Next-gen Moderna COVID-19 vaccine shows promise
Posted: 26 March 2024 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Phase III data shows that mRNA-1283 has a similar safety profile to Moderna’s approved COVID-19 vaccines, the company states.
Moderna’s next-generation COVID-19 vaccine mRNA-1283 demonstrated a higher immune response against SARS-CoV-2, interim results from the company’s Phase III trial show.
These findings were based on data comparing the treatment to mRNA-1273.222 (Spikevax®), Moderna’s licensed vaccine for the condition.
“We are excited to announce our fourth infectious disease vaccine programme with positive Phase III data,” stated Stéphane Bancel, Chief Executive Officer of Moderna. “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.”
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A promising mRNA vaccine
What the clinical data showed
Findings from the NextCOVE Phase III pivotal trial showed that mRNA-1283 facilitated a higher immune response in patients against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, compared to Moderna’s Spikevax vaccine.
Importantly, this benefit was mostly observed in individuals who were aged over 65 years old. Moderna acknowledged that this patient population has the greatest risk for severe outcomes from COVID-19.
Additionally, mRNA-1283 was found to have a similar safety profile to Moderna’s approved vaccines for COVID-19. In the Phase III clinical trial, the most common solicited adverse events included injection site pain (local) and headache, fatigue, myalgia and chills (systematic), Moderna confirmed.
Based on the storage, shelf life and pre-filled syringe presentation of the mRNA-1283, the COVID-19 vaccine could support increased access of the treatment into new settings, according to Moderna. Importantly, the next-generation design of the mRNA COVID-19 vaccine could lead to a combination vaccine as a treatment of for both influenza and COVID-19, the firm explained.
Further details
In October 2023, Moderna shared that the regulatory approval for the combination mRNA-1083 vaccine for adults 50 years and older was targeted for next year.
Moderna’s Spikevax XBB.1.5-adapted COVID-19 vaccine was authorised by the European Commission (EC) in September 2023.
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