FDA Just Approved Kids Covid Booster — with ZERO Testing!
Testing it on 8 baby mice was too much work for Pfizer
Pfizer just reported FDA’s decision to approve a bivalent Covid booster for “emergency use” for children 5-17 years of age.
What is amazing is that the approved bivalent vaccine was NOT tested on children or even on baby mice, at all!
For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.
May I ask, why no testing? The FDA and Pfizer had plenty of time: they were testing bivalent boosters on adults since the beginning of the year. No testing on children was done with any bivalent booster.
Could Pfizer at least purchase 8 baby mice and try their booster on 8 mouse babies? They surely could do that along with the adult dose testing.
An added touch of ridiculousness here is that the FDA also chose NOT to consult “FDA advisors” and thus did not convene the VRBPAC committee. That committee would, of course, approve anything. So, what is the reason for not convening it? The reason is that the FDA did not want to have any votes — even one vote — against this vaccine and did not want to have a public hearing about this travesty.
Three-Year-Old Spike Injections Still Required for Primary Series
It gets worse, of course. Only 30% of children 5-11 years of age are Covid vaccinated.
Should the parents of the 70% of unvaccinated children decide that they want their child to receive a bivalent (updated with Ba.5 formulation) shot, they would have to first give that child two shots of a three-year-old monovalent Wuhan-based vaccine (primary series), and only then they would be allowed to give their children the new and updated shot. Why? The FDA is not telling us.
The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age.
If someone asked me three years ago, whether it is possible that the FDA would approve a children’s vaccine with ZERO testing on children, I would of course laugh the question off as ludicrous. Now it is reality. Even worse, schools and camps may start requiring it.
I thought that the reputation of our health authorities could only bottom at zero. Clearly, though, they want to drive it down to the negative territory.
What do you think?