Pfizer and BioNTech Announces Submission of Initial Data to Support Booster Dose

Pfizer Inc. and BioNTech SE today announced that they have 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’ COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks.
Pfizer and BioNTech have submitted Phase 1 data – part of their Phase 1/2/3 clinical trial program – evaluating the safety, tolerability, and immunogenicity of a third dose of the COVID-19 vaccine in U.S. adult participants from the Phase 1 trial of the two-dose series. Participants received a 30-µg booster dose of BNT162b2 8 to 9 months after receiving the second dose. Results from this participant group show that the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus (wild type) compared to the levels observed after the two-dose primary series, as well as against the Beta variant and the highly infectious Delta variant.
Phase 3 results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities worldwide. In the U.S., Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application (BLA) in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021.