The FDA amended the Emergency Use Authorization for the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) to allow for use of a single booster, administered at least 6 months after the primary series, in the following individuals:
- individuals 65 years of age and older;
- individuals 18 through 64 years of age at high risk of severe COVID-19; and
- individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19, including severe COVID-19
The authorization applies only to the Pfizer-BioNTech COVID-19 vaccine. The FDA notes that the agency-authorized Pfizer-BioNTech COVID-19 vaccine is the same formulation as the FDA-approved Comirnaty, and the vaccines may be used interchangeably.
The FDA based its decision on the totality of available scientific evidence that a booster dose of Pfizer-BioNTech COVID-19 vaccine may be effective in preventing COVID-19 and that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use.
Acting FDA Commissioner Janet Woodcock, MD, noted that the agency amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as healthcare workers, teachers and day care staff, grocery workers, and those in homeless shelters or prisons. The FDA will continue to gather data about vaccine safety and effectiveness as it becomes available and will evaluate the rapidly changing science and make further decisions as appropriate based on the data.
