FDA advisers recommend Moderna COVID-19 booster shots

Advisers to the Food and Drug Administration decided in a unanimous 19-0 vote Thursday to endorse Moderna COVID-19 booster shots for the most vulnerable to severe complications despite some concerns about the depth of evidence, acknowledging that the urgency of the pandemic required prompt action.

The Vaccines and Related Biological Products Advisory Committee recommended a third Moderna shot for people who are 65 years old or older, adults with underlying health conditions that put them at higher risk for severe COVID-19 and adults at high risk of exposure because they work in an essential job or live in an institution like a prison or homeless shelter.

The panel suggested giving half the dose of the first two, given at least six months after the second shot.

The next step is for the FDA to formally issue an emergency use authorization. The agency usually follows its advisers’ recommendations. After that, the Centers for Disease Control and Prevention will undergo a similar process. Its advisers will likely endorse or refine the FDA’s decision in its own recommendations, and CDC Director Rochelle Walensky has a final say.

The FDA advisory panel met for nearly seven hours to parse data Moderna submitted to the FDA. Moderna found a booster shot ramped up antibodies without serious side effects.