FDA Panel Votes Down Pfizer/BioNTech COVID-19 Booster

An FDA advisory panel declined Friday to recommend approval of a Pfizer/BioNTech COVID-19 vaccine booster for the general population but it voted unanimously, 18-0, to grant an updated Emergency Use Authorization (EUA) covering boosters in people 65 years and older as well as those at high-risk of progressing to severe disease.

The 16-2 vote against boosters for the general population with the Pfizer/BioNTech shot has immediate ramifications for a campaign the Biden administration anticipated rolling out as soon as today.

On Wednesday, a separate advisory committee to the Centers for Disease Control and Prevention (CDC) will meet to clarify recommendations regarding what segments of the population should receive a COVID-19 booster. The FDA panel on Friday clearly did not believe that the available data make a convincing case that boosters are needed for the general population.

And the Biden administration has pledged to rely on science-based decisions by the FDA and the CDC to determine how it handles the rollout of boosters.

In an impromptu “poll” at Friday’s meeting, the FDA advisory panel also voted 18-0 in favor of having the EUA encompass healthcare workers or those at high-risk because of their jobs. In August, the FDA authorized a booster shot of either the Pfizer/BioNTech or Moderna COVID-19 vaccines but only for the immunocompromised (DID, Aug. 12).

“That’s the beauty of an EUA … It can be changed based on changing data,” said Arnold Monto, a public health expert with the University of Michigan and the advisory committee’s acting chair.

However, the FDA isn’t bound to follow recommendations from its advisory committees, a point made by Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, who implied boosters may be made available more broadly.

“The decision the FDA needs to make is based on complex data that’s evolving in front of our eyes,” said Marks shortly before voting on the first question began, adding that it’s “no secret here that there is still debate over the need of an additional COVID-19 vaccine at this stage in the pandemic.”

Data from real-world studies in Israel fueled much of the day’s debate. Those findings suggested that a Pfifzer/BioNTech booster significantly improved protection against COVID-19 and severe disease for older adults.

But many panelists were wary of extrapolating those results to the general U.S. population across all age groups, expressing concerns over possible risks of heart inflammation among certain groups, especially teenage boys and young men. There were also concerns about whether there was sufficient safety and efficacy data to determine that a booster’s benefits outweighed the risks and how long of an interval should be between a primary series and a third shot.

Among the dissenting panelists were the FDA’s Marion Gruber and Phil Krause, who recently penned a paper in The Lancet arguing that while evidence about boosters is still being gathered, it makes more sense to ensure that unvaccinated populations get vaccinated first than to provide boosters to those who have already gotten shots (DID, Sept. 14).

During the session, Marks thanked Gruber, director of the agency’s Office of Vaccines Research & Review (OVRR) and Krause, deputy director of OVRR, for their years of service to agency. Both announced their resignation in recent weeks, hinting at internal conflicts over the booster program (DID, Sept. 1).

The Pfizer/BioNTech received full FDA approval last month, making it the first and, so far, only COVID-19 vaccine to be granted that status in the U.S. (DID, Aug. 24).

Moderna has also filed a biologics license application that is under agency review and is expected to be next in line for a full approval (DID, June 2). ― Jason Scott