Moderna Next-Gen mRNA COVID-19 Vaccine Meets Primary Endpoints in NextCOVE Phase 3 Trial

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The new mRNA bivalent candidate vaccine against COVID-19 from Moderna has met the primary endpoints of the NextCOVE phase 3 clinical trial, according to a company announcement on March 26. The investigational mRNA-1283 resulted in a “more robust” immune response against both the SARS-CoV-2 Omicron BA.4/BA.5 variant and original wild virus when compared with Moderna’s licensed Spikevax COVID-19 vaccine, mRNA-1273.222, said Moderna.¹

An important finding is that the vaccine’s benefit was most prominent in study participants over age 65 years—a population highly vulnerable to infection and to severe outcomes from COVID-19.¹

In a parallel development program is the company’s investigational combined vaccine against influenza and COVID-19 for which mRNA-1283 is half of the formulation. "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."¹

The NEXTCove phase 3 clinical trial is designed to assess the safety, efficacy, reactogenicity, immunogenicity and relative efficacy of mRNA as a booster dose, vs mRNA-1273.222. The study enrolled approximately 11 400 participants aged 12 years and older from populations in the US, UK, and Canada. The safety profile of mRNA-1283 observed in the study was similar to that of Moderna’s approved COVID-19 vaccines and, as with those, the most commonly reported local side effect was injection site pain and systemic adverse effects included headache, fatigue, and muscle aches and chills, according to the news release.¹

mRNA-1283 is designed to be refrigerator-stable, said Moderna, a benefit that could prolong the shelf life and provide storage advantages. Along with the pre-filled syringe presentation of the vaccine, mRNA-1283 “could alleviate healthcare provider burden and potentially increase access into new settings to serve public health.”¹

Moderna plans to provide a detailed analysis of the NextCOVE data during the company’s fifth annual Vaccines Day update today, March 27, and to present the findings at future scientific conferences.²

Moderna previously reported interim results from a Phase I randomized clinical trial (NCT04813796) of mRNA-1283 that showed across the 10 µg, 30 µg, and 100 µg dose levels, administered on a 2-dose schedule 28 days apart, the vaccine was generally safe and produced robust immune responses comparable to mRNA-1273 at a dose of 100 µg.³

The most favorable tolerability profile was observed with the 10 µg lowest administered dose of mRNA-1293, which generated robust nAb and bAb responses to SARS-CoV-2 after the second dose, a response similar to that seen with mRNA-1273. Investigators stated that the results suggest a 2-dose regimen of mRNA-1283 at a lower dose level may produce similar efficacy to mRNA-1273.³

This article will be updated with further details as soon as they are available.

References

1. Moderna announces positive interim results form phase 3 trial of next-generation COVID-19 vaccine. News release. Moderna. March 26, 2024. Accessed March 27, 2024. https://investors.modernatx.com/news/news-details/2024/Moderna-Achieves-Positive-Interim-Results-from-Phase-3-Trial-of-Next-Generation-COVID-19-Vaccine/default.aspx
2. Moderna advances multiple vaccine programs to late-stage clinical trials. News release. Moderna. March 27, 2024. Accessed March 27, 2024. https://www.accesswire.com/847245/moderna-advances-multiple-vaccine-programs-to-late-stage-clinical-trials
3. Davy J. Phase III NextCOVE trial data show efficacy of Moderna's next-generation COVID-19 VAccine. Applied Clinical Trials. March 26, 2024. https://www.appliedclinicaltrialsonline.com/view/phase-iii-nextcove-trial-data-show-efficacy-of-moderna-s-next-generation-covid-19-vaccine