Moderna's flu vaccine trial shows promising results, leading to potential approval for combo shot

From CNBC: 2025-06-30 09:12:00

Moderna announced that its mRNA-based flu vaccine produced a stronger immune response than existing shots in a late-stage trial. The company voluntarily withdrew an application for a combination Covid and flu shot to include data from the flu vaccine’s trial. Moderna plans to resubmit both applications for approval this year.

The combination vaccine aims to simplify vaccination and reduce healthcare costs. Moderna is ahead of Pfizer and Novavax in the race to bring a combination shot to market. The company expects approvals for both shots next year, pending reviews. Moderna shares rose nearly 3% in premarket trading.

In a phase three trial with over 40,000 adults, Moderna’s mRNA-1010 flu shot was 26.6% more effective than a standard vaccine. The shot showed efficacy against major influenza strains and was 27.4% more effective in adults 65 and older. Moderna CEO Stephane Bancel called the results a significant milestone.

Data from the CDC showed a 15-year high in flu-related hospitalizations during the 2024-2025 season. More than 600,000 Americans were hospitalized due to flu-related illness. The mRNA-1010 vaccine’s safety data was consistent with previous studies. Moderna’s shares were down over 30% for the year due to policy changes by the Trump administration.

Despite uncertainty in the regulatory environment, Moderna is working closely with the FDA. The company believes it has a clear path for flu vaccine approval. Moderna is focused on bringing effective vaccines to market and reducing the burden of influenza on older adults.



Read more at CNBC: Moderna’s flu vaccine shows positive trial results, paving way for combo shot