FDA Panel Rejects Plan to Administer Pfizer’s COVID-19 Booster to Most Americans

The Associated Press
The Associated Press

A Food and Drug Administration (FDA) panel voted Friday afternoon to reject a plan to provide Pfizer-BioNTech coronavirus booster vaccines for most Americans, due to a lack of data showing that the additional doses are safe and effective. However, the agency’s advisory committee said it may still approve the shots for older individuals.

The panel opposed the proposal by a vote of 16-12.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” Dr. Cody Meissner, Tufts University professor, said as panel members debate the requirement for a booster shot. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”

“At this moment it is clear that the unvaccinated are driving transmission in the United States,” added Dr. Amanda Cohn of the Centers for Disease Control and Prevention (CDC).

Booster shots by Pfizer or Moderna have already been greenlighted for Americans who are immunocompromised.

The FDA panel’s overwhelming rejection came despite full-throated arguments about the need for boosters from both Pfizer and health officials from Israel, which began offering boosters to its citizens in July.

Sharon Alroy-Preis of Israel’s Ministry of Health said the booster dose improves protection tenfold against infection in people 60 and older.

“It’s like a fresh vaccine,” bringing protection back to original levels and helping Israel “dampen severe cases in the fourth wave,” she said.

The Associated Press contributed to this report. 

UPDATE: 4:30 P.M. EST. — The FDA advisory panel has voted unanimously to support boosters for 65+ year-olds and those “at high risk of severe Covid-19.”

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