Moderna, Inc. (MRNA) announced on Monday that its Phase 3 trial of mRNA-1083, a combination vaccine targeting both influenza and COVID-19, has successfully met its primary endpoints. This achievement positions Moderna as the sole company with a positive Phase 3 outcome for a flu and COVID-19 combination vaccine.
The mRNA-1083 vaccine elicited stronger immune responses against the influenza virus and SARS-CoV-2 compared to currently licensed flu and COVID-19 vaccines. This includes an enhanced response when compared to an existing influenza vaccine for adults aged 65 and older.
The mRNA-1083 vaccine integrates elements from mRNA-1010, Moderna's candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate. Both vaccines have independently demonstrated positive results in Phase 3 clinical trials.
"Combination vaccines have the potential to alleviate the burden of respiratory viruses on healthcare systems and pharmacies. They also offer a more convenient vaccination option, which could improve compliance and provide stronger protection against seasonal illnesses," said Stephane Bancel, CEO of Moderna.
The mRNA-1083 vaccine has shown an acceptable safety and tolerability profile. Moderna plans to engage with regulators to discuss the next steps.