Moderna’s latest late-stage trial shows that its experimental Moderna flu vaccine produces a stronger immune response than a currently available flu shot. This success brings the company closer to securing regulatory approval for both its stand-alone flu vaccine and its combination flu-Covid shot.
Back in May, Moderna voluntarily withdrew its application for the combination jab. The company planned to resubmit it with new efficacy data from the mRNA-1010 flu vaccine trial after talks with the Food and Drug Administration. The FDA, now operating under Health and Human Services Secretary Robert F. Kennedy Jr., has taken a more critical stance on vaccine policy.
With this new data, Moderna aims to refile for approval of the combination vaccine and submit a separate application for its stand-alone flu shot later this year. Stephen Hoge, the company’s head of research and development, said Moderna expects both products to receive approval in 2026 if regulators accept the data.
Moderna shares rose more than 5% in premarket trading Monday following the announcement.
Hoge emphasized that combining flu and Covid protection into one shot could simplify patient care. He said the dual-purpose vaccine would reduce workloads for medical staff, lower costs, and likely improve vaccine uptake.
Among vaccine makers, Moderna currently leads in developing a combined flu and Covid shot. While the company hasn’t released revenue projections, Hoge described flu, Covid, and RSV as multibillion-dollar markets. “We’re hoping our products earn a fair share of those markets,” he said.
The phase three trial enrolled over 40,000 adults aged 50 and older. Participants were randomly assigned to receive either Moderna’s mRNA-1010 or a standard competitor vaccine. The trial found Moderna’s shot to be 26.6% more effective overall.
It also demonstrated high efficacy across all major influenza strains, including A/H1N1, A/H3N2, and B/Victoria. The results remained consistent regardless of age, risk profile, or prior vaccination history.
In adults over 65, Moderna’s flu vaccine outperformed the standard shot by 27.4%. CEO Stéphane Bancel called this a major achievement in reducing flu’s burden among older adults. He also pointed out the severity of the 2024–2025 flu season, which saw the highest number of hospitalizations in 15 years.
The Centers for Disease Control and Prevention reported more than 600,000 flu-related hospitalizations last season alone.
The company confirmed that safety data for the Moderna flu vaccine matched earlier results. No new side effects emerged in the study.
Despite this progress, Moderna’s stock had dropped over 30% year-to-date before Monday. That decline followed several regulatory changes from the Trump administration. In one move, the administration canceled a federal contract supporting Moderna’s late-stage bird flu vaccine for humans.
Hoge acknowledged the uncertainty in current U.S. regulatory processes. However, he said the team maintains active communication with the FDA. “As far as flu goes, we believe the approval path is clear,” he said.
If approved, the Moderna flu vaccine could strengthen the company’s post-Covid portfolio and pave the way for the first widely available combination respiratory vaccine.
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