Moderna, Inc. announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The marketing authorization follows the Positive Opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). 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 highlights Moderna's mRNA leadership. This approval marks the first time an mRNA vaccine has been approved for a disease beyond COVID-19 in Europe," said Stéphane Bancel, Chief Executive Officer of Moderna. "mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration, which can reduce vaccine preparation time and administrative errors."

RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. It causes a particularly high burden of disease in infants and older adults. In the European Union, RSV is estimated to cause approximately 160,000 hospital admissions in adults each year, with 92% of these admissions occurring in adults aged 65 and over.¹

The marketing authorization for mRESVIA is based on positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy (VE) against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%), with these results published in The New England Journal of Medicine. In a supplementary analysis with 8.6 months of median follow-up, mRNA-1345 maintained durable efficacy, with 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 ≥2 symptoms, including shortness of breath, and VE was 63.0% (95% CI, 37.3%, 78.2%) against RSV LRTD including three or more symptoms. The stringent statistical criterion of the study, a lower bound on the 95% CI of >20%, continued to be met for both endpoints. The most commonly reported solicited 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 tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marked Moderna's second approved mRNA product. Moderna has filed for mRNA-1345 marketing authorization applications in multiple markets worldwide.