F.D.A. Panel Meets on Moderna Boosters – The New York Times

A key advisory committee to the Food and Drug Administration voted unanimously on Thursday to recommend a booster shot of the Moderna coronavirus vaccine for many of the vaccine’s recipients, at least six months after a second dose.

The panel endorsed a half-dose as a third injection for people 65 and older as well as younger adults at high risk because of their medical conditions or jobs, the same groups of people who became eligible for a Pfizer-BioNTech booster last month. While regulators are not obligated to follow the panel’s recommendations, they typically do.

Although committee members decried the lack of more robust data justifying a booster shot, several emphasized that F.D.A. had already set a precedent by authorizing additional shots on an emergency basis for many recipients of the Pfizer-BioNTech vaccine.

“From a pragmatic point of view,” said Dr. Stanley Perlman of the University of Iowa, “because we’ve already approved it for Pfizer, I don’t see how we can possibly not approve it for Moderna.”

The panel voted after hearing from Moderna officials, agency scientists and a top public health official from Israel, which began offering boosters to Pfizer recipients two and a half months ago.

Dr. Eric Rubin, an adjunct professor of immunology and infectious diseases at the Harvard T. H. Chan School of Public Health, questioned whether Moderna has enough data showing whether a booster shot will create adverse side effects.

Like Pfizer, “Moderna is presenting the results of a relatively small trial,” he said. But “Pfizer had all those real-world data from Israel” on its booster campaign, showing results from “millions of people who received the vaccine,” he said.

Johnson & Johnson has asked the Food and Drug Administration to issue emergency use authorization for a booster for recipients of their vaccines, and the panel will vote Friday on the company’s request. They will also hear then about the initial results of an ongoing federal study that found Johnson & Johnson recipients may benefit more from a booster of Moderna’s or Pfizer’s vaccineLater Thursday, the committee will discuss, but not vote on, whether to consider broader eligibility for boosters of both Pfizer and Moderna’s vaccines, allowing people younger than 65 but not at especially high risk to get them.