The Pfizer-BioNTech booster shot is authorized for use in persons aged ≥65 years, at high risk of severe disease, and who have frequent exposure to the virus increasing risk for severe infection.
The US Food and Drug Administration (FDA) on September 22, 2021 authorized a booster shot of the Pfizer COVID-19 vaccine, Comirnaty, for select populations.
The single booster shot, according to an FDA news release, is authorized to be administered at least 6 months after completion of the primary 2-dose series in:
“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, MD, in the release.
“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.
Woodcock assures the public that FDA will continue to parse the new vaccine safety and effectiveness data that become available daily, including use of booster shots.
The FDA's decision is based on consideration of data submitted by Pfizer/BioNTech, information presented at a meeting of the agency's Vaccines and Related Biological Products Advisory Committee, and the committee's discussion. Based on the totality of the available scientific evidence thus considered, the agency determined 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.
On August 23, 2021, the Pfizer-BionTech COVID-19 vaccine was the first COVD vaccine to receive full FDA approval, with an indication for use in persons aged 16 years and older.
“We’re grateful for the advice of the doctors, scientists, and leading vaccine experts on our advisory committee and the important role they have played in ensuring transparent discussions about COVID-19 vaccines,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, in the FDA statement.
“We appreciate the robust discussion, including the vote regarding individuals over 65 years of age and individuals at high risk for severe disease, as well as the committee’s views regarding the use of a booster dose for those with institutional or occupational exposure to SARS-CoV-2," continued Marks. "The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision. We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data.”