Moderna has announced positive interim results from the Phase III NextCOVE clinical trial, where its next-generation Covid-19 vaccine candidate, mRNA-1283, met the primary endpoints.
The randomised, active-controlled, observer-blind trial included nearly 11,400 participants aged 12 years and above from the UK, US, and Canada.
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It is designed to assess the safety, efficacy, reactogenicity, immunogenicity, and relative vaccine efficacy (rVE) of the mRNA-1283.222 vaccine as a booster dose, versus the mRNA-1273.222 vaccine, a licensed Covid-19 vaccine of the company.
In the trial, mRNA-1283 elicited a higher immune response against the SARS-CoV-2 virus, including the Omicron BA.4/BA.5 and original strains, when compared to mRNA-1273.222.
This enhanced response was particularly significant in participants above 65 years of age, a group at higher risk for severe Covid-19 outcomes.
Participants reported common local adverse events, such as pain at the injection site, and systemic adverse events, including fatigue, headache, myalgia, and chills.
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By GlobalDatamRNA-1283’s safety profile was found to be similar to that of the approved Covid-19 vaccines of Moderna.
The storage and handling characteristics of mRNA-1283, including its shelf life and pre-filled syringe presentation, could potentially reduce the burden on healthcare providers and improve vaccine access in public health settings.
Moderna is expected to share a detailed analysis of the Phase III trial data for mRNA-1283 in the near future.
Moderna CEO Stéphane Bancel said: “We are excited to announce our fourth infectious disease vaccine programme with positive Phase III data, further validating our robust mRNA platform.
“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.”
The latest development comes after last year, when the company announced plans to commence a Phase III trial of its flu and Covid-19 vaccine, mRNA-1083.
Moderna reported data from the Phase I/II trial, which demonstrated that this combination vaccine mRNA-1083 was as effective as individual doses.
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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