FDA Unanimously Approve Covid Vaccine for 0-4 Years: Unfathomable Decision Given the Trial Data

Health Advisory & Recovery Team (HART)

It was depressing that in the FDA open meeting, none of the members pointed out that 2 months follow-up is totally inadequate for assessing safety, nor questioned the use of an antibody level as a measure of success. 

… Moderna was also authorised for children at the same meeting, despite several countries having dropped it for all under 30s. 

… The Pfizer submission must be the most extreme case of data manipulation and bad science ever presented to the FDA. The study was approved on the basis of 4,500 participants but 3,000 of them did not make it to the end of the trial. That alone is enough to make the findings null and void. 

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