FDA panel unanimously recommends Moderna Covid booster shots for at-risk adults

A key Food and Drug Administration advisory committee unanimously recommended Thursday giving booster shots of Moderna’s Covid-19 vaccine to people age 65 and older and other vulnerable Americans, a crucial step before the U.S. can start administering third shots to some of the more than 69 million people who originally received that vaccine.

The nonbinding decision by the FDA’s Vaccines and Related Biological Products Advisory Committee would bring guidelines for Moderna in line with third shots of Pfizer and BioNTech’s vaccine. Those shots were authorized less than a month ago to a wide array of Americans, including the elderly, adults with underlying medical conditions and those who work or live in high-risk settings like health and grocery workers.

While the agency hasn’t always followed the advice of its committee, it often does. 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, booster shots could begin immediately for eligible Americans who completed their immunizations at least six months ago.

Booster shots have been a contentious topic for scientists — in and outside the government — especially as many people in the U.S. and other parts of the world have yet to receive even one dose of a vaccine. The World Health Organization is urging wealthy countries to hold off on distributing boosters, and some scientists say they aren’t convinced most Americans need boosters right now.

When the FDA committee met last month, they rejected a proposal to distribute booster shots of Pfizer and BioNTech’s vaccine to the general public. Some committee members at the time said they were concerned there wasn’t enough data to make a recommendation, while others argued third shots should be limited to certain groups.

After Moderna’s unanimous vote Thursday, 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.

Some members said the boosters should prevent so-called breakthrough infections, which they said is critical for protecting health-care institutions from becoming overwhelmed, while other members said the third shots should ensure those at high risk won’t suffer from severe disease. Some committee members also suggested young people may not need boosters as the initial shots are still holding up in those groups.

Dr. Paul Offit, another member, stressed 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 told his colleagues.

The Biden administration hopes giving the U.S. population additional doses will ensure long-term and durable protection against severe disease, hospitalization and death as the fast-moving delta variant continues to spread.

Dr. Peter Marks, the FDA’s top vaccine regulator, addressed the committee Thursday before the vote, telling the panel of experts that the agency encourages “all the different viewpoints” regarding the “complex and evolving” data.

“That said, as we proceed, 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 on issues related to global vaccine equity,” he added.

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