On May 31st, Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA-based respiratory syncytial virus (RSV) vaccine. This vaccine protects adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. This RSV vaccine approval, granted under a breakthrough therapy designation, marks the second mRNA product from Moderna to receive FDA approval.
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RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. It causes a particularly large burden of disease in infants and older adults. Each year in the U.S., approximately 60,000-160,000 older adults are hospitalized and 6,000-10,000 die due to RSV infection.
Stéphane Bancel, Chief Executive Officer of Moderna said mRESVIA is the only RSV vaccine available in a pre-filled syringe. This design maximizes ease of administration, saving vaccinators’ time and reducing the risk of administrative errors.
Analyzing RSV vaccine efficacy
The FDA’s approval of mRESVIA is based on positive data from the Phase 3 clinical trial ConquerRSV. Researchers conducted this study globally in approximately 37,000 adults aged 60 years or older.
The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%). These results were published in The New England Journal of Medicine.
Researchers performed a follow-up analysis of the primary endpoint during FDA review. This included cases started before the primary analysis cut-off date. Confirmation occurred afterward. The results were consistent with the primary analysis [VE 78.7% (CI 62.9%, 87.8%)]. An additional longer-term analysis showed continued protection against RSV LRTD over 8.6 months median follow-up.
Researchers identified no serious safety concerns in the Phase 3 trial. Some commonly reported adverse reactions included injection site pain, fatigue, headache, myalgia, and arthralgia.
Moderna expects mRESVIA to be available for eligible populations in the U.S. by the 2024/2025 respiratory virus season. They have filed for approval with regulators in multiple markets worldwide.
