Moderna Inc, a pioneer and leader in the field of mRNA medicine, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX (mRNA-1083), Moderna's combination vaccine indicated for active immunization for the prevention of influenza and Covid-19 caused by SARS-CoV-2 in individuals 50 years of age and older.
mCOMBRIAX is the world's first flu plus Covid-19 combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinion.
"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," said Stéphane Bancel, chief executive officer of Moderna. "Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA's rigorous scientific review."
mCOMBRIAX builds on the advances of?mNEXSPIKE, Moderna's Covid -19 vaccine, and mRNA-1010, Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the United States, the European Union, Canada and Australia.
The CHMP opinion is supported by results from the pivotal phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273), a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each. One cohort included adults 65 years of age and older and compared mRNA-1083 to co-administered Fluzone HD (licensed in the European Union as Efluelda), a high-dose influenza vaccine, and Spikevax, Moderna's licensed Covid-19 vaccine. The second cohort included adults 50 to 64 years of age and compared mRNA-1083 to co-administered Fluarix, a standard-dose influenza vaccine, and Spikevax.
mCOMBRIAX will be made available in the European Union, subject to final European Commission authorization and national regulatory and access procedures.
All primary endpoints demonstrating the non-inferiority of immune responses were met. Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2 and B/Victoria) and against SARS-CoV-2 in both age cohorts. The B/Yamagata strain, which is no longer recommended for inclusion in seasonal influenza vaccines, was the only strain for which a statistically significantly higher immune response was not observed for adults 65 years of age and older compared to the co-administered licensed comparator vaccines.
mRNA-1083 demonstrated an acceptable safety and tolerability profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial.
Following the CHMP's positive opinion, the European Commission will consider the recommendation and is expected to adopt a final decision on marketing authorization. Once the European Commission approves a product, the marketing authorization is valid in all EU Member States as well as in the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway. Upon European Commission approval, Moderna will work with national regulatory and health authorities to support local access and implementation.
Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.
With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. |