Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product

Resumo

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. COMIRNATY (COVID-19 Vaccine, mRNA) was approved on August 23, 2020, and a license was issued to BioNTech Manufacturing GmbH. FDA has determined that COMIRNATY (COVID-19 Vaccine, mRNA) meets the criteria for a material threat MCM priority review voucher, which has been issued to BioNTech Manufacturing GmbH.