Moderna Inc. received marketing authorization from the European Commission for its two-in-one vaccine for influenza and Covid-19, making it the first such combination shot to be cleared in the region for people 50 and older.
“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,” Stéphane Bancel, Chief Executive Officer of Moderna, said in a statement. The approval is valid in all 27 EU member states, plus Iceland, Liechtenstein and Norway.
The decision was supported by a Phase 3 trial involving approximately 8,000 adults, which found the combination shot, now named mCOMBRIAX, generated a stronger immune response than separate, co-administered doses of existing flu and Covid vaccines. The study showed statistically significantly higher immune responses against three influenza strains (A/H1N1, A/H3N2, and B/Victoria) and SARS-CoV-2. The vaccine’s safety profile was deemed acceptable and consistent with the licensed vaccines used in the trial.
The approval gives Moderna its fourth authorized product in the EU and a potential advantage over competitors like Pfizer Inc. and BioNTech SE, who are also developing a similar combination vaccine. While the EU approval is a significant win, Moderna faces a more uncertain path in the U.S. The company voluntarily withdrew its application for the combination vaccine in May 2025 and is awaiting further guidance from the Food and Drug Administration. The agency had initially refused to review the application for the flu component, mRNA-1010, before later agreeing to a review with a decision expected by August 5, 2026.
The EU approval could help bolster Moderna’s revenue as demand for its standalone Covid vaccines has declined. The combination shot is intended to simplify vaccination campaigns and improve public health by offering a single injection. Moderna’s stock has gained 83.8 percent year-to-date, significantly outperforming the industry’s 2.5 percent growth. Investors will now watch for the U.S. regulatory timeline and the commercial rollout across European nations.
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