Thorough Scientific Study Finds Dual Flu/COVID Vaccine Both Safe and Effective

European drug regulators have delivered a significant boost to Moderna, issuing a positive recommendation for the company’s combination influenza and COVID-19 vaccine after a thorough scientific evaluation determined the shot to be safe and effective.

The European Medicines Agency (EMA) on Friday endorsed the vaccine — branded mCombriax — for adults aged 50 and older. The shot now awaits formal authorization from the European Commission, a step that typically follows the agency’s scientific opinion.

In its assessment, the EMA concluded that mCombriax generated strong immune responses against both influenza and COVID-19 strains and met the European Union’s standards for safety, quality and efficacy. Regulators said the vaccine “triggered the production of adequate amounts of antibodies against both viruses,” and pointed to additional data showing the flu component can prevent influenza illness while producing an appropriate immune response profile.

The recommendation marks what Moderna CEO Stéphane Bancel called “an important milestone for respiratory virus vaccination,” describing mCombriax as the world’s first approved combination flu and COVID-19 vaccine. The endorsement is especially meaningful given the complex regulatory path the shot has faced in the United States.

Moderna initially filed for U.S. clearance of the combination vaccine in 2024, supported by late-stage trial data demonstrating robust immune responses to both viruses. In 2025, however, the U.S. Food and Drug Administration(FDA) requested additional data on the influenza component before proceeding with review of the combination product. The company withdrew its filing with plans to resubmit after gathering the requested information.

In contrast, the European review moved forward without similar delays. The EMA’s positive opinion underscores that, after comprehensive analysis of clinical trial data, the vaccine meets the bloc’s rigorous standards — reinforcing confidence in its safety profile and its ability to protect older adults against two major respiratory viruses in a single shot.