Moderna Focuses on Influenza - COVID Combination Vaccine Candidate

Moderna, Inc., today announced program and financial updates at its annual R&D Day event, demonstrating progress and strategic prioritization of its mRNA pipeline.

Stéphane Bancel, CEO of Moderna, commented in a press release, "The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these ten products to patients, slow down the pace of new R&D investment, and build our commercial business."

Moderna's updates on September 12, 2024, include but are not limited to, several seasonal influenza vaccine candidates in clinical development.

The Company's investigational seasonal flu vaccine, mRNA-1010, has demonstrated consistently acceptable safety and tolerability across three Phase 3 trials.

In the most recent Phase 3 trial (P303), which was designed to test the immunogenicity and safety of an optimized vaccine composition, mRNA-1010 met all immunogenicity primary endpoints, demonstrating higher antibody titers compared to a licensed standard-dose flu vaccine (Fluarix®).

In an older adult extension study of P303, mRNA-1010 met all primary immunogenicity, including superiority for all compared to a licensed enhanced flu vaccine (Fluzone HD®), and showed an acceptable reactogenicity profile.

The Company plans to start a confirmatory vaccine efficacy study for mRNA-1010 in 2024, funded by previously announced project financing through Blackstone Life Sciences.

Moderna also confirmed it is no longer pursuing an accelerated approval pathway for the regulatory submission of its standalone flu vaccine, mRNA-1010, to focus its resources on submitting a potentially more impactful flu/COVID combination vaccine, mRNA-1083, in 2024.

With the 2024-2025 flu season beginning in the United States, most health clinics and pharmacies offer flu shot vaccination services.

About 158 million flu vaccines had been distributed during the 2023-2024 season.