Moderna announces mRNA-1345, an investigational Respiratory Syncytial Virus (RSV) vaccine, has met primary efficacy endpoints in phase 3 trial in older adults

On January 17^th, Moderna announced positive topline data from its Phase 3 trial of mRNA-1345, an investigational mRNA vaccine targeting respiratory syncytial virus (RSV) in older adults.

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• mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
• mRNA-1345 was generally well-tolerated, with no safety concerns identified
• To date most solicited adverse reactions were few, and mild or moderate (injection site pain, fatigue, headache, myalgia, and arthralgia).

RSV, a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia, causes a particularly large burden of disease in infants and older adults. RSV can cause severe disease with an estimated 5.2 million cases and nearly half a million hospitalizations in adults 60 years or older reported across high-income countries in 2019.

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The trial is a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. FVR – Finnish Vaccine Research participates in this study as well as several other currently ongoing RSV vaccine studies.

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Based on these results, Moderna intends to submit for regulatory approval in the first half of 2023.

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A warm thanks to all volunteers participating in the study!

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Original release by Moderna >>

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FURTHER INFORMATION

Mika Rämet

CHIEF MEDICAL OFFICER

mika.ramet (at) fvr.fi