FDA Sharply Limits COVID Vaccine Approval, Because The Cranks Are In Charge Now
Sorry about your health.
The FDA announced Tuesday that it will only approve updated COVID-19 vaccines for adults over 65 and for other Americans who may be at greater risk if they get infected. Driven by the antivaxxer crazies who Donald Trump chose to run America’s public health agencies, the new policy is a shocking, nihilistic reversal of the previous federal COVID response. Up until now, the annual vaccine updates have been recommended for everyone over the age of six months, with particular emphasis on getting the vaccine to older Americans and people with complications.
Yr Doktor Zoom is not a medical Doktor, but we know this much: even if the change in policy somehow doesn’t result in an uptick in serious illness and death, it will restrict people’s ability to manage their own health care. If the FDA restricts approval of the vaccines to only some patients, insurance companies will probably no longer cover the vaccines for anyone else. So even if you just want to increase your vaccine protection, tough luck: You’ll have to pay for it out of pocket.
As actual vaccine expert Paul Offitt of the Children's Hospital of Philadelphia asked, “Is the pharmacist going to determine if you’re in a high-risk group? […] The only thing that can come of this will make vaccines less insurable and less available.”
The new COVID vaccine policy was announced in an op-ed in the New England Journal of Medicine by FDA Commissioner Marty Makary and FDA vaccine czar Vinay Prasad, both of whom have a long history of being antivaccine assholes. During the pandemic, in October 2021, Prasad wrote a now-deleted blog post titled “How Democracy Ends” (archive link) insisting that vaccine mandates would provide some future tyrant a blueprint for “military force and suspension of democratic norms,” under which that tyrant would surely postpone elections and pursue one-party rule, just like in Nazi Germany.
Prasad was chosen for the vaccine chief position after the administration forced out the previous director of the vaccine program, Dr. Peter Marks, in March, for being unacceptably normal. Marks wrote in his resignation letter that he had been willing to work with HHS Secretary Bobby Brainworms Jr, but nah:
“However, it has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote.
At the time, an unidentified FDA spox — doesn’t matter who, since all Trump spokespeople aim for the very same snotty tone of a social media post — said, “If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.” Then the spox presumably offered to beat up anyone who questioned the statement. Note especially in Trumpian discourse that phony-baloney use of terms like “golden standard” (sic), “radical transparency,” and “evidence-based,” which used to mean policy based on evidence but now means policy based on evidence or guesswork that goes over well with MAGA. (Or something they saw on YouTube.)
Makary has his own history of soft-pedaling measures meant to limit the pandemic, like criticizing mask and vaccine mandates, opposing widespead use of COVID boosters, exaggerating the potential risk of the COVID vaccine, and downplaying the seriousness of the disease. He claimed, wrongly, that the US could achieve herd immunity if only 20 percent of Americans were vaccinated, and in February 2021 predicted, also wrongly, that the virus would be virtually gone by April of that year because a combination of vaccination and people being infected would provide herd immunity, another thing that never happened. And in June 2021, Makary claimed “he had been unable to find evidence of a single covid death of a previously healthy child. By then there were many reports of such deaths, although children were much less likely than older people to suffer severe disease.”
In keeping with the new Trumpian redefinition of science, Makary and Prasad say in their op-ed that the US must have an “evidence based” policy on vaccinations. Again, up until Donald Trump took office, that’s what we had. The op-ed says that vaccine manufacturers must conduct new randomized controlled trials of their booster shots to show that the vaccine is safe and effective for healthy people aged six months to 65 years, and then the agency might think about allowing wider use of the vaccine again.
If you really appreciate HOLLOW MORDANT LAUGHTER, the chucklefuck doctors claim that authorizing widespread vaccination is no longer needed because, they claim, “uptake of the annual Covid-19 booster has been poor.” Talk about confusing cause and effect!
Less than 25% of Americans received boosters each year, ranging from less than 10% of children younger than 12 years of age in the 2024–2025 season to 50% of adults over 75 years old.4 Even health care workers remain hesitant, with less than one third participating in the 2023–2024 fall booster program.5
Gosh, what could POSSIBLY have led Americans to become skeptical of the COVID vaccines? Certainly couldn’t have been the rightwing fearmongering that masking and vaccinations were exactly like forcing Jews to wear yellow stars, could it?
Insanely, the op-ed even frets that all this doubt about the COVID vaccine, to which they contributed, has sadly spilled over into a wider “reluctance to vaccinate that is affecting even vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination, which has been clearly established as safe and highly effective.”
Why yes, that’s the very MMR vaccine that their boss, RFK Jr., continually undermines with disinformation (“aborted fetus debris!”), and can’t even bring himself to recommend during the worst outbreak of measles since the 1990s.
The announcement in the New England Journal also upends the normal federal process for vaccine recommendations and approval, which usually begins with discussions about a vaccine’s safety and efficacy by the FDA’s independent vaccine advisory group, which will hold its first meeting Thursday. Normally, any new guidance is released as a draft, with a mandatory public comment period, after which the FDA authorizes a vaccine. Then a separate CDC advisory panel recommends who should get the vaccine. The FDA’s announcement Tuesday basically puts the decision ahead of any of that process, which some people might consider a bit unscientific. Yes, hard to believe!
There’s still the possibility that, once the vaccine panels meet, they could modify Tuesday’s pre-decided guidance to allow people who aren’t in the two recommended groups to choose to get a booster, which could clear the way for insurance companies to cover it. We bet that if a lot of people called on their members of Congress to make that clear to the FDA, that might help.
[WaPo (gift link) / New England Journal of Medicine / KFF Health News / AP / NBC News]
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Time to schedule that covid booster! While insurance still covers it. If you are 6 months from your last one, do it! I am scheduling mine now.
Posting I recently viewed:
[Name blocked out]
"Herpes, AIDS and hepatitis are all viruses, so they tell us.
Ever see anybody wear a mask to prevent the spread of any of those?
Yeah, me neither."
[Name blocked out]
"Well, Karen, they're called condoms.
"Dick masks," if that helps."