FDA authorizes Pfizer boosters for patients over 65, at high risk of COVID-19

The agency did not recommend the additional shots for the general public.

The Food and Drug Administration (FDA) has authorized booster shots of the Pfizer COVID-19 vaccine, Comirnaty.

According to a news release, the single booster shot is authorized to be administered at least six months after the primary doses in patients 65 years of age and older, patients between 18 and 64 who are at high risk of severe COVID-19, and in patients who work in close proximity to the virus which leaves them at risk for severe COVID-19.

“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,” Acting FDA Commissioner Janet Woodcock, MD, says 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. 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 move was expected after the FDA Vaccines and Related Biological Products Advisory Committee held an open meeting Sept. 17 where they voted against authorizing the additional shots for the general public.

On Aug. 23, the Food and Drug Administration (FDA) fully approved the Pfizer-BionTech COVID-19 vaccine for use in people age 16 and older, the first COVID vaccine to receive such approval.

“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,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, says in the release. “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. 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.”