Moderna's latest clinical data confirms its mRNA technology can outperform traditional vaccines outside of Covid-19, setting the stage for a new front in the seasonal flu market.
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Moderna's mRNA flu vaccine shows 27% better efficacy in phase 3 data
Moderna Inc.’s experimental messenger RNA flu shot was 27 percent more effective than standard vaccines in a large-scale trial, a result that could pave the way for the first approval of an mRNA-based flu vaccine and challenge incumbents like GSK. The positive data, published in the New England Journal of Medicine, validates Moderna's technology beyond Covid-19 and sets up a critical U.S. Food and Drug Administration decision by August 5.
"These findings support the role of mRNA-1010 in improving influenza prevention," Dr. Isabel Leroux-Roels of Ghent University and colleagues wrote in the study, highlighting the potential for mRNA technology to offer better protection against a virus that constantly evolves.
The Phase 3 trial, which enrolled over 40,000 adults aged 50 and older, found that about 2 percent of recipients of the mRNA shot, known as mRNA-1010, contracted the flu, compared with 2.8 percent in the group that received a standard licensed vaccine. While side effects like fatigue and headache were more common in the mRNA group, they were typically mild and short-lived. Severe side effects were comparable between the two groups.
The results strengthen Moderna’s position as it seeks to diversify its revenue beyond its Covid-19 vaccine. With $7.5 billion in cash as of its first-quarter earnings report, the company is betting its mRNA platform can conquer multiple diseases. An approval for the flu vaccine would open up a multi-billion dollar annual market and provide a crucial proof-of-concept for its broader pipeline, including a combined flu and Covid shot.
A Faster, More Flexible Platform
The core advantage of Moderna's mRNA platform is speed. Traditional flu vaccines take months to produce, forcing health officials to select viral strains up to a year in advance. This time lag can lead to a mismatch if different strains circulate during flu season, sometimes reducing vaccine efficacy to as low as 20 percent.
"The ability to make vaccine in shorter time periods may help better match new vaccines to emerging influenza viruses,” said Dr. Jesse Goodman, a former FDA chief scientist at Georgetown University. Developing an mRNA shot is significantly faster, potentially allowing for strain selection later in the year and giving drugmakers more flexibility to adapt to viral changes.
The Road to Approval
Moderna’s path to approval has not been without challenges. The FDA initially rejected the company's application in February, arguing it should have tested its shot against a higher-dose vaccine recommended for adults 65 and older, rather than a standard-dose shot. The agency said the choice of comparator could make Moderna's vaccine appear more effective than it is.
Following discussions, the FDA reversed course and accepted an amended application. Moderna split its filing by age, seeking standard approval for adults 50 to 64 and accelerated approval for those 65 and up, with a commitment to run another trial in the older age group post-approval. With a PDUFA date of August 5, the company is now on the cusp of a decision that could reshape the flu vaccine market, currently dominated by companies like Sanofi, GSK, and CSL Seqirus.
This article is for informational purposes only and does not constitute investment advice.
[1] Moderna Announces New England Journal of Medicine Publication of Pivotal Phase 3 Clinical Safety and Efficacy Data for Its Investigational Seasonal Influenza Vaccine, mRNA-1010[2] Moderna’s mRNA flu vaccine more effective than standard shot in late-stage trial[3] Moderna's mRNA flu vaccine outperforms standard shot in late-stage trial[4] Moderna (MRNA) Q1 2026 Earnings Transcript[5] Novavax, Inc. (NVAX) Q1 2026 Earnings Call Transcript
