Sept 4, 2022 by Chris Flowers, M.D. based on findings by Team 1 physician and investigator, C.T.
Without a completed safety study or expert committee review, the FDA issued a supplemental Biologics License Application (“sBLA”) approval letter granting full FDA approval to Pfizer-BioNTech’s COMIRNATY® COVID-19 mRNA vaccine for use in children ages 12-15. This was done even though safety study completion, on which approval should be based, will not be completed until May 31, 2023. [https://www.fda.gov/media/159727/download and https://www.pfizer.com/news/announcements/pfizer-and-biontech-announce-us-fda-approval-their-covid-19-vaccine-comirnatyr] Additionally, the approval was issued even though COMIRNATY is still not available in the United States. [DeMasi, Maryanne. “Is Pfizer’s FDA-approved COMIRNATY Vaccine Available in the US?” Brownstone Institute, May 22, 2022. https://brownstone.org/articles/is-pfizers-fda-approved-comirnaty-vaccine-available-in-the-us/] Thus, the FDA has approved a commercial drug for children without appropriate evidence of safety.