Europe—not US—first to authorize Moderna's combo mRNA flu-COVID vaccine

Moderna's mRNA-1083 (branded as mCOMBRIAX) has received authorization from the European Commission, making it the world's first approved combination vaccine targeting both influenza and COVID-19 in a single dose. The decision follows a positive review from the European Medicines Agency's committee in February. The vaccine combines Moderna's existing COVID-19 vaccine with an investigational flu vaccine, mRNA-1010, which is still under review in Europe. Clinical data from a Phase III trial involving ~4,000 adults showed statistically significant higher immune responses against three common flu strains (A/H1N1, A/H3N2, B/Victoria) and SARS-CoV-2 compared to standard and high-dose flu vaccines, with no safety concerns.

While the vaccine will be available across all 27 EU members plus Iceland, Liechtenstein, and Norway—potentially hitting pharmacy shelves this upcoming flu season—US approval remains off the table. Moderna had submitted mCOMBRIAX for FDA approval but withdrew the application in May 2025 after consulting with the agency. The US has faced significant obstacles under the second Trump administration, with Health Secretary Robert F. Kennedy Jr. aggressively implementing anti-vaccine and anti-mRNA policies. The government canceled hundreds of millions in grants to Moderna for mRNA vaccine development. Additionally, the FDA initially refused to review Moderna's standalone flu vaccine, mRNA-1010, after political appointee Vinay Prasad overruled FDA staff—though the decision was later reversed. Prasad is set to exit the agency at the end of this month, with an FDA decision on the flu vaccine expected by August 5.