Europe Approves Moderna's Novel Flu-COVID-19 mRNA Combination Vaccine First
Moderna's mRNA combination vaccine, designed to prevent both influenza and COVID-19, has received marketing authorization in Europe, while facing setbacks in its country of origin, the United States. The European Commission has formally approved the vaccine, known as mCOMBRIAX (mRNA‑1083), making it the world’s first approved combination vaccine for these two respiratory viruses.
Moderna CEO Stéphane Bancel welcomed the development. In a press release, he noted that by integrating protection against two important respiratory viruses into a single vaccine, the company hopes to simplify the immunization process for adults, particularly providing a more convenient option for high-risk groups. Bancel stated that mCOMBRIAX provides an important new option for European citizens and also helps enhance the overall resilience of European healthcare systems.
It is reported that mCOMBRIAX combines Moderna’s existing COVID-19 mRNA vaccine with a flu candidate vaccine, mRNA‑1010, which is still under review. This approval is based on the results of a Phase 3 clinical trial involving approximately 4,000 adult participants. The trial was divided into two age groups: one for people aged 50 to 64, compared to a standard-dose flu vaccine; and another for those aged 65 and over, compared to a high-dose flu vaccine. In both age groups, mCOMBRIAX induced significantly higher immune responses against common flu strains (A/H1N1, A/H3N2, and B/Victoria) and against the SARS‑CoV‑2 virus compared to the control vaccines. Regulators stated that no significant safety or adverse event concerns were identified in the trial.
The approval at the EU level means the vaccine can be marketed in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, and is expected to be available in local pharmacies in time for the upcoming flu season. Moderna stated that the company is working closely with national authorities to support the rapid completion of access and supply arrangements at the national level.
In stark contrast to the smooth progress in Europe, the prospects for this combination vaccine in the United States remain uncertain. Since the second Trump administration took office last year, Health Secretary Robert F. Kennedy Jr. has begun to vigorously promote an anti-vaccine and anti-mRNA technology policy agenda, creating numerous obstacles for Moderna’s advancement of related products in the US. Under Kennedy’s policy direction, the US government canceled hundreds of millions of dollars in funding originally planned to support Moderna’s mRNA vaccine research and development, significantly impacting the company’s subsequent development.
Moderna had submitted a marketing application for mCOMBRIAX to the US Food and Drug Administration (FDA). However, in May 2025, the company announced that it had withdrawn the application after consultation with the FDA. At the time, Moderna stated that it planned to resubmit the application later that year after obtaining more clinical data on the candidate flu vaccine mRNA‑1010. However, even as the relevant data became available, the company has not yet resubmitted the application for approval of the combination vaccine in the United States.
Meanwhile, the review process for mRNA‑1010 itself has been fraught with twists and turns. In February of this year, the FDA unexpectedly refused to accept Moderna’s application for mRNA‑1010, a decision made by political appointee Vinay Prasad and contrary to the opinions of the FDA’s internal expert team. A week later, the FDA announced it was overturning the decision and agreeing to initiate the formal review process for the flu vaccine. Regulators currently expect to make a final decision on mRNA‑1010 by August 5th. Prasad himself expects to leave the agency at the end of this month, ending his controversial tenure.
As Europe leads the way in approving mCOMBRIAX, the US regulatory direction in the field of mRNA combination vaccines and the issue of political interference have once again become the focus of public attention. For Moderna, the positive signals from the European market may provide critical support for its mRNA vaccine pipeline, but when this innovative combination vaccine, led by a US company, will be approved and reach the public in the United States remains highly uncertain.