Moderna has cleared a major regulatory milestone in Europe after the EMA’s CHMP recommended approval of mRNA-1083 (mCOMBRIAX), the world’s first combined influenza and COVID-19 vaccine for adults aged 50 and older.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for Moderna’s mRNA-1083 (mCOMBRIAX), an investigational combination vaccine designed to protect against both influenza and COVID-19. The vaccine is intended for individuals aged 50 years and older and, if approved, would mark a global first in respiratory virus prevention.1
“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,” Moderna CEO Stéphane Bancel, said in a statement. “If approved, this would be Moderna's fourth marketed product in Europe. Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA's rigorous scientific review.”1
mRNA-1083 builds on Moderna’s established mRNA platform, combining elements of its COVID-19 vaccine, mNEXSPIKE, with mRNA-1010, the company’s investigational seasonal influenza vaccine currently under regulatory review in multiple regions, including the US, EU, Canada, and Australia.1
mCOMBRIAX could become the world’s first approved combination vaccine protecting against both influenza and COVID-19.
Phase 3 results showed non-inferior and often superior immune responses versus existing flu and COVID-19 vaccines, with a favorable safety profile.
A single combined shot could streamline immunization for older adults and support broader uptake across Europe.
The CHMP recommendation is supported by results from a pivotal phase 3 trial, a randomized, observer-blind, active-controlled study enrolling roughly 8,000 adults across two age cohorts (50–64 years and 65 years and older). In both cohorts, a single dose of mRNA-1083 met all primary endpoints, demonstrating non-inferior—and in many cases statistically superior—immune responses compared with co-administered licensed influenza and COVID-19 vaccines.
Higher immune responses were observed against three influenza strains (A/H1N1, A/H3N2, and B/Victoria) and SARS-CoV-2, with the exception of B/Yamagata in adults aged 65 and older, a strain no longer recommended for inclusion in seasonal flu vaccines.1
Data from a main study involving 8,000 people from 50 years of age showed that people who received mCombriax had levels of antibodies against influenza and SARS-CoV-2 that were statistically non‑inferior to those seen in people who received both Spikevax (an authorized COVID-19 mRNA vaccine) and either Fluzone HD or Fluarix (authorized influenza vaccines).2
Safety and tolerability findings were consistent with existing licensed vaccines, with most adverse reactions reported as mild to moderate (grade 1 or 2).1 The most common side effects with mCombriax (which can affect more than 1 in 10 people) are injection site pain, tiredness, muscle pain, joint pain, headache, chills, swollen lymph nodes, nausea and vomiting and fever. The median time to onset for these adverse reactions was 2 days, while the median duration was 3 days.2
Following the CHMP’s positive opinion, the European Commission is expected to issue a final decision on marketing authorization. If approved, the authorization would be valid across all EU Member States as well as European Economic Area countries, paving the way for coordinated rollout in collaboration with national health authorities.1
