The European Medicines Agency’s (EMA) drug review committee has taken a positive stance on granting marketing authorisation to Moderna’s combination Covid-19 and influenza vaccine, mCombriax (mRNA-1083).
The Committee for Medicinal Products for Human Use’s (CHMP) opinion is based on the results of a pivotal Phase III study (NCT06097273), where mCombriax prompted a significantly higher immune response against Covid-19 and three flu strains than a combination of Sanofi’s influenza jab, Fluzone high-dose quadrivalent (Fluzone HD) and Moderna’s Covid-19 vaccine, Spikevax.
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The EMA will now make the final decision on whether to give mCombriax the greenlight, which could become the first ever combination Covid-flu vaccine to reach the global market. According to Moderna’s CEO, Stéphane Bancel, combination vaccines hold the potential to “simplify vaccination and support improved health outcomes”.
The CHMP’s call will be welcome news for Moderna, which has encountered several hurdles while seeking US approval for its late-stage pipeline vaccines. Most recently, the US Food and Drug Administration (FDA) refused to review Moderna’s seasonal flu vaccine, mRNA-1010, due to the agency’s concerns around trial design. The regulator later pivoted on this decision following an appeal from Moderna, with the caveat that the vaccine will be reviewed differentially across the 50-64 and 65+ age categories.
mCombriax has also faced a rocky path to approval thus far, as Moderna pulled its application for the vaccine’s approval in May 2025 after filing for the FDA’s blessing the previous year. This is because the FDA requested to see data backing the efficacy of the jab’s flu component before approving the combination, marking a tightening of vaccine regulatory policy in the US.
At the time, Moderna noted it would resubmit its Biologics License Application (BLA) for mCombriax later in 2025, though it has not yet publicly announced this resubmission to date.
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By GlobalDataModerna pivots to cancer focus
As Moderna contends with a rapidly evolving vaccine landscape and waning sales of its Covid-19 vaccine portfolio, the company has seen a gradual reduction in revenue, with the company posting a net loss of $826m in Q4 2025.
However, in an interview with Bloomberg News, Bancel said he was looking to turn Moderna’s fortunes around by placing a stronger focus on its cancer and rare disease pipeline, while deprioritising investments into Phase III vaccine trials amid the shifting US regulatory landscape.
According to William Blair analyst Myles Minter, Moderna needs to establish a “path for new long-term growth drivers beyond the vaccine franchise”.
In a research note from 13 February, Minter names oncology as a new growth driver for the company, noting that William Blair sees the company “funded well through multiple late-stage oncology readouts expected in 2026”.
