FDA panel unanimously approves Moderna’s COVID-19 vaccine booster shots

An advisory committee for the Food and Drug Administration voted unanimously on Thursday to approve the Moderna COVID-19 booster shot for recipients over 18. In the first day of a two-day meeting to evaluate requests from both Moderna and Johnson & Johnson to authorize their booster doses, the panel voted 19-0 to approve Moderna boosters beginning at least six months after completion of the initial two-dose regimen. On Friday, the committee will meet to evaluate the Johnson & Johnson booster dose, which is produced by subsidiary Janssen.

The authorization applies to people 65 years and older as well to those between 18 and 64 who are at high risk for the disease. Moderna officials said in a tweet: “We are grateful for the opportunity to present the clinical data package for our COVID-19 booster vaccine to the FDA’s advisory committee today. We thank the committee for their review & for their unanimous vote in support of EUA of the 50 [microgram] booster dose.”

Last month, the FDA approved a third shot of the vaccine made by Pfizer for people over 65, as well as recipients between 18 and 64 who are at high risk of severe illness and who face frequent institutional or occupational exposure to COVID-19. Almost 9 million people in the United States have received a booster dose of the Pfizer vaccine over the past few weeks, according to the Centers for Disease Control and Prevention.

The panel’s recommendations will have to be approved by the FDA and CDC before Americans could begin to receive the Moderna and Janssen boosters. The soonest the agencies could grant that approval is Oct. 22.

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