Unanimous Yes From Expert Panel on Moderna’s COVID-19 Booster Shot

A unanimous thumbs up on Moderna’s mRNA booster shot. That was the outcome of a vote taken among the FDA’s vaccine expert panel yesterday.

All of the 19 members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted yes on granting Emergency Use Authorization (EUA) to Moderna’s 50 mcg booster for people age 65 and older, adults at high risk of severe COVID-19 and adults who are frequently exposed to COVID-19. The committee green- lighted administering the half-dose booster dose six months after the second full dose in the two-jab series.

This is the same authorization Pfizer-BioNTech got in September for their mRNA COVID-19 vaccine booster (DID, Sept. 23).

“This positive recommendation is supported by data on the 50-µg booster dose of our COVID-19 vaccine, which shows robust antibody responses against the original virus, but also against the Delta variant,” said Moderna CEO Stéphane Bancel.

Moderna estimates that the positive vote in support of and subsequent approval of its poster could result in up to 1 billion extra doses becoming available for distribution in 2022.

In documents posted publicly two days in advance of the vote, the FDA sounded less enthusiastic about Moderna’s booster, however, saying the company’s data showed that the booster increases protective antibodies — but that the gap between antibody levels before and after the booster shot wasn’t big enough to warrant need or approval. That was especially true in people whose antibody levels stayed high after their initial two doses of the Moderna vaccine, the agency said (DID, Oct. 13).

On Wednesday, researchers from the National Institutes of Health (NIH) found that a “mix and match” approach using different COVID-19 booster vaccines is safe and effective (DID, Oct. 14).

The preliminary findings, released ahead of the FDA advisory committee meeting exploring the issue yesterday and today, suggest that an extra shot of the Moderna or Pfizer/BioNTech jab induces greater immunity than another dose of the Johnson & Johnson (J&J) vaccine. The committee is discussing that topic today.

Meantime, Moderna was called out this week for not providing enough vaccine doses for countries in high need. David Kessler, the chief science officer for the White House COVID-19 response team, warned Moderna to “step up” and offer more doses to countries having a hard time getting the vaccine. Kessler said publicly that members of the Biden administration recently met with the Moderna board, asking the company to offer more doses worldwide via COVAX. He added that the administration could use its authority to make Moderna do so.

On Thursday, a VRBPAC panel member raised the issue at the meeting, and in response, Moderna’s infectious diseases lead Jacqueline Miller directed him to an open letter posted on Moderna’s website outlining major supply commitments for low-income countries in 2022 and a manufacturing plant Moderna says it will build in Africa to make vaccines for residents.

Today, the expert advisers will meet to discuss J&J’s application for approval for its COVID-19 booster shot.

In August, the Biden administration said it wanted to begin administering boosters on Sept. 20. Soon after, scientists from the FDA and elsewhere wrote an article in The Lancet, saying the evidence did not yet exist for boosters for the general public (DID, Sept. 14).

VRBPAC will meet again on Oct. 26 to assess whether to support Pfizer’s request for an updated EUA covering use of its COVID-19 vaccine in children aged five to 11 years old. — Suz Redfearn