FDA gives green light to Pfizer COVID booster for kids 5 to 11, disregards questionable efficacy data

Are we adding yet another series of pokes to the already bursting-at-the-seams childhood vaccine schedule?

The U.S. Food and Drug Administration’s recent decision to grant Pfizer yet another emergency use authorization (EUA) for its massively profitable COVID shot – this time affecting young children.

Government agency okayed COVID booster for young kids based on questionable evidence derived from fewer than five dozen trial participants

On May 17, 2022, the U.S. Food and Drug Administration (FDA) announced that they were amending the current EUA for the Pfizer-BioNTech COVID-19 Vaccine, effectively greenlighting “the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.”

This decision came despite the fact that the latest data suggests higher COVID-19 case rates among vaxxed children compared to vax-free, as reported by Children’s Health Defense.

In their press release, the FDA says it justified this massive decision based on the agency’s “analysis of immune response data” from an ongoing randomized placebo-controlled trial involving fewer than 70 kids.

“Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine,” says the FDA.  “The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose.”

Notice the FDA does NOT say that the booster shot in 5- to 11-year-old kids definitively reduced rates of SARS-CoV-2 infection – only that it stimulated a higher level of antibodies (aka, created a more robust immune response in the children’s bodies).Phrasing such as this does little to clarify whether this proves that a third dose of this mRNA therapeutic is indeed “safe,” “effective,” and offers benefits that outweigh the potential known and unknown risks. 

After all: how can we know if higher antibody levels actually translate to better protection?  In a pandemic where “breakthrough” cases are unbelievably common post-vax, clearly, antibody levels aren’t the only answer.  (See “The Flawed Science of Antibody Testing for SARS-CoV-2 Immunity,” published by JAMA on October 21, 2021.)

In other words: even if the antibody levels in triple-vaxxed 5-year-olds were higher than they were when the same kids were “only” double-vaxxed, how can we know that’s making any kind of clinically meaningful difference?

Unfortunately, the only thing we can know for sure at this point is that any child, like any adult who takes this drug (once, twice, or even three or four times), has now assumed any and all risks associated with it.

FDA went full steam ahead on this decision without customary Advisory Committee consultation – parents, do you think this kind of cutting corners is acceptable?

The FDA came to this decision without consulting with its Advisory Committee, as customary for all other EUA moves and claims that it “previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of Pfizer’s EUA request, the FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members.”