FDA advisors approve J&J COVID vaccine boosters


The Food and Drug Administration (FDA) vaccine advisory group today unanimously approved a booster dose of Johnson & Johnson (J&J) vaccine for all Americans 18 years old and older who received a single dose.

Also today, the experts discussed mix-and-match dosing, raising several questions and airing multiple issues, but they took no vote on the issue.

Booster would target all J&J recipients

Today’s vote by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)—affirming that data support the safety and effectiveness of the J&J booster dose—was unanimous and followed the group’s unanimous nod for Moderna boosters yesterday for high-risk groups.

The group’s decision is nonbinding, and FDA officials will make the final decision, paving the way for Center for Disease Control and Prevention vaccine advisors to hold their recommendation discussions, slated for next week. In February the FDA granted the J&J vaccine emergency use authorization (EUA) as a single-dose product.

Unlike the booster recommendation for the two mRNA vaccines (Moderna and Pfizer-BioNTech), which targets those at highest risk, today’s booster recommendation includes anyone who got the J&J vaccine. The booster should be given at least 2 months after the primary, or initial dose. About 14 million doses of the vaccine have been given in the United States.



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