FDA advisory committee recommends Pfizer COVID-19 boosters for people 65+ or at high risk of severe COVID-19

An advisory committee has voted in favor of recommending Pfizer-BioNTech COVID-19 vaccine booster shots for people ages 65 and above as well as for people with high risk of severe COVID-19.

The 18-0 vote came after the Vaccines and Related Biological Products Advisory Committee had already voted 16-2 against recommending Pfizer-BioNTech vaccine booster shots for individuals ages 16 and older.

The U.S. Food and Drug Administration is not bound to follow the committee’s recommendations, though it usually does, according to the New York Times.

In the 16-2 vote, a majority voted against recommending boosters for people 16 and older. The actual question read: “Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least 6 months after completion of the primary series for use in individuals 16 years of age and older?”

The committee later voted “yes” by 18-0 on the question: “Based on the totality of scientific evidence available, including the safety and effectiveness data from clinical trial C4591001, do the known and potential benefits outweigh the known and potential risks of a Pfizer-BioNTech COVID-19 vaccine booster dose administered at least 6 months after completion of the primary series for use in” people ages 65 and above, and people “at high risk of severe COVID-19.”

The panel also indicated that they believe people working in healthcare and other individuals facing high risk of occupational exposure should be included in the emergency use authorization.

So far 63.6% of the U.S. population ages 12 and above has been fully vaccinated against COVID-19, while 74.4% of that demographic has received at least one dose, according to the Centers for Disease Control and Prevention.

In August the FDA approved the the Pfizer vaccine for use in individuals ages 16 and older, making it the first COVID-19 vaccine to secure full approval from the agency. “The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” the FDA noted in announcing the approval last month.


Vaccines and Related Biological Products Advisory Committee – 9/17/2021

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Author: Alex Nitzberg


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