The European Commission has approved the Moderna RSV vaccine for people over 60.

The marketing authorisation was granted following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) European Medicines Agency (EMA) and is valid in all 27 EU Member States as well as Iceland, Liechtenstein and Norway.

“The approval of mRESVIA by the European Commission is an important milestone for public health and underlines Moderna’s leadership in mRNA. This approval represents the first authorization for use of an mRNA vaccine against a disease other than COVID-19 in Europe,” said Stéphane Bancel, CEO of Moderna.

The vaccine protects older adults from serious complications caused by RSV and is offered in pre-filled syringes for easier administration, which could reduce vaccine preparation time and reduce administrative errors, the company says.

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 around 160,000 adult hospitalisations each year, of which 92% are in people over 65 years of age.

The vaccine authorization is based on positive data from the Phase III ConquerRSV clinical trial, a global study 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-induced lower respiratory tract infection (LRTI) to be 83.7% (95.88% CI: 66.0%, 92.2%), the results were published in The New England Journal of Medicine.

In May 2024, the U.S. FDA approved the vaccine to protect adults over 60 years of age from lower respiratory disease caused by RSV infection. The approval was granted under breakthrough therapy designation.