On Aug. 16, 2021, Pfizer and BioNTech announced that they had submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companiesﾒ COVID-19 vaccine (BNT162b2) for future licensure. These data also was to be submitted to the European Medicines Agency and other regulatory authorities.