FDA Advisory Panel Set to Meet on COVID-19 Booster Shots

In COVID-19, Latest News
by Healthday

Public session could add clarity or controversy to what some feel has been a confusing decision-making process

THURSDAY, Sept. 2, 2021 (HealthDay News) — The U.S. Food and Drug Administration will hold a key advisory panel meeting on COVID-19 booster shots on Sept. 17, a mere three days before the Biden administration plans to begin offering third shots for Americans.

While the public session could add clarity to what some feel has been a confusing decision-making process, it also could fuel more controversy over the administration’s plan. Panel member Paul Offit, M.D., a vaccine expert at Children’s Hospital of Philadelphia, has questioned whether boosters are needed at this time because data indicate the vaccines still work well against severe COVID-19. But administration officials have stressed that protection is waning.

Though the stated purpose of the meeting is to review booster data on the Pfizer vaccine, it will likely deal with broader questions about booster shots, The Washington Post reported: Those include who should get booster shots and when, and what is the country’s obligation to other countries that are scrambling for first and second doses of the vaccines.

The panel’s recommendations are not binding. But a split between the FDA expert panel and agency officials could make it more difficult for the agency to approve boosters. If the committee concludes boosters are needed, it could strengthen the agency’s hand in approving a third Pfizer shot and later doing the same for boosters by Moderna and Johnson & Johnson, The Post said. The two-shot Pfizer regimen received full FDA approval last week, while the Moderna and Johnson & Johnson vaccines are still given under an emergency use authorization.

Peter Marks, director of the FDA Center for Biologics Evaluation and Research, told The Post that “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.”

The Washington Post Article

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