European drug regulators have issued a positive recommendation for Moderna’s combination flu and COVID-19 vaccine, giving a shot that’s had a tumultuous development path in the U.S. a chance to soon get to market elsewhere.
The European Medicines Agency on Friday said it has endorsed a clearance for a vaccine dubbed mCombriax in people at least 50 years of age. The shot would be officially cleared for use once the European Commission ratifies the decision.
The recommendation “represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world’s first flu plus COVID combination vaccine,” Moderna CEO Stéphane Bancel said in a statement.
The announcement represents a much-needed win for the company, which has faced intense scrutiny from the Food and Drug Administration that’s left the approval prospects for its combination shot in the U.S. unclear.
Moderna first filed for clearance of the combination shot in 2024 based on late-stage study results showing the vaccine sparked immune responses against both viruses. A year later, though, the company revealed that the FDA demanded additional data from the flu component of the vaccine before considering the combination shot. Moderna withdrew its submission, but said it planned to refile after gathering the new study results.
Moderna has since accumulated that data and used it to seek approval of that flu component as a standalone shot in the U.S. But there, the company has faced additional, unusual hurdles towards approval.
The agency earlier this month initially refused to review Moderna’s application, claiming its vaccine hadn’t been tested against the best available study comparator. The FDA faced backlash that reportedly escalated all the way to the White House. Though the regulator quickly reversed course and agreed to start an evaluation, some analysts remain skeptical as to whether Moderna will secure an approval and what the situation means for the combination shot’s U.S. prospects. Frustration with the climate in the U.S. has already led Moderna to reveal it would no longer invest in new late-stage vaccine trials and focus more on cancer.
In Europe, Moderna’s path has proven more straightforward. The EMA found mCombriax “triggered the production of adequate amounts of antibodies against both viruses,” and said the standalone flu data Moderna gathered “showed that it can prevent influenza illness and trigger an adequate immune response.”
The combination shot is important to Moderna’s future, providing another potential source of revenue amid sputtering COVID vaccine sales and minimal contributions from a respiratory syncytial virus vaccine.
On an investor call earlier this month, Chief Financial Officer Jamey Mock said the company expects revenue to grow in 2026, largely due to sales in international markets. Moderna’s 2026 forecasts assumed no revenue contribution from the combination shot.
