A Major Step for Respiratory Protection (Image Credits: Unsplash)
European regulators moved forward with Moderna’s innovative mCombriax vaccine, recommending it as the first single shot to combat both seasonal flu and COVID-19.[1][2]
A Major Step for Respiratory Protection
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion on February 26, 2026, paving the way for marketing authorization of mCombriax.[1] This mRNA-based vaccine targets adults aged 50 and older, offering protection against influenza disease and COVID-19 caused by SARS-CoV-2. The recommendation highlights its potential to streamline vaccination efforts during respiratory virus seasons.
Moderna’s CEO, Stéphane Bancel, hailed the decision as “an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world’s first flu plus COVID combination vaccine.”[3][2] He emphasized that combination vaccines could simplify administration and improve health outcomes. The European Commission now holds the final say, after which national authorities will determine rollout strategies, pricing, and reimbursement.
Inside the Vaccine: Targeting Key Viruses
mCombriax delivers mRNA instructions for cells to produce proteins from influenza viruses and SARS-CoV-2. It encodes haemagglutinin glycoproteins from influenza A (H1N1 and H3N2) and B (Victoria lineage), along with specific SARS-CoV-2 spike protein parts.[1] This approach triggers immune responses tailored to these pathogens, potentially updated annually to match circulating strains.
The vaccine promises convenience with one injection instead of two. As the EMA noted, it provides “people with the option of having a single shot to protect against both illnesses.”EMA statement[4] Moderna anticipates availability in select EU markets for the 2026-2027 season, pending full approval.[5]
Robust Evidence from Large-Scale Trials
A pivotal study involving around 8,000 participants aged 50 and older demonstrated that mCombriax elicited antibody levels against flu and SARS-CoV-2 statistically non-inferior to separate vaccines: Moderna’s Spikevax plus Fluzone HD or Fluarix.[4][2] Supportive data from a flu-only mRNA vaccine confirmed its ability to prevent illness and generate strong immunity.
- Non-inferior immune response compared to licensed alternatives.
- Coverage for key flu strains: A-H1N1, A-H3N2, B-Victoria.
- SARS-CoV-2 targeting based on 2023/2024 EMA recommendations.
- Potential for annual strain updates to address evolving threats.
- Efficacy backed by Phase 3 data from thousands of adults.
These results position mCombriax as a viable option for vaccination campaigns, especially among older populations vulnerable to both viruses.
US Pathway: Heightened Scrutiny and Setbacks
Moderna first sought US clearance in 2024, but the FDA required supplemental flu data, prompting withdrawal of the application.[2] The company gathered additional evidence and refiled for a standalone flu vaccine, only to receive an initial refusal-to-file letter earlier this month over comparator issues. The FDA reversed course after a meeting, setting an August 5 action date.
Higher US standards and past hesitations, including policy influences, have slowed progress.BioPharma Dive reporting[2] While the EU advances swiftly, American availability remains uncertain, reflecting divergent regulatory priorities.
Key Takeaways:
- EMA’s nod marks the first combo flu-COVID vaccine recommendation worldwide.
- Targets adults 50+, with non-inferior efficacy to separate shots.
- US FDA demands more data; decision pending August 5.
This development underscores the value of combo vaccines in simplifying public health responses to intertwined threats like flu and COVID-19. As Europe prepares for potential rollout, the US timeline will shape global access patterns. What implications do you see for vaccination strategies? Share your thoughts in the comments.