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FDA Advisors Vote to Recommend Moderna Boosters

Oct. 14, 2021 — A panel of experts that advises the FDA on vaccine decisions voted unanimously Thursday to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose — half the dose used in the primary series of shots — to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

  • Over age 65
  • Ages 18 to 64 who are at higher risk for severe COVID
  • Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of The New England Journal of Medicine and a temporary voting member on the committee.

The committee meeting is ongoing. This story will be updated.

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