mRNA-1283 generated a stronger immune response against both the Omicron BA.4/BA.5 and the original virus strains of SARS-CoV-2 compared with Spikevax, Moderna’s licensed COVID-19 vaccine.
Moderna’s next-generation COVID-19 vaccine, mRNA-1283, has met the primary endpoints of its phase 3 clinical trial, the company announced in a news release.1
Vaccine vials against Moderna backdrop / desertsands - stock.adobe.com
The vaccine generated a stronger immune response against both the Omicron BA.4/BA.5 and the original virus strains of SARS-CoV-2 compared with Spikevax (mRNA-1273.322), Moderna’s licensed COVID-19 vaccine. Notably, this protection was most pronounced in participants aged 65 years and older—the population that is most susceptible for severe COVID-19 outcomes.
Trial Name: A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19
ClinicalTrials.gov Identifier: NCT05815498
Sponsor: ModernaTX, Inc.
Summary: The purpose of this study is to evaluate the safety, reactogenicity, and relative vaccine efficacy (rVE) of the mRNA-1283.222 vaccine as well as its immunogenicity in comparison to the mRNA-1273.222 vaccine.
The vaccine also had comparable safety profiles to Moderna’s other approved COVID-19 vaccines. The most common solicited local adverse event was injection site pain, and the most common solicited systemic adverse events were headache, fatigue, myalgia, and chills.
Positive results for mRNA-1283 from the NextCOVE (NCT05815498) phase 3 pivotal trial, which recruited 11,400 individuals aged 12 years and older across the United States, United Kingdom, and Canada, pave the way for Moderna’s combination flu-COVID-19 vaccine, as its formulation is a key component.
“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.1 “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.”
What’s more, the storage, shelf life and pre-filled syringe presentation of mRNA-1283 could ease burdens on health care workers by simplifying logistics and administration, potentially expanding access to the vaccine, and promoting better public health outcomes.
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In 2020, Moderna developed one of the first FDA-approved mRNA vaccines for COVID-19, quickly becoming a household name. Since then, the company has set its sights on building its respiratory portfolio of immunizations.
Unlike traditional vaccines that use weakened or inactive viruses to fight infection, mRNA vaccines give cells instructions to build proteins that resemble a virus, in turn priming the immune system to fight the real virus. Using mRNA technology, Moderna aims to create a “new generation of transformative medicines.”2
In addition to its next-generation COVID-19 vaccine, Moderna has mRNA vaccines for influenza, as well as combination mRNA vaccines for COVID-19/flu and COVID-19/flu/respiratory syncytial virus vaccines in the pipeline. The company intends to introduce a combination vaccine to market as early as 2025.3
Full results of the mRNA-1283 phase 3 trial will be presented today, at Moderna’s Vaccines Day event, as well as at upcoming scientific conferences.
READ MORE: COVID-19 Resource Center
