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, … Continue reading Report 39: 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