Two Days Ahead of AdComm, FDA Says Moderna’s Booster Hasn’t Met Criteria

Just two days in advance of an independent advisory committee meeting to discuss whether or not the FDA should grant Emergency Use Authorization (EUA) to Moderna’s COVID-19 booster shot, the FDA has released documents saying Moderna hadn’t met all of the agency’s criteria to support use of a booster.

In documents posted publicly Tuesday, the agency said Moderna’s data do show that the company’s mRNA vaccine 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.

FDA’s documents as well as Moderna’s were posted publicly in advance of the FDA’s independent advisory panel meeting on Thursday to discuss Moderna’s application for its booster shot.

Moderna is seeking the green light for a 50-microgram booster for adults age 65 and over, as well as for high-risk individuals. The booster is half of the strength of the dose in the vaccine’s initial two-shot course.

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

On Friday, the expert advisers will meet to discuss Johnson & Johnson’s (J&J) application for approval for its COVID-19 booster shot.

In the briefing documents, J&J outlined the benefits of a booster for its one-shot vaccine and said its data showed that the booster could benefit high-risk people if given two months after the first dose and after six months for those at lower risk.

Also this week, the National Institutes of Health (NIH) will present data on mixing and matching different shots of the Pfizer/BioNTech, Moderna and J&J vaccines (DID, Oct. 4). NIH has said it will not release briefing documents ahead of that meeting.

If the FDA authorizes the boosters this week, advisers to the Centers for Disease Control and Prevention (CDC) will convene next week to hammer out recommendations on who can get the boosters.

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 does not yet exist for boosters for the general public (DID, Sept. 14).

The FDA’s Vaccines and Related Biological Products Advisory Committee 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.

Read the briefing documents here: bit.ly/3mP1ddP. — Suz Redfearn