The FDA Just Approved Bivalent Boosters for Kids with ZERO Testing

Good news, everyone! The Food and Drug Administration (FDA) just granted Emergency Use Authorization to Pfizer for their brand-new bivalent booster COVID shot, this time for kids in the 5 to 17 age group. You may remember from about a month ago that the bivalent booster was approved for adult humans after being rigorously tested on just 8 mice. But COVID has become such a desperate emergency now that the FDA approved the kiddie booster shot with no testing at all.

That’s not a typo. The bivalent COVID shot for 5- to 17-year-olds has not gone through any testing whatsoever on children – and it’s now available for them to take.

The FDA’s news release says that they “relied on immune response and safety data that it had previously evaluated from a clinical study in adults.” (That would be the 8 mice testing.) And that immune response and safety data was what they used to justify emergency authorization for the COVID kid boosters.

 

This latest booster shot is #4 in the sequence, for those keeping track at home. It is supposedly formulated to protect against the original COVID-19 variant, in addition to the BA.4 and BA.5 omicron variants. The FDA’s reasoning for not doing any testing on children was because the shot was first tested on adults. (Again: Those “adults” were 8 mice.)

The FDA didn’t even convene a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to vote on the boosters for kids. Under normal processes, VRBPAC holds an initial vote on whether to approve an experimental medicine. If it passes that vote, then the medicine gets another vote in the FDA on whether to approve it. They skipped the Advisory Committee vote entirely. Why?

One reason could be that everything has just gotten too crazy with these shots by now. If even one person on the Advisory Committee had voted no, it would have drawn public attention to the shot. The best way to avoid not having a unanimous approval vote is to not have a vote at all!

Another reason could be because VRBPAC hearings are public meetings. Anyone can jump on Zoom and watch the hearings. The broader FDA meetings and votes are not public. Therefore, in addition to having done no testing at all on these shots for kids, there has not even been a single public hearing on the kids’ booster shots. They just voted in secret and approved it, without requiring any testing whatsoever.

It was safely tested on the 8 mice, so what are you worried about, science deniers?

By the way, about that test on the 8 mice… they all caught COVID after being injected with the bivalent booster shots. It didn’t actually prevent any of the animals from catching BA.4 or BA.5. They all caught it when exposed after being boosted. The omicron variant is not supposed to be particularly bad on the lungs, because the virus has weakened. But in the 8 mice, they had higher than normal viral particles counted in their lungs. Whoops. So, after being boosted, the 8 mice caught worse cases of COVID than their unvaccinated counterparts can catch.

Here’s another odd thing about this latest development. The FDA is not making any changes to the original shot sequence. The first two shots – the ones people took to become “fully vaccinated” – were formulated to protect against the original Wuhan coronavirus. That variant is no longer circulating. It’s gone. It’s over. The COVID that’s floating around now is from the BA.4 and BA.5 variants.

But if a parent or adult wants to get protection against BA.4 or BA.5, they still have to take all the shots in sequence. Even though the first two shots and the first booster protect against strains that are no longer circulating. Only after a person takes those first three shots can they get the BA.4/BA.5 bivalent booster shot.

Anyway, the second booster shot for kids has been approved, despite no testing being done on the shot. Any parent who therefore gets their child boosted is making their child the human guinea pig. Pfizer didn’t even bother to get the kiddie booster shot tested on some mice. It’s not like the shot would have worked anyway, though. Mice and humans can still easily catch COVID after being double vaxed and double boosted.


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