Comirnaty

We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products.  The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards. 

Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. 

The review of this product was associated with the following National Clinical Trial (NCT) numbers: NCT04368728 and NCT04380701.

-- Approval Letter addressed to Pfizer-BioNTech from the US Food and Drug Administration authorizing the used of Comirnaty, the Pfizer covid vaccine, 23 August 2021