CHMP backs Moderna’s mCombriax vaccine for adults aged 50 and over.
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Moderna's combination mRNA vaccine mCombriax (mRNA-1083) against COVID-19 and seasonal influenza (flu) in those 50 years old and over.
Stéphane Bancel, Chief Executive Officer of Moderna, said: "The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine. If approved, this would be Moderna's fourth marketed product in Europe.
"Combination vaccines have the potential to simplify vaccination and support improved health outcomes."
The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine. If approved, this would be Moderna's fourth marketed product in Europe"
The positive opinion represents confidence from the EMA’s committee that the single dose is beneficial as a protective protocol in this age group.
The CHMP opinion is supported by results from a phase III clinical trial. A single dose of mRNA-1083 facilitated statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2 and B/Victoria) and against SARS-CoV-2.
Clinical data shows mCombriax enabled antibodies against influenza and SARS-CoV-2 that were statistically non‑inferior to those given both Spikevax and either Fluzone HD or Fluarix.
Further findings of a similar mRNA vaccine containing just the influenza component in mCombriax showed it can prevent influenza.
This news comes as David Berman joins Moderna as the company’s new Chief Development Officer. He replaces Dr Jacqueline Miller who served in the role for five and a half years.
Moderna shared last November that it plans to strengthen its US mRNA capabilities by investing over $140 million to expand its manufacturing, supporting onshoring efforts in the country. Speaking then, Moderna’s Bancel said: “By onshoring drug product manufacturing to our campus in Norwood, Massachusetts, we have completed the full manufacturing loop under one roof in the US.”
