A federal vaccine advisory panel today gave its stamp of approval to Moderna’s mRNA influenza vaccine (mRNA-1010) for older adults.

By a unanimous vote, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend approval of the investigational vaccine, which will be marketed under the brand name mFlusiva, for the prevention of flu in adults age 50 to 64. 

They also voted in support of accelerated approval in adults aged 65 and older. Moderna will be required to conduct a phase 4, post-marketing study to demonstrate effectiveness in the older group.

The recommendation comes after several months of regulatory uncertainty over the vaccine. After initially agreeing to review Moderna’s application for approval of the vaccine, the FDA changed course in February, saying that the phase 3 trial for mRNA-1010 was not “adequate and well-controlled” because it used a standard-dose seasonal flu vaccine as the comparator vaccine. 

Moderna said that while the FDA had expressed a preference to use a high-dose flu vaccine as a comparator, agency officials had agreed that a standard-dose flu vaccine was an acceptable comparator.

The move raised concerns about shifting regulatory standards under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., who has been openly critical of mRNA vaccines. In August 2025, Kennedy canceled $500 million in funding for 22 mRNA vaccine projects.

But a week later, the FDA reversed itself again after Moderna proposed a revised regulatory approach. The agency agreed to review the application for full approval in adults age 50 to 64 and accelerated approval for adults aged 65 and older, with an agreement to conduct a post-marketing study in the 65 and older group.

All nine members voted in favor of approval

The VRBPAC review focused on data from the phase 3 trial, which involved nearly 41,000 adults 50 years and older in 11 countries during the 2024-25 flu season. The trial found mRNA-1010 provided significantly better protection against flu-like illness than standard-dose shots, with a relative vaccine efficacy of 27%. Immunogenicity data indicated efficacy in the 65 and over group.

VRBPAC members were tasked with reviewing the data and voting on two questions: Do the benefits of mFlusiva outweigh the risks for the prevention of flu in adults aged 50 to 64, and do the benefits outweigh the risks in adults aged 65 and older? For the second question, members had to decide whether the immunogenicity results from the phase 3 trial provided a reasonable basis to predict clinical benefit.

Although there were questions about the length of the trial (which covered only one flu season), the lack of data in immunocompromised and very frail older adults, and more reactogenicity events (primarily fever) in those who received mRNA-1010, all nine panel members voted yes on both questions.

“I do believe the data presented support that the benefits of the vaccine in both age groups outweigh the risks,” said VRBPAC member Flor Munoz-Rivas, MD, an expert in pediatric infectious disease at Baylor College of Medicine.

Moderna officials hailed the recommendation.

“We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform,” Moderna CEO Stephane Bancel, MBA, MSc, said in a company press release. “We look forward to continuing to work with the FDA as it completes its review.”

Because mRNA-1010 uses mRNA technology instead of traditional egg-based methods, Moderna has suggested it could be updated more quickly to match circulating flu strains or a pandemic flu strain. Several VRBPAC members cited that as a potential benefit.

This is something that looks like it has considerable promise in a number of ways, so I think it’s very important that there has been a careful review and an open discussion.

“This particular platform adds exciting ways that we can actually move our vaccines to the future,” said Hayley Gans, MD, of Stanford Medicine.

In a media briefing after the vote, members of Georgetown University’s Expert Vaccine Analysis Team said they were happy that the FDA changed course and agreed to review the vaccine and that the VRBPAC members carefully and thoroughly weighed the risks and benefits of the vaccine before voting to recommend approval. 

“This is something that looks like it has considerable promise in a number of ways, so I think it’s very important that there has been a careful review and an open discussion,” said Jesse Goodman, MD, MPH, a professor of medicine and infectious diseases at Georgetown and former director of the FDA’s Center for Biologics Evaluation and Research.

The recommendation now heads to the FDA, which has said it will make its decision by August 5.