FDA Now Recommends Moderna Covid Booster for At-risk Adults

This week a key Food and Drug Administration committee has unanimously recommended giving booster shots of Moderna’s Covid-19 vaccine to people 65 and older and other vulnerable Americans.

The FDA’s vote was a crucial step before the U.S. can start giving third shots to roughly 69 million people who originally received that vaccine.

The nonbinding decision was made by the FDA’s Vaccines and Related Biological Products Advisory Committee and would bring guidelines for Moderna in line with third shots of the Pfizer-BioNTech vaccine.

The Pfizer-BioNTech shots were authorized less than a month ago.

A final FDA decision on Moderna boosters could come within days.

A CDC vaccine advisory committee is then expected to vote on the FDA’s proposal next week.

If it recommends approval and the CDC endorses it the booster shots could begin immediately for eligible Americans who have finished their immunizations at least six months ago.

FDA committee member Dr. Patrick Moore said the data the company submitted for authorization of a booster “was not well explained,” adding he voted yes more on “gut feeling.

“The data itself is not strong, but it is certainly going in a direction that is supportive of this vote,” he said.

Dr. Paul Offit, another member, said that most people who have received the first two doses of Moderna’s vaccine are still well protected and said he hopes the recommendation doesn’t send the “wrong message” to the general public.

“If we’re trying to prevent what is inevitable, which is a decline in neutralizing antibodies and an erosion in protection against mild or asymptomatic infection, that is a high bar to which we hold no other vaccine,” he added.

Dr. Peter Marks, the FDA’s top vaccine regulator remarked at the meeting, “I would ask that we do our best to focus our deliberations on the science related to the application under consideration today, and not on operational issues related to a booster campaign or issues related to global vaccine equity.”

Moderna applied for FDA authorization of a booster dose on Sept. 1.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.