Moderna announced that the European Commission has granted marketing authorization for its mRNA‑1083 vaccine, branded mCOMBRIAX, a combined influenza and COVID‑19 shot for adults 50 years and older, effective April 21 2026.
The approval followed a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and authorizes sales in all 27 EU member states plus Iceland, Liechtenstein and Norway. It marks the first time an mRNA‑based combination vaccine has received EU approval, positioning Moderna ahead of competitors in the emerging multi‑component respiratory vaccine market.
The regulatory win expands Moderna’s portfolio beyond its existing COVID‑19 and RSV products, creating a new revenue stream that could offset declining pandemic‑era sales. In Q4 2025, the company reported $678 million in revenue—down from $1.9 billion in full‑year 2025—and a net loss of $826 million, compared with a $2.8 billion loss for the year. Moderna has been cutting operating expenses by roughly $2.2 billion in 2025 and is targeting up to 10 % revenue growth in 2026.
CEO Stéphane Bancel highlighted the strategic importance of the approval, saying, “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.” He added that the approval “offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe.”
In the United States, Moderna withdrew its biologic license application for mCOMBRIAX in May 2025 after the FDA requested additional data, and the company received a refusal‑to‑file letter for its investigational flu vaccine mRNA‑1010. The EU approval therefore represents a contrasting regulatory success that validates the company’s mRNA platform for multi‑antigen products.
The approval underscores Moderna’s broader strategy to move beyond COVID‑19 vaccines and leverage its mRNA technology for other indications. It provides a first‑mover advantage in the flu‑COVID combination space and signals that the company’s platform can support complex, multi‑component vaccines, potentially opening new markets and revenue streams as the pandemic‑era demand continues to wane.
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