FDA panel approves Pfizer-BioNTech COVID-19 booster shots only for people 65 and older or at high risk

After hours of discussion and a request to revise the question they were being asked, a key federal advisory committee on Friday agreed to a third dose of the Pfizer-BioNTech COVID-19 vaccine six months after full vaccination for people aged 65 and older and those at high risk of severe COVID-19.

The initial question, posed by Pfizer, would have made the booster available to everyone aged 16 and up.

There isn’t yet sufficient evidence to show boosters for people under 65 are necessary, members of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee said.

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Who will be able to get COVID-19 booster shots and when: That’s still in limbo.

Members said getting it right, and waiting to follow the science, were important.

“We may need it but we don’t have the data yet,” said Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital.

The committee doesn’t make the decision for the FDA but FDA almost always takes its recommendations to heart.

The committee’s decision doesn’t mean booster shots for those who got Pfizer doses more than six months ago will immediately become available.

That could come next week, when a Centers for Disease Control and Prevention committee that decides how approved vaccines should be used meets. The Advisory Committee on Immunization Practices is scheduled to discuss the matter on Wednesday and Thursday.

FDA panel approves Pfizer-BioNTech COVID-19 booster shots only for people 65 and older or at high risk

In a somewhat unprecedented move, because of its reservations around the question of boosters, the committee decided to first hold an up-or-down vote on the question of whether to recommend a third dose of vaccine for everyone 16 and older.

It was clear the committee felt the data was strongest for people 65 and older, and possibly health care workers or those at high risk of disease.

The initial vote was two yes and 16 no, but with the understanding that the committee would then discuss a revised voting question. After almost 20 minutes of discussion, a second question was posed.

This one narrowed the use of boosters to people 65 and over and those at high risk of severe disease.

Committee members said there wasn’t yet sufficient evidence to say that the ability of the vaccine to protect against severe illness and death lessened over time in all age groups. They also wanted more safety information for different age groups.

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