As the flu season unfolded last year, the available vaccines turned out to be mismatched to the strain that became dominant. The vaccines still offered some protection, but that protection was diminished. A Moderna flu vaccine made with technology that enables quick adjustments to respond to viral mutations now has FDA approval, and the company will make this shot available for the upcoming respiratory virus season.
The regulatory approval announced late Wednesday covers adults age 50 and older. Known in development by the code name mRNA-1010, this Moderna messenger RNA flu vaccine will reach the market under the brand name mFLUSIVA. It joins a Moderna respiratory products lineup that includes mRNA vaccines for Covid-19 and respiratory syncytial virus (RSV).
Flu vaccines have historically been made from egg or cell culture, and the entire process from start to finish takes months. That means a decision on which strains to address each respiratory virus season must be made well in advance. By the time the season arrives, those strains may have mutated. That’s what happened last year.
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Vaccines based on mRNA can be manufactured more quickly, so decisions about strains can be made closer to the flu season, and further adjusted if there’s a change or even a pandemic. Moderna’s flu vaccine works by delivering mRNA to the protein-making machinery of cells, getting them to produce full-length hemagglutinin, a protein expressed on the surface of influenza viruses. This protein elicits an immune response that protects against the pathogen. Moderna’s new vaccine covers three flu strains.
In a video posted Wednesday to the investor relations section of the company’s website, Moderna President Stephen Hoge pointed to a June FDA advisory committee meeting where the vaccine received a unanimous vote of support. He noted that committee members said mFLUSIVA would diversify the sources of vaccine manufacturing with the additional ability to make updates more quickly in years where there’s a mismatch or a pandemic.
“Those sorts of benefits are really unique, we think, to our platform, or at least we’re really proud that they received a vote of support at the advisory committee for mFLUSIVA,” he said.
Moderna’s vaccine nearly lost the opportunity for an FDA review. In February, the regulator sent a refuse-to-file letter telling the company the clinical data submitted were not from adequate and well-controlled studies. That letter was signed by Vinay Prasad, the former director of the Center for Biologics Evaluation and Research. Prasad left the FDA in April. Moderna met with the agency after receiving the letter. Soon afterward, the FDA changed its position and agreed to review the vaccine, but by splitting the application according to age groups.
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For adults age 50 to 64, the FDA regulatory decision for mFLUSIVA is a standard approval. For adults age 65 and older, the Moderna vaccine received an accelerated approval that requires a confirmatory study. According to the FDA approval letter, this post-marketing study will be a safety study to evaluate deaths in a randomized population and an observational study for heart safety risks and Guillain-Barré syndrome, which is an immune response that affects nerves. Guillain-Barré is a rare risk associated with some vaccines, including influenza vaccines.
In note sent to investors on Thursday, William Blair analysts Myles Minter and John Boyle said the approval was expected following the FDA advisory committee’s vote of support. The bank projects mFLUSIVA could achieve $1.16 billion in peak U.S. sales. For context, the influenza market for the 2024-2025 flu season was about $5 billion with a 44% vaccination rate across the country. Moderna told the bank it does not expect mFLUSIVA will meaningfully contribute to revenue in the upcoming flu season due to the time it takes to secure pharmacy contracts and vaccine recommendations.
“Although longer term, we believe that with Moderna’s ability to manufacture updated mFLUSIVA strain vaccines in materially shorter time frames than traditional protein-based vaccines, better coverage, vaccine efficacy, and ultimately greater market share can be garnered by Moderna,” the William Blair analysts said.
Moderna’s flu vaccine still needs to be discussed by the Advisory Committee on Immunization Practices (ACIP), then receive a recommendation from that body and the Centers for Disease Control and Prevention. Though the next ACIP meeting is scheduled for October, the committee has not met all year. The first two meetings were canceled due to ongoing litigation.
The American Academy of Pediatrics and other health organizations have an ongoing lawsuit against Health and Human Services Secretary Robert F. Kennedy Jr., alleging his appointments to ACIP were made illegally. The suit also challenges the removal of five vaccines from the recommended vaccine schedule for children.
ACIP and the CDC can’t take away an FDA approval, but ACIP makes recommendations on how vaccines should be used. When the CDC adopts those recommendations, they become the agency’s policy. How or whether a vaccine receives a recommendation affects how payers cover it. The Affordable Care Act requires coverage of certain preventive services, including immunizations that receive an ACIP recommendation.
Moderna said it expects supplies of its mFLUSIVA will become available in coming weeks. This vaccine is also under regulatory review in the European Union, Canada, and Australia. Submissions in additional countries are planned for this year.
Photo: David L. Ryan/The Boston Globe, via Getty Images