FDA grants emergency use authorization for Pfizer-BioNTech COVID-19 vaccine

The U.S. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine developed by Pfizer Inc. and BioNTech SE against COVID-19 for individuals 16 years of age and older. This authorization allows for the immediate distribution of the first doses within the United States.

The vaccine's deployment will be managed as part of the U.S. government's "Operation Warp Speed" initiative. The Department of Defense, in partnership with agencies like the Centers for Disease Control and Prevention (CDC), will oversee the allocation and distribution of the vaccine. Priority groups for vaccination will be determined based on guidelines from the CDC's Advisory Committee on Immunization Practices (ACIP).

The FDA's decision follows the analysis of data from a pivotal Phase 3 clinical trial, recently published in The New England Journal of Medicine. The study demonstrated a 95% vaccine efficacy rate in participants who had not previously been infected with SARS-CoV-2. The vaccine's performance was consistent across various demographic groups including age, gender, and race or ethnicity. The trial's Data Monitoring Committee has not reported any serious safety concerns.

Pfizer and BioNTech will continue to monitor approximately 44,000 trial participants for two years following their second dose to assess long-term protection and safety. The companies expect to file a Biologics License Application (BLA) with the FDA for potential full regulatory approval in 2021, pending the collection of further data.