Trump's FDA just changed COVID vaccine rules for 2025 — will you still qualify for boosters under the new guidelines?

Time of India

22-05-2025

What does the new FDA policy mean for younger, healthy people?
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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 policy.Just 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 answers.The 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 strain.Although 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 said.Every 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 fall.Interestingly, 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 strain.The 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 Prasad.If 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 fall.Experts 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 use.But that could also mean that the shots are less effective against the latest virus variants, depending on how much the virus has changed.Even 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 guidelines.Among 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 want.Much 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 Services.In 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 wrote.Only seniors and high-risk individuals are eligible for routine COVID boosters.FDA is considering a formula change to match the LP.8.1 variant.