Despite Incomplete Safety Trials, the Food and Drug Administration (FDA) Grants Full Approval to Pfizer-BioNTech’s COMIRNATY® for Adolescents 12-15 Years of Age
Sep 4th 2022 4:59pm EDT
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 […]
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