FDA Panel Rejects Pfizer Booster Plan, Mulls Narrower One

(Bloomberg) — A U.S. Food and Drug Administration panel of expert advisers voted against a third dose of the Pfizer Inc.-BioNTech SE vaccine for everyone 16 and older but was considering a booster shot for a more limited population of older adults and other vulnerable populations.

© Bloomberg Booster Vaccines At French Retirement Home

The FDA had asked the advisory panel to vote on whether the safety and effectiveness data submitted by the companies support approval of a booster dose for people age 16 and up. 

Panelists are now weighing narrower options after rejecting that proposal in a 16-2 vote. The FDA has proposed voting on boosters for people age 65 and older, as well as those with chronic illnesses and people who could be exposed to the coronavirus through work.

The FDA will still ultimately decide on whether the booster is approved, and the agency doesn’t have to follow the panel’s recommendations, though it often takes them into consideration. The regulator could still grant a wide approval, or it could take a more tailored approach that clears the booster for narrower age groups.

Further, an outside advisory panel to the Centers for Disease Control and Prevention will also make recommendations for the use of any approved vaccine.

Some of the FDA panelists indicated that while they see a potential need for older or other more vulnerable groups to receive a third dose, the need for younger people could be less pressing, and may pose other medical risks.

“There are very clear populations where a booster may be appropriate, such as elderly or immunocompromised,” said National Institutes of Health scientist Michael Kurilla. “It’s not clear to me that the data we’re seeing right now is applicable or necessary for the general population.”

Panelist Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, also questioned the wide framing of the FDA question, and raised concerns about the risk of myocarditis, a kind of heart inflammation, for younger men.

The concerns from the panel prompted the chairman of the committee to vote earlier than scheduled to allow the committee time to discuss other options.

Shares of Pfizer declined 1.3% in New York trading at 3:55 p.m., and BioNTech shares were down 3.8%. Shares of Moderna Inc., maker of a similar Covid vaccine, were down 2.5%.

(Updates with more detail on voting plans throughout)

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