In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.
Moderna has secured the European Commission’s go-ahead for its combination flu and COVID-19 vaccine, handing the mRNA specialist a much-needed regulatory win after a rough few months of dealing with the U.S. FDA.
The shot, which will carry the brand name mCOMBRIAX, combines the next-generation COVID-19 vaccine mNEXSPIKE and the investigational flu vaccine mRNA-1010. The European approval covers its use across all 27 European Union member states—plus Iceland, Liechtenstein and Norway—for the active immunization of people 50 years and up, according to a Tuesday company release.
“We remain surprised at the willingness of the EC to grant approval,” William Blair said in a Tuesday note to investors, because mRNA-1010 has yet to be approved as a standalone shot in the EU. The Committee for Medicinal Products for Human Use gave the combo shot a positive opinion in February, effectively recommending approval.
Currently, MRNA-1010 is under review in the EU. “We view vaccine efficacy from mRNA-1010 as worth of approval,” the analysts continued. A Phase 3 readout in June showed that mRNA-1010 outperformed a current commercial flu shot, with a 26.6% vaccine efficacy edge in adults aged 50 years and older.
Moderna did not provide a specific timeline for when mCOMBRIAX will be available across the EU, only noting that it will hit shelves “subject to national regulatory and access procedures.”
While Moderna has secured European approval, its combo vaccine has faced considerable struggle in the U.S. In May 2025, after discussions with the FDA, Moderna decided to pull its approval application for the two-in-one shot. The company did not provide specific reasoning for the withdrawal, only noting at the time that it would file again after receiving more data for mRNA-1010.
Despite a June 2025 readout for the flu vaccine, Moderna is still sitting on the resubmission. In January, the company announced that mRNA-1010 had been filed for approval but made no such disclosures for the combo shot. In a fourth quarter earnings release in February, Moderna said that it is “awaiting further guidance from U.S. FDA” regarding a renewed application.
That same month, mRNA-1010 also ran into a regulatory roadblock; the FDA hit Moderna with a refusal-to-file letter for the flu vaccine, claiming that the company’s data package was insufficient to even warrant a review. Moderna, according to the FDA, had failed to conduct an “adequate and well-controlled” trial that compared mRNA-1010 against the “best-available standard of care.”
Analysts at the time noted that the FDA’s refusal to review mRNA-1010 could have some negative spillover to the combo shot, rendering the timeline of its resubmission uncertain. The FDA and Moderna have since come to a compromise, with the regulator accepting mRNA-1010 for review, setting a decision date in August.
Moderna did not make any statement on the status of the FDA application in the release announcing EU approval.
