Moderna’s combination Covid-Flu vaccine clears key European regulatory hurdle

UK—European regulators have backed Moderna’s pioneering dual-protection vaccine after encouraging trial results demonstrated superior immune response compared to separate jabs.

The European Medicines Agency’s (EMA) drug review committee, known as the Committee for Medicinal Products for Human Use (CHMP), has recommended approval for mCombriax (mRNA-1083), marking a significant step toward what could be the world’s first approved combination Covid-19 and influenza vaccine.

The recommendation comes from a Phase III study that showed mCombriax generated stronger immune responses against Covid-19 and three influenza strains than a combination of Sanofi’s Fluzone high-dose quadrivalent flu vaccine and Moderna’s Spikevax Covid-19 vaccine administered separately.

The EMA will now proceed with a final decision, potentially clearing the way for global distribution of this combination immunization.

Moderna’s Chief Executive Stéphane Bancel has emphasized that combination vaccines could streamline healthcare delivery and enhance patient outcomes by reducing the number of required injections.

Setbacks in U.S approval process

The EMA endorsement represents welcome progress for Moderna, which has faced considerable challenges navigating the American regulatory system.

The U.S. Food and Drug Administration previously declined to review Moderna’s seasonal flu vaccine, mRNA-1010, citing concerns about the trial methodology.

The agency subsequently reversed this decision following Moderna’s appeal, but with a requirement to evaluate the vaccine separately across two age groups: adults aged 50-64 and those 65 and older.

Similarly, mCombriax encountered obstacles during its approval journey in the United States.

Moderna withdrew its initial application in May 2025 after the FDA requested additional data demonstrating the flu component’s effectiveness before authorizing the combination product.

This regulatory shift reflected stricter vaccine approval standards in the United States.

The company indicated it would resubmit its application later that year, though no official announcement of this resubmission has materialized.

Strategic pivot amid revenue pressures

Moderna faces mounting pressure as Covid-19 vaccine demand continues to decline.

The pharmaceutical company reported a net loss of USD826m during the fourth quarter of 2025, reflecting the contracting market for its coronavirus vaccine portfolio.

In response to these financial headwinds, Bancel has signaled a strategic reorientation toward oncology and rare disease treatments, while scaling back investment in Phase III vaccine development programs.

This shift reflects the changing regulatory environment and market dynamics affecting vaccine profitability.

William Blair analyst Myles Minter has noted that Moderna requires new revenue streams beyond its vaccine business.

According to Minter’s February 13 research note, the company appears adequately capitalized to advance multiple late-stage cancer treatments scheduled for readout during 2026, positioning oncology as a potential growth catalyst for the organization.