FDA panel recommends booster only for seniors and high-risk individuals

The key scientific advisory council of the Food and Drug Administration (FDA)has voted to deny the use of a “booster” shot of Pfizer’s mRNA vaccine to the general public.

In a 16-2 vote on Sept. 17, 2021, an independent committee of physicians, scientists, and public health experts recommended against full use of the third dose of the vaccine, which now goes by the brand name “Comirnaty.”

However, the panel did recommend the shot for Americans age 65 and older or those at high risk for severe COVID-19. In recommending against the shot for the general public, the committee cited reasons such as lack of sufficient safety data in younger age groups as well as indications that the initial doses still seem to be providing robust protection against severe illness leading to hospitalization and death.

The panel also agreed in a poll – but not a formal vote – that boosters would be beneficial for certain populations, such as health care workers and others at high risk for occupational exposure.

Although the vote is not binding, it is likely that it will form the basis of a formal FDA recommendation.

“It’s likely beneficial, in my opinion, for the elderly and may eventually be indicated for the general population. I just don’t think we’re there yet in terms of the data,” said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

White House chief medical advisor Dr. Anthony Fauci said he wasn’t surprised they didn’t recommend the shots for people 16 and older. Fauci, who has publicly backed boosters, hesitated in an interview Friday on “Closing Bell” to guess what the committee would ultimately decide.

“I don’t want to get ahead of the advisory committee at the time that they’re deliberating,” he said.

The Biden Administration had already announced plans to begin administering boosters to seniors beginning this week.

 

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