Tuesday, Moderna Inc (NASDAQ: MRNA) said that mRNA-1283, the company's next-generation COVID-19 vaccine, has met the primary endpoints of its Phase 3 trial.
The data demonstrated a higher immune response against SARS-CoV-2 than mRNA-1273.222, Moderna's licensed COVID-19 vaccine.
"We are excited to announce our fourth infectious disease vaccine program with positive Phase 3 data, further validating our robust mRNA platform," said 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."
In the NextCOVE Phase 3 pivotal trial, mRNA-1283 was shown to elicit a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, compared to mRNA-1273.222.
The benefit was most acutely seen in participants over 65 years, the population at the highest risk for severe outcomes from COVID-19.
The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events included headache, fatigue, myalgia, and chills.
The NEXTCove clinical trial is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older.
mRNA-1283 was found to have a similar safety profile to Moderna's approved COVID-19 vaccines.
The storage, shelf life, and pre-filled syringe presentation of mRNA-1283 could alleviate the healthcare provider burden and potentially increase access to new settings to serve public health.
A detailed analysis of the Phase 3 clinical trial data for mRNA-1283 will be shared at the Company's Vaccines Day event on March 27 and presented at upcoming scientific conferences.
Price Action: MRNA shares are down 1.36% at $108.88 on the last check Tuesday.