The Food and Drug Administration has scheduled a meeting for its committee of outside vaccine advisers to discuss approving Pfizer-BioNTech COVID-19’s booster shots.


What You Need To Know

  • The Food and Drug Administration has scheduled a meeting for its committee of outside vaccine advisers to discuss approving Pfizer-BioNTech COVID-19’s booster shots

  • The meeting of the Vaccines and Related Biological Products Advisory Committee is scheduled for Sept. 17, three days before President Joe Biden said the U.S. would start offering the shots to certain people, pending FDA and CDC approval

  • The committee’s recommendation is not binding but will inform the FDA’s decision-making

  • To be transparent, the FDA intends to make background materials publicly available at least two business days before the meeting, which will be livestreamed on YouTube and the agency’s website

The meeting of the Vaccines and Related Biological Products Advisory Committee is scheduled for Sept. 17, three days before President Joe Biden said the U.S. would start offering the shots to people eight months after their initial vaccination was completed, pending approval from the FDA and the Centers for Disease Control and Prevention.

“The administration recently announced a plan to prepare for additional COVID-19 vaccine doses, or ‘boosters,’ this fall, and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses,” Dr. Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation, said in a statement.

The FDA granted full approval to the Pfizer-BioNTech vaccine last month, but booster shots require separate authorization. Boosters, however, are currently available in the U.S. to immunocompromised people.

Marks said the FDA is evaluating data from Pfizer and BioNTech, which the advisory panel will discuss at the committee. The committee’s recommendation is not binding but will inform the FDA’s decision-making. 

“A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines,” Marks said. “The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner.”

To be transparent, the FDA intends to make background materials publicly available at least two business days before the meeting, which will be livestreamed on YouTube and the agency’s website.

Biden’s announcement last month about his booster shot plan was met with criticism for different reasons. Some scientists have argued the move was premature because data showing booster shots are needed are not compelling enough. The World Health Organization’s director-general, Tedros Adhanom Ghebreyesus, called for a moratorium on administering booster shots, saying they would contribute to vaccine inequality among rich and poorer nations.

Those topics are likely to come up during the advisory panel's meeting.

Meanwhile, some health experts have accused Biden of exerting pressure on regulators by announcing his booster plan before they were able to formally review the data.

This week, two top FDA officials —  Director of the Office of Vaccines Research and Review Dr. Marion Gruber and her deputy, Dr. Philip Krause — announced they will be retiring in this fall. According to reports, Gruber and Krause have grown frustrated with the White House and other agencies interfering with the FDA’s work, although it’s not clear whether that is the reason they are retiring.

When asked about their departures Tuesday, Jeff Zients, the White House’s COVID-19 response coordinator, said the Biden administration has been clear all along that its booster shot plan hinges on the FDA and CDC and that the FDA’s acting commissioner, Dr. Janet Woodcock, was among the public health officials who signed off on the announcement.

Biden also said last month that Moderna’s boosters could be administered Sept. 20 as well, but the company only submitted its application to the FDA on Wednesday.

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