Pfizer and BioNTech announce submission of initial data to FDA to support booster dose of COVID-19 Vaccine

Pfizer Inc. and BioNTech SE announced that they have submitted Phase 1 data to the 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.

“Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.”.

Pfizer and BioNTech have submitted Phase 1 data – part of their Phase 1/II/III 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 III results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities worldwide.