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FDA panel backs Pfizer COVID booster for people 65+ and with weak immunity

vaccines
The Centers for Disease Control and Prevention already recommends boosters for those with weakened immune systems. (Bridge photo by Dale Young)

Oct. 18: COVID vaccine boosters: When, where and how to get them in Michigan
Sept. 24: Pfizer COVID vaccine booster approved for Michiganders. Now what?

Sept. 20: Pfizer: COVID vaccine gives ‘robust’ protection for children ages 5 to 11

A federal advisory panel Friday recommended approval of a booster shot of the Pfizer vaccine for people aged 65 and older and for those whose immune systems may be compromised, once six months have passed since they were fully vaccinated.

The same panel rejected a far broader request from the Biden Administration that would have permitted the general population over age 16 to be eligible for boosters this fall.

 

Following a nearly all-day hearing Friday, the U.S. Food and Drug Administration’s advisory committee first voted against approving a booster of the Pfizer vaccine for the general population. It then voted late in the day to give emergency authorization for the Pfizer booster for those who are immunocompromised and those who are 65 and older, since these groups are considered more vulnerable to the most severe symptoms of the disease and least able to mount a full vaccine-triggered immunity.

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In August, the Biden administration announced it would make Pfizer and Moderna boosters available for anyone 16 and older beginning Sept. 20. Those who were immunocompromised were immediately eligible for a booster.

In Michigan, more than 88,000 people already have received boosters, primarily those 65 and older, according to the state’s vaccine dashboard.

Overall, nearly 1.4 million Michigan residents (representing 78.4 percent of the nearly 1.8 million Michigan residents 65 or older) are fully vaccinated, receiving a mix of the three vaccines now available in the country.

The Biden administration had been criticized for making the booster announcement ahead of FDA approval. The FDA’s Vaccines and Related Biological Products Advisory Committee — chaired by University of Michigan epidemiologist Dr. Arnold Monto — focused only on the requested approval for a booster of the Pfizer vaccine, which now is marketed as Comirnaty and was given full FDA approval in August. 

Moderna has also asked for approval of its vaccine as a booster.

But the Biden administration aggressive push for boosters has met stiff resistance among government scientists and some health experts. The FDA panel said it worried there was not yet enough data to show boosters were broadly necessary, and some asked for more safety data on its impact on teenagers. 

Already, some have questioned the push for boosters when COVID vaccines are broadly available in the U.S. while so much of the globe’s population still awaits initial doses.

The vote on the recommendation for older and immunocompromised people now goes before the FDA. A hearing has been scheduled next week in front of the Centers for Disease Control’s Advisory Committee on Immunization Practices, which has scheduled a two-day meeting starting Wednesday.

The CDC must approve any booster dose before they can be given to the general population.

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