The U.S. government has not yet made its official recommendations for who should be able to get COVID booster shots this fall, but FDA officials published a policy position in the New England Journal of Medicine announcing that it intends to make some drastic policy changes. The changes could result in healthy people under age 65 losing access to COVID vaccines, according to vaccine experts who have spoken about the policies. Here’s what we know so far, and why the announced policy could be a problem. How COVID vaccines are currently approvedScientists have changed the formulation of COVID vaccines a few times over the years, because the COVID virus itself tends to mutate. Vaccines are updated to better match the strains that are circulating, and this has happened roughly once a year—similar to how flu shots are updated each year. Instead of designing new vaccine trials from scratch for each small change in the COVID vaccine, manufacturers conduct studies to show that the immunity people get from the new vaccine is equivalent to what people got from the old vaccine. After approval from the FDA, the CDC then issues a recommendation for who should get the vaccine. Currently, everyone aged 6 months and up is recommended to get a COVID vaccine. What might be changingThe new policy, according to the NEJM article, would be to accept those immunobridging studies only to approve vaccines for people aged 65 and up, and people above the age of 6 months who have one of the high-risk conditions on a list maintained by the CDC. For healthy people under 65, the FDA’s policy wouldn’t approve new COVID vaccines unless they were tested against a placebo. (The type of placebo is phrased vaguely: “The control group could receive a saline placebo,” the authors write.) The FDA doesn’t have the authority to change the recommendations on who should get vaccines that are already approved (that’s the CDC’s purview), but it is in charge of approving vaccines and can approve them only for specific populations. Why placebo-controlled trials are an absolutely wild idea for COVID vaccinesPublic health experts are, to put it mildly, not happy with this plan. That’s because we already have COVID vaccines that work. Doing a placebo-controlled trial would require withholding COVID vaccines from people in the control group; they would get saline instead of a functional vaccine. The normal way to do this type of trial (if you do one at all, rather than relying on immunobridging) is to compare the new vaccine or medication against one that is already considered effective. To use an extreme analogy, you wouldn’t test a new design of seatbelt by randomizing people to ride around without using any seatbelts at all. Vaccine scientist Peter Hotez told CNN that the FDA’s announced approach “essentially denies access to vaccines,” since such trials are not practical for companies to do. In a post on Bluesky, toxicologist Ryan Marino said that it amounts to “scientific misconduct.” Vaccine expert Paul Offit told NPR “I don't think it's ethical, given that we have a vaccine that works, given that we know that SARS-CoV2 [the COVID virus] continues to circulate and cause hospitalizations and death, and there's no group that has no risk.”More vaccine chaos may be comingThe new policy isn’t official yet, but it’s hard to imagine the FDA and CDC being allowed to approve and recommend vaccines the way it always has in the current political climate. Biologics director Vinay Prasad and FDA Commissioner Marty Makary, whose names appear on the FDA’s policy statement, have a history of arguing against COVID vaccine access for children. And both agencies are under the umbrella of HHS, the department of Health and Human Services, which is headed by Robert F. Kennedy, Jr—the same person whose anti-vaccine organization financed the movie Plandemic. If you don’t recall the details of that movie circulating in the early pandemic days, it implied both that COVID wasn’t real and that it was a bioweapon created by the government; the logic didn’t hold together but ultimately the point was that we should be suspicious of vaccines. (I have more on Plandemic here.) RFK, Jr has said a lot of bananas stuff about vaccines. He has compared childhood vaccines to the holocaust, claimed that Bill Gates put microchips in vaccines, and loudly questioned whether vaccines cause autism. How this man got put in charge of a health agency, I will never understand. Recent and future vaccine approvals may be at risk in this environment. Moderna had planned to submit a combined flu/COVID vaccine for approval; it has since withdrawn its application. (It’s not clear whether recent FDA policy announcements are directly related.) Novavax’s recent vaccine was approved recently, but only after a delay and only for older adults and for people with high-risk health conditions. Kennedy released a report today that questions the childhood vaccine schedule and implies that vaccines are part of the “stark reality of American children's declining health.”