FDA Authorizes COVID-19 Booster Dose in Certain Populations
A booster dose of the Pfizer-BioNTech COVID-19 vaccine has been authorized for use in certain populations by the US Food and Drug Administration (FDA).
Populations eligible for this booster dose include:
- Individuals aged 65 years or older
- Individuals aged 18 to 64 years who are at high-risk of severe disease
- Individuals aged 18 to 64 years who are at high risk of serious complications of COVID-19, including severe disease, due to frequent institutional or occupational exposure to SARS-CoV-2
The booster is administered in a single dose at least 6 months following completion of the primary vaccine series.
This authorization comes as an amendment to the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine following the recent recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee. The panel comprised various experts and recommended unanimously to provide booster doses to at-risk patient populations. However, they were divided 16 to 2 against providing booster doses for the general population.
The panel’s recommendation, the vaccine manufacturer’s data, and clinical trial data were all considered in the FDA’s approval decision.
“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” said Janet Woodcock, MD, who is the Acting FDA Commissioner. “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.”
FDA authorizes booster dose of Pfizer-BioNTech COVID-19 vaccine for certain populations. News release. US Food and Drug Administration; September 22, 2021. Accessed September 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations