The European Commission has granted marketing authorization for the respiratory syncytial virus (RSV) vaccine (RSVpreF) to protect both newborns, through maternal immunization, and older adults. The vaccine will be marketed under the name Abrysvo.

RSV is a contagious virus and a common cause of respiratory illnesses worldwide. In the EU, approximately 245,000 annual hospital admissions have been associated with RSV in children under the age of five. The disease burden for older adults is also significant. Each year, the virus causes more than 270,000 hospital admissions and approximately 20,000 deaths in 60 y.o. people and older.

The EU decision follows the positive opinion recently issued by the European Medicines Agency.
The approval is based on data from two Phase III studies, including the ongoing RENOIR study, the interim results of which demonstrated efficacy of 66.7% against RSV-associated lower respiratory tract disease and 85.7% against severe RSV disease in adults older than 60 years.
In the second study, named MATISSE, Abrysvo demonstrated 81.8% efficacy in preventing lower respiratory tract disease due to RSV in infants up to three months of age when administered to individuals during pregnancy, and 69.4% efficacy against severe disease requiring hospitalization or assisted breathing in newborns in the first six months of life.

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