AAPS Statement on FDA’s “Approval Decision” on Pfizer-BioNTech COVID-19 Vaccine

On Aug 23, 2021, the U.S. Food and Drug Administration (FDA) decided to issue an “approval decision” regarding the Pfizer-BioNTech product, to be marketed as Comirnaty, for individuals 16 years of age and older. The Pfizer product will continue to be available under Emergency Use Authorization (EUA) for individuals 12 through 15 years of age … Continue reading AAPS Statement on FDA’s “Approval Decision” on Pfizer-BioNTech COVID-19 Vaccine