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, […]
Report 11: Pfizer Vaccine – FDA Fails to Mention Risk of Heart Damage in Teens
BOMBSHELL: FDA MUST HAVE KNOWN THAT MYOCARDITIS IN TEENS WAS A RISK WHEN THEY ISSUED THE EMERGENCY USE AUTHORIZATION THAT DID NOT MENTION IT. In a paper published in pre-print last week (25th March, 2022) in the Journal of Pediatrics https://www.jpeds.com/article/S0022-3476(22)00282-7/fulltext#%20 Shauer et al. from the Seattle Children’s Hospital at the […]