FDA panel recommends Moderna COVID vaccine booster shot for Americans 65 and older or those at high risk

Moderna’s COVID-19 vaccine booster shot is one step closer to approval after a recommendation by a critical Food and Drug Administration panel on Thursday.

The agency’s Vaccines and Related Biological Products Advisory Committee voted to recommend Moderna’s booster, unanimously agreeing that a half-dose of the vaccine would be safe and effective for Americans 65 and older, or for those at-risk of severe infection or who work in high-risk settings.

“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,” the Cambridge-based company tweeted Thursday afternoon. “We thank the committee for their review & for their unanimous vote in support of [Emergency Use Authorization] of the 50 µg booster dose.”

The FDA, which isn’t required to follow the 19-member committee’s advice but often does, previously approved Pfizer-BioNTech vaccine booster shots for older and at-risk Americans.

An agency decision on the Moderna booster is likely within the next few days, followed by review and a final call by the Centers for Disease Control and Prevention.

The federal government continues its review of data on the safety and efficacy of the booster shot from vaccine maker Johnson & Johnson.

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