Moderna Announces Phase III Results for Influenza Vaccine

Moderna, the U.S.-based biotechnology company, has released significant data regarding its seasonal influenza vaccine candidate, mRNA-1010, which is based on messenger RNA technology. The study involved over 40,000 participants aged 50 and older across eleven countries, testing the safety and efficacy of mRNA-1010 against licensed standard-dose influenza vaccines.

Participants received either a dose of the mRNA vaccine candidate or a dose of one of the approved vaccines: Fluarix®, Influsplit® Tetra, Fluarix Tetra, or Alpharix® Tetra. The study aimed to evaluate vaccine reactions and the time until the first occurrence of a PCR-confirmed influenza illness.

The findings indicated that the mRNA vaccine outperformed the existing vaccines, demonstrating a relative vaccine efficacy (rVE) of 26.6%. This means that mRNA-1010 prevented influenza infections 26.6% more effectively than the comparator vaccines. The study also met the predefined superiority criteria, confirming the vaccine's potential. Notably, mRNA-1010 showed improved performance against specific influenza strains, including A/H1N1 (rVE: 29.6%) and B/Victoria (rVE: 29.1%). In participants aged 65 and older, the rVE was measured at 27.4%.

Previous Phase III studies had already indicated that mRNA-1010 exhibited superior seroconversion rates and geometric mean antibody titers compared to both standard and high-dose influenza vaccines. In terms of safety and tolerability, this latest study corroborated earlier results, with the most common local side effects being pain at the injection site, while systemic reactions primarily included fatigue, headache, and muscle pain. Severe or serious adverse effects occurred comparably rarely in both groups.

Moderna plans to present these findings at a medical conference and aims to submit them for publication in a scientific journal. The company is also engaging with regulatory authorities regarding the submission of applications for mRNA-1010. This vaccine candidate is expected to be included in Moderna's upcoming combination vaccine aimed at providing protection against both influenza and COVID-19.