Moderna says mRNA-1283 meets primary endpoints in Phase 3 trial

Moderna announced that mRNA-1283, the Company’s next-generation COVID-19 vaccine, has met the primary endpoints of its Phase 3 clinical trial, demonstrating a higher immune response against SARS-CoV-2 when compared to mRNA-1273.222, Moderna’s licensed COVID-19 vaccine. In the NextCOVE Phase 3 pivotal trial, mRNA-1283 was shown to elicit a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, compared to mRNA-1273.222. Importantly, this benefit was most acutely seen in participants over the age of 65 years, the population that remains at highest risk for severe outcomes from COVID-19. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events included headache, fatigue, myalgia and chills. The NEXTCove clinical trial is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older in the United States, United Kingdom and Canada. mRNA-1283 was found to have a similar safety profile to Moderna’s approved COVID-19 vaccines. The storage, shelf life and pre-filled syringe presentation of mRNA-1283 could alleviate healthcare provider burden and potentially increase access into new settings to serve public health. A detailed analysis of the Phase 3 clinical trial data for mRNA-1283 will be shared at the Company’s Vaccines Day event on March 27 and presented at upcoming scientific conferences.