FDA authorizes emergency use of Pfizer-BioNTech booster COVID-19 vaccines for vulnerable populations

While falling short of the full authorization Pfizer Inc. and BioNTech SE have clamored for, the United States Food and Drug Administration (FDA) has amended existing emergency use authorization (EUA) for the companies’ COVID-19 vaccine to allow a single booster dose for certain populations.

These populations include those 65 years old and older, or anyone between 18 and 64 years old either at high risk of severe COVID-19 or are at high risk of exposure to SARS-CoV-2 due to their jobs or environments. In these cases, those in need could be dosed with the extra shot at least six months after completion of the primary, two-dose vaccination series.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” Acting FDA Commissioner Dr. Janet Woodcock said. “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day.”

While other vaccines have been assessing the capabilities of boosters, this decision applies only to the Pfizer-BioNTech vaccine. The vaccine as a whole has been available under EUA since Dec. 11, 2020.