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FDA Panel Unanimously Endorses Moderna COVID Boosters for At-Risk Adults

A healthcare worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination site in New York City, January 29, 2021. (Mike Segar/Reuters)

A Food and Drug Administration advisory committee on Thursday unanimously endorsed booster shots of Moderna’s COVID-19 vaccine for those who are at high risk of severe COVID-19, occupational exposure to COVID-19 or are 65 years and older.

The FDA’s Vaccines and Related Biological Products Advisory Committee endorsed a half-dose as a third injection, at least six months after receiving a second dose.  The agency is not required to follow the panel’s recommendation, though it typically does.

An FDA decision could come within days. If the FDA chooses to accept the advice, the CDC vaccine advisory committee would then vote on the FDA’s proposal.

If the shots are approved, it would bring guidance for Moderna shots in line with Pfizer’s COVID-19 vaccine, which was approved for booster shots for the same groups of Americans less than a month ago.

The new guidance would clear up confusion for some of the more than 69 million people who originally received the Moderna shots.

The advisory committee’s recommendation comes after Moderna first applied for authorization of a third dose with the FDA on September 1.

Some FDA officials expressed a desire to “harmonize” its decision over Moderna boosters with what had already been decided for Pfizer to avoid unnecessary public confusion, according to Axios. However, several experts expressed concern over the lack of robust data to justify a Moderna booster shot. Pfizer was benefited by real-world data collected in Israel, which began offering boosters to Pfizer recipients two and a half months ago.

“From a pragmatic point of view, because we’ve already approved it for Pfizer, I don’t see how we can possibly not approve it for Moderna,” Dr. Stanley Perlman of the University of Iowa said.

The FDA advisory committee is set to discuss booster shots for the single-dose Johnson & Johnson COVID-19 vaccine on Friday. While data from the National Institutes of Health show that individuals who received the J&J vaccine may benefit from receiving a Pfizer or Moderna booster shot, the company has asked the FDA to approve a second shot of its own vaccine.

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