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FDA panel recommends COVID-19 booster for some, excludes teens

September 17, 2021

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A federal advisory panel on Friday unanimously recommended approval of emergency use authorization (EUA) for a booster dose of Comirnaty mRNA vaccine in a segment of the vaccinated population, including health care workers, individuals 65 years and older and those at increased risk of COVID-19.

However, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not recommend approval of a third dose of the Pfizer-BioNTech vaccine for everyone ages 16 and older.

The FDA is expected to review the panel’s recommendation for emergency use authorization of a booster dose six months after completing the primary series for those 65 and older and individuals at high risk of severe COVID-19. If approved by the FDA, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices would discuss the measure as early as next week.

The VRBPAC recommendation is based on the totality of scientific evidence available, including safety and effectiveness data from clinical trial C4591001.

In phase 3 studies of individuals ages 18 to 55 years old, safety and immunogenicity data met the FDA criteria for a booster dose, according to Pfizer.

Pediatrician members of VRBPAC expressed concern that there are not enough data to support a booster dose for younger ages.

Archana Chatterjee, M.D., Ph.D., FAAP, said she was concerned with the extrapolation of booster dose data from older populations to 16- and 17-year-olds.

“I think this (vote) should demonstrate to the public that the members of this committee are independent of the FDA and that in fact we do bring our voices to the table when we are asked to serve,” she said.

Members also said more data are needed regarding the risk of myocarditis after a booster, particularly for younger people.

Although the advisory panel did not approve a broad booster recommendation, Capt. Amanda Cohn, M.D., FAAP, of the CDC National Center for Immunizations and Respiratory Diseases, said the recommendation addresses the greatest need among those who were vaccinated early or otherwise need boosted protection.

“At this moment, it is clear that the unvaccinated are driving transmission in the United States,” she said. “Other interventions such as (physical) distancing and masking will have to be part of the solution.”

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