A phase 3 trial evaluating Moderna’s next-generation COVID-19 vaccine, mRNA-1283, met its primary vaccine efficacy endpoint.
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.
Results showed mRNA-1283 was noninferior to mRNA-1273.222 with regard to vaccine efficacy against COVID-19. Moreover, higher vaccine efficacy was observed with mRNA-1283 vs mRNA-1273.222 in individuals aged 65 years and older. These findings were consistent with previously reported immunogenicity results from the study.
The safety profile of mRNA-1283 was found to be similar to mRNA-1273.222. The most common solicited adverse reactions reported were injection site pain, headache, fatigue, and myalgia.
“We are very pleased that mRNA-1283 has now met its primary vaccine efficacy endpoint in phase 3, and showed higher efficacy in adults compared to Spikevax,” said Stéphane Bancel, CEO of Moderna. “With 5 vaccine programs that have achieved positive phase 3 results, Moderna’s platform is consistently demonstrating its ability to address significant unmet needs in public health.”
The Company recently announced positive results from a phase 3 trial evaluating a vaccine against both influenza and COVID-19 (ClinicalTrials.gov Identifier: NCT06097273). The combination vaccine candidate mRNA-1083 includes mRNA-1283.
References:
Moderna announces positive phase 3 efficacy data for mRNA-1283, the company’s next generation COVID-19 vaccine. News release. Moderna, Inc. June 13, 2024. https://www.accesswire.com/viewarticle.aspx?id=876794&lang=en
