Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Moderna: Phase III Covid-19 vaccine trial meets primary endpoints

Moderna has disclosed promising interim findings from the Phase III NextCOVE clinical trial, demonstrating the efficacy of its next-generation COVID-19 vaccine candidate, mRNA-1283. In this randomized, active-controlled, observer-blind trial involving nearly 11,400 participants aged 12 years and above from the UK, US, and Canada, mRNA-1283 met its primary endpoints.

Compared to Moderna's licensed COVID-19 vaccine mRNA-1273.222, mRNA-1283 elicited a superior immune response against various strains of the SARS-CoV-2 virus, including Omicron BA.4/BA.5 and original strains. Notably, this enhanced response was particularly significant among participants aged 65 and above, a group at higher risk for severe COVID-19 outcomes.

Common adverse events reported by participants included local reactions like pain at the injection site and systemic symptoms such as fatigue, headache, myalgia, and chills. Importantly, mRNA-1283 demonstrated a safety profile similar to that of Moderna's approved Covid-19 vaccines.

Furthermore, the storage and handling characteristics of mRNA-1283, including its shelf life and pre-filled syringe presentation, hold promise for reducing healthcare provider burden and improving vaccine access in public health settings.

Moderna also shared findings from the Phase I/II trial, indicating that the combination vaccine mRNA-1083 was comparably effective to individual doses.