— Advisors overwhelmingly support authorization, but shot down full approval bid

by Molly Walker

An FDA advisory panel recommended emergency use authorization (EUA) of a booster dose of the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) for individuals 65 and older, and those judged to be at high risk of severe COVID-19.

On Friday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 18-0 that the known and potential benefits of a booster dose outweighed the known and potential risks for older adults, and for individuals 16 and up at high risk of severe disease.

The committee also agreed that healthcare workers and others at high risk for occupational exposure should be included in the EUA, which Peter Marks, MD, PhD, of FDA’s Center for Biologics Evaluation and Research (CBER), said could include frontline workers, such as teachers, and certain infrastructure workers.

However, full approval of a booster dose was not recommended for all individuals ages 16 and older, by a vote of 2-16, with the committee mainly citing lack of safety data for the general population, including the risk for myocarditis in younger men.

Not only that, but VRBPAC did not buy manufacturer Pfizer’s argument about “waning vaccine efficacy” as a significant driver of transmission, as CDC staff noted that transmission in the U.S. was mainly driven by the unvaccinated population.

“I have major concerns with regards to the extrapolation of the much older population to 16- and 17-year-olds,” said Archana Chatterjee, MD, PhD, of Rosalind Franklin University in North Chicago. “There is no data on this population at all and the safety database presented was too small.”

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