Moderna’s Combined COVID-19 & Flu Vaccine Recommended for Approval in Europe

The European Medicines Agency (EMA) has recommended approval of a combined vaccine developed by Moderna, offering protection against both COVID-19 and influenza with a single dose. This potential landmark decision paves the way for the first single-dose vaccine targeting individuals aged 50 and older against both diseases within the European Union. The move aims to simplify vaccination schedules, currently requiring separate doses for each virus and addresses the need for annual updates to match circulating strains.

Streamlining Immunization: A Combined Approach

Currently, individuals require two separate vaccinations to protect against COVID-19 and influenza. The new vaccine, dubbed mCombriax, seeks to consolidate these into a single injection. This simplification is particularly relevant as public health officials continue to emphasize the importance of annual vaccination against both viruses, with formulations updated to address evolving variants. Moderna is banking on this combined vaccine, alongside its mRNA-based influenza vaccine, to revitalize revenue growth following a decline in demand for COVID-19 vaccines in the post-pandemic period. The company’s stock has experienced a significant downturn, losing approximately 90% of its value since its peak in 2021.

The EMA’s recommendation is based on data from a study involving around 8,000 participants. Results indicated that recipients of the combined vaccine generated higher levels of antibodies compared to those who received separate doses of Moderna’s Spikevax (COVID-19) and traditional influenza vaccines. The agency also considered additional data supporting the effectiveness of mRNA technology in eliciting an appropriate immune response against both influenza strains and SARS-CoV-2. Reuters reports that this data is crucial in demonstrating the vaccine’s potential to offer broad protection.

Understanding mRNA Technology and Immune Response

The Moderna vaccines, including mCombriax, utilize messenger RNA (mRNA) technology. MRNA delivers genetic instructions to cells, prompting them to produce a harmless piece of the virus – in this case, proteins from both the COVID-19 virus and influenza viruses. This triggers an immune response, preparing the body to fight off future infection. Unlike traditional vaccines that use weakened or inactivated viruses, mRNA vaccines do not contain the live virus, eliminating the risk of causing the disease. The EMA’s assessment considered the ability of this mRNA approach to effectively stimulate immunity against different strains of both viruses.

What the Recommendation Means for Public Health

This recommendation represents a significant step towards simplifying vaccination strategies and potentially increasing uptake, particularly among older adults who are at higher risk of severe illness from both COVID-19 and influenza. The World Health Organization (WHO) emphasizes the importance of annual influenza vaccination, especially for vulnerable populations, to reduce the burden of seasonal flu. Combining this with COVID-19 protection in a single dose could improve adherence and overall public health outcomes. However, it’s important to note that the EMA’s recommendation is just one step in the approval process.

The Regulatory Pathway and Timeline

Following the EMA’s recommendation, the European Commission will now review the agency’s opinion before making a final decision on granting marketing authorization within the EU member states. As of March 1, 2026, no definitive timeline has been established for this final decision. The Commission will consider factors such as the vaccine’s benefits, risks, and overall impact on public health. Individual member states will then determine how to incorporate the vaccine into their national immunization programs.

Study Details and Limitations

The study supporting the EMA’s recommendation involved approximately 8,000 participants and assessed the immunogenicity and safety of the combined vaccine. Immunogenicity refers to the vaccine’s ability to trigger an immune response, measured by antibody levels. Even as the study demonstrated higher antibody levels in the combined vaccine group, further research is needed to determine the real-world effectiveness of the vaccine in preventing infection and severe disease. It’s also important to consider potential limitations of the study, such as the specific populations included and the duration of follow-up. According to the Gregorian calendar, March 2026 falls within the Islamic month of Ramadan and Shawwal, potentially influencing study participation and logistical considerations.

What Comes Next: Surveillance and Ongoing Evaluation

Even after potential authorization, ongoing surveillance will be crucial to monitor the vaccine’s effectiveness and safety in real-world settings. Public health agencies will track infection rates, hospitalizations, and severe outcomes among vaccinated individuals to assess the vaccine’s impact. Continuous monitoring of circulating viral strains will also be essential to ensure the vaccine remains effective against evolving variants. Further studies may be conducted to evaluate the vaccine’s performance in specific populations, such as individuals with underlying health conditions or those who are immunocompromised. The EMA and national regulatory authorities will regularly review this data and update guidance as needed.