FDA grants full approval to Pfizer-BioNTech vaccine (Comirnaty)

FDA approved the first COVID-19 vaccine under a biologics license application for individuals 16+, while the Pfizer-BioNTech vaccine remained available under EUA for other uses; the release disclosed elevated myocarditis/pericarditis risk (highest in males 12–17) and required postmarketing studies. The approval became the legal and rhetorical foundation for a wave of mandates; critics called the review rushed and noted the approved-labeled product was largely unavailable while EUA-labeled doses were administered, while FDA said the review met standard BLA rigor and the products share the same formulation.