Moderna’s New COVID-19 Vaccine Elicits Strong Immune Response in Phase 3 Trial

Positive results were observed in a phase 3 trial evaluating Moderna’s next-generation COVID-19 vaccine, mRNA-1283.

The phase 3 NextCOVE study (ClinicalTrials.gov Identifier: NCT05815498) compared the safety, reactogenicity, relative vaccine efficacy and immunogenicity of mRNA-1283 to Moderna’s licensed COVID-19 vaccine, Spikevax^® (mRNA-1273.222). The randomized, observer-blind, active-controlled study enrolled approximately 11,400 participants aged 12 and older. 

Findings showed mRNA-1283 elicited a higher immune response against both Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, compared with mRNA-1273.222, particularly in individuals over the age of 65 years. The most common adverse reactions reported were injection site pain, headache, fatigue, myalgia and chills. The safety profile of mRNA-1283 was found to be similar to the currently approved Moderna COVID-19 vaccines.

“We are excited to announce our fourth infectious disease vaccine program with positive phase 3 data, further validating our robust mRNA platform,” said Stéphane Bancel, CEO  of Moderna. “mRNA-1283 is a critical component of our combination vaccine against flu and COVID-19, mRNA-1083, and this milestone gives us confidence in our ability to bring this much needed vaccine to market.”

In addition to a prefilled syringe presentation, mRNA-1283 is being developed with a longer shelf life and storage advantages. The Company expects these improvements will lessen the burden on providers and help increase access into new settings.