AMSTERDAM, Feb. 27, 2026 — Europe’s medicines regulator recommended marketing authorization for Moderna’s mCombriax, a combined COVID-19 and flu shot for adults 50 and older, a move that would make it the first single vaccine to cover both illnesses, according to the European Medicines Agency and Reuters.
The agency said its human medicines committee adopted a positive opinion and the recommendation now goes to the European Commission for an EU‑wide decision, after which member states decide on pricing and rollout, according to EMA and BioPharma Dive.
Evidence from late-stage data
The CHMP opinion was supported by a main study of about 8,000 people age 50 and older, showing antibody responses against SARS‑CoV‑2 and influenza that were non‑inferior to those seen with separate shots, according to EMA and Reuters.
In Moderna’s phase 3 trial, the vaccine (mRNA‑1083) was compared with Spikevax plus high‑dose or standard‑dose flu shots, and the company said primary immune‑response endpoints were met in both age cohorts, according to Moderna’s statement and EMA’s summary.
What the vaccine targets
EMA’s product summary says mCombriax is an mRNA‑based vaccine encoding SARS‑CoV‑2 spike components and influenza A(H1N1), A(H3N2) and B/Victoria strains, according to the EMA EPAR and the EMA news release.
The indication is active immunization for prevention of COVID‑19 and influenza in adults 50 and older, and Moderna said the positive opinion is a milestone for respiratory virus vaccination, according to EMA and Moderna.
Safety and regulatory path
Common side effects include injection‑site pain, fatigue, muscle and joint aches, headache, chills, swollen lymph nodes, nausea or vomiting and fever, according to EMA’s news release and the EPAR.
EMA noted the CHMP opinion is an intermediate step; the European Commission must issue the marketing authorization and national health systems will decide reimbursement and use, according to EMA and BioPharma Dive.
In the U.S., Moderna’s combination shot remains under more stringent scrutiny as regulators sought additional data on the flu component, even as Europe moves forward, according to Reuters and BioPharma Dive.
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Image: “COVID-19 Vaccine vial and syringe – US Census” by United States Census. Public domain. Source: https://commons.wikimedia.org/wiki/File:COVID-19_Vaccine_vial_and_syringe_-_US_Census.jpg. Modifications: resized to 1920×1080 (16:9) and converted to PNG.