The Food and Drug Administration (FDA) Grants Full Approval to Pfizer-BioNTech’s COMIRNATY for Adolescents 12-15 Years of Age Despite Incomplete Safety Trials

Aug 15th 2022 1:17pm EDT

Without having assembled an expert committee, the FDA issued a supplemental BLA (“sBLA”) approval letter granting full FDA approval to Pfizer-BioNTech’s COMIRNATY COVID-19 mRNA vaccine for use in children ages 12-15. They did this despite the fact that the safety study on which approval should be based will  not be completed until May 31, 2023.,  […]

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