Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine

• mRNA-1283 induced a more robust immune response compared to Spikevax COVID-19 vaccine, mRNA-1273.222
• Next-generation mRNA vaccine design offers the potential of longer shelf life and storage advantages, and paves the way for combination vaccine against influenza and COVID-19, mRNA-1083

CAMBRIDGE, MA / ACCESSWIRE / March 26, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that mRNA-1283, the Company's next-generation COVID-19 vaccine, has successfully met the primary endpoints of its Phase 3 clinical trial, demonstrating a higher immune response against SARS-CoV-2 when compared to 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 (NCT05815498) 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. Importantly, this benefit was most acutely seen in participants over the age of 65 years, the population that remains at 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 in the United States, United Kingdom and Canada. 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 healthcare provider burden and potentially increase access into 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.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.


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