EMA CHMP Backs Moderna’s mCOMBRIAX®: Pioneering Flu-COVID Combo Vaccine for Seniors

Moderna, Inc. announced a significant regulatory milestone today that the European Medicines Agency’s (CHMP) Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization for mCOMBRIAX® (mRNA-1083) in the European Union.  This investigational combination vaccine targets active immunization against influenza and COVID-19 caused by SARS-CoV-2 in adults aged 50 and older. If granted final approval by the European Commission which is expected following this recommendation, mCOMBRIAX would mark Moderna’s fourth approved product in Europe.

“This represents an important milestone for respiratory virus vaccination,” said Stéphane Bancel, Moderna’s CEO. He emphasized the potential of combination vaccines to streamline immunization schedules and enhance health outcomes, thanking the EMA for its rigorous review.

Strong Phase 3 Evidence Supports Efficacy

The CHMP’s opinion based on a pivotal Phase 3 trial (NCT06097273), a randomized, observer-blind, active-controlled study involving about 4,000 adults in two cohorts: those aged 65+ and 50-64.

65+ cohort: mRNA-1083 was compared to co-administered Fluzone HD® (Efluelda® in the EU, a high-dose flu vaccine) and Spikevax® (Moderna’s COVID-19 vaccine).

50-64 cohort: Compared to co-administered Fluarix® (standard-dose flu vaccine) and Spikevax®.

All primary endpoints confirmed non-inferior immune responses. Notably, a single dose of mRNA-1083 produced statistically superior responses against three influenza strains (A/H1N1, A/H3N2, B/Victoria) and SARS-CoV-2 in both groups. The only exception was the B/Yamagata strain in older adults, which is no longer recommended for seasonal flu vaccines anyway.

Safety data showed an acceptable profile, with most solicited adverse reactions mild (grade 1 or 2) and aligning with the comparator vaccines.

 Built on mRNA‑1010 and recent regulatory lessons

mCOMBRIAX builds on the advances of mNEXSPIKE®, Moderna’s authorized COVID‑19 vaccine, and mRNA‑1010, its investigational seasonal influenza vaccine candidate. mRNA‑1010 itself is already under review in the United States, the European Union, Canada, and Australia, signaling broad interest in the platform’s potential against seasonal flu.

However, that platform has recently navigated a high‑profile regulatory episode in the US: in early 2026, the FDA issued a refusal‑to‑file letter for mRNA‑1010, citing concerns over comparator vaccines, only to reverse course within days and resume the review while Moderna addresses outstanding questions. 

Against this backdrop, the CHMP’s positive opinion for mCOMBRIAX may be seen as a vote of confidence in the underlying mRNA‑1010 platform, now applied in a combination‑vaccine format.

Next Steps and Broader Impact

The European Commission will now review the CHMP recommendation, with a decision anticipated soon. Approval would extend validity across all EU member states and EEA countries (Iceland, Liechtenstein, Norway). Moderna plans close collaboration with national authorities to facilitate rollout.

This advances combo vaccination strategies amid ongoing respiratory threats, potentially boosting adherence by reducing shots needed.

Reference

European Medicines Agency’s Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna’s mRNA Combination Vaccine Against Influenza and COVID-19, 27 February 2026, News Release

A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age, ClinicalTrials.gov ID NCT06097273, https://clinicaltrials.gov/study/NCT06097273