U.S. Food and Drug Administration authorizes a booster dose of the Pfizer-BioNTech COVID-19 vaccine for certain populations
On 22 September 2021, the U.S. Food and Drug Administration (FDA) reported that it had amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow the use of a single booster dose – to be given at least six months after completing the primary series of immunizations with the same vaccine – for the following individuals:
- People age 65 and older;
- People ages 18 to 64 at high risk of severe COVID-19; and
- People ages 18 to 64 whose institutional or occupational exposure to SARS-CoV-2 puts them at high risk for serious complications from COVID-19, including severe COVID-19.
The FDA examined the data submitted by the vaccine manufacturer, along with information presented at the 17 September meeting of the Vaccine and Related Biological Products Advisory Committee (VRBPAC), and determined that, based on the totality of available scientific evidence, a booster dose of the Pfizer-BioNTech COVID-19 vaccine may be effective in preventing COVID-19. It also determined that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations designated by the FDA. The booster dose is authorized for administration to these individuals at least six months following completion of their primary series, and may be given at any point after that time.