The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on February 26 2026, and the announcement of that opinion was released on February 27 2026, recommending marketing authorization for Moderna’s mCOMBRIAX (mRNA‑1083).
mCOMBRIAX is Moderna’s first combined influenza and COVID‑19 vaccine and would be the world’s first single‑dose shot that protects against seasonal flu and SARS‑CoV‑2. The vaccine is intended for individuals aged 50 and older and is based on Moderna’s mRNA platform. Phase 3 clinical trials involving approximately 8,000 adults demonstrated non‑inferior immune responses against the influenza strains and SARS‑CoV‑2, with a safety profile consistent with Moderna’s other mRNA products.
The positive opinion marks a significant regulatory milestone for Moderna, which has been shifting its focus from pandemic‑era revenue to a diversified portfolio. 2025 full‑year revenue is projected between $1.6 billion and $2.0 billion, a sharp decline from pandemic peaks, and Q3 2025 revenue of $1 billion was down 45% year‑over‑year, with more than 95% of sales driven by COVID‑19 vaccines. mCOMBRIAX would become Moderna’s fourth marketed product in the European Union and could open a new revenue stream in the post‑pandemic market.
Investors reacted with mixed sentiment. While the regulatory approval was viewed as a positive development, concerns about Moderna’s long‑term profitability and the decline in COVID‑19 vaccine demand tempered enthusiasm. The market’s cautious response reflects the broader challenge of transitioning from a pandemic‑era success story to a sustainable, diversified biotechnology company.
"The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine. If approved, this would be Moderna's fourth marketed product in Europe," said Stéphane Bancel, CEO of Moderna. Bancel added, "Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA's rigorous scientific review."
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