October 14, 2021 – A panel of experts advising the FDA on vaccine decisions voted unanimously on Thursday to approve booster doses of Moderna’s COVID-19 vaccine.
All 19 members of the FDA’s Vaccines and Related Biologics Advisory Committee voted to allow a dose of 50 milligrams – half the dose used in the first round of injections – to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups that got the go-ahead for third doses of Pfizer. They include people:
- Over 65
- 18 to 64 year olds at higher risk of severe COVID
- Who are more at risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as are healthcare workers
The agency is not bound by the committee vote but generally follows its recommendations.
Some committee members said they were not happy with the data Moderna submitted in support of its claim but, for practical reasons, said it would not be fair to take the booster doses off the table for patients. Moderna recipients when Pfizer recalls were already available.
“The data is not perfect, but these are extraordinary times and we have to work with data that is not perfect,” said Eric Rubin, MD, editor-in-chief of The New England Journal of Medicine and a temporary voting member of the committee.
The committee meeting is in progress. This story will be updated.