it can transmit comparatively more efficiently because of its immune escape capability.)\u003c/p>\n\u003cp class=\"p1\">In fact, some experts anticipate that in the United States, variants like Delta, Beta and Gamma could start to claw away at Alpha’s dominance because they have greater abilities to spread among vaccinated populations, though the likelihood of that will depend on how many people remain unvaccinated. (Beta, or B.1.351, first appeared in South Africa, while Gamma, or P.1, emerged in Brazil.)\u003c/p>\n\u003cp class=\"p1\">But Delta also appears to have some other advantages. “The virus itself is fitter in human airway cells,” Barclay said about what early research indicates. That means that an infected person will likely emit more virus into the air, and that the virus is more adept at infecting cells, so people need to be exposed to less of it to contract it.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2021/06/10/more-transmissible-variant-covid-19-vaccinations-even-more-crucial/\" 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 class=\"p1\">\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">I\u003c/span>\u003c/span>t’s getting even riskier to remain unvaccinated.\u003c/p>\n\u003cp class=\"p1\">The United States, as a whole, is still in good shape for the summer of reunions and revived activities. But for those who haven’t been immunized against COVID-19, there is a new concern: the emergence of yet another coronavirus variant, one with a nasty combination of features that makes it even more dangerous than the other strains that have caused global alarms.\u003c/p>\n\u003cp class=\"p1\">The variant, known as Delta, was first spotted in India and helped power that country’s recent explosive outbreaks. Also called B.1.617.2, it seems to be the most transmissible version of the coronavirus seen thus far, but also carries some ability to get around the body’s immune protection generated after vaccination or an initial infection. (There’s also some evidence that it is more likely to cause severe disease, though researchers are still trying to confirm that.)\u003c/p>\n\u003cp class=\"p1\">“It’s really like the worst of both worlds,” said epidemiologist Nathan Grubaugh of the Yale School of Public Health.\u003c/p>\n\u003cp class=\"p1\">Globally, the variant’s march around the world could ignite major epidemics, \u003ca href=\"https://apnews.com/article/uganda-south-africa-cape-town-africa-coronavirus-pandemic-c5d7c2b0f927c8bd4d8d91fbf2cda1ea\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">given vaccine shortages\u003c/span>\u003c/a> in many nations. In unvaccinated populations, experts generally have greater fears about more transmissible variants than ones that are, say, just deadlier, because by causing more cases than would have occurred otherwise, the faster spreading strains can result in greater hospitalizations and deaths overall. Delta appears to be able to do that and more.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“Taken all together, this is something which is really, really anxiety-inducing from a global health perspective,” said epidemiologist William Hanage of Harvard’s T.H. Chan School of Public Health.\u003c/p>\n\u003cp class=\"p1\">In the United States, Delta accounts for just 6% of sequenced cases, federal health officials said this week, though its prevalence is building.\u003c/p>\n\u003cp class=\"p1\">On an individual level, people who have had their full vaccine regimens — a figure that this week in the U.S. \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#vaccinations\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">crossed\u003c/span>\u003c/a> 50% among those 12 and older — don’t need to be particularly worried about Delta. The COVID-19 immunizations retain the large bulk of their effectiveness against the variant, though with different vaccines used in different parts of the world, scientists are still parsing how each of them fare. Experts so far have been particularly impressed with how strongly the two-dose mRNA vaccines from Moderna and Pfizer-BioNTech, which account for the bulk of shots delivered in the U.S., stand up to different versions of the virus.\u003c/p>\n\u003cp class=\"p1\">But it’s not as if the SARS-CoV-2 virus has disappeared from the United States. It’s been clear that it would continue to circulate among unvaccinated people going forward. Now, any clusters that emerge and are driven by Delta will grow bigger and faster. And for those who do contract it — with some evidence from England indicating that people infected with Delta are more likely to be hospitalized — “it’s going to be worse for them,” Hanage said.\u003c/p>\n\u003cp class=\"p1\">With so many people vaccinated, whatever outbreaks occur likely won’t lead to huge spikes that inundate hospitals — but they will lead to some people dying.\u003c/p>\n\u003cp class=\"p1\">Nationwide, cases have plunged from where they were just months ago, though the pace of decline has slowed. Study after study has shown the vaccines aren’t just protecting people from COVID-19, but are blunting transmission.\u003c/p>\n\u003cp class=\"p1\">That wall of protection will benefit people who are unvaccinated as well, as will other factors that could be contributing to lower transmission rates, including immunity levels from natural infection and seasonal factors that seem to put some brake on spread.\u003c/p>\n\u003cp class=\"p1\">But some unvaccinated people remain more vulnerable than others.\u003c/p>\n\u003cp class=\"p1\">The story of the pandemic — both globally and within the United States — has been one of hot spots and areas that are better protected. Now, states where immunization rates are lagging — like Idaho, Wyoming, Louisiana, Alabama, Tennessee and Mississippi — are going to be more susceptible to ongoing outbreaks than states like those in the Northeast, where vaccine uptake has been much higher, particularly as communities slough off remaining countermeasures.\u003c/p>\n\u003cp class=\"p1\">Plus, more transmissible variants like Delta require a higher level of population immunity to be slowed.\u003c/p>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\n\u003cp class=\"p1\">The silver lining of the appearance of different variants is that, for whatever twists evolution has thrown our way, \u003ca href=\"https://www.statnews.com/2021/05/13/vaccines-work-variants-complicated/\">\u003cspan class=\"s1\">the vaccines have largely been able to withstand them\u003c/span>\u003c/a>. Variants that have some capability to “escape” the immune response elicited by vaccines might cause breakthrough infections at higher rates, and their transmission might not be slowed as quickly. The shots, however, have maintained their incredibly robust ability to prevent sickness and severe outcomes from COVID-19.\u003c/p>\n\u003cp class=\"p1\">But research into Delta has also underscored the importance of getting both shots of the two-dose vaccines. \u003ca href=\"https://www.gov.uk/government/news/vaccines-highly-effective-against-b-1-617-2-variant-after-2-doses\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">A study\u003c/span>\u003c/a> from Public Health England last month showed the Pfizer regimen was 88% effective at protecting against symptomatic illness from the variant, and the AstraZeneca vaccine was 60% effective — just slight drops in performance compared to other forms of the virus. But after just one shot, those figures plummeted to 33% for both vaccines. (The AstraZeneca vaccine has not been authorized in the United States.)\u003c/p>\n\u003cp class=\"p1\">“After the second dose, we see the amount of antibody in a person’s blood is even higher than after the first dose, and therefore more people will be above a threshold,” Wendy Barclay, a virologist at Imperial College London, said at a press briefing Wednesday. “There’s a certain level of antibody and immunity you need to be protected. We know that’s a certain level for the Alpha variant, and there will be a slightly higher level required to protect against Delta variant.”\u003c/p>\n\u003cp class=\"p1\">The Alpha variant Barclay referenced is also known as B.1.1.7 and first appeared last fall in the United Kingdom. Before Delta, it was the most transmissible variant and became dominant in a number of countries, including the United States, but does not have any meaningful immune escape prowess.\u003c/p>\n\u003cp class=\"p1\">Scientists have estimated that Delta is perhaps 60% even more transmissible than Alpha. And in the U.K., it’s overtaken Alpha in frequency — which some experts have speculated could happen in the United States as well. \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#variant-proportions\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">The latest U.S. data\u003c/span>\u003c/a> indicate Alpha accounted for nearly 70% of sequenced cases, but Delta is amassing.\u003c/p>\n\u003cp class=\"p1\">The urgency, then, is to get as many people immunized as quickly as possible, so more people are protected and there are fewer infections overall, as Delta increasingly accounts for more of the country’s cases.\u003c/p>\n\u003cp class=\"p1\">“If you’ve had your first dose, make sure you get that second dose, and for those who have been not vaccinated yet, please, get vaccinated,” Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said at a White House briefing Tuesday, where he highlighted the threat of Delta.\u003c/p>\n\u003cp class=\"p1\">There are several factors that appear to give Delta its transmission boost over Alpha. For one, Delta “can transmit more easily in a vaccinated population than the Alpha variant can,” epidemiologist Neil Ferguson of Imperial College London told reporters Wednesday. That advantage will become particularly noticeable in countries with higher vaccination coverage, like the United Kingdom and the United States, because Alpha will encounter greater barriers as it tries to spread. (It’s not that Delta can run rampant through vaccinated populations; it’s a matter that it can transmit comparatively more efficiently because of its immune escape capability.)\u003c/p>\n\u003cp class=\"p1\">In fact, some experts anticipate that in the United States, variants like Delta, Beta and Gamma could start to claw away at Alpha’s dominance because they have greater abilities to spread among vaccinated populations, though the likelihood of that will depend on how many people remain unvaccinated. (Beta, or B.1.351, first appeared in South Africa, while Gamma, or P.1, emerged in Brazil.)\u003c/p>\n\u003cp class=\"p1\">But Delta also appears to have some other advantages. “The virus itself is fitter in human airway cells,” Barclay said about what early research indicates. That means that an infected person will likely emit more virus into the air, and that the virus is more adept at infecting cells, so people need to be exposed to less of it to contract it.\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/2021/06/10/more-transmissible-variant-covid-19-vaccinations-even-more-crucial/\" 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 class=\"p1\">The Bay Area continues to outpace most of the country in terms of vaccination rates. Other key contenders include the state of Vermont and the city of Seattle.\u003c/p>\n\u003cp class=\"p1\">Marin County is leading the nine Bay Area counties with \u003ca href=\"https://coronavirus.marinhhs.org/vaccine/data\">\u003cspan class=\"s1\">78%\u003c/span>\u003c/a> of all residents at least partially vaccinated. San Francisco is next in line with \u003ca href=\"https://data.sfgov.org/stories/s/COVID-19-Vaccinations-Progress/7mye-zncy/\">\u003cspan class=\"s1\">72%\u003c/span>\u003c/a>.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">Vaccine rates in the other local counties hover in the high 60s. Solano County is at the back of the pack with \u003ca href=\"https://doitgis.maps.arcgis.com/apps/MapSeries/index.html?appid=055f81e9fe154da5860257e3f2489d67\">\u003cspan class=\"s1\">64%\u003c/span>\u003c/a> of eligible residents vaccinated, which is on par with Los Angeles County’s vaccine \u003ca href=\"http://www.publichealth.lacounty.gov/media/coronavirus/vaccine/vaccine-dashboard.htm\">\u003cspan class=\"s1\">rate\u003c/span>\u003c/a>.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">When a majority of people are immune to COVID-19, either through a vaccine or because they have caught the bug, the virus can no longer spread because it runs out of vulnerable people to infect.\u003c/p>\n\u003cp>Epidemiologists predict these conditions for COVID-19 will occur when 75% to 85% of a population is protected.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp class=\"p1\">“We are closing in on herd immunity,” said \u003cspan class=\"s2\">UCSF epidemiologist Dr. George Rutherfor\u003c/span>d. “It is very exciting. Very gratifying. It’s a miracle of modern molecular biology.”\u003c/p>\n\u003cp class=\"p1\">However, herd immunity is not a finish line because it’s impermanent. There are many factors at play. The virus can still mutate and kids under 12 have not received their shots yet. Plus scientists are just guessing at this point because they do not know what level of vaccination will actually keep the virus at bay.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">But Rutherford says he is not worried about potential outbreaks following the state’s reopening on \u003ca href=\"https://covid19.ca.gov/safer-economy/\">\u003cspan class=\"s1\">June 15\u003c/span>\u003c/a>. Small clusters of illness may arise but, he says, they are not likely to ignite substantial transmission. The virus can no longer spread rapidly within the community because a majority of the population is protected. The surges the Bay Area experienced when restrictions were lifted in the past are highly unlikely this time around.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">Officials at the San Francisco Department of Public Health are encouraged by local numbers, but also stress the delicacy of the situation. “There are some populations that continue to be susceptible to the virus, including communities that have lower vaccination rates as well as those people who are ineligible for vaccines, such as children below 12 years of age,” a spokesperson wrote in an email. “New variants are emerging, and the pace of vaccinations varies across the world.”\u003c/p>\n\u003cp class=\"p1\">Although current \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html?s_cid=10493:covid%20vaccine:sem.ga:p:RG:GM:gen:PTN:FY21\">\u003cspan class=\"s1\">data\u003c/span>\u003c/a> is encouraging, scientists do not know if a vaccinated person can transmit the virus, and doctors do not know how long immunity to the virus lasts. Plus, we live in a highly global society connected by roads, trains and international airports.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">“Herd immunity is really a term that’s designed for closed populations,” said Stanford epidemiologist Julie Parsonnet. “We are not a closed population by any stretch of the imagination. Until the world has immunity, then no one really has an immunity.”\u003c/p>\n\u003cp class=\"p3\">Parsonnet worries that focusing on the idea of herd immunity could send the wrong message to the public — especially when some people are still hesitant about getting a shot. They may interpret high vaccination rates as a sign that getting vaccinated is no longer necessary.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">“And that’s not really the truth,” she said. “I think there are a lot of things that can still go wrong. We can’t predict the future and we need to prepare for it by using the tools that we have as aggressively as we can.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">In other words, high vaccination rates alone are not a panacea to stamp out the pandemic. Contact tracing and testing will still be required to quell small outbreaks going forward.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp class=\"p3\">Parsonnet underlines that it took about 40-years to reach herd immunity for measles and doctors only had to vaccinate children to stop that virus. Every time someone is vaccinated it prevents further cases and potentially saves lives. The only way to truly stop COVID-19 is one shot at a time.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"p1\">The Bay Area continues to outpace most of the country in terms of vaccination rates. Other key contenders include the state of Vermont and the city of Seattle.\u003c/p>\n\u003cp class=\"p1\">Marin County is leading the nine Bay Area counties with \u003ca href=\"https://coronavirus.marinhhs.org/vaccine/data\">\u003cspan class=\"s1\">78%\u003c/span>\u003c/a> of all residents at least partially vaccinated. San Francisco is next in line with \u003ca href=\"https://data.sfgov.org/stories/s/COVID-19-Vaccinations-Progress/7mye-zncy/\">\u003cspan class=\"s1\">72%\u003c/span>\u003c/a>.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">Vaccine rates in the other local counties hover in the high 60s. Solano County is at the back of the pack with \u003ca href=\"https://doitgis.maps.arcgis.com/apps/MapSeries/index.html?appid=055f81e9fe154da5860257e3f2489d67\">\u003cspan class=\"s1\">64%\u003c/span>\u003c/a> of eligible residents vaccinated, which is on par with Los Angeles County’s vaccine \u003ca href=\"http://www.publichealth.lacounty.gov/media/coronavirus/vaccine/vaccine-dashboard.htm\">\u003cspan class=\"s1\">rate\u003c/span>\u003c/a>.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">When a majority of people are immune to COVID-19, either through a vaccine or because they have caught the bug, the virus can no longer spread because it runs out of vulnerable people to infect.\u003c/p>\n\u003cp>Epidemiologists predict these conditions for COVID-19 will occur when 75% to 85% of a population is protected.\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 class=\"p1\">“We are closing in on herd immunity,” said \u003cspan class=\"s2\">UCSF epidemiologist Dr. George Rutherfor\u003c/span>d. “It is very exciting. Very gratifying. It’s a miracle of modern molecular biology.”\u003c/p>\n\u003cp class=\"p1\">However, herd immunity is not a finish line because it’s impermanent. There are many factors at play. The virus can still mutate and kids under 12 have not received their shots yet. Plus scientists are just guessing at this point because they do not know what level of vaccination will actually keep the virus at bay.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">But Rutherford says he is not worried about potential outbreaks following the state’s reopening on \u003ca href=\"https://covid19.ca.gov/safer-economy/\">\u003cspan class=\"s1\">June 15\u003c/span>\u003c/a>. Small clusters of illness may arise but, he says, they are not likely to ignite substantial transmission. The virus can no longer spread rapidly within the community because a majority of the population is protected. The surges the Bay Area experienced when restrictions were lifted in the past are highly unlikely this time around.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">Officials at the San Francisco Department of Public Health are encouraged by local numbers, but also stress the delicacy of the situation. “There are some populations that continue to be susceptible to the virus, including communities that have lower vaccination rates as well as those people who are ineligible for vaccines, such as children below 12 years of age,” a spokesperson wrote in an email. “New variants are emerging, and the pace of vaccinations varies across the world.”\u003c/p>\n\u003cp class=\"p1\">Although current \u003ca href=\"https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html?s_cid=10493:covid%20vaccine:sem.ga:p:RG:GM:gen:PTN:FY21\">\u003cspan class=\"s1\">data\u003c/span>\u003c/a> is encouraging, scientists do not know if a vaccinated person can transmit the virus, and doctors do not know how long immunity to the virus lasts. Plus, we live in a highly global society connected by roads, trains and international airports.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">“Herd immunity is really a term that’s designed for closed populations,” said Stanford epidemiologist Julie Parsonnet. “We are not a closed population by any stretch of the imagination. Until the world has immunity, then no one really has an immunity.”\u003c/p>\n\u003cp class=\"p3\">Parsonnet worries that focusing on the idea of herd immunity could send the wrong message to the public — especially when some people are still hesitant about getting a shot. They may interpret high vaccination rates as a sign that getting vaccinated is no longer necessary.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">“And that’s not really the truth,” she said. “I think there are a lot of things that can still go wrong. We can’t predict the future and we need to prepare for it by using the tools that we have as aggressively as we can.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p3\">In other words, high vaccination rates alone are not a panacea to stamp out the pandemic. Contact tracing and testing will still be required to quell small outbreaks going forward.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp class=\"p3\">Parsonnet underlines that it took about 40-years to reach herd immunity for measles and doctors only had to vaccinate children to stop that virus. Every time someone is vaccinated it prevents further cases and potentially saves lives. The only way to truly stop COVID-19 is one shot at a time.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "The FDA's Controversial Approval of a New Alzheimer's Drug Explained",
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"content": "\u003cp>The Food and Drug Administration \u003ca href=\"https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease\">approved\u003c/a> the drug \u003ca href=\"https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/aducanumab-marketed-aduhelm-information\">aducanumab\u003c/a> to treat patients with Alzheimer’s disease on Monday. It is the first new drug approved by the agency for Alzheimer’s disease since 2003.\u003c/p>\n\u003cp>The drug is the first to show significant progress against the sticky brain plaques that are the hallmark of Alzheimer’s disease.\u003c/p>\n\u003cp>The drug has proved highly effective at reducing the plaques, called beta-amyloid, that build up in the brains of people with Alzheimer’s.\u003c/p>\n\u003cp>But does the drug actually slow the progression of the disease when it reduces the plaques? It’s not yet clear. Two large studies offered conflicting evidence about whether the treatment slows declines in memory and thinking. A panel of expert advisers to the FDA \u003ca href=\"https://www.npr.org/2020/11/06/932215023/fda-advisory-panel-rejects-controversial-alzheimers-drug\">recommended in November\u003c/a> that the agency not approve the drug.\u003c/p>\n\u003cp>As a condition of approval, the FDA is requiring Biogen, the drug’s maker, to conduct another clinical study to confirm that the reduction of amyloid plaques results in clinical improvement for patients. If the subsequent study doesn’t show a clinical improvement, the agency could move to withdraw the approval.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>There are also concerns that the FDA’s approval will make it difficult for Biogen and Eisai, the companies marketing the drug, to find enough patients to participate in its next clinical trials as patients might not want to risk getting the placebo and can get the drug without being in a study.\u003c/p>\n\u003cp>The medicine will be marketed under the trade name Aduhelm.\u003c/p>\n\u003cp>The FDA acknowledged the controversy and attention the drug’s approval has garnered from the Alzheimer’s patient community, elected officials and others.\u003c/p>\n\u003cp>The agency opted to put Aduhelm on the FDA’s accelerated approval pathway, which is meant to speed access to potentially valuable therapies for patients with serious diseases to serve an unmet need, and where a clinical benefit is expected — even if there is still some uncertainty about that benefit.\u003c/p>\n\u003cp>“[T]he Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said in a statement.\u003c/p>\n\u003cp>It could take several years to conclude the clinical trials the FDA is requiring. But in the meantime, Aduhelm will be available to patients.\u003c/p>\n\u003cp>Patients will receive the drug in monthly infusions. They will also need regular brain scans to detect a rare side effect: bleeding or swelling in the brain.\u003c/p>\n\u003cp>Biogen and Eisai said Monday that the annual wholesale cost for those taking maintenance doses \u003ca href=\"https://investors.biogen.com/news-releases/news-release-details/biogen-and-eisai-launch-multiple-initiatives-help-patients\">would be $56,000\u003c/a> a year for a patient of average U.S. weight with mild cognitive impairment or mild dementia. The net price could change based on discounts and rebates.\u003c/p>\n\u003cp>Trading in Biogen shares was halted due to the announcement. After trading resumed midafternoon, shares were up more than $110, or 39%.\u003c/p>\n\u003cp>The Alzheimer’s Association, which has been pushing for approval, applauded the news.\u003c/p>\n\u003cp>“This is the first drug that slows Alzheimer’s disease. And, this is the beginning of a completely new future for Alzheimer’s treatments,” the group said in a statement. “This is a new type of Alzheimer’s treatment; it addresses the disease in a way that has never been done before, compared to currently approved drugs.”\u003c/p>\n\u003cp>But others say the drugmakers have not yet proved that aducanumab’s benefits outweigh its risks.\u003c/p>\n\u003cp>In November, an FDA advisory committee of medical experts voted that the evidence did not show the drug to be effective at slowing Alzheimer’s. One major study found that aducanumab slowed down the progress of Alzheimer’s, while the other showed it didn’t.\u003c/p>\n\u003cp>“Usually, you need two big studies finding the same thing to approve a drug,” NPR \u003ca href=\"https://www.npr.org/2020/11/06/932215023/fda-advisory-panel-rejects-controversial-alzheimers-drug\">reported\u003c/a> after the vote last year. But at that meeting, “the FDA asked its experts to focus only on the positive study, and it also presented analysis of the data that was really very favorable to the drug. All of that did not go over well with these advisers. Some of them seemed to feel like they were being railroaded by the FDA.”\u003c/p>\n\u003cp>An independent think tank also assessed the two phase 3 clinical trials of aducanumab and \u003ca href=\"https://icer.org/wp-content/uploads/2020/10/ICER_ALZ_Draft_Evidence_Report_050521.pdf\">found\u003c/a> the evidence “insufficient to conclude that the clinical benefits of aducanumab outweigh its harms or, indeed, that it reduces progression” of Alzheimer’s disease.\u003c/p>\n\u003cp>Dr. \u003ca href=\"https://www.med.upenn.edu/apps/faculty/index.php/g275/p7909\">Jason Karlawish\u003c/a>, professor of medicine and medical ethics and an Alzheimer’s expert at the University of Pennsylvania’s Perelman School of Medicine, \u003ca href=\"https://www.statnews.com/2021/05/30/if-the-fda-approves-biogens-alzheimers-treatment-i-wont-prescribe-it/\">wrote last week\u003c/a> that he would not prescribe aducanumab to his patients even with FDA approval, due to risks of small bleeds in the brain, financial cost and unclear benefits.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“[T]he data to make this case are murky and, even if they were clear, the drug’s benefits are ambiguous at best and not worth this cost. Putting it on the market will stress Medicare’s resources,” he wrote.\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=The+FDA+Has+Approved+A+New+Alzheimer%27s+Drug+%E2%80%94+Here%27s+Why+That%27s+Controversial&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 \u003ca href=\"https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease\">approved\u003c/a> the drug \u003ca href=\"https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/aducanumab-marketed-aduhelm-information\">aducanumab\u003c/a> to treat patients with Alzheimer’s disease on Monday. It is the first new drug approved by the agency for Alzheimer’s disease since 2003.\u003c/p>\n\u003cp>The drug is the first to show significant progress against the sticky brain plaques that are the hallmark of Alzheimer’s disease.\u003c/p>\n\u003cp>The drug has proved highly effective at reducing the plaques, called beta-amyloid, that build up in the brains of people with Alzheimer’s.\u003c/p>\n\u003cp>But does the drug actually slow the progression of the disease when it reduces the plaques? It’s not yet clear. Two large studies offered conflicting evidence about whether the treatment slows declines in memory and thinking. A panel of expert advisers to the FDA \u003ca href=\"https://www.npr.org/2020/11/06/932215023/fda-advisory-panel-rejects-controversial-alzheimers-drug\">recommended in November\u003c/a> that the agency not approve the drug.\u003c/p>\n\u003cp>As a condition of approval, the FDA is requiring Biogen, the drug’s maker, to conduct another clinical study to confirm that the reduction of amyloid plaques results in clinical improvement for patients. If the subsequent study doesn’t show a clinical improvement, the agency could move to withdraw the approval.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>There are also concerns that the FDA’s approval will make it difficult for Biogen and Eisai, the companies marketing the drug, to find enough patients to participate in its next clinical trials as patients might not want to risk getting the placebo and can get the drug without being in a study.\u003c/p>\n\u003cp>The medicine will be marketed under the trade name Aduhelm.\u003c/p>\n\u003cp>The FDA acknowledged the controversy and attention the drug’s approval has garnered from the Alzheimer’s patient community, elected officials and others.\u003c/p>\n\u003cp>The agency opted to put Aduhelm on the FDA’s accelerated approval pathway, which is meant to speed access to potentially valuable therapies for patients with serious diseases to serve an unmet need, and where a clinical benefit is expected — even if there is still some uncertainty about that benefit.\u003c/p>\n\u003cp>“[T]he Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said in a statement.\u003c/p>\n\u003cp>It could take several years to conclude the clinical trials the FDA is requiring. But in the meantime, Aduhelm will be available to patients.\u003c/p>\n\u003cp>Patients will receive the drug in monthly infusions. They will also need regular brain scans to detect a rare side effect: bleeding or swelling in the brain.\u003c/p>\n\u003cp>Biogen and Eisai said Monday that the annual wholesale cost for those taking maintenance doses \u003ca href=\"https://investors.biogen.com/news-releases/news-release-details/biogen-and-eisai-launch-multiple-initiatives-help-patients\">would be $56,000\u003c/a> a year for a patient of average U.S. weight with mild cognitive impairment or mild dementia. The net price could change based on discounts and rebates.\u003c/p>\n\u003cp>Trading in Biogen shares was halted due to the announcement. After trading resumed midafternoon, shares were up more than $110, or 39%.\u003c/p>\n\u003cp>The Alzheimer’s Association, which has been pushing for approval, applauded the news.\u003c/p>\n\u003cp>“This is the first drug that slows Alzheimer’s disease. And, this is the beginning of a completely new future for Alzheimer’s treatments,” the group said in a statement. “This is a new type of Alzheimer’s treatment; it addresses the disease in a way that has never been done before, compared to currently approved drugs.”\u003c/p>\n\u003cp>But others say the drugmakers have not yet proved that aducanumab’s benefits outweigh its risks.\u003c/p>\n\u003cp>In November, an FDA advisory committee of medical experts voted that the evidence did not show the drug to be effective at slowing Alzheimer’s. One major study found that aducanumab slowed down the progress of Alzheimer’s, while the other showed it didn’t.\u003c/p>\n\u003cp>“Usually, you need two big studies finding the same thing to approve a drug,” NPR \u003ca href=\"https://www.npr.org/2020/11/06/932215023/fda-advisory-panel-rejects-controversial-alzheimers-drug\">reported\u003c/a> after the vote last year. But at that meeting, “the FDA asked its experts to focus only on the positive study, and it also presented analysis of the data that was really very favorable to the drug. All of that did not go over well with these advisers. Some of them seemed to feel like they were being railroaded by the FDA.”\u003c/p>\n\u003cp>An independent think tank also assessed the two phase 3 clinical trials of aducanumab and \u003ca href=\"https://icer.org/wp-content/uploads/2020/10/ICER_ALZ_Draft_Evidence_Report_050521.pdf\">found\u003c/a> the evidence “insufficient to conclude that the clinical benefits of aducanumab outweigh its harms or, indeed, that it reduces progression” of Alzheimer’s disease.\u003c/p>\n\u003cp>Dr. \u003ca href=\"https://www.med.upenn.edu/apps/faculty/index.php/g275/p7909\">Jason Karlawish\u003c/a>, professor of medicine and medical ethics and an Alzheimer’s expert at the University of Pennsylvania’s Perelman School of Medicine, \u003ca href=\"https://www.statnews.com/2021/05/30/if-the-fda-approves-biogens-alzheimers-treatment-i-wont-prescribe-it/\">wrote last week\u003c/a> that he would not prescribe aducanumab to his patients even with FDA approval, due to risks of small bleeds in the brain, financial cost and unclear benefits.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“[T]he data to make this case are murky and, even if they were clear, the drug’s benefits are ambiguous at best and not worth this cost. Putting it on the market will stress Medicare’s resources,” he wrote.\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=The+FDA+Has+Approved+A+New+Alzheimer%27s+Drug+%E2%80%94+Here%27s+Why+That%27s+Controversial&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"info": "Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.",
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"soldout": {
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"title": "SOLD OUT: Rethinking Housing in America",
"tagline": "A new future for housing",
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