Moderna's combined vaccine for both influenza and COVID-19, mRNA-1083, has been recommended for approval in the EU under mCombriax brand name.
The endorsement by the EMA's human medicines committee, the CHMP, is the first for a combined flu/COVID shot and exposes the widening gap between Europe and the US when it comes to regulating vaccines.
Moderna withdrew its marketing application in the US for mRNA-1083 in patients aged 50 and over last year after the FDA said it would have to see the data from a large-scale phase 3 trial first.
Since then, the FDA – which has seen its vaccine policies reworked under HHS Secretary Robert F Kennedy Jr – also said it would not review Moderna's mRNA-based seasonal flu vaccine candidate mRNA-1010, arguing that the company had not used a suitable comparator group in the main clinical trial supporting the filing.
The agency has since allowed the review to proceed with a narrower indication, and mRNA-1010 is also under regulatory review in Europe after a filing in January.
With the CHMP affirmation, Moderna is on course to get EU approval for its fourth vaccine product and break new ground in shots for seasonal respiratory infections with a product that simultaneously protects against SARS-CoV-2 as well as influenza A types H1N1 and H3N2 and Victoria variant influenza type B.
The committee has recommended a marketing authorisation for mCombriax for protecting people aged 50 years and older against COVID-19 and flu, noting that while most cases are mild or moderate, some can be severe – particularly when there is co-infection with the two viruses.
The vaccine protects against viral variants selected by the World Health Organisation (WHO) as those most likely to be problematic in 2023/24, and the EMA said the composition of mCombriax is expected to be updated regularly to match the strains circulating in the community.
Moderna's chief executive, Stéphane Bancel, said the recommendation is "an important milestone for respiratory virus vaccination and for Moderna," adding: "Combination vaccines have the potential to simplify vaccination and support improved health outcomes."
The European Commission generally follows the CHMP's lead and approves its recommendations within a few weeks, so mCombriax should be an option for consideration by EU member states as they select vaccines for the forthcoming 2026/27 flu season.
In light of the increasingly vaccine-mistrustful environment in the US under President Donald Trump, Moderna has reined back its investments in infectious disease vaccines and is pivoting towards other areas, including cancer, for its mRNA programmes.
https://pharmaphorum.com/news/moderna-closes-eu-approval-combined-flucovid-jab
https://pharmaphorum.com/news/moderna-closes-eu-approval-combined-flucovid-jab
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