CAMBRIDGE, MA / ACCESSWIRE / June 10, 2024 – Moderna, Inc. (NASDAQ:MRNA) has unveiled exciting news regarding its Phase 3 trial of mRNA-1083, a groundbreaking combination vaccine designed to combat both influenza – COVID-19. The trial has achieved its primary objectives, demonstrating significantly higher immune responses compared to licensed vaccines used as comparators. The positive results mark a significant advancement in the quest for more effective and convenient vaccination options, particularly for individuals aged 50 and older.
Introduction to mRNA-1083: A Game-Changing Combination Vaccine
mRNA-1083 represents a pivotal step forward in vaccination technology, combining elements of Moderna’s mRNA-1010 for seasonal influenza. With both individual vaccine candidates showing promise in prior Phase 3 trials, the integration of their components into mRNA-1083 offers a synergistic approach to combating respiratory viruses.
Stéphane Bancel’s Vision: Revolutionizing Public Health
StéphaneBancel, Chief Executive Officer of Moderna, expressed optimism regarding the potential impact of combination vaccines on global health. He emphasized the significance of reducing the burden of respiratory illnesses on healthcare systems and highlighted the potential for enhanced protection and improved compliance offered by combination vaccines.
Unveiling the Trial Design and Results
The Phase 3 clinical trial, registered under ClinicalTrials.gov Identifier:NCT06097273, adopted a randomized, observer-blind, active control design. Approximately 8,000 adults were divided into two age cohorts: adults aged 65 and older and those aged 50 to 64. The trial evaluated the safety, reactogenicity, and immunogenicity of mRNA-1083 compared to licensed comparator vaccines.
Promising Immunogenicity Data
The trial results demonstrated non-inferior immune responses from a single dose of mRNA-1083 compared to co-administered licensed vaccines. Moreover, mRNA-1083 elicited statistically significantly higher immune responses against multiple strains of influenza virus and SARS-CoV-2 in both age cohorts.
Safety Profile and Tolerability
mRNA-1083 exhibited an acceptable safety profile, with the majority of adverse reactions being mild to moderate in severity and consistent with those observed with licensed vaccines. Common solicited adverse reactions included injection site pain, fatigue, myalgia, and headache.
Implications for Future Vaccine Development
The successful Phase 3 trial of mRNA-1083 marks a significant milestone in the development of combination vaccines. Moderna plans to share the trial data at upcoming medical conferences and submit it for publication. Additionally, the company intends to engage with regulators to advance the next steps in the approval process.
About Moderna: Pioneering mRNA Medicine
Moderna has been at the forefront of mRNA medicine, leveraging cutting-edge technology to revolutionize the treatment and prevention of diseases. With a focus on infectious diseases, immuno-oncology, rare diseases, and autoimmune disorders, Moderna is committed to delivering impactful solutions to global health challenges.
Forward-Looking Statements
While the positive Phase 3 data for mRNA-1083 are promising, Moderna acknowledges the inherent uncertainties and risks associated with drug development. The company remains dedicated to ongoing research and innovation to address unmet medical needs and improve public health outcomes.
In conclusion, Moderna’s breakthrough combination vaccine represents a significant advancement in the fight against respiratory viruses, offering hope for a future with enhanced protection and greater convenience in vaccination efforts.
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