EMA Recommends mCombriax: First Combined COVID-19 and Flu Vaccine
The European Medicines Agency (EMA) has recommended granting marketing authorization in the European Union (EU) for mCombriax, an mRNA vaccine designed to protect individuals aged 50 years and older against both COVID-19 and seasonal influenza.
This recommendation positions mCombriax as the first combined vaccine offering protection against both respiratory illnesses in a single injection.
Understanding mCombriax: The Combined Vaccine
mCombriax is an mRNA vaccine intended to protect against the SARS-CoV-2 virus and specific seasonal influenza strains, including type A-H1N1, type A-H3N2, and type B of the Victoria lineage. The vaccine functions by delivering messenger RNA instructions to the body's cells, prompting them to produce proteins found on these targeted viruses. This process prepares the immune system to recognize and defend against future infections.
Its composition is expected to be regularly updated to align with circulating viral strains. The SARS-CoV-2 component aligns with EMA's 2023/2024 recommendations, and the influenza strains are based on WHO's 2023/2024 recommendations.
Robust Clinical Evaluation Supports Authorization
The EMA's human medicines committee (CHMP) based its recommendation on clinical trial data demonstrating that mCombriax triggered adequate antibody production against both the SARS-CoV-2 virus and influenza.
A primary study involved 8,000 participants aged 50 years and older. Data from this study showed that antibody levels in mCombriax recipients against influenza and SARS-CoV-2 were statistically non-inferior to those observed in individuals who received both an authorized COVID-19 mRNA vaccine (Spikevax) and an authorized influenza vaccine (either Fluzone HD or Fluarix).
Additionally, a separate study of a similar mRNA vaccine, which contained only the influenza component present in mCombriax, indicated its ability to prevent influenza illness and elicit an adequate immune response.
Addressing a Dual Public Health Challenge
COVID-19 and seasonal influenza are respiratory illnesses characterized by symptoms such as cough, nasal congestion, fever, and chills. While many cases are mild, severe outcomes can occur, particularly in older individuals and those with weakened immune systems. Co-infection with both the influenza virus and SARS-CoV-2 has been observed to lead to more severe disease than either infection alone.
As of February 1, 2026, the World Health Organization reported over 281 million COVID-19 cases in Europe. Seasonal influenza also contributes to a significant health burden, with up to 50 million symptomatic cases annually in the European Economic Area (EEA).
Understanding Potential Side Effects
Common side effects, reported in more than 1 in 10 individuals, include:
- Pain at the injection site
- Tiredness or fatigue
- Muscle pain
- Joint pain
- Headache
- Chills
- Swollen lymph nodes
- Nausea
- Vomiting
- Fever
The median onset time for these reactions was 2 days, with a median duration of 3 days.
What Comes Next: The Path to Availability
The CHMP's opinion represents an interim step in the regulatory process. This recommendation will now be submitted to the European Commission, which will make a final decision on an EU-wide marketing authorization.
Following authorization, decisions regarding pricing and reimbursement for mCombriax will be made by individual Member States. These decisions will consider the vaccine's role within their national health systems. mCombriax is intended to provide national authorities with an additional option for their vaccination campaigns against COVID-19 and influenza.