Scientists 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.
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 changing
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.)
Public 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.
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 coming
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.)
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 Moderna had planned to submit a combined flu/COVID vaccine for approval; it has since withdrawn its application.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.”
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