Pfizer and BioNTech announce first authorization in the U.S. of BNT162b2 vaccine to prevent COVID-19.

Pfizer Inc. and BioNTech SE announced that the FDA has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. The vaccine is now authorized under an Emergency Use Authorization (EUA) while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021. Under Operation Warp Speed, the Department of Defense (DoD) in partnership with agencies within the Department of Health and Human Services (HHS), including the U.S. Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines.