How the FDA Could Make It Harder to Get COVID Vaccines This Year
The U.S. government hasn’t yet issued formal guidance on 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 sweeping policy changes. The changes could result in healthy people under 65 losing access to COVID vaccines, according to vaccine experts who spoke about the policy. Here’s what we know so far, and why the announced policy could be a problem.
How COVID Vaccines Are Currently Approved
Scientists have changed the formula for COVID vaccines several times over the years because the COVID virus itself tends to mutate. Vaccines are updated to better match circulating strains, and this happens about once a year — similar to how flu shots are updated annually.
Rather than designing new vaccine trials from scratch for every small change in a COVID vaccine, manufacturers are conducting studies to show that the immunity people get from the new vaccine is equivalent to what people got from the old vaccine.
Once the FDA approves a vaccine, the CDC issues a recommendation on who should get the vaccine. Currently, the COVID vaccine is recommended for everyone 6 months of age and older .
What might change
According to the NEJM article, the new policy will only accept results from immune bridge studies to approve vaccines for people 65 and older, and for people 6 months and older who have one of the high-risk conditions listed by the CDC.
For healthy people under 65, the FDA’s policy is not to approve new COVID vaccines unless they are tested with a placebo. (The type of placebo is vague: “The control group could receive a saline placebo,” the authors write.)
The FDA does not have the authority to change recommendations about who should get vaccines that have already been approved (that’s the CDC’s purview), but it is responsible for approving vaccines and can approve them only for certain groups of people.
Why Placebo-Controlled Trials Are a Totally Wild Idea for COVID Vaccines
Public health experts are not thrilled about this plan, to say the least. That’s because we already have COVID vaccines that work. Conducting a placebo-controlled trial would require withholding COVID vaccines from people in the control group; they would be injected with saline instead of the functional vaccine.
The usual way to conduct this type of trial (if you conduct it at all, rather than relying on an immune bridge) is to compare a new vaccine or drug to one that is already considered effective. To use an extreme analogy, you wouldn’t test a new seat belt design by randomizing people to drive without wearing seat belts at all.
Vaccine expert Peter Hotez told CNN that the FDA’s announced approach “essentially takes away access to vaccines” because such trials are not worthwhile for companies. In a post on Bluesky, toxicologist Ryan Marino said 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 deaths, and there’s no group that’s not at risk.”
More chaos could ensue with vaccines
The new policy is not yet official, but it is hard to imagine the FDA and CDC being allowed to approve and recommend vaccines as they have always done in the current political climate. Biologics Director Vinay Prasad and FDA Commissioner Marty Makary, whose names are listed on the FDA policy statement, have a history of opposing children’s access to a COVID vaccine.
And both agencies fall under the auspices of HHS, the Department of Health and Human Services, which is headed by Robert F. Kennedy Jr. — the same man whose anti-vaccine organization funded the movie Plandemic . If you don’t remember the details of that movie, which circulated in the early days of the pandemic, it implied that COVID didn’t exist and was a government-created bioweapon; the logic didn’t stand up to scrutiny, but the point was ultimately that we should be suspicious of vaccines. ( Read more about Plandemic here .)
RFK Jr. has said a lot of crap about vaccines . He compared childhood vaccines to the Holocaust, claimed that Bill Gates was putting microchips in vaccines, and wondered loudly whether vaccines cause autism. How this man ended up in charge of a health agency I will never understand.
Recent and future vaccine approvals could be at risk in this environment. Moderna had planned to submit a combination flu/COVID vaccine for approval; it has since withdrawn its application . (It’s unclear whether the FDA’s recent policy announcements are directly related.) Novavax’s recent vaccine was recently approved, but only on a delayed basis and only for older adults and people with high-risk medical conditions . Kennedy released a report today that questions the childhood vaccination schedule and implies that vaccines are part of “the harsh reality of America’s children’s declining health.”