Moderna Receives European Commission Approval for RSV Vaccine for People Over 60

Today, Moderna announced that the European Commission (EC) has granted a marketing authorization for mRESVIA (mRNA-1345), an mRNA vaccine against respiratory syncytial virus (RSV), to protect adults aged 60 years and over against lower respiratory tract disease caused by RSV infection. The marketing authorization is in accordance with a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The authorization is valid in all 27 EU Member States, as well as Iceland, Liechtenstein and Norway.

“The European Commission’s approval of mRESVIA is an important milestone for public health and underscores Moderna’s leadership in mRNA. This approval marks the first authorization for use of an mRNA vaccine against a disease other than COVID-19 in Europe,” said Stéphane Bancel, CEO of Moderna. “mRESVIA protects older adults from the serious consequences of RSV and is uniquely offered in pre-filled syringes for ease of administration, which could reduce vaccine preparation time and administrative errors.”

RSV is a highly contagious seasonal respiratory virus and a major cause of lower respiratory tract infections and pneumonia. The disease burden is particularly high in infants and the elderly. In the European Union, the virus is estimated to cause approximately 160,000 adult hospitalisations each year, of which 92% occur in people over 65 years of age1.

The marketing authorization of mRESVIA is based on positive data from the Phase 3 ConquerRSV clinical trial, a global study conducted in approximately 37,000 adults aged 60 years and older in 22 countries. The primary analysis with a median follow-up of 3.7 months found vaccine efficacy (VE) against RSV lower respiratory tract infection (LRTI) of 83.7% (95.88% CI: 66.0%, 92.2%), the results are published in The New England Journal of Medicine. In an additional analysis with a median follow-up of 8.6 months, mRNA-1345 demonstrated durable efficacy with 63.3% (95% CI: 48.7%, 73.7%) efficacy versus ETRI in RSV, including two or more symptoms. The efficacy was 74.6% (95% CI: 50.7–86.9) against RSV ETRI with two or more symptoms, including dyspnoea, and 63.0% (95% CI: 37.9; 0.3% to 78.2%) compared with RSV ETRI with three or more symptoms. The statistical criteria of the study remained strict: the lower limit of the 95% CI was greater than 20%, consistent with both endpoints. The most common adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345) to protect adults aged 60 years and older from lower respiratory disease caused by VRS infection. The approval was granted under breakthrough therapy designation, with a second approval granted to Moderna.