Moderna, Inc. (NASDAQ) has announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA vaccine designed to protect adults aged 60 and older from lower respiratory tract disease caused by RSV (respiratory syncytial virus). This authorization follows a Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
Stéphane Bancel, CEO of Moderna, stated, “The European Commission’s approval of mRESVIA is a significant milestone for public health and underscores Moderna’s leadership in mRNA technology. This is the first mRNA vaccine approved for a condition other than COVID-19 in Europe. mRESVIA provides protection for older adults against severe RSV outcomes and is uniquely available in a pre-filled syringe to simplify administration, reduce preparation time, and minimize administrative errors.”
RSV is a highly contagious seasonal virus and a leading cause of lower respiratory tract infections and pneumonia, particularly affecting infants and older adults. In the European Union, RSV is estimated to lead to around 160,000 hospital admissions annually among adults, with 92% of these admissions occurring in those aged 65 and older.
The marketing authorization for mRESVIA is based on positive results from the Phase 3 ConquerRSV clinical trial, a global study involving approximately 37,000 adults aged 60 and older across 22 countries. The primary analysis, with a median follow-up of 3.7 months, showed a vaccine efficacy (VE) of 83.7% (95.88% CI 66.0%, 92.2%) against RSV lower respiratory tract disease (LRTD), as published in The New England Journal of Medicine. In a supplementary analysis with a median follow-up of 8.6 months, mRNA-1345 demonstrated durable efficacy, with a sustained VE of 63.3% (95% CI 48.7%, 73.7%) against RSV-LRTD, including two or more symptoms. VE was 74.6% (95% CI 50.7%, 86.9%) against RSV-LRTD with two or more symptoms, including shortness of breath, and 63.0% (95% CI 37.3%, 78.2%) against RSV-LRTD with three or more symptoms. The study’s stringent statistical criteria were met for both endpoints. Common adverse reactions reported were injection site pain, fatigue, headache, myalgia, and arthralgia.
In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345) for protecting adults aged 60 and older from RSV-related lower respiratory tract disease. This approval, granted under breakthrough therapy designation, marked Moderna’s second approved mRNA product. Moderna has submitted marketing authorization applications for mRNA-1345 in multiple global markets.
