Moderna’s Combination COVID-19 and Flu Vaccine Receives Positive EMA Recommendation
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for mCombriax® (mRNA-1083), Moderna’s combination vaccine designed to protect against both COVID-19 and influenza. This potential approval would mark a significant milestone, as mCombriax could become the first combination COVID-19 and flu vaccine available globally.
Superior Immune Response Demonstrated in Clinical Trials
The CHMP’s recommendation is based on data from a pivotal Phase III study (NCT06097273). Results showed that mCombriax elicited a significantly higher immune response against COVID-19 and three influenza strains compared to administering Sanofi’s Fluzone HD influenza vaccine and Moderna’s Spikevax COVID-19 vaccine separately. Pharmaceutical Technology
Regulatory Challenges and US Approval Pathway
While the EMA review is progressing favorably, Moderna has faced hurdles in securing US approval for its investigational vaccines. The US Food and Drug Administration (FDA) initially refused to review Moderna’s seasonal flu vaccine, mRNA-1010, citing concerns regarding the trial design. However, the FDA later agreed to review the vaccine with specific considerations for the 50-64 and 65+ age groups following an appeal from Moderna. Pharmaceutical Technology
mCombriax similarly experienced a setback in the US, with Moderna withdrawing its application for approval in May 2025 after the FDA requested additional data on the vaccine’s influenza component efficacy. The company intends to resubmit its Biologics License Application (BLA) but has not yet announced a specific timeline. Pharmaceutical Technology
Moderna’s Strategic Shift Towards Oncology
As Moderna navigates a changing vaccine market and declining COVID-19 vaccine sales – reporting a net loss of $826 million in Q4 2025 – the company is strategically refocusing its efforts on oncology and rare disease pipelines. This shift involves deprioritizing investments in late-stage vaccine trials amid evolving US regulatory requirements. Pharmaceutical Technology
According to William Blair analyst Myles Minter, establishing “a path for new long-term growth drivers beyond the vaccine franchise” is crucial for Moderna’s future. Oncology is identified as a key area for potential growth, with several late-stage oncology readouts expected in 2026. Pharmaceutical Technology
Recent Moderna Vaccine Approvals
Despite challenges with some vaccine approvals, Moderna has continued to receive positive regulatory news. In December 2025, the EMA’s CHMP recommended the use of Moderna’s BA.1 targeting bivalent COVID-19 booster in children aged 6-11 years in the European Union. Moderna Press Releases
Moderna received US FDA approval in August 2025 for updated COVID-19 vaccines targeting the LP.8.1 variant of SARS-CoV-2, and Health Canada approval for the same variant in September 2025. Moderna Press Releases
The EMA also granted positive opinions for Moderna’s COVID-19 mRNA vaccines targeting the JN.1 and LP.8.1 variants in September and December 2025, respectively. Moderna Press Releases
mNEXSPIKE Receives Positive CHMP Opinion
In December 2025, the CHMP also adopted a positive opinion recommending marketing authorization of mNEXSPIKE® (mRNA-1283), a new COVID vaccine for individuals aged 12 years and older. Access Newswire
The final decision on mCombriax’s approval rests with the European Commission. Moderna CEO Stéphane Bancel believes combination vaccines have the potential to “simplify vaccination and support improved health outcomes.”