Pfizer, BioNTech to Submit Emergency Use Authorization Request to FDA for COVID-19 Vaccine

New York: Pfizer Inc and BioNTech SE announced they will submit a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.

The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose, the companies said.

The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission is also supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose. The submission also includes solicited safety data on approximately 100 children 12-15 years of age.

Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.

The companies have already initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency (EMA) and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days.