Stronger immune response clears path for combo Covid-flu shot
Moderna announced Monday that its experimental mRNA-based flu vaccine outperformed an existing standard shot in a pivotal late-stage trial. The results bring the company a step closer to launching its stand-alone flu jab and a combined influenza-Covid vaccine, potentially reshaping the future of immunization.
The new data showed Moderna’s vaccine, mRNA-1010, was 26.6% more effective than a standard flu vaccine across a study of over 40,000 adults aged 50 and older. Among seniors aged 65 and up, the shot proved 27.4% more effective. Moderna said the benefits were consistent across various demographics, including those with underlying risk factors and prior flu vaccine history.
Moderna eyes resubmission and FDA approval
Moderna voluntarily withdrew its previous application for the combination shot in May, intending to resubmit it with stronger efficacy data following talks with the FDA. With these new results in hand, the company now plans to refile both the combo vaccine and the stand-alone flu shot later this year. Approvals could come in 2025, according to Moderna’s head of R&D, Stephen Hoge.
The breakthrough is especially timely, as the FDA faces a major restructuring under Health and Human Services Secretary Robert F. Kennedy Jr., a controversial figure due to his long-standing criticism of vaccines. Hoge said Moderna is working closely with regulators to navigate the shifting environment and ensure compliance with all requirements.
Strategic edge over rivals in multibillion-dollar market
Moderna appears to be ahead of competitors Pfizer and Novavax in the race to launch a dual-use vaccine. The combination jab, which simplifies the vaccination process by merging flu and Covid protection, could significantly reduce healthcare burdens and boost vaccination rates, Hoge said. Though the company has not issued specific financial forecasts, Moderna sees Covid, flu, and RSV as multibillion-dollar opportunities.
The mRNA-1010 vaccine targets major flu strains, including A/H1N1, A/H3N2, and B/Victoria. Safety results from the phase three trial align with previous data, reinforcing confidence in the product’s profile. CEO Stephane Bancel called the findings a “significant milestone” and noted that the severity of the past flu season highlights the urgent need for more effective vaccines.
Regulatory hurdles and political headwinds
Despite the scientific success, Moderna has faced regulatory and political challenges. The Trump administration recently canceled a major government contract for Moderna’s avian flu vaccine, adding uncertainty to the company’s broader immunization pipeline. Shares were down over 30% year-to-date prior to Monday’s announcement, though they rose nearly 3% in premarket trading following the news.
Moderna’s results arrive as the CDC reports that the 2024–2025 flu season saw over 600,000 hospitalizations, the highest in 15 years. The company hopes its next-generation mRNA approach can help reverse this trend while reinforcing its position at the forefront of vaccine innovation.