FDA authorizes Pfizer COVID-19 booster for people at high risk

Third shot would be available for high-risk people six months after initial vaccination

Colored tape on the floor guides COVID-19 vaccine recipients to the vaccine administration room at a neighborhood vaccination center in Washington earlier this year. The FDA authorized a third shot for the Pfizer vaccine on Wednesday.  (Bill Clark/CQ Roll Call)
Colored tape on the floor guides COVID-19 vaccine recipients to the vaccine administration room at a neighborhood vaccination center in Washington earlier this year. The FDA authorized a third shot for the Pfizer vaccine on Wednesday. (Bill Clark/CQ Roll Call)
Posted September 22, 2021 at 8:32pm

The Food and Drug Administration authorized a third shot of the Pfizer COVID-19 vaccine Wednesday night for people most vulnerable to COVID-19.

The FDA amended the emergency use authorization of the Pfizer vaccine to allow for boosters six months after initial vaccination for people 65 years of age and older, people 18 and older at risk of getting severe COVID-19 due to their medical history and people at high risk of exposure through a job or institution. 

“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,” said acting FDA Commissioner Janet Woodcock in a statement. 

Woodcock added that the FDA would continue to evaluate the need for boosters as the pandemic evolves and would keep the public informed. 

The vaccine has already been fully approved by the FDA for two doses.

Regulators scrambled to find a creative solution when the FDA’s independent advisers on Friday resoundingly rejected recommending Pfizer’s request to approve boosters for all. Citing evidence of enduring long-term immunity in most populations, the Vaccines and Related Biological Products Advisory Committee instead voted in favor of a more narrow booster program focused on the most vulnerable, including those age 65 and over and people in high-risk occupations.

The days of delay come amid tensions between the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, who supported a third shot, and the division’s top vaccine reviewers, Director of the Office of Vaccines Research and Review Marion Gruber and her deputy Phil Krause, who publicly opposed boosters in favor of global donations. Both Gruber and Krause recently announced their retirements.

“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 Marks in a statement, adding that "the FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision."

The emergency use authorization also gives the FDA flexibility to continue to evaluate the data for signs of waning immunity in other populations, experts say. 

"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," Marks said.

“I think this really gives FDA the room they need and the time they need to say alright, we know there's additional data out there,” said Norman Baylor, a pharmaceutical consultant and former director of FDA’s Office of Vaccines Research and Review, in a media briefing after the advisory committee meeting Friday. 

Some health experts worry the unusually tumultuous process risks leaving the public confused. 

President Joe Biden had set a goal of starting to offer around Sept. 20 a third shot to people eight months after their vaccinations. That raised the eyebrows of public health experts concerned it would put pressure on the scientific agencies to authorize that. They questioned why the president set a specific deadline before all the data had rolled in. 

Pfizer submitted data on the safety and efficacy of booster shots at a median of six months after completing the two-dose vaccination series, not eight months as the president’s original plan suggested.

“What the Biden administration said was that on Sept. 20…, we are going to be offering vaccines to the general public. This isn’t that. We’re going to test the water one foot at a time,” said Paul Offit, a member of the FDA’s advisory committee and director of the Vaccine Education Center at Children's Hospital of Philadelphia, on Friday.