Amid heated debate, FDA hands limited nod to Pfizer for COVID-19 vaccine boosters

The FDA's limited emergency use authorization of a third dose of Pfizer's COVID-19 vaccine stopped short of the more sweeping approval of the shot the company was hoping for, which was no surprise given that an advisory board voted 16-2 against making boosters available to all adults. Now, the company is facing a booster rollout amid heated debate on the necessity of additional shots and revelations that two top vaccine experts will depart the FDA before the end of the year.

The FDA ruled yesterday that booster shots of Pfizer’s Comirnaty vaccine should be made available to people age 65 and older, as well as adults with conditions that make them more susceptible to serious complications of the virus or who have jobs that put them at a higher risk of exposure. The Centers for Disease Control and Prevention plans to meet today to refine the booster approval, recommending who can get the shots and when they’ll become eligible.

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Pfizer CEO Albert Bourla, Ph.D., cast the emergency use authorization in a positive light despite its limitations. “We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated,” Bourla said in a statement. “Today’s FDA action is an important step in helping the most vulnerable among us remain protected from COVID-19.”

The U.S. will join other countries that have already started booster programs, including Israel, France, England and Germany. In fact, Pfizer used data from the rollout in Israel to try to bolster its case for making boosters available to all adults in the U.S.

But it appears the FDA wasn't convinced a broad rollout of COVID-19 booster shots is needed in the U.S. “The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision,” Peter Marks, M.D., who leads the FDA’s Center for Biologics Evaluation and Research, said in a statement. Marks said the agency will continue to evaluate data to make further decisions on boosters.

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The debate over COVID-19 booster shots has been contentious, to say the least. When the Biden administration announced plans to make boosters available this week, pending FDA authorization, some experts questioned whether that plan was scientifically sound. The World Health Organization griped that vaccine doses should go to unvaccinated people in developing countries before those in wealthier nations get access to boosters.

During last week's meeting of the Vaccines and Related Biological Products Advisory Committee, several experts pointed out that the data are insufficient to support a sweeping approval. Pfizer cited the boost in antibody levels provided by a third shot, but it wasn't clear how that correlated to protection and transmission, they said. The panelists also raised questions about the safety of a booster dose—especially in younger people—and pointed to the lack of data to properly evaluate the risk.

As the debate erupted last month, news emerged that two key FDA officials are preparing to leave the agency: Office of Vaccines Research and Review Director Marion Gruber, Ph.D., and Deputy Director Phillip Krause, M.D. That leaves Marks as acting director of the vaccines unit until replacements can be found.

Wednesday’s decision on COVID-19 booster shots applies only to those who have been inoculated with the Pfizer vaccine. The FDA will evaluate booster data for the Moderna and Johnson & Johnson vaccines in the coming weeks.