Capitol Correspondence - 10.19.21

FDA Advisory Committee Votes to Approve Moderna and Johnson & Johnson Boosters

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The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) held two meetings last week on COVID-19 vaccine boosters. On Thursday, the committee met to discuss the Emergency Use Authorization of the Moderna COVID-19 vaccine for the administration of a booster dose for individuals 18 years of age and older. The VRBPAC voted unanimously to approve a half-dose (a 50-microgram booster dose) at least six months after the second dose for certain groups: people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 whose setting or occupational exposure to the coronavirus puts them at risk for COVID-19 complications or severe illness.

On Friday, the VRBPAC met to discuss the Emergency Use Authorization of the Johnson & Johnson COVID-19 vaccine for the administration of a booster dose to individuals 18 years of age and older. The committee unanimously approved emergency authorization of a second shot of the vaccine for people who received Johnson & Johnson’s COVID-19 vaccine at least two months after completing their first dose.

The VRBPAC’s recommendations will now go to the FDA, which will make a final ruling soon. The FDA is not bound by the committee’s recommendations, but it generally follows them.