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Her work is regularly rebroadcast on numerous NPR and PBS shows. She has won several regional Emmy awards, a regional and a national Edward R. Murrow award. The Association for Health Journalists awarded Lesley best beat coverage. The Society of Professional Journalists has recognized her reporting several times. The Society of Environmental Journalists spotlighted her ongoing coverage of California's historic drought. Before joining KQED in 2016, she covered food and sustainability for Capital Public Radio, the environment for Colorado Public Radio, and reported for both KUOW and KCTS9 in Seattle. When not hunched over her laptop Lesley enjoys skiing with her daughter, cycling with her partner or scheming their next globetrotting adventure. Before motherhood she relished dancing tango till sunrise. 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Kevin joined KQED in 2019, and has covered issues related to energy, wildfire, climate change and the environment.","avatar":"https://secure.gravatar.com/avatar/1f646bf546a63d638e04ff23b52b0e79?s=600&d=blank&r=g","twitter":"starkkev","facebook":null,"instagram":null,"linkedin":null,"sites":[{"site":"","roles":["editor"]},{"site":"news","roles":["editor"]},{"site":"science","roles":["administrator"]}],"headData":{"title":"Kevin Stark | KQED","description":"Senior Editor","ogImgSrc":"https://secure.gravatar.com/avatar/1f646bf546a63d638e04ff23b52b0e79?s=600&d=blank&r=g","twImgSrc":"https://secure.gravatar.com/avatar/1f646bf546a63d638e04ff23b52b0e79?s=600&d=blank&r=g"},"isLoading":false,"link":"/author/kevinstark"}},"breakingNewsReducer":{},"campaignFinanceReducer":{},"firebase":{"requesting":{},"requested":{},"timestamps":{},"data":{},"ordered":{},"auth":{"isLoaded":false,"isEmpty":true},"authError":null,"profile":{"isLoaded":false,"isEmpty":true},"listeners":{"byId":{},"allIds":[]},"isInitializing":false,"errors":[]},"navBarReducer":{"navBarId":"news","fullView":true,"showPlayer":false},"navMenuReducer":{"menus":[{"key":"menu1","items":[{"name":"News","link":"/","type":"title"},{"name":"Politics","link":"/politics"},{"name":"Science","link":"/science"},{"name":"Education","link":"/educationnews"},{"name":"Housing","link":"/housing"},{"name":"Immigration","link":"/immigration"},{"name":"Criminal Justice","link":"/criminaljustice"},{"name":"Silicon Valley","link":"/siliconvalley"},{"name":"Forum","link":"/forum"},{"name":"The California Report","link":"/californiareport"}]},{"key":"menu2","items":[{"name":"Arts & Culture","link":"/arts","type":"title"},{"name":"Critics’ Picks","link":"/thedolist"},{"name":"Cultural Commentary","link":"/artscommentary"},{"name":"Food & Drink","link":"/food"},{"name":"Bay Area Hip-Hop","link":"/bayareahiphop"},{"name":"Rebel Girls","link":"/rebelgirls"},{"name":"Arts Video","link":"/artsvideos"}]},{"key":"menu3","items":[{"name":"Podcasts","link":"/podcasts","type":"title"},{"name":"Bay Curious","link":"/podcasts/baycurious"},{"name":"Rightnowish","link":"/podcasts/rightnowish"},{"name":"The Bay","link":"/podcasts/thebay"},{"name":"On Our Watch","link":"/podcasts/onourwatch"},{"name":"Mindshift","link":"/podcasts/mindshift"},{"name":"Consider This","link":"/podcasts/considerthis"},{"name":"Political Breakdown","link":"/podcasts/politicalbreakdown"}]},{"key":"menu4","items":[{"name":"Live Radio","link":"/radio","type":"title"},{"name":"TV","link":"/tv","type":"title"},{"name":"Events","link":"/events","type":"title"},{"name":"For Educators","link":"/education","type":"title"},{"name":"Support KQED","link":"/support","type":"title"},{"name":"About","link":"/about","type":"title"},{"name":"Help Center","link":"https://kqed-helpcenter.kqed.org/s","type":"title"}]}]},"pagesReducer":{},"postsReducer":{"stream_live":{"type":"live","id":"stream_live","audioUrl":"https://streams.kqed.org/kqedradio","title":"Live Stream","excerpt":"Live Stream information currently unavailable.","link":"/radio","featImg":"","label":{"name":"KQED Live","link":"/"}},"stream_kqedNewscast":{"type":"posts","id":"stream_kqedNewscast","audioUrl":"https://www.kqed.org/.stream/anon/radio/RDnews/newscast.mp3?_=1","title":"KQED Newscast","featImg":"","label":{"name":"88.5 FM","link":"/"}},"science_1984096":{"type":"posts","id":"science_1984096","meta":{"index":"posts_1591205157","site":"science","id":"1984096","score":null,"sort":[1693220426000]},"guestAuthors":[],"slug":"wiley-covid-stoked-by-eris-escapes-predictability-once-again","title":"Fueled by 'Eris,' COVID Escapes Predictability Once Again","publishDate":1693220426,"format":"standard","headTitle":"Fueled by ‘Eris,’ COVID Escapes Predictability Once Again | KQED","labelTerm":{},"content":"\u003cp>Once again, COVID-19 has not taken a summer vacation.\u003c/p>\n\u003cp>\u003ca href=\"https://data.wastewaterscan.org/\">Wastewater measurements\u003c/a> reveal a swell in virus levels across the Bay Area and the state.\u003c/p>\n\u003cp>\u003ca href=\"https://www.kqed.org/news/11957790/the-new-covid-eris-variant-and-rising-cases-what-you-need-to-know\">“Eris,” or EG.5 is the dominant strain in the U.S. right now\u003c/a> and is driving the local activity, too. The variant does not seem to be any more dangerous than previous variants, but it is more transmissible.\u003c/p>\n\u003cp>“The interesting thing is: COVID hasn’t really changed too much, since winter to now,” said Peter Chin-Hong, infectious disease specialist at UCSF. “It’s just been variations on the theme.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>That could be changing. A subvariant that’s just beginning to surface may be the best yet at evading immunity. Scientists for the Centers for Disease and Prevention are watching \u003ca href=\"https://www.cdc.gov/respiratory-viruses/whats-new/covid-19-variant.html\" target=\"_blank\" rel=\"noopener\">BA.286\u003c/a> because it has even greater potential to escape the antibodies that protect people from getting sick, even if you’ve recently tested positive or been vaccinated. It is too early to know if it causes more serious illness. There are only a handful of cases in the U.S.\u003c/p>\n\u003cp>This is the fourth summer in a row that COVID-19 has spread rapidly in California. Health experts offer several explanations for the recent uptick. People may be seeking relief from scorching temperatures by staying inside air-conditioned spaces. For most folks life is back to normal, so large gatherings have resumed in full force. And, immunity may be declining because the last vaccine campaign was in the fall.\u003c/p>\n\u003cp>All of these factors, in addition to a wily virus, are likely why scientists are not seeing a predictable seasonal pattern like influenza, which typically strikes when it’s cold. It’s not clear when COVID-19 will settle into an annual surge.\u003c/p>\n\u003cp>“I’d hope it would be a once-a-year virus,” said Chin-Hong. “But it just seems that the summer increase in cases is something that we continue to see.”\u003c/p>\n\u003cp>Virus levels are still lower than earlier surges. And it’s worth noting that the wastewater data is pretty noisy.[aside label=\"Related Stories\" postID=\"science_1984081,news_11957790,forum_2010101894165\"]At a sewage plant in Redwood City, levels are spiking, but declining in San Francisco’s Oceanside neighborhood and falling dramatically at similar facilities in Sunnyvale and Palo Alto.\u003c/p>\n\u003cp>Los Angeles is seeing a slow rise, while virus levels started to slowly fall off in Sacramento recently.\u003c/p>\n\u003cp>Given the current numbers, Chin-Hong does recommend taking additional precautions. He suggested people who are immunocompromised and those over the age of 65 consider masking indoors, given their higher susceptibility to severe illness.\u003c/p>\n\u003cp>Everyone else may want to weigh the consequences of falling ill at this time. Can you miss work? Do you have a special occasion on the books that you’d have to miss if you were isolated for five days, which public health officials still recommend people do after a positive test? Then it may be a good time to err on the safe side if you don’t want to end up at home alone. You could carry your well-fitting N95 mask in case you find yourself in a crowded indoor space.\u003c/p>\n\u003cp>The public will have the opportunity to fortify immunity soon. A new booster shot will likely be available in late September, designed to target the variants in wide circulation now.\u003c/p>\n\u003cp>Feeling like a pin cushion? There’s good news for those suffering from booster fatigue. Scientists are working on a \u003ca href=\"https://www.nih.gov/news-events/nih-research-matters/research-context-progress-toward-universal-vaccines\" target=\"_blank\" rel=\"noopener\">universal vaccine\u003c/a>, which, in theory, would allow one-stop shopping. Unlike current vaccines, which offer protection against one or several strains of a disease, universal vaccines are designed to teach the immune system to defend against all versions of a pathogen — even versions that don’t exist yet. This is possible by targeting an element of the pathogen that is the same across all strains and types.\u003c/p>\n\u003cp>“That is the holy grail,” said Chin-Hong. “I think we will probably get something in the next two-to-three years. They are also working on that for influenza.”\u003c/p>\n\u003cp>In the meantime, he says, we could see a combination vaccine that provides protection for COVID-19 and influenza as early as next year.\u003c/p>\n\u003cp> \u003c/p>\n\u003cp> \u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\n","blocks":[],"excerpt":"While Bay Area virus levels are still lower than earlier surges, it may be time to take precautions. Plus, a universal vaccine is in the works.","status":"publish","parent":0,"modified":1704845914,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":18,"wordCount":727},"headData":{"title":"Fueled by 'Eris,' COVID Escapes Predictability Once Again | KQED","description":"While Bay Area virus levels are still lower than earlier surges, it may be time to take precautions. Plus, a universal vaccine is in the works.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Fueled by 'Eris,' COVID Escapes Predictability Once Again","datePublished":"2023-08-28T11:00:26.000Z","dateModified":"2024-01-10T00:18:34.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"COVID-19","sticky":false,"excludeFromSiteSearch":"Include","articleAge":"0","path":"/science/1984096/wiley-covid-stoked-by-eris-escapes-predictability-once-again","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Once again, COVID-19 has not taken a summer vacation.\u003c/p>\n\u003cp>\u003ca href=\"https://data.wastewaterscan.org/\">Wastewater measurements\u003c/a> reveal a swell in virus levels across the Bay Area and the state.\u003c/p>\n\u003cp>\u003ca href=\"https://www.kqed.org/news/11957790/the-new-covid-eris-variant-and-rising-cases-what-you-need-to-know\">“Eris,” or EG.5 is the dominant strain in the U.S. right now\u003c/a> and is driving the local activity, too. The variant does not seem to be any more dangerous than previous variants, but it is more transmissible.\u003c/p>\n\u003cp>“The interesting thing is: COVID hasn’t really changed too much, since winter to now,” said Peter Chin-Hong, infectious disease specialist at UCSF. “It’s just been variations on the theme.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>That could be changing. A subvariant that’s just beginning to surface may be the best yet at evading immunity. Scientists for the Centers for Disease and Prevention are watching \u003ca href=\"https://www.cdc.gov/respiratory-viruses/whats-new/covid-19-variant.html\" target=\"_blank\" rel=\"noopener\">BA.286\u003c/a> because it has even greater potential to escape the antibodies that protect people from getting sick, even if you’ve recently tested positive or been vaccinated. It is too early to know if it causes more serious illness. There are only a handful of cases in the U.S.\u003c/p>\n\u003cp>This is the fourth summer in a row that COVID-19 has spread rapidly in California. Health experts offer several explanations for the recent uptick. People may be seeking relief from scorching temperatures by staying inside air-conditioned spaces. For most folks life is back to normal, so large gatherings have resumed in full force. And, immunity may be declining because the last vaccine campaign was in the fall.\u003c/p>\n\u003cp>All of these factors, in addition to a wily virus, are likely why scientists are not seeing a predictable seasonal pattern like influenza, which typically strikes when it’s cold. It’s not clear when COVID-19 will settle into an annual surge.\u003c/p>\n\u003cp>“I’d hope it would be a once-a-year virus,” said Chin-Hong. “But it just seems that the summer increase in cases is something that we continue to see.”\u003c/p>\n\u003cp>Virus levels are still lower than earlier surges. And it’s worth noting that the wastewater data is pretty noisy.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"label":"Related Stories ","postid":"science_1984081,news_11957790,forum_2010101894165"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>At a sewage plant in Redwood City, levels are spiking, but declining in San Francisco’s Oceanside neighborhood and falling dramatically at similar facilities in Sunnyvale and Palo Alto.\u003c/p>\n\u003cp>Los Angeles is seeing a slow rise, while virus levels started to slowly fall off in Sacramento recently.\u003c/p>\n\u003cp>Given the current numbers, Chin-Hong does recommend taking additional precautions. He suggested people who are immunocompromised and those over the age of 65 consider masking indoors, given their higher susceptibility to severe illness.\u003c/p>\n\u003cp>Everyone else may want to weigh the consequences of falling ill at this time. Can you miss work? Do you have a special occasion on the books that you’d have to miss if you were isolated for five days, which public health officials still recommend people do after a positive test? Then it may be a good time to err on the safe side if you don’t want to end up at home alone. You could carry your well-fitting N95 mask in case you find yourself in a crowded indoor space.\u003c/p>\n\u003cp>The public will have the opportunity to fortify immunity soon. A new booster shot will likely be available in late September, designed to target the variants in wide circulation now.\u003c/p>\n\u003cp>Feeling like a pin cushion? There’s good news for those suffering from booster fatigue. Scientists are working on a \u003ca href=\"https://www.nih.gov/news-events/nih-research-matters/research-context-progress-toward-universal-vaccines\" target=\"_blank\" rel=\"noopener\">universal vaccine\u003c/a>, which, in theory, would allow one-stop shopping. Unlike current vaccines, which offer protection against one or several strains of a disease, universal vaccines are designed to teach the immune system to defend against all versions of a pathogen — even versions that don’t exist yet. This is possible by targeting an element of the pathogen that is the same across all strains and types.\u003c/p>\n\u003cp>“That is the holy grail,” said Chin-Hong. “I think we will probably get something in the next two-to-three years. They are also working on that for influenza.”\u003c/p>\n\u003cp>In the meantime, he says, we could see a combination vaccine that provides protection for COVID-19 and influenza as early as next year.\u003c/p>\n\u003cp> \u003c/p>\n\u003cp> \u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1984096/wiley-covid-stoked-by-eris-escapes-predictability-once-again","authors":["11229"],"categories":["science_39","science_40","science_4450"],"tags":["science_4992","science_4329","science_4368","science_197","science_2926","science_2581"],"featImg":"science_1984110","label":"source_science_1984096"},"science_1984081":{"type":"posts","id":"science_1984081","meta":{"index":"posts_1591205157","site":"science","id":"1984081","score":null,"sort":[1692990057000]},"guestAuthors":[],"slug":"covid-19-a-disease-with-tricks-up-its-sleeve-hasnt-fallen-into-a-seasonal-pattern-yet","title":"COVID-19, a Disease With Tricks Up Its Sleeve, Hasn’t Fallen Into a Seasonal Pattern — Yet","publishDate":1692990057,"format":"standard","headTitle":"COVID-19, a Disease With Tricks Up Its Sleeve, Hasn’t Fallen Into a Seasonal Pattern — Yet | KQED","labelTerm":{},"content":"\u003cp>To most people on the planet, the COVID-19 pandemic is over. But for many scientists who have been tracking the largest global infectious disease event in the era of molecular biology, there is still a step that the virus that caused it, SARS-CoV-2, hasn’t yet taken. It has not fallen into a predictable seasonal pattern of the type most respiratory pathogens follow.\u003c/p>\n\u003cp>Influenza strikes — at least in temperate climates — in the winter months, with activity often peaking in January or February. In the pre-COVID times, that was also true for RSV — respiratory syncytial virus — and a number of other bugs that inflict cold- and flu-like illnesses. Some respiratory pathogens seem to prefer fall or spring. Even measles, when that disease circulated widely, had a seasonality in our part of the world, typically striking in late winter or early spring.\u003c/p>\n\u003cp>To be sure, you can contract these viruses at any time of the year. But transmission takes off during a particular pathogen’s season. (The COVID pandemic knocked a number of these bugs \u003ca href=\"https://www.statnews.com/2022/05/25/viruses-that-were-on-hiatus-during-covid-are-back-and-behaving-in-unexpected-ways/\">out of their regular orbits\u003c/a>, though they may be heading back to more normal transmission patterns. The next few months should be telling.)\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>It’s been widely expected that SARS-2 will ease into that type of a transmission pattern, once human immune systems and the virus reach a sort of detente. But most experts STAT spoke to about this question said that, so far, the virus has not obliged. Their views differ on the margins. Some expect seasonality to set in soon while others don’t venture to guess when the virus will settle into a seasonal pattern.\u003c/p>\n\u003cp>“I don’t see clear seasonality for SARS-CoV-2 yet,” Kanta Subbarao, director of the World Health Organization’s Collaborating Centre for Reference and Research on Influenza at the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia, said via email. Subbarao is also chair of the WHO’s technical advisory group on COVID-19 vaccine composition, an independent panel that recommends which version or versions of SARS-2 should be included in updated COVID vaccines.\u003c/p>\n\u003cp>Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, agreed. “There just isn’t a definable pattern yet that would call this a seasonal virus. That’s not to suggest it might not be some day.”[pullquote align=\"right\" size=\"medium\" citation=\"Ben Cowling, infectious diseases epidemiologist, University of Hong Kong\"]‘At the moment I don’t think COVID is predictable but it is showing all the signs of becoming the fifth ‘human coronavirus’ along with OC43, NL63, 229E and HKU1.’[/pullquote]Maria Van Kerkhove, the WHO’s technical lead for COVID, told STAT in a recent interview that the lack of seasonality is clear. “We expect there to be some seasonality in the coming years. Just based on people’s behavior, perhaps, just because it’s respiratory,” she said. Van Kerkhove does, though, think there are hints of a transmission pattern that is coming into view, something she and others refer to as “periodicity.”\u003c/p>\n\u003cp>“If you kind of squint, you could see a little, you know, in different places,” Van Kerkhove said. “I think you can see sort of waves of infection every five, six months or so depending on the population. But that isn’t at a national level. … And it’s not hemispheric.”\u003c/p>\n\u003cp>Questions posed over SARS-2’s lack of seasonality aren’t purely academic. Knowing when to expect a disease is critical for health care labor force planning. The tsunami of RSV-infected babies struggling to breathe in the late summer and early fall of 2022 was made worse by the fact that hospitals weren’t as prepared as they could have been; they normally see RSV peaks in the winter months. Likewise, knowing when to expect SARS-2 surges helps the Food and Drug Administration and the Centers for Disease Control and Prevention time the rollout of COVID booster shots. The protection against infection generated by the vaccines wanes quickly, so giving them too soon or too late would undermine the efficacy of this countermeasure.\u003c/p>\n\u003cp>Van Kerkhove thinks waning immunity in the population is the reason for the periodic swells of transmission. Protection against severe disease — whether induced by infection, vaccination, or the two combined — appears to hold up reasonably well. But when it comes to SARS-2, protection against basic infection is short-lived. That’s not a surprise given what’s known about the four human coronaviruses that predate the arrival of SARS-2. A study in the Netherlands that followed healthy volunteers for more than 35 years found that people can be reinfected with human coronaviruses within about a year after infection, and sometimes after a mere six months. With SARS-2, there are reports of intervals that are shorter still.\u003c/p>\n\u003cp>Michael Mina, an infectious diseases epidemiologist who previously taught at the Harvard School of Public Health, is a bit of an outlier in this conversation. He believes SARS-2 has been displaying seasonal behavior for a while, though what he describes sounds like the periodicity that Van Kerkhove and some other experts speak of.\u003c/p>\n\u003cp>Mina thinks of seasonality in terms of predictability, “that certain periods of time are going to see increases and decreases, but not necessarily that it has to just be winter or summer.”\u003c/p>\n\u003cp>“I don’t think I use the word wrong but I don’t think it’s well defined one way or the other,” he noted.[aside label=\"Related Stories\" postID=\"news_11957790,news_11954507,forum_2010101894165\"]Ben Cowling, an infectious diseases epidemiologist at the University of Hong Kong, also thinks seasonality and predictability are intertwined. He doesn’t think SARS-2 is there yet — but believes it’s on its way.\u003c/p>\n\u003cp>“At the moment I don’t think COVID is predictable but it is showing all the signs of becoming the fifth ‘human coronavirus’ along with OC43, NL63, 229E and HKU1,” he said in an email, ticking off the names of the four human coronaviruses that predated SARS-2.\u003c/p>\n\u003cp>Osterholm doesn’t agree, arguing that even if they follow a pattern, swells of COVID cases at different points in a year doesn’t equate to seasonality. Furthermore, he noted that the patterns we’ve seen to date have been largely tied to the emergence of new variants, like Beta, Delta, and Omicron, with large surges of infections when those versions of SARS-2 arrived in the spring, summer, and late autumn of 2021 respectively.\u003c/p>\n\u003cp>“It wasn’t tied to some kind of environmental conditions. And that’s what you often think of with seasonality,” Osterholm said.\u003c/p>\n\u003cp>It’s thought that with new viruses, the vast number of susceptible people allows a virus to override conditions that would constrain more established pathogens — kids being out of school, unfavorable atmospheric conditions — and transmit at a time when it normally should not be able to. Epidemiologists refer to this override capacity as the “force of infection.”\u003c/p>\n\u003cp>That, in turn, can impact the ability of other pathogens to transmit during their accustomed times, as was the case with COVID’s disruption of flu and RSV. “When a virus is in a pandemic mode, there are forces occurring that we just don’t understand,” Osterholm said.\u003c/p>\n\u003cp>There are a number of theories about why some viruses hew to a seasonal pattern. It’s thought an interplay of factors is at work. Some have been mapped out, others remain in the realm of the unexplained.\u003c/p>\n\u003cp>Some relate to human activities, like school, that bring together lots of children, who are \u003ca href=\"https://www.statnews.com/2020/02/27/coronavirus-kids-what-role-transmission/\">expert at amplifying\u003c/a> respiratory pathogens. Or holiday travel, potentially. Marion Koopmans, head of virology at Erasmus Medical Center in Rotterdam, the Netherlands, noted that \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8324533/\">a study\u003c/a> published in Nature suggested that a surge in Covid cases in the summer of 2020 in Europe was likely due to people vacationing. “Without detailed analysis, I do not think we can rule out that what we see is ‘holiday traffic,’” Koopmans said, referring to the upticks of cases that have been reported every Northern Hemisphere summer since 2020.\u003c/p>\n\u003cp>Environmental factors are also thought to be at play. The lack of humidity in the air in cold winters affects the integrity of mucus membranes, and it allows viruses to \u003ca href=\"https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1003194\">survive better\u003c/a> outside a human host. People in temperate climates crowd together indoors during the winter, often in settings where air quality is suboptimal. Interestingly, the defined flu seasons that the Northern and Southern Hemispheres experience are not observed in tropical climates, where transmission occurs on a more \u003ca href=\"https://www.embopress.org/doi/full/10.15252/emmm.202115352\">year-round basis\u003c/a>, without the sharp peaks seen in temperate zones.\u003c/p>\n\u003cp>“There is now a much stronger evidence base on the impact of climate variables (esp. temperature, humidity) on pathogen survival and how this translates to an impact on transmission in the population,” Nick Grassly, an infectious diseases modeler at the school of public health at Imperial College London, said in an email. “The focus has been much more on environmental drivers (particularly humidity, temperature, rainfall, etc.) than human behavior.”\u003c/p>\n\u003cp>Grassly is one of the people who thinks SARS-2 seasonality is falling into place, noting that the Joint Committee on Vaccination and Immunisation — Britain’s equivalent of the Advisory Committee on Immunization Practices, an expert committee that helps the CDC craft vaccination use guidelines — is now recommending a targeted \u003ca href=\"https://www.gov.uk/government/news/jcvi-advises-an-autumn-covid-19-vaccine-booster\">autumn COVID vaccination campaign\u003c/a> for high-risk individuals, in anticipation of a surge of COVID activity this winter. A similar, though more broadly aimed campaign is planned for the United States.\u003c/p>\n\u003cp>“It remains possible that a new variant showing substantial immune escape could spread rapidly, even in summer, and so disrupt seasonal patterns and planning,” Grassly noted. “I think it is hard to estimate the probability that this happens, but it would deviate from the recent pattern of successive Omicron variants which have emerged without large increases in overall incidence.”\u003c/p>\n\u003cp>Stanley Perlman, a coronavirus expert whose bona fides in the field stretch back to the pre-SARS-1 days, agrees with Grassly.[pullquote align=\"right\" size=\"medium\" citation=\"Marion Koopmans, head of virology, Erasmus Medical Center\"]‘I think that — at this stage — all we can say is that we can assume that there are some seasonal effects … but that we really cannot say the circulation of these viruses is predictable yet, at least not like we have come to know for flu.’[/pullquote]“I think for all these viruses” — human coronaviruses — “they probably circulate all year round. But you get large numbers of infections in the late fall, winter, when people are inside, and they spread. That’s what this virus seems to be doing,” said Perlman, a professor of microbiology and immunology at the University of Iowa. “As opposed to last summer, the number of cases is way down this summer. And the prediction is they will increase in the late fall, winter again.”\u003c/p>\n\u003cp>A break from seasonal transmission of respiratory pathogens can be a sign something is amiss, with off-season spread having been observed during flu pandemics going back to the Spanish flu pandemic of 1918. The first observed cases in that pandemic occurred in the spring, at a time when flu season would normally have concluded. The 1957 pandemic began in Asia in February of that year, but the virus arrived in, and started spreading through, the United States, during the summer. The 1968 pandemic began in July. The 2009 H1N1 pandemic was first detected in April and the pandemic’s major wave ran through the summer, peaked in September and trailed off in October.\u003c/p>\n\u003cp>“Pandemic influenza doesn’t follow a seasonal pattern in any way, shape or form,” said Osterholm.\u003c/p>\n\u003cp>It remains to be seen when it will be apparent that SARS-2 has lost its override capabilities, when we’ll feel confident that we know when to expect — plus or minus a month or two — COVID’s annual onslaught.\u003c/p>\n\u003cp>“I think that — at this stage — all we can say is that we can assume that there are some seasonal effects (since we know seasonality does have an effect on other respiratory infections, both by effects on virus stability and on the host) but that we really cannot say the circulation of these viruses is predictable yet, at least not like we have come to know for flu,” Koopmans wrote.\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n","blocks":[],"excerpt":"SARS-CoV-2 has not yet fallen into a predictable seasonal pattern of the type most respiratory pathogens follow, experts say.","status":"publish","parent":0,"modified":1704845916,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":31,"wordCount":2199},"headData":{"title":"COVID-19, a Disease With Tricks Up Its Sleeve, Hasn’t Fallen Into a Seasonal Pattern — Yet | KQED","description":"SARS-CoV-2 has not yet fallen into a predictable seasonal pattern of the type most respiratory pathogens follow, experts say.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"COVID-19, a Disease With Tricks Up Its Sleeve, Hasn’t Fallen Into a Seasonal Pattern — Yet","datePublished":"2023-08-25T19:00:57.000Z","dateModified":"2024-01-10T00:18:36.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"STAT","sourceUrl":"https://www.statnews.com/","sticky":false,"nprByline":"\u003ca href=\"https://www.statnews.com/staff/helen-branswell/\">Helen Branswell\u003c/a>","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","articleAge":"0","path":"/science/1984081/covid-19-a-disease-with-tricks-up-its-sleeve-hasnt-fallen-into-a-seasonal-pattern-yet","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>To most people on the planet, the COVID-19 pandemic is over. But for many scientists who have been tracking the largest global infectious disease event in the era of molecular biology, there is still a step that the virus that caused it, SARS-CoV-2, hasn’t yet taken. It has not fallen into a predictable seasonal pattern of the type most respiratory pathogens follow.\u003c/p>\n\u003cp>Influenza strikes — at least in temperate climates — in the winter months, with activity often peaking in January or February. In the pre-COVID times, that was also true for RSV — respiratory syncytial virus — and a number of other bugs that inflict cold- and flu-like illnesses. Some respiratory pathogens seem to prefer fall or spring. Even measles, when that disease circulated widely, had a seasonality in our part of the world, typically striking in late winter or early spring.\u003c/p>\n\u003cp>To be sure, you can contract these viruses at any time of the year. But transmission takes off during a particular pathogen’s season. (The COVID pandemic knocked a number of these bugs \u003ca href=\"https://www.statnews.com/2022/05/25/viruses-that-were-on-hiatus-during-covid-are-back-and-behaving-in-unexpected-ways/\">out of their regular orbits\u003c/a>, though they may be heading back to more normal transmission patterns. The next few months should be telling.)\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>It’s been widely expected that SARS-2 will ease into that type of a transmission pattern, once human immune systems and the virus reach a sort of detente. But most experts STAT spoke to about this question said that, so far, the virus has not obliged. Their views differ on the margins. Some expect seasonality to set in soon while others don’t venture to guess when the virus will settle into a seasonal pattern.\u003c/p>\n\u003cp>“I don’t see clear seasonality for SARS-CoV-2 yet,” Kanta Subbarao, director of the World Health Organization’s Collaborating Centre for Reference and Research on Influenza at the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia, said via email. Subbarao is also chair of the WHO’s technical advisory group on COVID-19 vaccine composition, an independent panel that recommends which version or versions of SARS-2 should be included in updated COVID vaccines.\u003c/p>\n\u003cp>Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, agreed. “There just isn’t a definable pattern yet that would call this a seasonal virus. That’s not to suggest it might not be some day.”\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘At the moment I don’t think COVID is predictable but it is showing all the signs of becoming the fifth ‘human coronavirus’ along with OC43, NL63, 229E and HKU1.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Ben Cowling, infectious diseases epidemiologist, University of Hong Kong","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>Maria Van Kerkhove, the WHO’s technical lead for COVID, told STAT in a recent interview that the lack of seasonality is clear. “We expect there to be some seasonality in the coming years. Just based on people’s behavior, perhaps, just because it’s respiratory,” she said. Van Kerkhove does, though, think there are hints of a transmission pattern that is coming into view, something she and others refer to as “periodicity.”\u003c/p>\n\u003cp>“If you kind of squint, you could see a little, you know, in different places,” Van Kerkhove said. “I think you can see sort of waves of infection every five, six months or so depending on the population. But that isn’t at a national level. … And it’s not hemispheric.”\u003c/p>\n\u003cp>Questions posed over SARS-2’s lack of seasonality aren’t purely academic. Knowing when to expect a disease is critical for health care labor force planning. The tsunami of RSV-infected babies struggling to breathe in the late summer and early fall of 2022 was made worse by the fact that hospitals weren’t as prepared as they could have been; they normally see RSV peaks in the winter months. Likewise, knowing when to expect SARS-2 surges helps the Food and Drug Administration and the Centers for Disease Control and Prevention time the rollout of COVID booster shots. The protection against infection generated by the vaccines wanes quickly, so giving them too soon or too late would undermine the efficacy of this countermeasure.\u003c/p>\n\u003cp>Van Kerkhove thinks waning immunity in the population is the reason for the periodic swells of transmission. Protection against severe disease — whether induced by infection, vaccination, or the two combined — appears to hold up reasonably well. But when it comes to SARS-2, protection against basic infection is short-lived. That’s not a surprise given what’s known about the four human coronaviruses that predate the arrival of SARS-2. A study in the Netherlands that followed healthy volunteers for more than 35 years found that people can be reinfected with human coronaviruses within about a year after infection, and sometimes after a mere six months. With SARS-2, there are reports of intervals that are shorter still.\u003c/p>\n\u003cp>Michael Mina, an infectious diseases epidemiologist who previously taught at the Harvard School of Public Health, is a bit of an outlier in this conversation. He believes SARS-2 has been displaying seasonal behavior for a while, though what he describes sounds like the periodicity that Van Kerkhove and some other experts speak of.\u003c/p>\n\u003cp>Mina thinks of seasonality in terms of predictability, “that certain periods of time are going to see increases and decreases, but not necessarily that it has to just be winter or summer.”\u003c/p>\n\u003cp>“I don’t think I use the word wrong but I don’t think it’s well defined one way or the other,” he noted.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"label":"Related Stories ","postid":"news_11957790,news_11954507,forum_2010101894165"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>Ben Cowling, an infectious diseases epidemiologist at the University of Hong Kong, also thinks seasonality and predictability are intertwined. He doesn’t think SARS-2 is there yet — but believes it’s on its way.\u003c/p>\n\u003cp>“At the moment I don’t think COVID is predictable but it is showing all the signs of becoming the fifth ‘human coronavirus’ along with OC43, NL63, 229E and HKU1,” he said in an email, ticking off the names of the four human coronaviruses that predated SARS-2.\u003c/p>\n\u003cp>Osterholm doesn’t agree, arguing that even if they follow a pattern, swells of COVID cases at different points in a year doesn’t equate to seasonality. Furthermore, he noted that the patterns we’ve seen to date have been largely tied to the emergence of new variants, like Beta, Delta, and Omicron, with large surges of infections when those versions of SARS-2 arrived in the spring, summer, and late autumn of 2021 respectively.\u003c/p>\n\u003cp>“It wasn’t tied to some kind of environmental conditions. And that’s what you often think of with seasonality,” Osterholm said.\u003c/p>\n\u003cp>It’s thought that with new viruses, the vast number of susceptible people allows a virus to override conditions that would constrain more established pathogens — kids being out of school, unfavorable atmospheric conditions — and transmit at a time when it normally should not be able to. Epidemiologists refer to this override capacity as the “force of infection.”\u003c/p>\n\u003cp>That, in turn, can impact the ability of other pathogens to transmit during their accustomed times, as was the case with COVID’s disruption of flu and RSV. “When a virus is in a pandemic mode, there are forces occurring that we just don’t understand,” Osterholm said.\u003c/p>\n\u003cp>There are a number of theories about why some viruses hew to a seasonal pattern. It’s thought an interplay of factors is at work. Some have been mapped out, others remain in the realm of the unexplained.\u003c/p>\n\u003cp>Some relate to human activities, like school, that bring together lots of children, who are \u003ca href=\"https://www.statnews.com/2020/02/27/coronavirus-kids-what-role-transmission/\">expert at amplifying\u003c/a> respiratory pathogens. Or holiday travel, potentially. Marion Koopmans, head of virology at Erasmus Medical Center in Rotterdam, the Netherlands, noted that \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8324533/\">a study\u003c/a> published in Nature suggested that a surge in Covid cases in the summer of 2020 in Europe was likely due to people vacationing. “Without detailed analysis, I do not think we can rule out that what we see is ‘holiday traffic,’” Koopmans said, referring to the upticks of cases that have been reported every Northern Hemisphere summer since 2020.\u003c/p>\n\u003cp>Environmental factors are also thought to be at play. The lack of humidity in the air in cold winters affects the integrity of mucus membranes, and it allows viruses to \u003ca href=\"https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1003194\">survive better\u003c/a> outside a human host. People in temperate climates crowd together indoors during the winter, often in settings where air quality is suboptimal. Interestingly, the defined flu seasons that the Northern and Southern Hemispheres experience are not observed in tropical climates, where transmission occurs on a more \u003ca href=\"https://www.embopress.org/doi/full/10.15252/emmm.202115352\">year-round basis\u003c/a>, without the sharp peaks seen in temperate zones.\u003c/p>\n\u003cp>“There is now a much stronger evidence base on the impact of climate variables (esp. temperature, humidity) on pathogen survival and how this translates to an impact on transmission in the population,” Nick Grassly, an infectious diseases modeler at the school of public health at Imperial College London, said in an email. “The focus has been much more on environmental drivers (particularly humidity, temperature, rainfall, etc.) than human behavior.”\u003c/p>\n\u003cp>Grassly is one of the people who thinks SARS-2 seasonality is falling into place, noting that the Joint Committee on Vaccination and Immunisation — Britain’s equivalent of the Advisory Committee on Immunization Practices, an expert committee that helps the CDC craft vaccination use guidelines — is now recommending a targeted \u003ca href=\"https://www.gov.uk/government/news/jcvi-advises-an-autumn-covid-19-vaccine-booster\">autumn COVID vaccination campaign\u003c/a> for high-risk individuals, in anticipation of a surge of COVID activity this winter. A similar, though more broadly aimed campaign is planned for the United States.\u003c/p>\n\u003cp>“It remains possible that a new variant showing substantial immune escape could spread rapidly, even in summer, and so disrupt seasonal patterns and planning,” Grassly noted. “I think it is hard to estimate the probability that this happens, but it would deviate from the recent pattern of successive Omicron variants which have emerged without large increases in overall incidence.”\u003c/p>\n\u003cp>Stanley Perlman, a coronavirus expert whose bona fides in the field stretch back to the pre-SARS-1 days, agrees with Grassly.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘I think that — at this stage — all we can say is that we can assume that there are some seasonal effects … but that we really cannot say the circulation of these viruses is predictable yet, at least not like we have come to know for flu.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Marion Koopmans, head of virology, Erasmus Medical Center","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>“I think for all these viruses” — human coronaviruses — “they probably circulate all year round. But you get large numbers of infections in the late fall, winter, when people are inside, and they spread. That’s what this virus seems to be doing,” said Perlman, a professor of microbiology and immunology at the University of Iowa. “As opposed to last summer, the number of cases is way down this summer. And the prediction is they will increase in the late fall, winter again.”\u003c/p>\n\u003cp>A break from seasonal transmission of respiratory pathogens can be a sign something is amiss, with off-season spread having been observed during flu pandemics going back to the Spanish flu pandemic of 1918. The first observed cases in that pandemic occurred in the spring, at a time when flu season would normally have concluded. The 1957 pandemic began in Asia in February of that year, but the virus arrived in, and started spreading through, the United States, during the summer. The 1968 pandemic began in July. The 2009 H1N1 pandemic was first detected in April and the pandemic’s major wave ran through the summer, peaked in September and trailed off in October.\u003c/p>\n\u003cp>“Pandemic influenza doesn’t follow a seasonal pattern in any way, shape or form,” said Osterholm.\u003c/p>\n\u003cp>It remains to be seen when it will be apparent that SARS-2 has lost its override capabilities, when we’ll feel confident that we know when to expect — plus or minus a month or two — COVID’s annual onslaught.\u003c/p>\n\u003cp>“I think that — at this stage — all we can say is that we can assume that there are some seasonal effects (since we know seasonality does have an effect on other respiratory infections, both by effects on virus stability and on the host) but that we really cannot say the circulation of these viruses is predictable yet, at least not like we have come to know for flu,” Koopmans wrote.\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1984081/covid-19-a-disease-with-tricks-up-its-sleeve-hasnt-fallen-into-a-seasonal-pattern-yet","authors":["byline_science_1984081"],"categories":["science_39","science_40","science_4450"],"tags":["science_3643","science_4329","science_1050","science_1520","science_197"],"featImg":"science_1984085","label":"source_science_1984081"},"science_1978903":{"type":"posts","id":"science_1978903","meta":{"index":"posts_1591205157","site":"science","id":"1978903","score":null,"sort":[1648679118000]},"guestAuthors":[],"slug":"the-omicron-subvariant-ba-2-has-been-in-the-bay-area-for-weeks-with-limited-impact","title":"The Omicron Subvariant BA.2 Has Been in the Bay Area for Weeks — With Limited Impact","publishDate":1648679118,"format":"audio","headTitle":"The Omicron Subvariant BA.2 Has Been in the Bay Area for Weeks — With Limited Impact | KQED","labelTerm":{},"content":"\u003cp>We’ve seen this play out before: Just as we start letting down our guard, the coronavirus mutates into another insidious version, wreaking havoc on our plans.\u003c/p>\n\u003cp>Cue BA.2, or \u003ca href=\"https://www.ama-assn.org/delivering-care/public-health/what-ba2-or-stealth-omicron-subvariant\">stealth omicron\u003c/a>.\u003c/p>\n\u003cp>Earlier this month when mask mandates started falling away, the subvariant struck parts of Europe and Asia, driving \u003ca href=\"https://www.cnbc.com/2022/03/23/omicrons-subvariant-bapoint2-could-spread-wildly-in-europe-epidemiologist.html\">unprecedented spikes\u003c/a>. Now, it’s traveling fast within the U.S.\u003c/p>\n\u003cp>BA.2 is both the dominant strain globally and, now, nationally, according to the \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#variant-proportions\" target=\"_blank\" rel=\"noopener noreferrer\">Centers for Disease Control and Prevention\u003c/a>, which credits more than half of U.S. cases to stealth omicron. Infections are edging up in parts of the Northeast, and \u003ca href=\"https://soe-wbe-pilot.wl.r.appspot.com/charts#page=overview\">recent wastewater data\u003c/a> from Palo Alto, Sunnyvale and Davis suggest BA.2 is starting to push cases up around Northern California — the first real sign that it’s having an impact in the region.\u003c/p>\n\u003cp>But the data does not suggest a repeat of last winter’s surge.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“It’s not that sharp, dramatic increase from the beginning of the omicron wave,” said Marlene Wolfe of Emory University, one of the researchers who monitors wastewater sites across Northern California. “It’s something to watch, something to be careful of, something that we are glad we have this data to speak to.”\u003c/p>\n\u003ch2>Here’s what you need to know about BA.2 across California\u003c/h2>\n\u003cp>BA.2 is really good at its job: To date, it’s the most transmissible strain of the coronavirus. A \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.01.28.22270044v1\" target=\"_blank\" rel=\"noopener noreferrer\">Danish study\u003c/a> shows the virus spreads very quickly inside households, and a recent \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.03.26.22272984v1\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s2\">Swedish study\u003c/span>\u003c/a> shows that the viral loads are twice as high as the original omicron, which helps to explain why the latest strain of COVID-19 is furiously outcompeting its predecessor.\u003c/p>\n\u003cp>The good news is BA.2 does not appear to lead to more severe symptoms than the original omicron. Patients complain of cough, fatigue, congestion, dizziness and a runny nose.\u003c/p>\n\u003cp>“It’s not causing more intensive care hospital admissions in Europe,” said Dr. Susan Philip, San Francisco’s health officer. “[This is] a positive thing when we look at the characteristics of this virus.”\u003c/p>\n\u003ch2>How worried should we be?\u003c/h2>\n\u003cp>Not too worried, according to Dr. Bob Wachter, chair of UCSF’s department of medicine. “It might well lead to a small increase in cases, which we should watch carefully,” he said in an email. “It is unlikely to cause a major surge given the extent of [local] vax and infection-related immunity.”\u003c/p>\n\u003cp>That sentiment is shared by other local experts. UCSF epidemiologist Dr. George Rutherford suspects the impact in Northern California will be “relatively minor.” He estimates immunity coverage in the Bay Area is hovering around 90% due to high vaccine rates and the recent omicron wave, which left many people with natural immunity, at least in the short term. Those two factors wrap the region in a protective layer.\u003c/p>\n\u003cp>Rutherford points to what he sees as hopeful signs unfolding overseas. “Look at Western European data,” he said. “Cases are going up in some countries and not in others. A surge is not inevitable.”\u003c/p>\n\u003ch2>California cases continue to plummet\u003c/h2>\n\u003cp>It’s not time to panic. \u003ca href=\"https://covid19.ca.gov/?gclid=Cj0KCQjw3IqSBhCoARIsAMBkTb0HWWvfRHDNjPLxgEaX7PUdfx_IgCF7LJ77g3o8FIZ0HxBPJmRdTDIaAtYAEALw_wcB\">Cases across the state\u003c/a> have fallen about 32% over the past two weeks. Hospitalizations are not increasing and death rates continue to fall. Some regions are experiencing very slight upticks, but nothing concerning to public health officials.\u003c/p>\n\u003cp>Still, BA.2 poses the highest risk to anyone who is not vaccinated and did not catch omicron during the last surge. “The consequences for hospitalizations and deaths will be largely determined by how many people are vaccinated and how many older people are boosted,” said Bill Hanage, a Harvard epidemiologist.\u003c/p>\n\u003cp>This means children who are not yet old enough for a vaccine, as well as many disabled and immunocompromised people, remain at high risk.\u003c/p>\n\u003cp>If an actual surge were to form, regions with low vaccination rates would be the most vulnerable. In California that means rural areas and parts of the Central Valley.\u003c/p>\n\u003ch2>How can I protect myself?\u003c/h2>\n\u003cp>At this point California health officials are not recommending people make any course corrections to their daily lives. The state has a \u003ca href=\"https://files.covid19.ca.gov/pdf/smarter-plan--en.pdf\">road map for potential surges\u003c/a>, if the situation were to change.\u003c/p>\n\u003cp>“If we do start to see concerning increases in cases, increased severity or increasing hospitalization — we may need to reinstate some of our prior tools, things like masking,” California State Epidemiologist Dr. Erica Pan told KQED.\u003c/p>\n\u003cp>She recommends making sure you’re up to date on your vaccinations, and stocking up on \u003ca href=\"https://www.kqed.org/news/11901928/you-can-now-order-free-covid-at-home-tests-via-usps\"> home testing kits\u003c/a> to protect loved ones.\u003c/p>\n\u003ch2>Should I get a 4th dose if I’m over age 50?\u003c/h2>\n\u003cp>The U.S. Food and Drug Administration announced Tuesday that it has approved a fourth shot for people over 50. Until now the only people authorized for a fourth dose were those \u003ca href=\"https://www.nytimes.com/2022/01/09/health/immunocompromised-fourth-dose-booster.html\">with weakened immune systems\u003c/a>.\u003c/p>\n\u003cp>UCSF’s Wachter recommends a fourth shot for older adults who didn’t catch omicron in the last wave. This is especially critical if folks are engaging in riskier behaviors like eating inside restaurants. For those who caught the virus recently, Wachter suggests holding off on a fourth shot for a few months because a recent infection offers similar protection.\u003c/p>\n\u003cp>There’s \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.02.01.22270232v1.full.pdfre-pharmaceuticals/israeli-study-2nd-vaccine-booster-significantly-lowers-covid-death-rate-2022-03-27/\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s2\">compelling mortality data out of Israel\u003c/span>\u003c/a> suggesting a fourth shot dramatically lowers severe illness. However, the available data is preliminary and it’s not clear how long the benefits of a fourth dose will last.\u003c/p>\n\u003cp>https://twitter.com/Bob_Wachter/status/1508444987783929858?s=20&t=yr0py0rn9KRqRoEXy1Nb6Q\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“I’m going to get it when I can,” \u003ca href=\"https://twitter.com/Bob_Wachter/status/1508446942887485440?s=20&t=yr0py0rn9KRqRoEXy1Nb6Q\">Wachter said in another tweet\u003c/a>. “I see the advantages of the 2nd boost as outweighing the small potential downside.”\u003c/p>\n\n","blocks":[],"excerpt":"BA.2 is the most transmissible strain of the coronavirus but does not appear to lead to more severe symptoms.","status":"publish","parent":0,"modified":1704846289,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":25,"wordCount":986},"headData":{"title":"The Omicron Subvariant BA.2 Has Been in the Bay Area for Weeks — With Limited Impact | KQED","description":"BA.2 is the most transmissible strain of the coronavirus but does not appear to lead to more severe symptoms.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"The Omicron Subvariant BA.2 Has Been in the Bay Area for Weeks — With Limited Impact","datePublished":"2022-03-30T22:25:18.000Z","dateModified":"2024-01-10T00:24:49.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"Coronavirus","sticky":false,"excludeFromSiteSearch":"Include","path":"/science/1978903/the-omicron-subvariant-ba-2-has-been-in-the-bay-area-for-weeks-with-limited-impact","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>We’ve seen this play out before: Just as we start letting down our guard, the coronavirus mutates into another insidious version, wreaking havoc on our plans.\u003c/p>\n\u003cp>Cue BA.2, or \u003ca href=\"https://www.ama-assn.org/delivering-care/public-health/what-ba2-or-stealth-omicron-subvariant\">stealth omicron\u003c/a>.\u003c/p>\n\u003cp>Earlier this month when mask mandates started falling away, the subvariant struck parts of Europe and Asia, driving \u003ca href=\"https://www.cnbc.com/2022/03/23/omicrons-subvariant-bapoint2-could-spread-wildly-in-europe-epidemiologist.html\">unprecedented spikes\u003c/a>. Now, it’s traveling fast within the U.S.\u003c/p>\n\u003cp>BA.2 is both the dominant strain globally and, now, nationally, according to the \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#variant-proportions\" target=\"_blank\" rel=\"noopener noreferrer\">Centers for Disease Control and Prevention\u003c/a>, which credits more than half of U.S. cases to stealth omicron. Infections are edging up in parts of the Northeast, and \u003ca href=\"https://soe-wbe-pilot.wl.r.appspot.com/charts#page=overview\">recent wastewater data\u003c/a> from Palo Alto, Sunnyvale and Davis suggest BA.2 is starting to push cases up around Northern California — the first real sign that it’s having an impact in the region.\u003c/p>\n\u003cp>But the data does not suggest a repeat of last winter’s surge.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“It’s not that sharp, dramatic increase from the beginning of the omicron wave,” said Marlene Wolfe of Emory University, one of the researchers who monitors wastewater sites across Northern California. “It’s something to watch, something to be careful of, something that we are glad we have this data to speak to.”\u003c/p>\n\u003ch2>Here’s what you need to know about BA.2 across California\u003c/h2>\n\u003cp>BA.2 is really good at its job: To date, it’s the most transmissible strain of the coronavirus. A \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.01.28.22270044v1\" target=\"_blank\" rel=\"noopener noreferrer\">Danish study\u003c/a> shows the virus spreads very quickly inside households, and a recent \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.03.26.22272984v1\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s2\">Swedish study\u003c/span>\u003c/a> shows that the viral loads are twice as high as the original omicron, which helps to explain why the latest strain of COVID-19 is furiously outcompeting its predecessor.\u003c/p>\n\u003cp>The good news is BA.2 does not appear to lead to more severe symptoms than the original omicron. Patients complain of cough, fatigue, congestion, dizziness and a runny nose.\u003c/p>\n\u003cp>“It’s not causing more intensive care hospital admissions in Europe,” said Dr. Susan Philip, San Francisco’s health officer. “[This is] a positive thing when we look at the characteristics of this virus.”\u003c/p>\n\u003ch2>How worried should we be?\u003c/h2>\n\u003cp>Not too worried, according to Dr. Bob Wachter, chair of UCSF’s department of medicine. “It might well lead to a small increase in cases, which we should watch carefully,” he said in an email. “It is unlikely to cause a major surge given the extent of [local] vax and infection-related immunity.”\u003c/p>\n\u003cp>That sentiment is shared by other local experts. UCSF epidemiologist Dr. George Rutherford suspects the impact in Northern California will be “relatively minor.” He estimates immunity coverage in the Bay Area is hovering around 90% due to high vaccine rates and the recent omicron wave, which left many people with natural immunity, at least in the short term. Those two factors wrap the region in a protective layer.\u003c/p>\n\u003cp>Rutherford points to what he sees as hopeful signs unfolding overseas. “Look at Western European data,” he said. “Cases are going up in some countries and not in others. A surge is not inevitable.”\u003c/p>\n\u003ch2>California cases continue to plummet\u003c/h2>\n\u003cp>It’s not time to panic. \u003ca href=\"https://covid19.ca.gov/?gclid=Cj0KCQjw3IqSBhCoARIsAMBkTb0HWWvfRHDNjPLxgEaX7PUdfx_IgCF7LJ77g3o8FIZ0HxBPJmRdTDIaAtYAEALw_wcB\">Cases across the state\u003c/a> have fallen about 32% over the past two weeks. Hospitalizations are not increasing and death rates continue to fall. Some regions are experiencing very slight upticks, but nothing concerning to public health officials.\u003c/p>\n\u003cp>Still, BA.2 poses the highest risk to anyone who is not vaccinated and did not catch omicron during the last surge. “The consequences for hospitalizations and deaths will be largely determined by how many people are vaccinated and how many older people are boosted,” said Bill Hanage, a Harvard epidemiologist.\u003c/p>\n\u003cp>This means children who are not yet old enough for a vaccine, as well as many disabled and immunocompromised people, remain at high risk.\u003c/p>\n\u003cp>If an actual surge were to form, regions with low vaccination rates would be the most vulnerable. In California that means rural areas and parts of the Central Valley.\u003c/p>\n\u003ch2>How can I protect myself?\u003c/h2>\n\u003cp>At this point California health officials are not recommending people make any course corrections to their daily lives. The state has a \u003ca href=\"https://files.covid19.ca.gov/pdf/smarter-plan--en.pdf\">road map for potential surges\u003c/a>, if the situation were to change.\u003c/p>\n\u003cp>“If we do start to see concerning increases in cases, increased severity or increasing hospitalization — we may need to reinstate some of our prior tools, things like masking,” California State Epidemiologist Dr. Erica Pan told KQED.\u003c/p>\n\u003cp>She recommends making sure you’re up to date on your vaccinations, and stocking up on \u003ca href=\"https://www.kqed.org/news/11901928/you-can-now-order-free-covid-at-home-tests-via-usps\"> home testing kits\u003c/a> to protect loved ones.\u003c/p>\n\u003ch2>Should I get a 4th dose if I’m over age 50?\u003c/h2>\n\u003cp>The U.S. Food and Drug Administration announced Tuesday that it has approved a fourth shot for people over 50. Until now the only people authorized for a fourth dose were those \u003ca href=\"https://www.nytimes.com/2022/01/09/health/immunocompromised-fourth-dose-booster.html\">with weakened immune systems\u003c/a>.\u003c/p>\n\u003cp>UCSF’s Wachter recommends a fourth shot for older adults who didn’t catch omicron in the last wave. This is especially critical if folks are engaging in riskier behaviors like eating inside restaurants. For those who caught the virus recently, Wachter suggests holding off on a fourth shot for a few months because a recent infection offers similar protection.\u003c/p>\n\u003cp>There’s \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.02.01.22270232v1.full.pdfre-pharmaceuticals/israeli-study-2nd-vaccine-booster-significantly-lowers-covid-death-rate-2022-03-27/\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s2\">compelling mortality data out of Israel\u003c/span>\u003c/a> suggesting a fourth shot dramatically lowers severe illness. However, the available data is preliminary and it’s not clear how long the benefits of a fourth dose will last.\u003c/p>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"singleTwitterStatus","attributes":{"named":{"id":"1508444987783929858"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\n\u003cp>\u003c/p>\n\u003cp>“I’m going to get it when I can,” \u003ca href=\"https://twitter.com/Bob_Wachter/status/1508446942887485440?s=20&t=yr0py0rn9KRqRoEXy1Nb6Q\">Wachter said in another tweet\u003c/a>. “I see the advantages of the 2nd boost as outweighing the small potential downside.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1978903/the-omicron-subvariant-ba-2-has-been-in-the-bay-area-for-weeks-with-limited-impact","authors":["11229"],"categories":["science_39","science_3890","science_40","science_4450"],"tags":["science_3643","science_4329","science_4368","science_1050","science_197"],"featImg":"science_1978921","label":"source_science_1978903"},"science_1978289":{"type":"posts","id":"science_1978289","meta":{"index":"posts_1591205157","site":"science","id":"1978289","score":null,"sort":[1643332579000]},"guestAuthors":[],"slug":"omicron-was-in-california-before-it-was-named-omicron-according-to-sewage-samples","title":"Omicron Was in California Before It Was Named Omicron, According to Sewage Samples","publishDate":1643332579,"format":"standard","headTitle":"Omicron Was in California Before It Was Named Omicron, According to Sewage Samples | KQED","labelTerm":{},"content":"\u003cp>We’ve learned a lot about COVID-19 by examining what we’ve flushed down the toilet.\u003c/p>\n\u003cp>Here are a few of those things.\u003c/p>\n\u003cp>The variant was in a waste sample collected in Merced County on Nov. 25 — that’s a day before the World Health Organization named it omicron.\u003c/p>\n\u003cp>Scientists in New York found it in a sample collected even earlier, on Nov. 21, predating the alarms from leaders in South Africa about a troubling new variant.\u003c/p>\n\u003cp>Officials in Texas also detected omicron early through wastewater surveillance.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>A new \u003ca href=\"https://www.cdc.gov/mmwr/volumes/71/wr/mm7103a5.htm?s_cid=mm7103a5_w&utm_source=STAT+Newsletters&utm_campaign=6439030dc2-MR_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-6439030dc2-151495997#T1_down\">\u003cspan class=\"s1\">report\u003c/span>\u003c/a> last week from the Centers for Disease Control and Prevention outlined these facts.\u003c/p>\n\u003cp>Agency scientists describe this as “strong early evidence that the Omicron variant was likely present or more widely distributed in these communities than originally indicated by clinical testing alone.”\u003c/p>\n\u003cp>The report makes a case that by the time officials have detected a new variant, it likely has spread to numerous other countries.\u003c/p>\n\u003cp>In this light, travel bans look ineffective and like “closing the barn door after the horses have fled,” as researchers from the University of Illinois argued in a \u003ca href=\"https://thehill.com/opinion/healthcare/583337-omicron-is-already-global-tests-for-international-flights-are-far-better\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">recent op-ed\u003c/span>\u003c/a>.\u003c/p>\n\u003cp>Requiring testing on international flights would be a much more effective policy, they wrote.\u003c/p>\n\u003cp>The study also underscores the potency of this new surveillance tool, which counties increasingly rely on as demand for COVID-19 tests outpace supply.\u003c/p>\n\u003cp>“The ability to ramp up the infrastructure to test the number of people that need to be tested right now is an enormous strain on the health care system and on our testing systems that we’ve set up,” said Marlene Wolfe of Emory University, one of the researchers who monitors sites across Northern California. “But with this wastewater data, we have not had to increase our capacity at all. We are doing exactly what we’ve been doing for a year.”\u003c/p>\n\u003cp>Wolfe’s method can detect as few as one or two cases per 100,000 people.\u003c/p>\n\u003cp>“We’re in close communication with public health officials,” she said. “They’re able to use that data to plan for what’s next. It’s similar to how they would use clinical case data but is actually more reliable. We are not biased by the fact that it’s so difficult to find a test right now.”\u003c/p>\n\u003cp>Wolfe says this moment is a good opportunity to expand the surveillance regime and collect data on other diseases.\u003c/p>\n\u003cp>“We’re starting to monitor for \u003ca href=\"https://www.cdc.gov/rsv/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">respiratory syncytial virus\u003c/a> and influenza,” she said. “There are a lot of areas where we can provide very useful public health data using wastewater because we have developed these tools so fully over the course of this pandemic.”\u003c/p>\n\u003cp>Not all of the information in the CDC’s report is new, although now it’s been verified by federal scientists.\u003c/p>\n\u003cp>KQED’s Raquel Maria Dillon was the first to \u003ca href=\"https://www.kqed.org/news/11898161/scientists-find-traces-of-omicron-in-sewage-from-sacramento-and-merced\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">report\u003c/span>\u003c/a> on the detection in Merced, as well as a similar sample found in Sacramento on Nov. 30 — that’s a day before health officials confirmed the \u003ca href=\"https://www.kqed.org/science/1977807/first-u-s-case-of-omicron-variant-found-in-california\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">first U.S. case in a San Francisco resident on Dec. 1\u003c/span>\u003c/a>.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Researchers notified Sacramento of the findings, and officials there described the data as useful and “one of the tools that helps us identify new variants.”\u003c/p>\n\n","blocks":[],"excerpt":"Sewage sampling can detect as few as one or two cases in 100,000 people, making the method especially useful when it's difficult for people to find tests.","status":"publish","parent":0,"modified":1704846325,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":21,"wordCount":577},"headData":{"title":"Omicron Was in California Before It Was Named Omicron, According to Sewage Samples | KQED","description":"Sewage sampling can detect as few as one or two cases in 100,000 people, making the method especially useful when it's difficult for people to find tests.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Omicron Was in California Before It Was Named Omicron, According to Sewage Samples","datePublished":"2022-01-28T01:16:19.000Z","dateModified":"2024-01-10T00:25:25.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"Coronavirus ","sticky":false,"excludeFromSiteSearch":"Include","path":"/science/1978289/omicron-was-in-california-before-it-was-named-omicron-according-to-sewage-samples","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>We’ve learned a lot about COVID-19 by examining what we’ve flushed down the toilet.\u003c/p>\n\u003cp>Here are a few of those things.\u003c/p>\n\u003cp>The variant was in a waste sample collected in Merced County on Nov. 25 — that’s a day before the World Health Organization named it omicron.\u003c/p>\n\u003cp>Scientists in New York found it in a sample collected even earlier, on Nov. 21, predating the alarms from leaders in South Africa about a troubling new variant.\u003c/p>\n\u003cp>Officials in Texas also detected omicron early through wastewater surveillance.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>A new \u003ca href=\"https://www.cdc.gov/mmwr/volumes/71/wr/mm7103a5.htm?s_cid=mm7103a5_w&utm_source=STAT+Newsletters&utm_campaign=6439030dc2-MR_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-6439030dc2-151495997#T1_down\">\u003cspan class=\"s1\">report\u003c/span>\u003c/a> last week from the Centers for Disease Control and Prevention outlined these facts.\u003c/p>\n\u003cp>Agency scientists describe this as “strong early evidence that the Omicron variant was likely present or more widely distributed in these communities than originally indicated by clinical testing alone.”\u003c/p>\n\u003cp>The report makes a case that by the time officials have detected a new variant, it likely has spread to numerous other countries.\u003c/p>\n\u003cp>In this light, travel bans look ineffective and like “closing the barn door after the horses have fled,” as researchers from the University of Illinois argued in a \u003ca href=\"https://thehill.com/opinion/healthcare/583337-omicron-is-already-global-tests-for-international-flights-are-far-better\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">recent op-ed\u003c/span>\u003c/a>.\u003c/p>\n\u003cp>Requiring testing on international flights would be a much more effective policy, they wrote.\u003c/p>\n\u003cp>The study also underscores the potency of this new surveillance tool, which counties increasingly rely on as demand for COVID-19 tests outpace supply.\u003c/p>\n\u003cp>“The ability to ramp up the infrastructure to test the number of people that need to be tested right now is an enormous strain on the health care system and on our testing systems that we’ve set up,” said Marlene Wolfe of Emory University, one of the researchers who monitors sites across Northern California. “But with this wastewater data, we have not had to increase our capacity at all. We are doing exactly what we’ve been doing for a year.”\u003c/p>\n\u003cp>Wolfe’s method can detect as few as one or two cases per 100,000 people.\u003c/p>\n\u003cp>“We’re in close communication with public health officials,” she said. “They’re able to use that data to plan for what’s next. It’s similar to how they would use clinical case data but is actually more reliable. We are not biased by the fact that it’s so difficult to find a test right now.”\u003c/p>\n\u003cp>Wolfe says this moment is a good opportunity to expand the surveillance regime and collect data on other diseases.\u003c/p>\n\u003cp>“We’re starting to monitor for \u003ca href=\"https://www.cdc.gov/rsv/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">respiratory syncytial virus\u003c/a> and influenza,” she said. “There are a lot of areas where we can provide very useful public health data using wastewater because we have developed these tools so fully over the course of this pandemic.”\u003c/p>\n\u003cp>Not all of the information in the CDC’s report is new, although now it’s been verified by federal scientists.\u003c/p>\n\u003cp>KQED’s Raquel Maria Dillon was the first to \u003ca href=\"https://www.kqed.org/news/11898161/scientists-find-traces-of-omicron-in-sewage-from-sacramento-and-merced\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">report\u003c/span>\u003c/a> on the detection in Merced, as well as a similar sample found in Sacramento on Nov. 30 — that’s a day before health officials confirmed the \u003ca href=\"https://www.kqed.org/science/1977807/first-u-s-case-of-omicron-variant-found-in-california\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s1\">first U.S. case in a San Francisco resident on Dec. 1\u003c/span>\u003c/a>.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Researchers notified Sacramento of the findings, and officials there described the data as useful and “one of the tools that helps us identify new variants.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1978289/omicron-was-in-california-before-it-was-named-omicron-according-to-sewage-samples","authors":["11608"],"categories":["science_39","science_3890","science_40","science_4450"],"tags":["science_3643","science_4329","science_4368","science_4414"],"featImg":"science_1978290","label":"source_science_1978289"},"science_1977734":{"type":"posts","id":"science_1977734","meta":{"index":"posts_1591205157","site":"science","id":"1977734","score":null,"sort":[1637188718000]},"guestAuthors":[],"slug":"here-are-8-lingering-questions-about-the-new-covid-pills-from-merck-and-pfizer","title":"Here Are 8 Lingering Questions About the New COVID Pills From Merck and Pfizer","publishDate":1637188718,"format":"standard","headTitle":"Here Are 8 Lingering Questions About the New COVID Pills From Merck and Pfizer | KQED","labelTerm":{},"content":"\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">T\u003c/span>\u003c/span>he past two months have brought extremely good news in the fight against COVID-19. Two different oral treatments have proved effective at both preventing people newly diagnosed with COVID-19 from entering the hospital and from dying.\u003c/p>\n\u003cp>“We’re accelerating our path out of this pandemic,” President Biden said after data on the second COVID pill became available. The wide availability of oral drugs could make COVID-19 less lethal, making it less risky for people to return to in-person work and to their normal lives.\u003c/p>\n\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\">first results\u003c/a>, from Merck and Ridgeback Therapeutics, were released in October and will be considered by an advisory panel to the Food and Drug Administration in December. That could lead to an emergency use authorization in the U.S. by the end of the year. That drug, molnupiravir, reduced hospitalizations by 50% and prevented deaths entirely a large randomized clinical trial when it was given within five days of when symptoms began. The pill is given as a five-day course during which patients take a total of 40 pills.\u003c/p>\n\u003cp>In November, Pfizer announced that its COVID pill, Paxlovid, reduced hospitalizations by 89% and also prevented deaths in its own large randomized study. As with the Merck drug, Paxlovid is given as a five-day course. It must be given with a second medicine, a booster, called ritonavir, which is made by AbbVie, another large drug firm. The Pfizer regimen involves taking 30 pills over a five-day period.\u003c/p>\n\u003cp>Though the topline results are similar, the medicines could have different risks and benefits. The companies have only issued data in press releases, not scientific articles, and doctors need to know a lot more about both. Here is an overview of what we still don’t know about the COVID pills and when we might learn it.\u003c/p>\n\u003ch3>Which one works better?\u003c/h3>\n\u003cp>At the headline level, Pfizer’s pill reduced the risk of hospitalization and death \u003ca href=\"https://www.statnews.com/2021/11/05/experimental-pfizer-pill-prevents-covid-hospitalizations-and-deaths/\" target=\"_blank\" rel=\"noopener noreferrer\">by 89%,\u003c/a> while Merck showed \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\">a reduction of 50%\u003c/a>. But neither firm has disclosed detailed data from its pivotal studies, and the trials were not identically designed.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The studies enrolled similar populations — unvaccinated people with mild to moderate COVID-19 and at least one risk factor for severe disease — but they had slightly different measures of efficacy. Pfizer’s 89% figure comes from patients who started getting its pill, Paxlovid, within three days of their first COVID-19 symptoms. Merck’s 50% applies to patients who began treatment within five days. In the Paxlovid study, patients who started treatment within five days saw an 85% improvement in hospitalization or death versus placebo. Merck has not shared data on patients who got its drug within three days of symptom onset.\u003c/p>\n\u003cp>What the studies had in common was 100% efficacy against death, regardless of when patients started treatment. Merck’s study counted eight deaths among patients on placebo, and Pfizer’s observed 10.\u003c/p>\n\u003cp>On the safety side, the rate of side effects in both studies was similar between the treatment groups and placebo groups. In each study, fewer patients in the treatment group left the study due to side effects compared to those in the placebo group. Neither company has disclosed detailed data on the type and severity of side effects.\u003c/p>\n\u003cp>Each treatment is administered twice a day for five total days, amounting to 10 doses in total. Pfizer’s drug is co-administered with a common antiviral called ritonavir.\u003c/p>\n\u003ch3>Will the antiviral be available for vaccinated patients with breakthrough infections?\u003c/h3>\n\u003cp>Both companies conducted their studies entirely in patients who were at high risk of complications if they caught COVID and who also had not been vaccinated. That leads to a big question for policymakers: Should those who have been vaccinated, but who develop a breakthrough infection of SARS-CoV-2, be given the pills?\u003c/p>\n\u003cp>Right now that is a question without data. A third antiviral pill, from the biotech firm Atea and the large drug firm Roche, failed to prove it was effective in its own study, and Wall Street analysts suspect the reason is that the companies included vaccinated patients in the research. For those who have received the vaccine, hospitalization and death are much less likely. This means that it is harder for a drug to show efficacy, because there are fewer infections to prevent.\u003c/p>\n\u003cp>So regulators and public health officials will have to make a judgement on the risks and benefits of the COVID pills for people with breakthrough infections — without direct data in these populations.\u003c/p>\n\u003cp>Pfizer is running a clinical trial, with results due next year, that does include vaccinated patients, and the company’s executives have expressed confidence based on the results so far that the treatment should work. Both Merck and Pfizer are also running studies to show that the drugs can prevent people from developing symptoms if they take the antivirals after they are exposed to the virus.\u003c/p>\n\u003ch3>Do the drugs work the same way?\u003c/h3>\n\u003cp>No, not really. While both drugs interfere with the process the coronavirus uses to reproduce itself, each drug interferes at a very different point.\u003c/p>\n\u003cp>Merck’s drug throws a wrench into the works quite early. After someone takes molnupiravir, the drug is transformed into something uncannily similar to one of RNA’s chemical building blocks.\u003c/p>\n\u003cp>The modification is so subtle that not only will the coronavirus use molnupiravir in place of other building blocks when it replicates itself, but coronaviruses’ unusual proofreading mechanism can’t even pick up on the imposter compound. Over time, the drug will encourage the virus to introduce even more mistakes.\u003c/p>\n\u003cp>“Ultimately, this leads to what’s known as error catastrophe. It’s introducing so many different mutations that, eventually, nothing further can happen,” said Katherine Seley-Radtke, a medicinal chemist at the University of Maryland, Baltimore County. “You’ve got this completely mutated RNA.”\u003c/p>\n\u003cp>Pfizer’s drug, Paxlovid, acts at a completely different point in the virus’ reproductive process.\u003c/p>\n\u003cp>“It’s apples and oranges,” said Ronald Swanstrom, a biochemistry professor at the University of North Carolina School of Medicine.\u003c/p>\n\u003cp>Unlike molnupiravir, Paxlovid allows the strings of viral RNA to be assembled correctly. It even allows those strings to be used to create viral proteins, which are initially produced in one big chunk. Like a bolt of fabric before it’s cut to a clothing pattern, this protein needs to be chopped down to size before it can work.\u003c/p>\n\u003cp>That cutting is what Paxlovid prohibits. The drug is designed to bind to a particularly important point in an enzyme called a protease which slices up proteins. Without a functioning protease, the virus can’t create functional copies; no working virus, no problem.\u003c/p>\n\u003cp>Protease inhibitors have been used for decades to create more than a dozen drugs for HIV and hepatitis C; in some cases, they’ve also been used as cancer drugs.\u003c/p>\n\u003cp>“There’s a long history of medicinal chemistry targeting proteases,” said Bryan Dickinson, a chemical biologist at the University of Chicago.\u003c/p>\n\u003cp>Paxlovid is designed with a SARS-CoV-2-specific protease in mind, so it works more specifically on this coronavirus than molnupiravir.\u003c/p>\n\u003cp>But Paxlovid can’t work as well if it’s taken on its own. The body’s defense mechanisms will get rid of anything that it doesn’t recognize — including drugs, which can be digested by enzymes in a person’s liver. Another drug called ritonavir blocks the liver enzyme that would likely chew up Paxlovid, which gives the latter drug the space it needs to work.\u003c/p>\n\u003ch3>How do they compare with monoclonal antibodies?\u003c/h3>\n\u003cp>Regeneron Pharmaceuticals and Eli Lilly have each won FDA authorization for antibody combination therapies that keep recently diagnosed COVID-19 patients from hospitalization and death. In a Phase 3 study enrolling recently diagnosed patients at high risk for severe disease, Regeneron’s treatment reduced the risk of hospitalization or death \u003ca href=\"https://investor.regeneron.com/news-releases/news-release-details/phase-3-trial-shows-regen-covtm-casirivimab-imdevimab-antibody\" target=\"_blank\" rel=\"noopener noreferrer\">by 70%\u003c/a> compared to placebo. In a similar study, Lilly’s therapy showed \u003ca href=\"https://www.prnewswire.com/news-releases/lillys-bamlanivimab-and-etesevimab-together-reduced-hospitalizations-and-death-in-phase-3-trial-for-early-covid-19-301243984.html\" target=\"_blank\" rel=\"noopener noreferrer\">an 87% reduction\u003c/a>.\u003c/p>\n\u003cp>The biggest difference is one of convenience. The antibody treatments are administered intravenously in a one-time, roughly hour-long process (Regeneron’s is authorized for subcutaneous injection when an IV procedure is not feasible). That could make the treatments from Pfizer and Merck, taken orally at home, preferable to patients unable to visit an infusion center.\u003c/p>\n\u003cp>There’s also a difference in cost. Regeneron and Lilly have signed deals with the federal government to sell their treatments at about $1,250 per dose. Merck’s agreement with the U.S. works out to about $700 for a five-day course of molnupiravir. Pfizer is still negotiating contracts but is expected to set a similar price for Paxlovid.\u003c/p>\n\u003ch3>How easy will they be to get?\u003c/h3>\n\u003cp>A pill is a huge leap in terms of logistical ease over infused therapies like monoclonal antibodies. For those treatments, not only did people have to make their way to clinics for their infusions, but hospitals and other facilities had to set up places where people who were actively infectious could come get treated without risking others’ health. (The other antiviral authorized to treat COVID-19, Gilead’s remdesivir, is an infusion and approved only for hospitalized patients, but some data indicate that if it were to be given to patients earlier in their infections, it could have a greater effect. If its approval ever covered outpatients, however, it would still run into the same logistical challenges of an infused therapy.)\u003c/p>\n\u003cp>Still, the COVID pills come with a key challenge of their own. They’re most effective when given early in the infection, so people need to be able to get tested and get their prescription rapidly. And the U.S. testing landscape is still limited. PCR tests can take days to return a result, and though the Biden administration has upped its effort to expand the availability of at-home rapid tests, finding one at a store is still hit or miss — success feels like scoring this holiday season’s hottest gift. Any delay in getting diagnosed undercuts the power of these pills; even a day or two has real implications for a treatment meant to clear out an acute infection like COVID-19.\u003c/p>\n\u003ch3>Will it affect a patient’s DNA?\u003c/h3>\n\u003cp>This is really a question only for Merck’s molnupiravir, since it works by sneaking subtly corrupted parts into the coronavirus’s RNA sequence.\u003c/p>\n\u003cp>Once the virus has mutated too much, it can’t work — mission accomplished. But there’s a theoretical chance that molnupiravir could also influence normal human DNA when it replicates, too. If mutations happen during that process, it could spell real trouble.\u003c/p>\n\u003cp>Merck did some tests during molnupiravir’s development to check this possibility out. In two different types of animal studies using higher and longer doses than are given to humans, Merck’s scientists didn’t see any increased risk of unwanted mutations.\u003c/p>\n\u003cp>“We are very confident in the safety profile of molnupiravir based on our preclinical and clinical data,” executive vice president Dean Li told investors in an October conference call, according to a transcript in the financial database Sentieo.\u003c/p>\n\u003cp>But UNC’s Swanstrom isn’t completely convinced that the tests Merck did were sensitive enough. In August, he and his colleagues \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/33961695/\" target=\"_blank\" rel=\"noopener noreferrer\">published a paper in\u003c/a> the Journal of Infectious Diseases showing that a key metabolite of molnupiravir could mutate DNA in animal cells.\u003c/p>\n\u003cp>Given these results, Swanstrom said he would be particularly interested in seeing a long-term study of people who took molnupiravir to continue to monitor this potential effect over the next 10 or 20 years.\u003c/p>\n\u003cp>“This thing is going to go into thousands of people. And are we just going to ignore the fact that there’s this potential risk?” he said. “The risk could be zero. It could be no worse than going to get a dental X-ray — or it could do something more. But unless we find out, you know, we’re going to learn this lesson the hard way, way later than we should.”\u003c/p>\n\u003ch3>What might the new antivirals mean for cancer patients?\u003c/h3>\n\u003cp>Because the new antiviral Pfizer is developing is a protease inhibitor, infectious disease specialists are familiar with how it works. So we already know: These drugs have the potential to interfere with many therapies used to treat cancer, Tobias Hohl, chief of the infectious diseases service at Memorial Sloan Kettering Cancer Center in New York, told STAT.\u003c/p>\n\u003cp>“They’re going to be very helpful [in our] armamentarium, but they will not substitute for prevention or vaccination efforts because these are not medicines that are completely benign and harmless in terms of their drug-drug interactions and toxicity,” he said. “So we’re going to have to be careful and thoughtful about how we use our protease inhibitors.”\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\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Matthew Herper, Damian Garde, Kate Sheridan, Adam Feuerstein, Andrew Joseph, and Elizabeth Cooney contributed reporting.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"Two different oral treatments have proved effective at both preventing people newly diagnosed with COVID-19 from entering the hospital and from dying.","status":"publish","parent":0,"modified":1704846362,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":44,"wordCount":2251},"headData":{"title":"Here Are 8 Lingering Questions About the New COVID Pills From Merck and Pfizer | KQED","description":"Two different oral treatments have proved effective at both preventing people newly diagnosed with COVID-19 from entering the hospital and from dying.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Here Are 8 Lingering Questions About the New COVID Pills From Merck and Pfizer","datePublished":"2021-11-17T22:38:38.000Z","dateModified":"2024-01-10T00:26:02.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"STAT","sticky":false,"nprByline":"STAT staff","excludeFromSiteSearch":"Include","path":"/science/1977734/here-are-8-lingering-questions-about-the-new-covid-pills-from-merck-and-pfizer","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">T\u003c/span>\u003c/span>he past two months have brought extremely good news in the fight against COVID-19. Two different oral treatments have proved effective at both preventing people newly diagnosed with COVID-19 from entering the hospital and from dying.\u003c/p>\n\u003cp>“We’re accelerating our path out of this pandemic,” President Biden said after data on the second COVID pill became available. The wide availability of oral drugs could make COVID-19 less lethal, making it less risky for people to return to in-person work and to their normal lives.\u003c/p>\n\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\">first results\u003c/a>, from Merck and Ridgeback Therapeutics, were released in October and will be considered by an advisory panel to the Food and Drug Administration in December. That could lead to an emergency use authorization in the U.S. by the end of the year. That drug, molnupiravir, reduced hospitalizations by 50% and prevented deaths entirely a large randomized clinical trial when it was given within five days of when symptoms began. The pill is given as a five-day course during which patients take a total of 40 pills.\u003c/p>\n\u003cp>In November, Pfizer announced that its COVID pill, Paxlovid, reduced hospitalizations by 89% and also prevented deaths in its own large randomized study. As with the Merck drug, Paxlovid is given as a five-day course. It must be given with a second medicine, a booster, called ritonavir, which is made by AbbVie, another large drug firm. The Pfizer regimen involves taking 30 pills over a five-day period.\u003c/p>\n\u003cp>Though the topline results are similar, the medicines could have different risks and benefits. The companies have only issued data in press releases, not scientific articles, and doctors need to know a lot more about both. Here is an overview of what we still don’t know about the COVID pills and when we might learn it.\u003c/p>\n\u003ch3>Which one works better?\u003c/h3>\n\u003cp>At the headline level, Pfizer’s pill reduced the risk of hospitalization and death \u003ca href=\"https://www.statnews.com/2021/11/05/experimental-pfizer-pill-prevents-covid-hospitalizations-and-deaths/\" target=\"_blank\" rel=\"noopener noreferrer\">by 89%,\u003c/a> while Merck showed \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\">a reduction of 50%\u003c/a>. But neither firm has disclosed detailed data from its pivotal studies, and the trials were not identically designed.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The studies enrolled similar populations — unvaccinated people with mild to moderate COVID-19 and at least one risk factor for severe disease — but they had slightly different measures of efficacy. Pfizer’s 89% figure comes from patients who started getting its pill, Paxlovid, within three days of their first COVID-19 symptoms. Merck’s 50% applies to patients who began treatment within five days. In the Paxlovid study, patients who started treatment within five days saw an 85% improvement in hospitalization or death versus placebo. Merck has not shared data on patients who got its drug within three days of symptom onset.\u003c/p>\n\u003cp>What the studies had in common was 100% efficacy against death, regardless of when patients started treatment. Merck’s study counted eight deaths among patients on placebo, and Pfizer’s observed 10.\u003c/p>\n\u003cp>On the safety side, the rate of side effects in both studies was similar between the treatment groups and placebo groups. In each study, fewer patients in the treatment group left the study due to side effects compared to those in the placebo group. Neither company has disclosed detailed data on the type and severity of side effects.\u003c/p>\n\u003cp>Each treatment is administered twice a day for five total days, amounting to 10 doses in total. Pfizer’s drug is co-administered with a common antiviral called ritonavir.\u003c/p>\n\u003ch3>Will the antiviral be available for vaccinated patients with breakthrough infections?\u003c/h3>\n\u003cp>Both companies conducted their studies entirely in patients who were at high risk of complications if they caught COVID and who also had not been vaccinated. That leads to a big question for policymakers: Should those who have been vaccinated, but who develop a breakthrough infection of SARS-CoV-2, be given the pills?\u003c/p>\n\u003cp>Right now that is a question without data. A third antiviral pill, from the biotech firm Atea and the large drug firm Roche, failed to prove it was effective in its own study, and Wall Street analysts suspect the reason is that the companies included vaccinated patients in the research. For those who have received the vaccine, hospitalization and death are much less likely. This means that it is harder for a drug to show efficacy, because there are fewer infections to prevent.\u003c/p>\n\u003cp>So regulators and public health officials will have to make a judgement on the risks and benefits of the COVID pills for people with breakthrough infections — without direct data in these populations.\u003c/p>\n\u003cp>Pfizer is running a clinical trial, with results due next year, that does include vaccinated patients, and the company’s executives have expressed confidence based on the results so far that the treatment should work. Both Merck and Pfizer are also running studies to show that the drugs can prevent people from developing symptoms if they take the antivirals after they are exposed to the virus.\u003c/p>\n\u003ch3>Do the drugs work the same way?\u003c/h3>\n\u003cp>No, not really. While both drugs interfere with the process the coronavirus uses to reproduce itself, each drug interferes at a very different point.\u003c/p>\n\u003cp>Merck’s drug throws a wrench into the works quite early. After someone takes molnupiravir, the drug is transformed into something uncannily similar to one of RNA’s chemical building blocks.\u003c/p>\n\u003cp>The modification is so subtle that not only will the coronavirus use molnupiravir in place of other building blocks when it replicates itself, but coronaviruses’ unusual proofreading mechanism can’t even pick up on the imposter compound. Over time, the drug will encourage the virus to introduce even more mistakes.\u003c/p>\n\u003cp>“Ultimately, this leads to what’s known as error catastrophe. It’s introducing so many different mutations that, eventually, nothing further can happen,” said Katherine Seley-Radtke, a medicinal chemist at the University of Maryland, Baltimore County. “You’ve got this completely mutated RNA.”\u003c/p>\n\u003cp>Pfizer’s drug, Paxlovid, acts at a completely different point in the virus’ reproductive process.\u003c/p>\n\u003cp>“It’s apples and oranges,” said Ronald Swanstrom, a biochemistry professor at the University of North Carolina School of Medicine.\u003c/p>\n\u003cp>Unlike molnupiravir, Paxlovid allows the strings of viral RNA to be assembled correctly. It even allows those strings to be used to create viral proteins, which are initially produced in one big chunk. Like a bolt of fabric before it’s cut to a clothing pattern, this protein needs to be chopped down to size before it can work.\u003c/p>\n\u003cp>That cutting is what Paxlovid prohibits. The drug is designed to bind to a particularly important point in an enzyme called a protease which slices up proteins. Without a functioning protease, the virus can’t create functional copies; no working virus, no problem.\u003c/p>\n\u003cp>Protease inhibitors have been used for decades to create more than a dozen drugs for HIV and hepatitis C; in some cases, they’ve also been used as cancer drugs.\u003c/p>\n\u003cp>“There’s a long history of medicinal chemistry targeting proteases,” said Bryan Dickinson, a chemical biologist at the University of Chicago.\u003c/p>\n\u003cp>Paxlovid is designed with a SARS-CoV-2-specific protease in mind, so it works more specifically on this coronavirus than molnupiravir.\u003c/p>\n\u003cp>But Paxlovid can’t work as well if it’s taken on its own. The body’s defense mechanisms will get rid of anything that it doesn’t recognize — including drugs, which can be digested by enzymes in a person’s liver. Another drug called ritonavir blocks the liver enzyme that would likely chew up Paxlovid, which gives the latter drug the space it needs to work.\u003c/p>\n\u003ch3>How do they compare with monoclonal antibodies?\u003c/h3>\n\u003cp>Regeneron Pharmaceuticals and Eli Lilly have each won FDA authorization for antibody combination therapies that keep recently diagnosed COVID-19 patients from hospitalization and death. In a Phase 3 study enrolling recently diagnosed patients at high risk for severe disease, Regeneron’s treatment reduced the risk of hospitalization or death \u003ca href=\"https://investor.regeneron.com/news-releases/news-release-details/phase-3-trial-shows-regen-covtm-casirivimab-imdevimab-antibody\" target=\"_blank\" rel=\"noopener noreferrer\">by 70%\u003c/a> compared to placebo. In a similar study, Lilly’s therapy showed \u003ca href=\"https://www.prnewswire.com/news-releases/lillys-bamlanivimab-and-etesevimab-together-reduced-hospitalizations-and-death-in-phase-3-trial-for-early-covid-19-301243984.html\" target=\"_blank\" rel=\"noopener noreferrer\">an 87% reduction\u003c/a>.\u003c/p>\n\u003cp>The biggest difference is one of convenience. The antibody treatments are administered intravenously in a one-time, roughly hour-long process (Regeneron’s is authorized for subcutaneous injection when an IV procedure is not feasible). That could make the treatments from Pfizer and Merck, taken orally at home, preferable to patients unable to visit an infusion center.\u003c/p>\n\u003cp>There’s also a difference in cost. Regeneron and Lilly have signed deals with the federal government to sell their treatments at about $1,250 per dose. Merck’s agreement with the U.S. works out to about $700 for a five-day course of molnupiravir. Pfizer is still negotiating contracts but is expected to set a similar price for Paxlovid.\u003c/p>\n\u003ch3>How easy will they be to get?\u003c/h3>\n\u003cp>A pill is a huge leap in terms of logistical ease over infused therapies like monoclonal antibodies. For those treatments, not only did people have to make their way to clinics for their infusions, but hospitals and other facilities had to set up places where people who were actively infectious could come get treated without risking others’ health. (The other antiviral authorized to treat COVID-19, Gilead’s remdesivir, is an infusion and approved only for hospitalized patients, but some data indicate that if it were to be given to patients earlier in their infections, it could have a greater effect. If its approval ever covered outpatients, however, it would still run into the same logistical challenges of an infused therapy.)\u003c/p>\n\u003cp>Still, the COVID pills come with a key challenge of their own. They’re most effective when given early in the infection, so people need to be able to get tested and get their prescription rapidly. And the U.S. testing landscape is still limited. PCR tests can take days to return a result, and though the Biden administration has upped its effort to expand the availability of at-home rapid tests, finding one at a store is still hit or miss — success feels like scoring this holiday season’s hottest gift. Any delay in getting diagnosed undercuts the power of these pills; even a day or two has real implications for a treatment meant to clear out an acute infection like COVID-19.\u003c/p>\n\u003ch3>Will it affect a patient’s DNA?\u003c/h3>\n\u003cp>This is really a question only for Merck’s molnupiravir, since it works by sneaking subtly corrupted parts into the coronavirus’s RNA sequence.\u003c/p>\n\u003cp>Once the virus has mutated too much, it can’t work — mission accomplished. But there’s a theoretical chance that molnupiravir could also influence normal human DNA when it replicates, too. If mutations happen during that process, it could spell real trouble.\u003c/p>\n\u003cp>Merck did some tests during molnupiravir’s development to check this possibility out. In two different types of animal studies using higher and longer doses than are given to humans, Merck’s scientists didn’t see any increased risk of unwanted mutations.\u003c/p>\n\u003cp>“We are very confident in the safety profile of molnupiravir based on our preclinical and clinical data,” executive vice president Dean Li told investors in an October conference call, according to a transcript in the financial database Sentieo.\u003c/p>\n\u003cp>But UNC’s Swanstrom isn’t completely convinced that the tests Merck did were sensitive enough. In August, he and his colleagues \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/33961695/\" target=\"_blank\" rel=\"noopener noreferrer\">published a paper in\u003c/a> the Journal of Infectious Diseases showing that a key metabolite of molnupiravir could mutate DNA in animal cells.\u003c/p>\n\u003cp>Given these results, Swanstrom said he would be particularly interested in seeing a long-term study of people who took molnupiravir to continue to monitor this potential effect over the next 10 or 20 years.\u003c/p>\n\u003cp>“This thing is going to go into thousands of people. And are we just going to ignore the fact that there’s this potential risk?” he said. “The risk could be zero. It could be no worse than going to get a dental X-ray — or it could do something more. But unless we find out, you know, we’re going to learn this lesson the hard way, way later than we should.”\u003c/p>\n\u003ch3>What might the new antivirals mean for cancer patients?\u003c/h3>\n\u003cp>Because the new antiviral Pfizer is developing is a protease inhibitor, infectious disease specialists are familiar with how it works. So we already know: These drugs have the potential to interfere with many therapies used to treat cancer, Tobias Hohl, chief of the infectious diseases service at Memorial Sloan Kettering Cancer Center in New York, told STAT.\u003c/p>\n\u003cp>“They’re going to be very helpful [in our] armamentarium, but they will not substitute for prevention or vaccination efforts because these are not medicines that are completely benign and harmless in terms of their drug-drug interactions and toxicity,” he said. “So we’re going to have to be careful and thoughtful about how we use our protease inhibitors.”\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\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>Matthew Herper, Damian Garde, Kate Sheridan, Adam Feuerstein, Andrew Joseph, and Elizabeth Cooney contributed reporting.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1977734/here-are-8-lingering-questions-about-the-new-covid-pills-from-merck-and-pfizer","authors":["byline_science_1977734"],"categories":["science_39","science_3890","science_40","science_4450"],"tags":["science_4329","science_4368","science_4414","science_5181","science_3977"],"featImg":"science_1977738","label":"source_science_1977734"},"science_1977118":{"type":"posts","id":"science_1977118","meta":{"index":"posts_1591205157","site":"science","id":"1977118","score":null,"sort":[1634151482000]},"guestAuthors":[],"slug":"a-primer-on-what-we-know-about-matching-covid-vaccines","title":"Mixing and Matching COVID Vaccines: What We Know","publishDate":1634151482,"format":"standard","headTitle":"Mixing and Matching COVID Vaccines: What We Know | KQED","labelTerm":{},"content":"\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">L\u003c/span>\u003c/span>ater this week an expert committee that advises the Centers for Disease Control and Prevention will hear about the results of a clinical trial that could influence how COVID-19 vaccines are used in this country at some point in the future. The trial, conducted by the National Institute of Allergy and Infectious Diseases, is a so-called mix-and-match trial, testing the vaccines authorized in the U.S. in combinations with each other.\u003c/p>\n\u003cp>The goal of the trial was to see whether using a different vaccine as a booster shot improves protection. So does getting a dose of Pfizer vaccine after getting a single dose of Johnson & Johnson’s vaccine trigger production of more antibodies than a second dose of the J&J would? Are the messenger RNA vaccines made by Pfizer and Moderna virtually interchangeable, or does switching produce a broader set of immune responses?\u003c/p>\n\u003cp>This isn’t theoretical. The booster shot most vaccinated Americans are in the process of getting or booking may not be the last needed. Figuring out how to optimize use of the current generation of COVID-19 vaccines is critical, a number of experts have told STAT.\u003c/p>\n\u003cp>Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy, said we need to realize that many questions remain to be answered about use of these vaccines. We don’t know the optimal dose. We don’t know the most effective interval between doses. We don’t know how many doses we’re going to need and we don’t know whether we would get more durable protection if we mix up the vaccines each person receives, he said.\u003c/p>\n\u003cp>In terms of how we use COVID-19 vaccines, we’re in the very early days, Osterholm said, adding that now that we have effective vaccines, we need to start figuring out how best to use them. “We have to start adopting a public health mindset for decision making,” he said.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>What follows is a primer on what we know about mixing COVID-19 vaccines.\u003c/p>\n\u003ch3>Let’s start with the terminology\u003c/h3>\n\u003cp>If you get a booster jab that is of the same brand as your previous jab or jabs, you are getting a \u003cem>homologous \u003c/em>booster. In the United States, most people who have been vaccinated have had homologous vaccine series and homologous boosters.\u003c/p>\n\u003cp>There may be some exceptions. Earlier in the vaccine rollout, when supplies were scarce, the CDC advised that people could be given a second shot of whatever vaccine was on hand if they were due for their second shot of vaccine and no supplies of the brand they were due to get were available.\u003c/p>\n\u003cp>If your original series of vaccines or the booster were from different manufacturers, you have what’s called a \u003cem>heterologous\u003c/em> vaccine series or a heterologous boost.\u003c/p>\n\u003cp>A few vaccines are actually designed to capture the benefits of heterologous boosting. For instance, Johnson & Johnson’s Ebola vaccine uses two different types of vaccines — one of which is made using a similar design to the company’s COVID-19 vaccine. Likewise, the Sputnik V vaccine is made up of two doses of similar but not identical vaccines, each made using a different adenovirus that has been modified to carry genetic material from the SARS-CoV-2 virus. In both cases, the goal was to ensure that the immune response the first dose generated didn’t prevent the second shot from taking effect.\u003c/p>\n\u003ch3>Necessity is the mother of invention\u003c/h3>\n\u003cp>As mentioned above, most immunized people in the United States were vaccinated with a homologous series of vaccines. But elsewhere heterologous regimens were used for a couple of different reasons.\u003c/p>\n\u003cp>In the early days of the vaccine rollout, some countries opted to use heterologous boosts because they didn’t have adequate supply to be able to give people a matching shot when they were due for their second dose. And after the AstraZeneca vaccine was seen to cause serious clotting problems in some people who received it (a problem later seen with the J&J vaccine too), some countries stopped using it or limited its use to older adults, for whom the risk of a clotting event after vaccination appeared to be lower. Younger adults were offered one of the mRNA vaccines as their second dose instead.\u003c/p>\n\u003cp>Kathryn Edwards, a vaccines researcher at Vanderbilt University, suggested the United States should probably look at whether specific brands of booster doses should be targeted at certain populations — or more specifically, if certain people should be steered away from certain vaccines when it comes time for them to get boosters. With concerns about myocarditis in young males associated with mRNA vaccines and clotting problems reported mainly with younger women who got one of the viral vectored vaccines, such as the J&J, maybe it’s time to think about who gets which type of COVID-19 vaccine, Edwards said.\u003c/p>\n\u003ch3>A natural experiment turns into a border barrier\u003c/h3>\n\u003cp>Countries like the United Kingdom, Canada, France, and Germany that used heterologous vaccine approaches have created a travel conundrum for their citizens.\u003c/p>\n\u003cp>A number of countries — the United States among them — do not consider people who received two different brands of vaccines fully vaccinated, even if the person’s home country does. This means someone who got an mRNA vaccine as a second dose after receiving an AstraZeneca shot as a priming dose is not deemed fully vaccinated and is not eligible to travel to the U.S. or other countries with the same rule.\u003c/p>\n\u003cp>Canada has roughly 4 million people who were vaccinated on a heterologous schedule. The U.S. and its northern neighbor share the world’s longest border and in pre-Covid times, travel across it was brisk. Now many Canadians are in limbo, unsure if or when they will be allowed to cross into the U.S.\u003c/p>\n\u003cp>Figuring out how to deal with a range of vaccines used in a variety of ways around the world is going to be a challenge that the Biden administration and other governments will have to grapple with as international travel increases.\u003c/p>\n\u003ch3>All combos may not be created equal\u003c/h3>\n\u003cp>Is it possible that any combination of vaccine types or brands will work as well — or better — than if the shots were all of a single brand? That’s not yet clear, but it’s possible — even likely — that the combinations and the order in which the vaccines are given will matter.\u003c/p>\n\u003cp>“A followed by B may not be the same as B followed by A,” explained Bruce Gellin, chief of global public health strategy for the Rockefeller Foundation’s pandemic prevention institute.\u003c/p>\n\u003cp>A number of small studies done in Europe have shown that following up AstraZeneca’s adenovirus-vectored vaccine with a Pfizer or a \u003ca href=\"https://www.nejm.org/doi/10.1056/NEJMc2110716\" target=\"_blank\" rel=\"noopener noreferrer\">Moderna\u003c/a> mRNA booster elicits a greater immune response than what is seen from two doses of the AstraZeneca alone. But an ongoing research effort at Britain’s University of Oxford comparing COVID-19 vaccine combinations called the Com-CoV trials suggests that the inverse may not be true.\u003c/p>\n\u003cp>Scientists conducting the original \u003ca href=\"https://www.thelancet.com/action/showPdf?pii=S0140-6736%2821%2901694-9\" target=\"_blank\" rel=\"noopener noreferrer\">Com-CoV trial\u003c/a> gave volunteers two doses apiece of either AstraZeneca or Pfizer, comparing the antibody levels those regimens elicited to AstraZeneca followed by Pfizer or Pfizer followed by AstraZeneca. Pfizer after AstraZeneca generated higher antibody levels than two doses of AstraZeneca alone; but AstraZeneca after Pfizer was not better than two doses of Pfizer.\u003c/p>\n\u003cp>“The priming event is really important,” said \u003ca href=\"https://www.statnews.com/2021/09/13/barney-graham-leaves-nih-vaccine-research-center/\">Barney Graham\u003c/a>, who was deputy director of the National Institutes of Health’s Vaccine Research Center until the end of August and who played a critical role in the design of the Moderna and other vaccine prototypes.\u003c/p>\n\u003cp>Graham explained that the kind of immune response one gets from COVID-19 vaccines is determined by the first dose. “And so it kind of locks you into a repertoire and a pattern of antibody, T-cell balances that carry on through subsequent boosters,” he said.\u003c/p>\n\u003cp>Much remains to be learned about how to effectively mix COVID-19 vaccines — and it will take time to answer these questions, Graham said. “Those are the kind of things that happen over a 12-year development program. We didn’t do that this time.”\u003c/p>\n\u003ch3>Mixed vaccines carry a punch\u003c/h3>\n\u003cp>In general, COVID-19 vaccines are what’s known as reactogenic; they can carry a wallop. Fevers, sore arms, fatigue, and malaise — a lot of people report feeling kind of crappy in the hours or even day or two after getting a shot.\u003c/p>\n\u003cp>Complaints about reactogenicity were even greater among people who got mixed vaccine brands, the \u003ca href=\"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01115-6/fulltext\" target=\"_blank\" rel=\"noopener noreferrer\">Com-CoV trial\u003c/a> reported. So, potentially more post-vaccination side effects, but nothing unmanageable. “It is reassuring that all reactogenicity symptoms were short lived,” the Com-CoV researchers said in a short study published in late May in The Lancet.\u003c/p>\n\u003ch3>The challenge ahead\u003c/h3>\n\u003cp>If evidence continues to amass suggesting that mixing vaccine brands would be of benefit, how do those data get translated into public policy? That won’t be easy, experts warn.\u003c/p>\n\u003cp>Typically, regulators like the Food and Drug Administration act on requests from companies. They review data provided by a manufacturer and decide yes, this vaccine or drug can be given to these people or no, it should not be.\u003c/p>\n\u003cp>But when you are talking about a plan that involves combining products from two different companies, things become much more complex. None of these companies have asked to have a rival’s vaccine used as a booster for their COVID-19 shot — and they’re not likely to.\u003c/p>\n\u003cp>“Normally the manufacturer puts in an application to do something,” said Glen Nowak, director of the Center for Health and Risk Communication at Grady College of Journalism and Mass Communication. “Who then has that responsibility to bring forward a recommendation to mix and match? I think it’s a very good question.”\u003c/p>\n\u003cp>The CDC could address the issue, said Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s Office of Vaccines. Its advisory panel, ACIP, could evaluate the data and, if it supports using heterologous boosts, recommend that this is the way the vaccines could be used. Such advice could take the form of what is known as preferential recommendations — effectively not saying that vaccine B must be used after vaccine A, but noting it would be advisable to do so.\u003c/p>\n\u003cp>Could that happen? Possibly. But if it does happen, it will likely affect the way COVID-19 vaccines are used in the future — in people who haven’t yet started to be vaccinated, or if and when people in the country need a fourth dose of vaccine. Because by the time there are enough data to move forward with this type of policy, most Americans who are currently due for a booster jab will likely have had one.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003ci data-stringify-type=\"italic\">This story was originally published by \u003c/i>\u003ci data-stringify-type=\"italic\">\u003ca class=\"c-link\" href=\"https://www.statnews.com/2021/10/12/a-primer-on-what-we-know-about-mixing-and-matching-covid-vaccines/?utm_content=bufferd53a2&utm_medium=social&utm_source=facebook&utm_campaign=facebook_organic\" target=\"_blank\" rel=\"noopener noreferrer\" data-stringify-link=\"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/\" data-sk=\"tooltip_parent\" data-remove-tab-index=\"true\">STAT\u003c/a>\u003c/i>\u003ci data-stringify-type=\"italic\">, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/i>\u003c/p>\n\n","blocks":[],"excerpt":"An expert committee advising the CDC will examine results of a so-called mix-and-match trial, testing COVID-19 vaccines in combination. ","status":"publish","parent":0,"modified":1704846405,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":35,"wordCount":1914},"headData":{"title":"Mixing and Matching COVID Vaccines: What We Know | KQED","description":"Later this week an expert committee that advises the Centers for Disease Control and Prevention will hear about the results of a clinical trial that could influence how Covid vaccines are used in this country at some point in the future. The trial, conducted by the National Institute of Allergy and Infectious Diseases, is a so-called mix-and-match trial, testing the Covid vaccines authorized in the U.S. in combinations with each other.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","socialDescription":"Later this week an expert committee that advises the Centers for Disease Control and Prevention will hear about the results of a clinical trial that could influence how Covid vaccines are used in this country at some point in the future. The trial, conducted by the National Institute of Allergy and Infectious Diseases, is a so-called mix-and-match trial, testing the Covid vaccines authorized in the U.S. in combinations with each other.","schema":{"@context":"http://schema.org","@type":"Article","headline":"Mixing and Matching COVID Vaccines: What We Know","datePublished":"2021-10-13T18:58:02.000Z","dateModified":"2024-01-10T00:26:45.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"STAT","sticky":false,"nprByline":"Helen Branswell \u003cbr />STAT\u003cbr>","path":"/science/1977118/a-primer-on-what-we-know-about-matching-covid-vaccines","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">L\u003c/span>\u003c/span>ater this week an expert committee that advises the Centers for Disease Control and Prevention will hear about the results of a clinical trial that could influence how COVID-19 vaccines are used in this country at some point in the future. The trial, conducted by the National Institute of Allergy and Infectious Diseases, is a so-called mix-and-match trial, testing the vaccines authorized in the U.S. in combinations with each other.\u003c/p>\n\u003cp>The goal of the trial was to see whether using a different vaccine as a booster shot improves protection. So does getting a dose of Pfizer vaccine after getting a single dose of Johnson & Johnson’s vaccine trigger production of more antibodies than a second dose of the J&J would? Are the messenger RNA vaccines made by Pfizer and Moderna virtually interchangeable, or does switching produce a broader set of immune responses?\u003c/p>\n\u003cp>This isn’t theoretical. The booster shot most vaccinated Americans are in the process of getting or booking may not be the last needed. Figuring out how to optimize use of the current generation of COVID-19 vaccines is critical, a number of experts have told STAT.\u003c/p>\n\u003cp>Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy, said we need to realize that many questions remain to be answered about use of these vaccines. We don’t know the optimal dose. We don’t know the most effective interval between doses. We don’t know how many doses we’re going to need and we don’t know whether we would get more durable protection if we mix up the vaccines each person receives, he said.\u003c/p>\n\u003cp>In terms of how we use COVID-19 vaccines, we’re in the very early days, Osterholm said, adding that now that we have effective vaccines, we need to start figuring out how best to use them. “We have to start adopting a public health mindset for decision making,” he said.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>What follows is a primer on what we know about mixing COVID-19 vaccines.\u003c/p>\n\u003ch3>Let’s start with the terminology\u003c/h3>\n\u003cp>If you get a booster jab that is of the same brand as your previous jab or jabs, you are getting a \u003cem>homologous \u003c/em>booster. In the United States, most people who have been vaccinated have had homologous vaccine series and homologous boosters.\u003c/p>\n\u003cp>There may be some exceptions. Earlier in the vaccine rollout, when supplies were scarce, the CDC advised that people could be given a second shot of whatever vaccine was on hand if they were due for their second shot of vaccine and no supplies of the brand they were due to get were available.\u003c/p>\n\u003cp>If your original series of vaccines or the booster were from different manufacturers, you have what’s called a \u003cem>heterologous\u003c/em> vaccine series or a heterologous boost.\u003c/p>\n\u003cp>A few vaccines are actually designed to capture the benefits of heterologous boosting. For instance, Johnson & Johnson’s Ebola vaccine uses two different types of vaccines — one of which is made using a similar design to the company’s COVID-19 vaccine. Likewise, the Sputnik V vaccine is made up of two doses of similar but not identical vaccines, each made using a different adenovirus that has been modified to carry genetic material from the SARS-CoV-2 virus. In both cases, the goal was to ensure that the immune response the first dose generated didn’t prevent the second shot from taking effect.\u003c/p>\n\u003ch3>Necessity is the mother of invention\u003c/h3>\n\u003cp>As mentioned above, most immunized people in the United States were vaccinated with a homologous series of vaccines. But elsewhere heterologous regimens were used for a couple of different reasons.\u003c/p>\n\u003cp>In the early days of the vaccine rollout, some countries opted to use heterologous boosts because they didn’t have adequate supply to be able to give people a matching shot when they were due for their second dose. And after the AstraZeneca vaccine was seen to cause serious clotting problems in some people who received it (a problem later seen with the J&J vaccine too), some countries stopped using it or limited its use to older adults, for whom the risk of a clotting event after vaccination appeared to be lower. Younger adults were offered one of the mRNA vaccines as their second dose instead.\u003c/p>\n\u003cp>Kathryn Edwards, a vaccines researcher at Vanderbilt University, suggested the United States should probably look at whether specific brands of booster doses should be targeted at certain populations — or more specifically, if certain people should be steered away from certain vaccines when it comes time for them to get boosters. With concerns about myocarditis in young males associated with mRNA vaccines and clotting problems reported mainly with younger women who got one of the viral vectored vaccines, such as the J&J, maybe it’s time to think about who gets which type of COVID-19 vaccine, Edwards said.\u003c/p>\n\u003ch3>A natural experiment turns into a border barrier\u003c/h3>\n\u003cp>Countries like the United Kingdom, Canada, France, and Germany that used heterologous vaccine approaches have created a travel conundrum for their citizens.\u003c/p>\n\u003cp>A number of countries — the United States among them — do not consider people who received two different brands of vaccines fully vaccinated, even if the person’s home country does. This means someone who got an mRNA vaccine as a second dose after receiving an AstraZeneca shot as a priming dose is not deemed fully vaccinated and is not eligible to travel to the U.S. or other countries with the same rule.\u003c/p>\n\u003cp>Canada has roughly 4 million people who were vaccinated on a heterologous schedule. The U.S. and its northern neighbor share the world’s longest border and in pre-Covid times, travel across it was brisk. Now many Canadians are in limbo, unsure if or when they will be allowed to cross into the U.S.\u003c/p>\n\u003cp>Figuring out how to deal with a range of vaccines used in a variety of ways around the world is going to be a challenge that the Biden administration and other governments will have to grapple with as international travel increases.\u003c/p>\n\u003ch3>All combos may not be created equal\u003c/h3>\n\u003cp>Is it possible that any combination of vaccine types or brands will work as well — or better — than if the shots were all of a single brand? That’s not yet clear, but it’s possible — even likely — that the combinations and the order in which the vaccines are given will matter.\u003c/p>\n\u003cp>“A followed by B may not be the same as B followed by A,” explained Bruce Gellin, chief of global public health strategy for the Rockefeller Foundation’s pandemic prevention institute.\u003c/p>\n\u003cp>A number of small studies done in Europe have shown that following up AstraZeneca’s adenovirus-vectored vaccine with a Pfizer or a \u003ca href=\"https://www.nejm.org/doi/10.1056/NEJMc2110716\" target=\"_blank\" rel=\"noopener noreferrer\">Moderna\u003c/a> mRNA booster elicits a greater immune response than what is seen from two doses of the AstraZeneca alone. But an ongoing research effort at Britain’s University of Oxford comparing COVID-19 vaccine combinations called the Com-CoV trials suggests that the inverse may not be true.\u003c/p>\n\u003cp>Scientists conducting the original \u003ca href=\"https://www.thelancet.com/action/showPdf?pii=S0140-6736%2821%2901694-9\" target=\"_blank\" rel=\"noopener noreferrer\">Com-CoV trial\u003c/a> gave volunteers two doses apiece of either AstraZeneca or Pfizer, comparing the antibody levels those regimens elicited to AstraZeneca followed by Pfizer or Pfizer followed by AstraZeneca. Pfizer after AstraZeneca generated higher antibody levels than two doses of AstraZeneca alone; but AstraZeneca after Pfizer was not better than two doses of Pfizer.\u003c/p>\n\u003cp>“The priming event is really important,” said \u003ca href=\"https://www.statnews.com/2021/09/13/barney-graham-leaves-nih-vaccine-research-center/\">Barney Graham\u003c/a>, who was deputy director of the National Institutes of Health’s Vaccine Research Center until the end of August and who played a critical role in the design of the Moderna and other vaccine prototypes.\u003c/p>\n\u003cp>Graham explained that the kind of immune response one gets from COVID-19 vaccines is determined by the first dose. “And so it kind of locks you into a repertoire and a pattern of antibody, T-cell balances that carry on through subsequent boosters,” he said.\u003c/p>\n\u003cp>Much remains to be learned about how to effectively mix COVID-19 vaccines — and it will take time to answer these questions, Graham said. “Those are the kind of things that happen over a 12-year development program. We didn’t do that this time.”\u003c/p>\n\u003ch3>Mixed vaccines carry a punch\u003c/h3>\n\u003cp>In general, COVID-19 vaccines are what’s known as reactogenic; they can carry a wallop. Fevers, sore arms, fatigue, and malaise — a lot of people report feeling kind of crappy in the hours or even day or two after getting a shot.\u003c/p>\n\u003cp>Complaints about reactogenicity were even greater among people who got mixed vaccine brands, the \u003ca href=\"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01115-6/fulltext\" target=\"_blank\" rel=\"noopener noreferrer\">Com-CoV trial\u003c/a> reported. So, potentially more post-vaccination side effects, but nothing unmanageable. “It is reassuring that all reactogenicity symptoms were short lived,” the Com-CoV researchers said in a short study published in late May in The Lancet.\u003c/p>\n\u003ch3>The challenge ahead\u003c/h3>\n\u003cp>If evidence continues to amass suggesting that mixing vaccine brands would be of benefit, how do those data get translated into public policy? That won’t be easy, experts warn.\u003c/p>\n\u003cp>Typically, regulators like the Food and Drug Administration act on requests from companies. They review data provided by a manufacturer and decide yes, this vaccine or drug can be given to these people or no, it should not be.\u003c/p>\n\u003cp>But when you are talking about a plan that involves combining products from two different companies, things become much more complex. None of these companies have asked to have a rival’s vaccine used as a booster for their COVID-19 shot — and they’re not likely to.\u003c/p>\n\u003cp>“Normally the manufacturer puts in an application to do something,” said Glen Nowak, director of the Center for Health and Risk Communication at Grady College of Journalism and Mass Communication. “Who then has that responsibility to bring forward a recommendation to mix and match? I think it’s a very good question.”\u003c/p>\n\u003cp>The CDC could address the issue, said Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s Office of Vaccines. Its advisory panel, ACIP, could evaluate the data and, if it supports using heterologous boosts, recommend that this is the way the vaccines could be used. Such advice could take the form of what is known as preferential recommendations — effectively not saying that vaccine B must be used after vaccine A, but noting it would be advisable to do so.\u003c/p>\n\u003cp>Could that happen? Possibly. But if it does happen, it will likely affect the way COVID-19 vaccines are used in the future — in people who haven’t yet started to be vaccinated, or if and when people in the country need a fourth dose of vaccine. Because by the time there are enough data to move forward with this type of policy, most Americans who are currently due for a booster jab will likely have had one.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003ci data-stringify-type=\"italic\">This story was originally published by \u003c/i>\u003ci data-stringify-type=\"italic\">\u003ca class=\"c-link\" href=\"https://www.statnews.com/2021/10/12/a-primer-on-what-we-know-about-mixing-and-matching-covid-vaccines/?utm_content=bufferd53a2&utm_medium=social&utm_source=facebook&utm_campaign=facebook_organic\" target=\"_blank\" rel=\"noopener noreferrer\" data-stringify-link=\"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/\" data-sk=\"tooltip_parent\" data-remove-tab-index=\"true\">STAT\u003c/a>\u003c/i>\u003ci data-stringify-type=\"italic\">, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/i>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1977118/a-primer-on-what-we-know-about-matching-covid-vaccines","authors":["byline_science_1977118"],"categories":["science_39","science_40","science_4450"],"tags":["science_4329","science_4368","science_3977"],"featImg":"science_1977119","label":"source_science_1977118"},"science_1977100":{"type":"posts","id":"science_1977100","meta":{"index":"posts_1591205157","site":"science","id":"1977100","score":null,"sort":[1634054423000]},"guestAuthors":[],"slug":"mercks-new-covid-19-pill-what-we-know","title":"Merck's New COVID-19 Pill: What We Know","publishDate":1634054423,"format":"standard","headTitle":"Merck’s New COVID-19 Pill: What We Know | KQED","labelTerm":{},"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","blocks":[],"excerpt":"The drugmaker asked U.S. regulators Monday to authorize its pill against COVID-19. ","status":"publish","parent":0,"modified":1704846407,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":32,"wordCount":1601},"headData":{"title":"Merck's New COVID-19 Pill: What We Know | KQED","description":"The drugmaker asked U.S. regulators Monday to authorize its pill against COVID-19. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Merck's New COVID-19 Pill: What We Know","datePublished":"2021-10-12T16:00:23.000Z","dateModified":"2024-01-10T00:26:47.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"STAT","sticky":false,"nprByline":"Matthew Herper \u003cbr />STAT\u003cbr>","path":"/science/1977100/mercks-new-covid-19-pill-what-we-know","audioTrackLength":null,"parsedContent":[{"type":"contentString","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>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","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>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","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>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1977100/mercks-new-covid-19-pill-what-we-know","authors":["byline_science_1977100"],"categories":["science_3890","science_40","science_4450"],"tags":["science_4329","science_4368","science_4414","science_3977"],"featImg":"science_1977102","label":"source_science_1977100"},"science_1976827":{"type":"posts","id":"science_1976827","meta":{"index":"posts_1591205157","site":"science","id":"1976827","score":null,"sort":[1632162092000]},"guestAuthors":[],"slug":"covid-vaccine-safe-and-effective-for-kids-5-to-11-pfizer-says","title":"COVID Vaccine Safe and Effective for Kids 5 to 11, Pfizer Says","publishDate":1632162092,"format":"standard","headTitle":"COVID Vaccine Safe and Effective for Kids 5 to 11, Pfizer Says | KQED","labelTerm":{},"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","blocks":[],"excerpt":"Pfizer and BioNTech say that early trial results show their vaccine established a strong antibody response against the coronavirus. FDA review is still needed.","status":"publish","parent":0,"modified":1704846430,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":13,"wordCount":489},"headData":{"title":"COVID Vaccine Safe and Effective for Kids 5 to 11, Pfizer Says | KQED","description":"Pfizer and BioNTech say that early trial results show their vaccine established a strong antibody response against the coronavirus. FDA review is still needed.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"COVID Vaccine Safe and Effective for Kids 5 to 11, Pfizer Says","datePublished":"2021-09-20T18:21:32.000Z","dateModified":"2024-01-10T00:27:10.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"NPR","sticky":false,"nprImageCredit":"Matt Rourke","nprByline":"Jaclyn Diaz \u003cbr />NPR\u003cbr>","nprImageAgency":"AP","nprStoryId":"1038832951","nprApiLink":"http://api.npr.org/query?id=1038832951&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/coronavirus-live-updates/2021/09/20/1038832951/pfizer-and-biontech-vaccine-trials-for-kids-show-the-shots-are-safe-and-effectiv?ft=nprml&f=1038832951","nprRetrievedStory":"1","nprPubDate":"Mon, 20 Sep 2021 10:51:00 -0400","nprStoryDate":"Mon, 20 Sep 2021 06:57:05 -0400","nprLastModifiedDate":"Mon, 20 Sep 2021 10:51:38 -0400","path":"/science/1976827/covid-vaccine-safe-and-effective-for-kids-5-to-11-pfizer-says","audioTrackLength":null,"parsedContent":[{"type":"contentString","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>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","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>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1976827/covid-vaccine-safe-and-effective-for-kids-5-to-11-pfizer-says","authors":["byline_science_1976827"],"categories":["science_39","science_3890","science_40","science_4450"],"tags":["science_4329","science_4368","science_4414","science_2936"],"featImg":"science_1976828","label":"source_science_1976827"},"science_1976811":{"type":"posts","id":"science_1976811","meta":{"index":"posts_1591205157","site":"science","id":"1976811","score":null,"sort":[1631732173000]},"guestAuthors":[],"slug":"why-some-fda-scientists-are-arguing-against-covid-boosters","title":"Why Some FDA Scientists Are Arguing Against COVID Boosters","publishDate":1631732173,"format":"standard","headTitle":"Why Some FDA Scientists Are Arguing Against COVID Boosters | KQED","labelTerm":{},"content":"\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">F\u003c/span>\u003c/span>ood and Drug Administration scientists have expressed skepticism about the need for additional doses of Pfizer’s COVID-19 vaccine for all people who have received it.\u003c/p>\n\u003cp>The assessment by the agency’s staff, included in \u003ca href=\"https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement\" target=\"_blank\" rel=\"noopener noreferrer\">documents released Wednesday\u003c/a>, sets up a high-stakes debate over who will need an additional booster dose — and when they will need it — at the meeting of experts being convened by the Food and Drug Administration on Friday.\u003c/p>\n\u003cp>In the documents, the FDA’s own scientists seemed to strike a skeptical position about the need for widespread booster shots. Overall, they said, “data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.”\u003c/p>\n\u003cp>Other data released Wednesday, both in briefing documents for the Friday panel and by other researchers, add to the swirling debate over a question that will affect millions of people who have been vaccinated against COVID-19 around the world: If the effectiveness of the vaccine wanes, do people need to top it off with an additional dose? If so, when should that happen given that much of the world has not received a first dose of vaccine yet? And should that decision vary by age and by whether people have other health conditions that could make Covid worse if they do become infected with the SARS-CoV-2 virus?\u003c/p>\n\u003cp>On one side are drug companies and some researchers, who point to data showing the efficacy of the vaccines to protect all infections is waning and that a third shot will provide additional protection. On the other are those who point out that these vaccines are still keeping people out of the hospital and preventing them from dying, indicating that a booster is not needed yet.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The advice of the FDA’s advisory panel on the matter will not be binding, but the agency is likely to consider it. If the FDA authorizes a booster dose, the decision on whether to give them broadly will be taken up by a separate advisory committee convened by the Centers for Disease Control and Prevention. There has been no date set yet for a meeting of that group, the Advisory Committee on Immunization Practices.\u003c/p>\n\u003cp>Still, any decision by the FDA that limits the approval for booster shots, or even expresses hesitancy about how they should be used, will be seen as a rebuke to the Biden administration, which in August took the unusual step of unveiling a plan to offer boosters to the U.S. population, ahead of decisions from the FDA and the CDC.\u003c/p>\n\u003cp>Among those who have challenged the need for boosters at this point are two senior FDA officials who recently announced \u003ca href=\"https://www.statnews.com/2021/08/31/top-vaccine-officials-leave-fda/\" target=\"_blank\" rel=\"noopener noreferrer\">they will retire\u003c/a> from the agency this fall, a move seen to be motivated by their disagreement with the administration on the booster question. Marion Gruber and Phil Krause, director and deputy director, respectively, of FDA’s Office of Vaccines Research and Review, were also co-authors of a \u003ca href=\"https://www.statnews.com/2021/09/13/international-review-argues-against-covid-19-vaccine-boosters/\" target=\"_blank\" rel=\"noopener noreferrer\">paper published Monday\u003c/a> in The Lancet that argued against the need for booster shots for the general public at this time.\u003c/p>\n\u003cp>In the briefing documents made available Wednesday, Pfizer argued that the effectiveness of its vaccine is declining and that a third dose would return efficacy to the 95% level seen in clinical trials.\u003c/p>\n\u003cp>Recent data from Israel showed the efficacy of the vaccine against infection with SARS-CoV-2 dropped from 95% in January to 39% in June. In an analysis of Pfizer’s own Phase 3 trial, which resulted in the vaccine’s approval, the incidence of breakthrough cases was higher among patients who received their second dose before December 2020 than in those who received their second dose after March.\u003c/p>\n\u003cp>The company also released new data from a study conducted by Kaiser Permanente in Southern California that showed the waning efficacy is likely due to the vaccine becoming less effective over time, not because the new Delta variant is more resistant to the vaccine.\u003c/p>\n\u003cp>In the Kaiser data, the efficacy of the vaccine at preventing SARS-CoV-2 infection with the Delta variant dropped from 93% for those vaccinated less than one month to 53% for those vaccinated more than four months ago. For other variants, this drop was from 97% to 67%. At this point, about 88% of SARS-2 viruses detected globally are from the Delta family.\u003c/p>\n\u003cp>However, the vaccine still did a very good job preventing hospitalizations in this dataset, reducing hospitalization by 93% in cases infected with the Delta variant.\u003c/p>\n\u003cp>“It should be recognized that while observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability,” FDA scientists state in their report. “Due to these biases some studies may be more reliable than others. Furthermore, US-based studies of post- authorization effectiveness of [the vaccine] may most accurately represent vaccine effectiveness in the US population.”\u003c/p>\n\u003cp>The FDA documents assessed questions about the \u003ca href=\"https://www.statnews.com/2021/09/07/how-risk-side-effects-could-change-covid-19-vaccine-boosters/\" target=\"_blank\" rel=\"noopener noreferrer\">safety of giving a third dose of the vaccine\u003c/a>, noting that for some issues, there are no answers. For instance, it is not known if a third dose would trigger elevated rates of myocarditis and pericarditis, a side effect seen mainly in males under the age of 40.\u003c/p>\n\u003cp>“It is currently not known if there will be an increased risk of myocarditis/pericarditis or other adverse reactions after a booster dose of Comirnaty. These risks and associated uncertainties have to be considered when assessing benefit and risk,” the agency’s scientists wrote. Comirnaty is the brand name of Pfizer’s vaccine.\u003c/p>\n\u003cp>Meanwhile, an \u003ca href=\"https://khub.net/documents/135939561/338928724/Vaccine+effectiveness+and+duration+of+protection+of+covid+vaccines+against+mild+and+severe+COVID-19+in+the+UK.pdf/10dcd99c-0441-0403-dfd8-11ba2c6f5801\" target=\"_blank\" rel=\"noopener noreferrer\">analysis of vaccine efficacy from the United Kingdom\u003c/a> — the first country to begin vaccination with the vaccines developed in the West — gives further ammunition to those who have argued that booster shots for all are not warranted at this time.\u003c/p>\n\u003cp>The analysis from Public Health England, which has not yet been peer-reviewed, found protection against hospitalization and deaths remains high for the Pfizer jab, even among older adults who are healthy.\u003c/p>\n\u003cp>“Given the sustained high [vaccine efficacy] against hospitalization and death, the additional benefit of a third dose against these more serious outcomes is limited in the current epidemiological situation,” the authors of the British study concluded. They added that vaccine efficacy “may, however, continue to wane over time and it is likely that booster doses may have a bigger impact on the more severe outcomes with longer intervals between the second and third doses.”\u003c/p>\n\u003cp>The most significant waning of protection is occurring in people aged 65 and older who have significant health issues, the paper said. It is based on a comparison of the vaccination status of nearly 1.5 million people who tested positive for Covid-19 to nearly 3.3 million people who tested negative for the virus.\u003c/p>\n\u003cp>“We found that waning was greatest among individuals in clinical risk groups, suggesting that this group should be prioritized for boosters, whenever they are recommended,” the authors said.\u003c/p>\n\u003cp>Despite the findings, Britain’s Joint Committee on Vaccination and Immunization recommended Wednesday that everyone who was at the front of the line when the country began its vaccine rollout last December should receive a booster shot, once six months had passed since their second jab.\u003c/p>\n\u003cp>Those listed as being at the head of the priority list for boosters in the U.K. are those living in long-term care facilities, adults 50 years of age and older, front-line health care workers and social workers, people 16 to 49 years old with underlying health conditions that put them at high risk of developing severe disease if they contract the virus, and adults who live with immunocompromised people.\u003c/p>\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\u003caside class=\"read-more standard\">\u003c/aside>\n\n","blocks":[],"excerpt":"FDA scientists strike a skeptical tone on the need for a COVID-19 vaccine booster at this time, likely fueling debate.","status":"publish","parent":0,"modified":1704846432,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":26,"wordCount":1347},"headData":{"title":"Why Some FDA Scientists Are Arguing Against COVID Boosters | KQED","description":"FDA scientists strike a skeptical tone on the need for a COVID-19 vaccine booster at this time, likely fueling debate.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Why Some FDA Scientists Are Arguing Against COVID Boosters","datePublished":"2021-09-15T18:56:13.000Z","dateModified":"2024-01-10T00:27:12.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"STAT","sticky":false,"nprByline":"Matthew Herper and Helen Branswell \u003cbr />STAT\u003cbr>","path":"/science/1976811/why-some-fda-scientists-are-arguing-against-covid-boosters","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">F\u003c/span>\u003c/span>ood and Drug Administration scientists have expressed skepticism about the need for additional doses of Pfizer’s COVID-19 vaccine for all people who have received it.\u003c/p>\n\u003cp>The assessment by the agency’s staff, included in \u003ca href=\"https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement\" target=\"_blank\" rel=\"noopener noreferrer\">documents released Wednesday\u003c/a>, sets up a high-stakes debate over who will need an additional booster dose — and when they will need it — at the meeting of experts being convened by the Food and Drug Administration on Friday.\u003c/p>\n\u003cp>In the documents, the FDA’s own scientists seemed to strike a skeptical position about the need for widespread booster shots. Overall, they said, “data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.”\u003c/p>\n\u003cp>Other data released Wednesday, both in briefing documents for the Friday panel and by other researchers, add to the swirling debate over a question that will affect millions of people who have been vaccinated against COVID-19 around the world: If the effectiveness of the vaccine wanes, do people need to top it off with an additional dose? If so, when should that happen given that much of the world has not received a first dose of vaccine yet? And should that decision vary by age and by whether people have other health conditions that could make Covid worse if they do become infected with the SARS-CoV-2 virus?\u003c/p>\n\u003cp>On one side are drug companies and some researchers, who point to data showing the efficacy of the vaccines to protect all infections is waning and that a third shot will provide additional protection. On the other are those who point out that these vaccines are still keeping people out of the hospital and preventing them from dying, indicating that a booster is not needed yet.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The advice of the FDA’s advisory panel on the matter will not be binding, but the agency is likely to consider it. If the FDA authorizes a booster dose, the decision on whether to give them broadly will be taken up by a separate advisory committee convened by the Centers for Disease Control and Prevention. There has been no date set yet for a meeting of that group, the Advisory Committee on Immunization Practices.\u003c/p>\n\u003cp>Still, any decision by the FDA that limits the approval for booster shots, or even expresses hesitancy about how they should be used, will be seen as a rebuke to the Biden administration, which in August took the unusual step of unveiling a plan to offer boosters to the U.S. population, ahead of decisions from the FDA and the CDC.\u003c/p>\n\u003cp>Among those who have challenged the need for boosters at this point are two senior FDA officials who recently announced \u003ca href=\"https://www.statnews.com/2021/08/31/top-vaccine-officials-leave-fda/\" target=\"_blank\" rel=\"noopener noreferrer\">they will retire\u003c/a> from the agency this fall, a move seen to be motivated by their disagreement with the administration on the booster question. Marion Gruber and Phil Krause, director and deputy director, respectively, of FDA’s Office of Vaccines Research and Review, were also co-authors of a \u003ca href=\"https://www.statnews.com/2021/09/13/international-review-argues-against-covid-19-vaccine-boosters/\" target=\"_blank\" rel=\"noopener noreferrer\">paper published Monday\u003c/a> in The Lancet that argued against the need for booster shots for the general public at this time.\u003c/p>\n\u003cp>In the briefing documents made available Wednesday, Pfizer argued that the effectiveness of its vaccine is declining and that a third dose would return efficacy to the 95% level seen in clinical trials.\u003c/p>\n\u003cp>Recent data from Israel showed the efficacy of the vaccine against infection with SARS-CoV-2 dropped from 95% in January to 39% in June. In an analysis of Pfizer’s own Phase 3 trial, which resulted in the vaccine’s approval, the incidence of breakthrough cases was higher among patients who received their second dose before December 2020 than in those who received their second dose after March.\u003c/p>\n\u003cp>The company also released new data from a study conducted by Kaiser Permanente in Southern California that showed the waning efficacy is likely due to the vaccine becoming less effective over time, not because the new Delta variant is more resistant to the vaccine.\u003c/p>\n\u003cp>In the Kaiser data, the efficacy of the vaccine at preventing SARS-CoV-2 infection with the Delta variant dropped from 93% for those vaccinated less than one month to 53% for those vaccinated more than four months ago. For other variants, this drop was from 97% to 67%. At this point, about 88% of SARS-2 viruses detected globally are from the Delta family.\u003c/p>\n\u003cp>However, the vaccine still did a very good job preventing hospitalizations in this dataset, reducing hospitalization by 93% in cases infected with the Delta variant.\u003c/p>\n\u003cp>“It should be recognized that while observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability,” FDA scientists state in their report. “Due to these biases some studies may be more reliable than others. Furthermore, US-based studies of post- authorization effectiveness of [the vaccine] may most accurately represent vaccine effectiveness in the US population.”\u003c/p>\n\u003cp>The FDA documents assessed questions about the \u003ca href=\"https://www.statnews.com/2021/09/07/how-risk-side-effects-could-change-covid-19-vaccine-boosters/\" target=\"_blank\" rel=\"noopener noreferrer\">safety of giving a third dose of the vaccine\u003c/a>, noting that for some issues, there are no answers. For instance, it is not known if a third dose would trigger elevated rates of myocarditis and pericarditis, a side effect seen mainly in males under the age of 40.\u003c/p>\n\u003cp>“It is currently not known if there will be an increased risk of myocarditis/pericarditis or other adverse reactions after a booster dose of Comirnaty. These risks and associated uncertainties have to be considered when assessing benefit and risk,” the agency’s scientists wrote. Comirnaty is the brand name of Pfizer’s vaccine.\u003c/p>\n\u003cp>Meanwhile, an \u003ca href=\"https://khub.net/documents/135939561/338928724/Vaccine+effectiveness+and+duration+of+protection+of+covid+vaccines+against+mild+and+severe+COVID-19+in+the+UK.pdf/10dcd99c-0441-0403-dfd8-11ba2c6f5801\" target=\"_blank\" rel=\"noopener noreferrer\">analysis of vaccine efficacy from the United Kingdom\u003c/a> — the first country to begin vaccination with the vaccines developed in the West — gives further ammunition to those who have argued that booster shots for all are not warranted at this time.\u003c/p>\n\u003cp>The analysis from Public Health England, which has not yet been peer-reviewed, found protection against hospitalization and deaths remains high for the Pfizer jab, even among older adults who are healthy.\u003c/p>\n\u003cp>“Given the sustained high [vaccine efficacy] against hospitalization and death, the additional benefit of a third dose against these more serious outcomes is limited in the current epidemiological situation,” the authors of the British study concluded. They added that vaccine efficacy “may, however, continue to wane over time and it is likely that booster doses may have a bigger impact on the more severe outcomes with longer intervals between the second and third doses.”\u003c/p>\n\u003cp>The most significant waning of protection is occurring in people aged 65 and older who have significant health issues, the paper said. It is based on a comparison of the vaccination status of nearly 1.5 million people who tested positive for Covid-19 to nearly 3.3 million people who tested negative for the virus.\u003c/p>\n\u003cp>“We found that waning was greatest among individuals in clinical risk groups, suggesting that this group should be prioritized for boosters, whenever they are recommended,” the authors said.\u003c/p>\n\u003cp>Despite the findings, Britain’s Joint Committee on Vaccination and Immunization recommended Wednesday that everyone who was at the front of the line when the country began its vaccine rollout last December should receive a booster shot, once six months had passed since their second jab.\u003c/p>\n\u003cp>Those listed as being at the head of the priority list for boosters in the U.K. are those living in long-term care facilities, adults 50 years of age and older, front-line health care workers and social workers, people 16 to 49 years old with underlying health conditions that put them at high risk of developing severe disease if they contract the virus, and adults who live with immunocompromised people.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","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\u003caside class=\"read-more standard\">\u003c/aside>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1976811/why-some-fda-scientists-are-arguing-against-covid-boosters","authors":["byline_science_1976811"],"categories":["science_31","science_40","science_4450"],"tags":["science_4329","science_4417","science_3977"],"featImg":"science_1976812","label":"source_science_1976811"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. 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You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />","airtime":"SUN 9pm-10pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Code-Switch-Life-Kit-Podcast-Tile-360x360-1.jpg","meta":{"site":"radio","source":"npr"},"link":"/radio/program/code-switch-life-kit","subscribe":{"apple":"https://podcasts.apple.com/podcast/1112190608?mt=2&at=11l79Y&ct=nprdirectory","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93d3cubnByLm9yZy9yc3MvcG9kY2FzdC5waHA_aWQ9NTEwMzEy","spotify":"https://open.spotify.com/show/3bExJ9JQpkwNhoHvaIIuyV","rss":"https://feeds.npr.org/510312/podcast.xml"}},"commonwealth-club":{"id":"commonwealth-club","title":"Commonwealth Club of California Podcast","info":"The Commonwealth Club of California is the nation's oldest and largest public affairs forum. 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