Latest news with #JerryWeir
The Hindu
23-05-2025
- Health
- The Hindu
FDA panel is split on updates to COVID shots as questions loom for fall vaccinations
Government advisers were split Thursday on whether drugmakers need to update their COVID-19 vaccines for next season, a decision overshadowed by confusion over a new Trump administration policy that may limit which Americans can get the shots. The Food and Drug Administration's outside experts have met annually since the launch of the first COVID-19 vaccines to discuss tweaking their recipes to stay ahead of the virus. The challenge is trying to gauge how the virus might evolve before fall vaccinations begin. Covid vaccine strain options under review 'We all want to make the perfect choice and that's probably not possible," FDA's Jerry Weir told the panel of outside experts. Some of the panelists voiced support for a switch to a newer coronavirus subtype named LP.8.1. It's currently the dominant version and part of the same family that circulated last year — known as the JN.1 branch of the virus family tree. 'We cannot predict the future, but it seems like LP.8 would be more likely to provide us better coverage," said Eric Rubin, a Harvard infectious disease expert and editor of the New England Journal of Medicine. Other panelists noted that subtype is such a close relative that last year's shots seem to offer cross-protection, at least for now but with no guarantee there wouldn't be a different version circulating by the time a vaccination campaign ramps up in the late summer or early fall. Several advisers noted that people who want to get ahead of a summer surge like the U.S. typically experiences could seek out the current vaccines. Policy shifts and uncertainty Hanging over the meeting was an FDA announcement earlier this week that upended the prior U.S. policy of recommending annual COVID-19 boosters for all Americans ages 6 months and older. Instead, the FDA said routine vaccine approvals will be limited to seniors and younger people with underlying medical risks, pending new research for healthy adults and children. While that change has big implications for a fall vaccination campaign, FDA leaders repeatedly sidestepped questions from advisers about whether recommending an updated formula would trigger restrictions outlined in the new policy. 'I don't have an answer today,' said Weir. 'I think a lot of this is still under discussion.' FDA staffers also wouldn't confirm whether the advisers would be given a chance to meet about the new standards later. FDA vaccine chief Vinay Prasad said in opening the meeting that the agency wants 'to give people a little more time to digest' the new policy and is open to feedback from its experts — although apparently not in Thursday's public forum. Experts debate best covid variant for fall vaccine Last fall's recipe was tailored to the so-called JN.1 family of omicron descendants. The advisory panel voted unanimously that the family still is the right overall target, but left the FDA to decide which specific subtype to choose. Novavax brewed shots targeting the parent JN.1 variant and said Thursday it was a good choice for this fall as well. Pfizer and Moderna vaccines last year targeted a subtype called KP.2 and company representatives told the FDA meeting that it showed cross-protection, but that they favored an update. The debate reflected an international difference of opinion on the closely related virus strains. The World Health Organization recently issued guidance that last year's version remained OK but that vaccine-makers could also choose an update, while the European Medicines Agency preferred that newer LP.8.1 subtype. CDC to weigh who should get fall covid booster While demand for vaccinations has dropped, the Centers for Disease Control and Prevention estimates 30,000 to 50,000 adults have died from COVID-19 since October. The virus continues to cause 'enormous burden' on the health care system, CDC's Dr. Fiona Havers told panelists. Older adults count for most hospitalisations and deaths but COVID-19 also is 'a major cause of paediatric hospitalisation,' especially in children under 2 — many of whom had no underlying medical problems before their infections. The strain decision normally isn't the final word on recommendations about who should be vaccinated. The CDC's own advisory panel meets in June to make recommendations about the fall shots. Among its options are keeping universal access or recommending vaccination for high-risk groups but still giving lower-risk people the choice in getting a shot. CDC staffers presented real-world data Thursday showing that getting a booster last fall offered added protection even in people who had been infected and previously vaccinated. Company studies reached the same conclusion — including one by Moderna that compared medical records of about 900,000 people.
United News of India
23-05-2025
- Health
- United News of India
New COVID variant NB.1.8.1 sparks fresh concern as US observes evolution of vaccination and preventive strategies
Atlanta, May 23 (UNI) A newly emerging COVID-19 variant, NB.1.8.1, is rapidly gaining ground across Asia and has now made its way into the United States — prompting scientists and health officials to reassess their vaccine playbook ahead of the coming winter season. The variant, a descendant of the JN.1 lineage, has triggered a sharp spike in cases in China and is now showing up in passengers arriving at American airports, including those in California, Washington, Virginia and the New York area. Sequencing data from the CDC's airport screening programme, in partnership with Ginkgo Bioworks, reveals that infected travellers came from a wide range of countries — including Japan, Thailand, Vietnam, France, the Netherlands and Taiwan. Though still relatively new, NB.1.8.1 has swiftly become the dominant strain in China and is spreading through Asia. Hong Kong health officials say COVID-related A&E visits have surged to their highest levels in over a year, while Taiwan has also reported rising hospitalisations and deaths. In response, authorities in both regions are reinstating measures like mask-wearing and building up stockpiles of vaccines and antiviral treatments, according to CBS News. So far, there is no sign that NB.1.8.1 causes more severe illness than previous strains. But what it lacks in evasiveness, it may make up for in speed. Early research from China suggests the variant binds more effectively to human cells, which could make it more contagious than its predecessors. 'Although one can't predict evolution, the overwhelming odds are that what dominates in the next few months will come from something already circulating,' said Jerry Weir, head of the FDA's viral products division. The variant has also become a focal point for US health regulators, as the Food and Drug Administration (FDA) considers which strain to target with this year's updated COVID vaccines. At a recent advisory meeting, independent experts unanimously backed updating the jabs to target a member of the JN.1 family — the same lineage as NB.1.8.1 — though opinions varied on exactly which subvariant should be chosen, reports The Guardian. Moderna and Pfizer presented early findings suggesting that a vaccine targeting LP.8.1, another JN.1 offshoot, would also offer protection against NB.1.8.1. 'The LP.8.1 vaccine has the highest titers against LP.8.1, which is dominant in the U.S. and many other regions and cross-neutralises other currently circulating variants, including NB.1.8.1,' said Darin Edwards, Moderna's COVID-19 programme lead. The NB.1.8.1 variant is part of the JN.1 family, a descendant of Omicron, which has dominated global COVID trends since late 2023. Although most Americans now have some level of immunity — either from vaccination, infection, or both — that protection fades over time. Health authorities globally are grappling with how to balance vaccine updates with practical policy, as the virus settles into a more seasonal, but still dangerous, pattern. At the same time, the US is shifting its wider vaccine policy. Under a new framework, boosters will be prioritised for over-65s and high-risk individuals, with younger, healthier groups required to wait for further clinical trial data. The change comes amid ongoing leadership reshuffles at the FDA and reflects a more cautious, long-term approach. Back on the ground, COVID cases in the US remain at relatively low levels — tracked through hospital data and wastewater testing. But the virus continues to claim lives, particularly among the elderly and the very young. Since October, between 30,000 and 50,000 Americans are estimated to have died from COVID-19, with as many as 430,000 hospitalised. According to CDC virologist Natalie Thornburg, while the virus has shown fewer dramatic shifts in recent months, its future trajectory remains uncertain. 'We are seeing very distinct patterns now — a kind of seasonality is emerging,' she said. 'But that doesn't mean the virus won't surprise us again.' Nearly five years into the pandemic, NB.1.8.1 is a reminder that COVID-19 is far from done evolving — and that global health systems must continue to adapt, even as many countries have scaled back health measures. As vaccine updates and public health strategies evolve on both sides of the Atlantic, the world is once again watching closely, and focusing on preventive measures across all sectors. While immunity level of the global population is higher than ever — thanks to widespread past infection and vaccination — experts warn that updated vaccines will still play a vital role in controlling the disease as new variants appear, serving as a dark reminder that the battle against COVID is ongoing. UNI ANV GNK
Yahoo
23-05-2025
- Health
- Yahoo
With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations
A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be included in this year's Covid-19 vaccines, giving the agency latitude to keep the current shots or update its formulas to more closely match circulating viruses. Several of the committee members asked at Thursday's meeting about the FDA's new vaccine approval framework. Some expressed concern that changing the strain targeted in this year's vaccine might decrease access to the shots in the fall, since the updated version would require new FDA approval. Capt. Sarah Meyer, a pediatrician who directs the Immunization Safety Office at the US Centers for Disease Control and Prevention, posed it as the first question of the meeting. 'I did have a question on how the new regulatory framework put forward this week might affect aspects related to selecting the strain. For example, if a different strain was selected for this season, would that require additional clinical trials, etc.?' she asked. 'I think that's a little off-topic,' said Dr. Jerry Weir, a longtime FDA staffer who is director of the Division of Viral Products within the agency's Center for Biologics Evaluation and Research. 'I think for today, we focus mainly on what we think in this committee should be in the vaccine, and then the rest of it, we'll work on that later.' Under the new framework, the agency says, it will accept the same kind of study data it has been using to approve annual flu shots and updated Covid-19 vaccines, but only for certain groups: those 65 and older and people with underlying medical conditions that put them at higher risk of severe illness. In order to approve Covid-19 vaccines for healthy younger adults and children, however, the agency now wants to see placebo-controlled clinical trials, which take longer and are expensive to run. Even if vaccine manufacturers choose to run those studies, it's unlikely that the research could be conducted in time for them to have shots ready for everyone 6 months and older by the fall. 'Is there a possibility that if we choose a different vaccine, [there are] actually going to be different regulatory measures that are taken that would delay the vaccine getting to the market?' asked committee member Dr. Stanley Perlman, a microbiologist and immunologist at the University of Iowa. FDA representatives attending the meeting had no firm answers about whether changing the targeted coronavirus strain might put the shots out of reach for some groups this fall. 'I think that the goal today is to figure out what the selection of the strain is, but we don't anticipate and our goal is not to impact the timely availability of vaccines,' said Dr. David Kaslow, director of the FDA's Office of Vaccines Research and Review. The voting members of the FDA's Vaccine and Related Biological Products Advisory Committee agreed that next respiratory season's shots should target the JN.1 family of viruses that swept the globe last year, although they stopped short of making a specific recommendation. The JN.1 branch of the Omicron family tree was a big shift from the viruses that came before, and it quickly replaced the XBB lineage viruses that had been circulating. It has sprouted its own descendants, which are now the predominant variants. Although JN.1 and its offshoot KP.2 – the sublineage used to make the Pfizer and Moderna Covid-19 vaccines in the US last year – are no longer circulating, several more viruses derived from them continue to drive Covid-19 transmission. They're all part of the JN.1 family, and so vaccines based on that virus are still protective. Last week, the World Health Organization said that single-strain inoculations based on JN.1 or KP.2 remain 'appropriate' choices. The FDA advisory committee heard evidence from vaccine manufacturers that vaccination with JN.1-or KP.2-based shots continues to boost antibodies to protective levels, even against newer viruses with slightly different mutations. But manufacturers also presented data showing that updated shots based on a newer member of the JN.1 family – LP.8.1, which is currently the dominant variant in the US – could boost antibodies even more robustly. 'We need to stay ahead of this virus, as opposed to behind it,' said committee member Dr. Hayley Gans, a pediatrician at Stanford, who said she favored updating the vaccine formula for the fall to LP.8.1. 'I think what we need to do is to have the most effective vaccine, not one that predicts that it would be less effective down the line.' Committee member Dr. Eric Rubin, a professor of immunology and infectious disease at the Harvard T.H. Chan School of Public Health and editor of the New England Journal of Medicine, agreed. 'The data suggest that there are not enormous differences right now, but we're trying to pick an antigen for the future, and not an antigen for now.' Kaslow said the FDA would decide on the specific composition of the 2025-26 vaccine shortly so manufacturers could have the shots ready in time for the fall.
CNN
22-05-2025
- Health
- CNN
With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations
A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be included in this year's Covid-19 vaccines, giving the agency latitude to keep the current shots or update its formulas to more closely match circulating viruses. Several of the committee members asked at Thursday's meeting about the FDA's new vaccine approval framework. Some expressed concern that changing the strain targeted in this year's vaccine might decrease access to the shots in the fall, since the updated version would require new FDA approval. Capt. Sarah Meyer, a pediatrician who directs the Immunization Safety Office at the US Centers for Disease Control and Prevention, posed it as the first question of the meeting. 'I did have a question on how the new regulatory framework put forward this week might affect aspects related to selecting the strain. For example, if a different strain was selected for this season, would that require additional clinical trials, etc.?' she asked. 'I think that's a little off-topic,' said Dr. Jerry Weir, a longtime FDA staffer who is director of the Division of Viral Products within the agency's Center for Biologics Evaluation and Research. 'I think for today, we focus mainly on what we think in this committee should be in the vaccine, and then the rest of it, we'll work on that later.' Under the new framework, the agency says, it will accept the same kind of study data it has been using to approve annual flu shots and updated Covid-19 vaccines, but only for certain groups: those 65 and older and people with underlying medical conditions that put them at higher risk of severe illness. In order to approve Covid-19 vaccines for healthy younger adults and children, however, the agency now wants to see placebo-controlled clinical trials, which take longer and are expensive to run. Even if vaccine manufacturers choose to run those studies, it's unlikely that the research could be conducted in time for them to have shots ready for everyone 6 months and older by the fall. 'Is there a possibility that if we choose a different vaccine, [there are] actually going to be different regulatory measures that are taken that would delay the vaccine getting to the market?' asked committee member Dr. Stanley Perlman, a microbiologist and immunologist at the University of Iowa. FDA representatives attending the meeting had no firm answers about whether changing the targeted coronavirus strain might put the shots out of reach for some groups this fall. 'I think that the goal today is to figure out what the selection of the strain is, but we don't anticipate and our goal is not to impact the timely availability of vaccines,' said Dr. David Kaslow, director of the FDA's Office of Vaccines Research and Review. The voting members of the FDA's Vaccine and Related Biological Products Advisory Committee agreed that next respiratory season's shots should target the JN.1 family of viruses that swept the globe last year, although they stopped short of making a specific recommendation. The JN.1 branch of the Omicron family tree was a big shift from the viruses that came before, and it quickly replaced the XBB lineage viruses that had been circulating. It has sprouted its own descendants, which are now the predominant variants. Although JN.1 and its offshoot KP.2 – the sublineage used to make the Pfizer and Moderna Covid-19 vaccines in the US last year – are no longer circulating, several more viruses derived from them continue to drive Covid-19 transmission. They're all part of the JN.1 family, and so vaccines based on that virus are still protective. Last week, the World Health Organization said that single-strain inoculations based on JN.1 or KP.2 remain 'appropriate' choices. The FDA advisory committee heard evidence from vaccine manufacturers that vaccination with JN.1-or KP.2-based shots continues to boost antibodies to protective levels, even against newer viruses with slightly different mutations. But manufacturers also presented data showing that updated shots based on a newer member of the JN.1 family – LP.8.1, which is currently the dominant variant in the US – could boost antibodies even more robustly. 'We need to stay ahead of this virus, as opposed to behind it,' said committee member Dr. Hayley Gans, a pediatrician at Stanford, who said she favored updating the vaccine formula for the fall to LP.8.1. 'I think what we need to do is to have the most effective vaccine, not one that predicts that it would be less effective down the line.' Committee member Dr. Eric Rubin, a professor of immunology and infectious disease at the Harvard T.H. Chan School of Public Health and editor of the New England Journal of Medicine, agreed. 'The data suggest that there are not enormous differences right now, but we're trying to pick an antigen for the future, and not an antigen for now.' Kaslow said the FDA would decide on the specific composition of the 2025-26 vaccine shortly so manufacturers could have the shots ready in time for the fall.
CNN
22-05-2025
- Health
- CNN
With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations
A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be included in this year's Covid-19 vaccines, giving the agency latitude to keep the current shots or update its formulas to more closely match circulating viruses. Several of the committee members asked at Thursday's meeting about the FDA's new vaccine approval framework. Some expressed concern that changing the strain targeted in this year's vaccine might decrease access to the shots in the fall, since the updated version would require new FDA approval. Capt. Sarah Meyer, a pediatrician who directs the Immunization Safety Office at the US Centers for Disease Control and Prevention, posed it as the first question of the meeting. 'I did have a question on how the new regulatory framework put forward this week might affect aspects related to selecting the strain. For example, if a different strain was selected for this season, would that require additional clinical trials, etc.?' she asked. 'I think that's a little off-topic,' said Dr. Jerry Weir, a longtime FDA staffer who is director of the Division of Viral Products within the agency's Center for Biologics Evaluation and Research. 'I think for today, we focus mainly on what we think in this committee should be in the vaccine, and then the rest of it, we'll work on that later.' Under the new framework, the agency says, it will accept the same kind of study data it has been using to approve annual flu shots and updated Covid-19 vaccines, but only for certain groups: those 65 and older and people with underlying medical conditions that put them at higher risk of severe illness. In order to approve Covid-19 vaccines for healthy younger adults and children, however, the agency now wants to see placebo-controlled clinical trials, which take longer and are expensive to run. Even if vaccine manufacturers choose to run those studies, it's unlikely that the research could be conducted in time for them to have shots ready for everyone 6 months and older by the fall. 'Is there a possibility that if we choose a different vaccine, [there are] actually going to be different regulatory measures that are taken that would delay the vaccine getting to the market?' asked committee member Dr. Stanley Perlman, a microbiologist and immunologist at the University of Iowa. FDA representatives attending the meeting had no firm answers about whether changing the targeted coronavirus strain might put the shots out of reach for some groups this fall. 'I think that the goal today is to figure out what the selection of the strain is, but we don't anticipate and our goal is not to impact the timely availability of vaccines,' said Dr. David Kaslow, director of the FDA's Office of Vaccines Research and Review. The voting members of the FDA's Vaccine and Related Biological Products Advisory Committee agreed that next respiratory season's shots should target the JN.1 family of viruses that swept the globe last year, although they stopped short of making a specific recommendation. The JN.1 branch of the Omicron family tree was a big shift from the viruses that came before, and it quickly replaced the XBB lineage viruses that had been circulating. It has sprouted its own descendants, which are now the predominant variants. Although JN.1 and its offshoot KP.2 – the sublineage used to make the Pfizer and Moderna Covid-19 vaccines in the US last year – are no longer circulating, several more viruses derived from them continue to drive Covid-19 transmission. They're all part of the JN.1 family, and so vaccines based on that virus are still protective. Last week, the World Health Organization said that single-strain inoculations based on JN.1 or KP.2 remain 'appropriate' choices. The FDA advisory committee heard evidence from vaccine manufacturers that vaccination with JN.1-or KP.2-based shots continues to boost antibodies to protective levels, even against newer viruses with slightly different mutations. But manufacturers also presented data showing that updated shots based on a newer member of the JN.1 family – LP.8.1, which is currently the dominant variant in the US – could boost antibodies even more robustly. 'We need to stay ahead of this virus, as opposed to behind it,' said committee member Dr. Hayley Gans, a pediatrician at Stanford, who said she favored updating the vaccine formula for the fall to LP.8.1. 'I think what we need to do is to have the most effective vaccine, not one that predicts that it would be less effective down the line.' Committee member Dr. Eric Rubin, a professor of immunology and infectious disease at the Harvard T.H. Chan School of Public Health and editor of the New England Journal of Medicine, agreed. 'The data suggest that there are not enormous differences right now, but we're trying to pick an antigen for the future, and not an antigen for now.' Kaslow said the FDA would decide on the specific composition of the 2025-26 vaccine shortly so manufacturers could have the shots ready in time for the fall.
