FDA  Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
Marisa Lloyd

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

Food and Drug Administration.

Wednesday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:

  • 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.

Wednesday's authorization applies only to the Pfizer-BioNTech COVID-19 Vaccine. 

“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 Acting FDA Commissioner Janet Woodcock, M.D. "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 daycare staff, grocery workers and those in homeless shelters or prisons, among others."

Originally, Phizer asked for the FDA's approval for the third dose in everyone that was 16 and older six months after they had received their second vaccine, however, this got denied on Friday by the FDA advisory committee. 

This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

The official statements can be found at https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations for more information on how the FDA came to this conclusion. 

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