Europe approves world's first flu-COVID combination vaccine as US development stalls

The European Commission has authorized Moderna's mRNA-based combination vaccine against both flu and COVID-19, making it the world's first authorized combination shot for the two respiratory viruses.

The decision follows a positive review in February from a key European Medicines Agency committee, which paved the way for the approval. The vaccine, mRNA-1083 or mCOMBRIAX, will be available in all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway.

Moderna CEO Stéphane Bancel welcomed the news. "By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk," Bancel said in a press release. "mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe."

mCOMBRIAX combines Moderna's COVID-19 vaccine with an investigational influenza vaccine called mRNA-1010, which is still under review in Europe. The combination shot was authorized based on findings from a Phase III clinical trial of around 4,000 adults.

The trial contained two groups, one with participants aged 50 to 64 that included a comparison of a standard flu vaccine, and another aged 65 and up that included a comparison of a high-dose flu vaccine. In both groups, mCOMBRIAX spurred statistically-significant higher immune responses against common flu strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 than the comparator vaccines. There were no concerns over safety or adverse events.

Meanwhile, availability is not yet on the horizon for the US. Since the second Trump administration took office last year and Health Secretary Robert F. Kennedy Jr. began aggressively implementing his anti-vaccine and anti-mRNA agenda, Moderna has faced significant obstacles.

Under Kennedy, the government has canceled hundreds of millions of dollars in grants to Moderna that would have supported the development of mRNA vaccines. Moderna had previously submitted mCOMBRIAX for approval from the Food and Drug Administration. But in May 2025, Moderna announced that it had withdrawn its application, saying it did so in consultation with the agency.

At the time, the company said it expected to resubmit the application later that year after it collected more data on the investigational flu vaccine, mRNA-1010. But, while more data came in, Moderna has still not resubmitted the combination shot.

Meanwhile, in February this year, the FDA shockingly refused to review Moderna's application for mRNA-1010—a decision made by political appointee Vinay Prasad over objections by FDA staff. A week later, it reversed the decision. The FDA is now expected to issue a decision on the flu vaccine by August 5. Prasad is set to exit the agency at the end of this month.