Moderna, Inc. (MRNA) announced Monday that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints. Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine.
mRNA-1083 elicited higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older.
mRNA-1083 comprises components of mRNA-1010, Moderna\'s vaccine candidate for seasonal influenza, and mRNA-1283, Moderna\'s next-generation COVID-19 vaccine candidate. Each investigational vaccine has independently demonstrated positive Phase 3 clinical trial results.
\"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses,\" said Stephane Bancel, CEO of Moderna.
mRNA-1083 showed an acceptable tolerability and safety profile. The Company will engage with regulators on next steps.