Latest news with #MichaelOsterholm
Time of India
22-05-2025
- Health
- Time of India
Trump's FDA just changed COVID vaccine rules for 2025 — will you still qualify for boosters under the new guidelines?
What does the new FDA policy mean for younger, healthy people? Live Events Will COVID-19 vaccines be updated for fall 2025? Who decides what strain the COVID vaccine should target? Will there be enough time to study new COVID-19 vaccines? What will the CDC recommend for fall vaccinations? FAQs: (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel As the United States prepares for another COVID-19 season, the story surrounding updated COVID vaccines is taking a sharp turn. On Thursday, the FDA's independent vaccine advisers met to discuss whether this fall's COVID-19 booster shots should be reformulated — but the conversation is now clouded by a major shift in federal two days before the meeting, the Food and Drug Administration changed course on who should routinely receive COVID-19 boosters. Instead of recommending annual boosters for everyone aged 6 months and older, the FDA now says that only seniors and high-risk younger individuals will be routinely eligible. That sudden change is leaving health experts and families with more questions than FDA's updated stance means that healthy people under 65 may not automatically be approved to get a COVID-19 booster this fall. Under the new rules, vaccine makers will need to run additional studies to prove that new versions of the shot are still helpful for people who aren't at high risk.'This is a mess,' said Dr. Michael Osterholm, an infectious disease expert at the University of Minnesota. 'The one thing we don't want to do is put a barrier in place that prevents parents from getting their children vaccinated if they want to.'The concern now is access: Even if people want a booster, will they be allowed to get one? And will their insurance pay for it if it's no longer officially recommended?That's what Thursday's FDA advisory meeting was really about — deciding whether the current COVID-19 vaccines should be changed to better match the virus variants expected this fall and winter. The shots used last year targeted omicron subvariants in the JN.1 family. Moderna and Pfizer used a version called KP.2, while Novavax based theirs on the parent JN.1 the JN.1 family is still the most common, the virus keeps changing. The most dominant strain right now is LP.8.1. The big question: is the current vaccine still protective enough, or should drugmakers switch to target LP.8.1 directly?Dr. Vinay Prasad, head of the FDA's vaccine office, said during the meeting that they want to give people time to understand the new policy shift, but still need to decide quickly which variant the new shots should target. 'We are asking for guidance to help the FDA decide what strain to select for COVID-19 vaccines going forward,' Prasad year, the FDA brings together outside experts to assess whether the current vaccine formula still matches the circulating strains. These advisers weigh virus data, vaccine performance, and public health trends to suggest whether the shots should be updated. Their recommendation influences what Pfizer, Moderna, and Novavax produce for the there's no global consensus. The World Health Organization recently said that last year's JN.1-based vaccines were still acceptable. However, the European Medicines Agency has already recommended switching to match the LP.8.1 FDA hasn't made its position clear yet — though it's leaning toward letting science dictate the timing of updates, not the calendar. 'Instead of having a COVID-19 strategy that's year-to-year where we change things every single year, why don't we let the science tell us when to change?' said vaccine makers decide to change the strain, the FDA wants them to conduct studies to prove the new shot works well — especially for lower-risk individuals. But those studies could take up to six months, making it hard to get new vaccines ready in time for warn that requiring large clinical trials for updated vaccines could delay access or even discourage companies from making changes. If manufacturers stick with last year's strain, those extra studies wouldn't be needed — making it easier to get the shots approved for broader that could also mean that the shots are less effective against the latest virus variants, depending on how much the virus has if the FDA makes a decision on the strain, the Centers for Disease Control and Prevention (CDC) will make the final call onho should get the COVID vaccine this fall. The CDC's advisory committee is expected to meet in June to finalize those the options: continuing to offer the booster to everyone, or limiting it to high-risk groups while still allowing lower-risk people to opt in if they of the uncertainty also stems from the people now running the FDA's vaccine division. Both Dr. Prasad and FDA Commissioner Dr. Marty Makary have publicly criticized the government's broad approach to COVID-19 shots in the past — especially for children and young, healthy adults. Before joining the agency, they were praised by vaccine skeptic Robert F. Kennedy Jr., who now leads Health and Human a recent editorial, Prasad and Makary argued that the U.S. has been too aggressive with its vaccine recommendations, unlike countries in Europe that take a more targeted approach. 'The one-size-fits-all booster strategy no longer makes sense,' they seniors and high-risk individuals are eligible for routine COVID is considering a formula change to match the LP.8.1 variant.
The Independent
22-05-2025
- Health
- The Independent
FDA panel debates COVID vaccine recipe as questions swirl about fall shots
Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and winter — even as a new Trump administration policy has thrown into question who may be eligible for a shot. The Food and Drug Administration's outside experts have met regularly since the launch of the first COVID-19 vaccines to discuss tweaking their recipes to stay ahead of the virus. Thursday's meeting is the group's first since President Donald Trump took office. But it comes just two days after FDA leaders 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 approval of COVID-19 boosters will be limited to seniors and to younger people who are at high risk of severe infection. Manufacturers will need to do new studies to show whether seasonal shots still benefit healthy people younger than 65. That raises big implications for next fall's vaccination campaign, with uncertainty over whether healthy people still could get a vaccine even if it's not recommended for them — or whether insurers will keep paying for the shots for everyone. Nor is it clear what the policy means for babies who have never been vaccinated. 'This is a mess,' said Michael Osterholm, a University of Minnesota infectious disease expert. 'The one thing we don't want to do is put a barrier in place that prevents parents from getting their children vaccinated if they want to.' FDA's independent advisers may raise those issues Thursday, but the changes are not the focus of the meeting, which was scheduled before FDA's announcement. Instead, the panel is set to recommend whether the virus has mutated enough to warrant strain updates for shots from Pfizer, Moderna and Novavax. 'We are asking for guidance to help the FDA decide what strain to select for COVID-19 vaccines going forward,' FDA vaccine chief Dr. Vinay Prasad said in comments opening the meeting. Prasad added that the agency wants 'to give people a little more time to digest,' the new policy on vaccines and is open to feedback. Last fall's recipe was tailored to omicron descendants on the JN.1 branch of the virus family tree. Novavax brewed shots targeting the parent JN.1 variant while Pfizer and Moderna opted for a subtype called KP.2. That JN.1 family still dominates, although it continues to evolve. The question is whether last fall's shots still offer enough cross-protection or if manufacturers instead should match today's most common subtype, called LP.8.1. The World Health Organization recently said last year's version was OK but that vaccine makers could choose an update. The European Medicines Agency instead recommended targeting the newest subtype. FDA officials didn't express a preference in documents posted online ahead of Thursday's meeting. suggested earlier in the week that the government should move away from yearly updates. 'Instead of having a COVID-19 strategy that's year-to-year where we change things every single year, why don't we let the science tell us when to change?' Prasad said. Debating that science is what the FDA's vaccine advisers do each year. If they recommend leaving the shots unchanged — and the FDA agrees — it's possible that healthy adults and children may still get access to a fall booster, since this week's policy changes suggest new studies would be required only if manufacturers switch strains or introduce a completely new vaccine. Those would be large, six-month studies, and vaccine experts question if their cost and logistics could make them unfeasible. Still, the FDA's strain decision normally isn't the final word on recommendations about who should be vaccinated. The Centers for Disease Control and Prevention'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. Prasad and FDA Commissioner Marty Makary were both outspoken critics of the government's handling of COVID-19 shots during the pandemic, particularly the recommendation for use in young, healthy adults and children. Before joining government, they each garnered attention from Health Secretary Robert F. Kennedy Jr., who built a national following by casting doubt on the safety and benefits of vaccines. In a medical journal editorial outlining the FDA's new approach, they criticized the U.S.'s 'one-size-fits-all' approach, saying it has long been out of step with Europe and other places with more limited recommendations for boosters. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Associated Press
22-05-2025
- Health
- Associated Press
FDA panel debates COVID vaccine recipe as questions swirl about fall shots
WASHINGTON (AP) — Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and winter — even as a new Trump administration policy has thrown into question who may be eligible for a shot. The Food and Drug Administration's outside experts have met regularly since the launch of the first COVID-19 vaccines to discuss tweaking their recipes to stay ahead of the virus. Thursday's meeting is the group's first since President Donald Trump took office. But it comes just two days after FDA leaders 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 approval of COVID-19 boosters will be limited to seniors and to younger people who are at high risk of severe infection. Manufacturers will need to do new studies to show whether seasonal shots still benefit healthy people younger than 65. That raises big implications for next fall's vaccination campaign, with uncertainty over whether healthy people still could get a vaccine even if it's not recommended for them — or whether insurers will keep paying for the shots for everyone. Nor is it clear what the policy means for babies who have never been vaccinated. 'This is a mess,' said Michael Osterholm, a University of Minnesota infectious disease expert. 'The one thing we don't want to do is put a barrier in place that prevents parents from getting their children vaccinated if they want to.' FDA's independent advisers may raise those issues Thursday, but the changes are not the focus of the meeting, which was scheduled before FDA's announcement. Instead, the panel is set to recommend whether the virus has mutated enough to warrant strain updates for shots from Pfizer, Moderna and Novavax. 'We are asking for guidance to help the FDA decide what strain to select for COVID-19 vaccines going forward,' FDA vaccine chief Dr. Vinay Prasad said in comments opening the meeting. Prasad added that the agency wants 'to give people a little more time to digest,' the new policy on vaccines and is open to feedback. Last fall's recipe was tailored to omicron descendants on the JN.1 branch of the virus family tree. Novavax brewed shots targeting the parent JN.1 variant while Pfizer and Moderna opted for a subtype called KP.2. That JN.1 family still dominates, although it continues to evolve. The question is whether last fall's shots still offer enough cross-protection or if manufacturers instead should match today's most common subtype, called LP.8.1. The World Health Organization recently said last year's version was OK but that vaccine makers could choose an update. The European Medicines Agency instead recommended targeting the newest subtype. FDA officials didn't express a preference in documents posted online ahead of Thursday's meeting. suggested earlier in the week that the government should move away from yearly updates. 'Instead of having a COVID-19 strategy that's year-to-year where we change things every single year, why don't we let the science tell us when to change?' Prasad said. Debating that science is what the FDA's vaccine advisers do each year. If they recommend leaving the shots unchanged — and the FDA agrees — it's possible that healthy adults and children may still get access to a fall booster, since this week's policy changes suggest new studies would be required only if manufacturers switch strains or introduce a completely new vaccine. Those would be large, six-month studies, and vaccine experts question if their cost and logistics could make them unfeasible. Still, the FDA's strain decision normally isn't the final word on recommendations about who should be vaccinated. The Centers for Disease Control and Prevention'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. Prasad and FDA Commissioner Marty Makary were both outspoken critics of the government's handling of COVID-19 shots during the pandemic, particularly the recommendation for use in young, healthy adults and children. Before joining government, they each garnered attention from Health Secretary Robert F. Kennedy Jr., who built a national following by casting doubt on the safety and benefits of vaccines. In a medical journal editorial outlining the FDA's new approach, they criticized the U.S.'s 'one-size-fits-all' approach, saying it has long been out of step with Europe and other places with more limited recommendations for boosters. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Mint
21-05-2025
- Health
- Mint
Covid is quiet right now, but doctors are vigilant for a summer rise
The Covid-19 virus in the U.S. has largely faded from view. But it hasn't faded away. National wastewater data shows low Covid-19 activity, according to the Centers for Disease Control and Prevention. The weekly reported Covid-19 deaths in April were slightly down compared with the same time a year earlier, federal data shows. Still, more than 300 Covid-19-related deaths were reported weekly as recently as mid-April. Some infectious-disease specialists said they expect more cases this summer, as there have been somewhat regular summertime increases in the past. Others cautioned that Covid-19 can still surprise us, more than five years after it spurred a global pandemic that killed more than 1.2 million Americans. 'It is at our lowest levels it has been since the beginning of the pandemic," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. 'Our challenge is we don't know what that means for tomorrow." The Trump administration on Tuesday released a more stringent set of guidelines for approving Covid-19 vaccines, requiring randomized controlled trials for new Covid-19 vaccines for many children and adults. The Food and Drug Administration expects it will be able to approve shots for adults older than 64 and other high-risk groups based on antibody testing. The original Covid-19 shots were tested in large, randomized trials with placebos. The updated vaccines to match newer versions of the virus have been tested with antibody testing to ensure that they triggered an immune response. As of May 10, the CDC projected that 70% of cases were caused by a version of the virus called LP. 8.1, an offshoot of the Omicron variant, which first appeared in late 2021. It is related to the JN.1 variant, which was the target of last season's booster shots. The LP. 8.1 version has picked up new mutations but hasn't yet led to an increase in cases or hospitalizations. 'Because there are so many people who have been vaccinated and infected, there is a high amount of immunity in the population," said Andrew Pekosz, director of the center for emerging viruses and infectious diseases at Johns Hopkins University. 'I think we're also seeing that as a way to dampen the spread of the virus." Surveillance and monitoring for changes to the virus is continuing, Pekosz said, but at much lower levels than before, so there is more reliance on modeling to suss out variant spread. Hospitalization and death data remain the most solid. Covid-related hospitalizations in the U.S. are currently on the decline. There were some 1.3 hospitalizations per 100,000 people during the week ended with April 26, down from a winter peak of 4.2 per 100,000 people for the week ended Jan. 4, CDC data show. That rate is down from last winter, when hospitalization rates peaked at 7.8 per 100,000 people. Most years, the U.S. has experienced additional Covid-19 waves in late spring or summer, in addition to wintertime surges. Last year, a summertime wave peaked at around the week of Aug. 31, with more than 1,300 deaths reported, CDC data shows. Write to Brianna Abbott at
Boston Globe
19-05-2025
- Health
- Boston Globe
The US hasn't seen a human bird flu case in three months. Experts are wondering why.
The H5N1 bird flu has been spreading widely among wild birds, poultry and other animals around the world for several years, and starting early last year became a problem in people and cows in the U.S. Advertisement In the last 14 months, infections have been reported in 70 people in the U.S. — most of them workers on dairy and poultry farms. One person died, but most of the infected people had mild illnesses. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up The most recent infections confirmed by the Centers for Disease Control and Prevention were in early February in Nevada, Ohio and Wyoming. California had been a hotspot, with three-quarters of the nation's infections in dairy cattle. But testing and cases among people have fallen off. At least 50 people were tested each month in late 2024, but just three people were tested in March, one in April and none in May so far, state records show. Overall, the state has confirmed H5N1 infections in 38 people, none after Jan. 14. Advertisement The possible natural reason bird flu cases are down During a call with U.S. doctors this month, one CDC official noted that there is a seasonality to bird flu: Cases peak in the fall and early winter, possibly due to the migration patterns of wild birds that are primary spreaders of the virus. That could mean the U.S. is experiencing a natural — maybe temporary — decline in cases. It's unlikely that a severe human infection, requiring hospitalization, would go unnoticed, said Michael Osterholm, a University of Minnesota expert on infectious diseases. What's more, a patchwork system that monitors viruses in sewage and wastewater has suggested limited activity recently. New infections are still being detected in birds and cattle, but not as frequently as several months ago. 'Given the fact that the number of animal detections has fallen according to USDA data, it's not surprising that human cases have declined as well,' the CDC said in a statement. Are government cuts affecting bird flu monitoring? Dr. Gregory Gray said he wasn't concerned about the CDC not identifying new cases in months. 'I don't think that anybody's hiding anything,' said Gray, an infectious disease speicialist at the University of Texas Medical Branch in Galveston. But Osterholm and some other experts think it's likely that at least some milder infections are going undetected. And they worry that the effort to find them has been eroding. Resignations at the U.S. Department of Agriculture and the Food and Drug Administration's Center for Veterinary Medicine could slow the government's bird flu monitoring, said Keith Poulsen, director of the Wisconsin Veterinary Diagnostic Laboratory. Three of 14 experts accepted deferred resignation offers at the National Animal Health Laboratory Network, which responds to disease outbreaks with crucial diagnostic information, he said. They are among more than 15,000 USDA staff to accept the offers, an agency spokesperson said. Advertisement And dozens of staff were fired at the FDA's Veterinary Laboratory Investigation and Response Network, which investigates animal diseases caused by problems including contaminated pet food. Cats in several states have been sickened and died after eating raw pet food found to contain poultry infected with H5N1. Angela Rasmussen, a virologist at the University of Saskatchewan in Canada, said 'targeted surveillance has really dropped off precipitously since Trump took office.' She wonders if immigrant farmworkers are too scared to come forward. 'I can't argue with anyone who would be risking getting shipped to a Salvadoran gulag for reporting an exposure or seeking testing,' she said. CDC says the risk to the general public remains low The CDC characterizes the risk to the general public as low, although it is higher for people who work with cattle and poultry or who are in contact with wild birds. Earlier this month, an agency assessment said there is a 'moderate risk' that currently circulating strains of bird flu could cause a future pandemic, but the CDC stressed that other emerging forms of bird flu has been similarly labeled in the past. Still, research is continuing. Texas A&M University scientists have collected blood samples from dairy workers in multiple states to test for signs of past H5N1 exposure, said David Douphrate, a workplace health and safety expert leading the project. The yearlong study is funded by a nearly $4 million grant from the CDC and is expected to conclude in July. Douphrate said he leveraged two decades of relationships with dairy producers and workers to gain access to the farms. Advertisement 'We have had very good participation,' Douphrate said. 'They have been very willing.' Similar surveillance is 'urgently needed' among domestic cats, said Kristen Coleman, a researcher at the University of Maryland at College Park who studies emerging animal diseases. She recently released a paper reviewing bird flu in infections in cats between 2004 and 2024. Barn cats that died after drinking raw milk were one of the first signs that dairy cows were becoming infected with bird flu in 2024. Since then, the Agriculture Department has confirmed more than 120 domestic cats infected with the virus across the U.S. Infections have mostly been found in cats that died. Less is known about milder infections, whether cats can recover from bird flu — or whether the virus can spill over into people. Coleman has been collecting blood samples from cats across the U.S. to see if they have evidence of previous exposure to the virus. But the process is slow and research funding is uncertain. 'It's easy to downplay something because that's usually what humans do,' she said. 'But what we really need to be doing is ramping up.'
