**Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to prevent RSV-associated lower respiratory tract disease (LRTD) in individuals aged 18 to 59 years.**
The expanded indication makes Abrysvo the first and only RSV vaccine approved in the EU for non-pregnant adults in this age population.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in certain groups, including older adults, infants and those with certain underlying chronic conditions.
Abrysvo is already approved in the EU to protect adults aged 60 years and older against RSV, as well as infants through maternal immunisation during pregnancy.
The EC’s latest decision on the vaccine follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage MONeT trial, which evaluated Abrysvo in adults aged 18 to 59 years who are at risk of RSV-associated LRTD due to certain chronic medical conditions.
The trial achieved its co-primary immunogenicity endpoints and primary safety endpoint, with patients demonstrating RSV-A and RSV-B subgroup neutralising responses that were non-inferior to the responses seen in the phase 3 RENOIR study of the vaccine in adults aged 60 years and older.
Those enrolled in MONeT also achieved at least a four-fold increase in serum neutralising titres for RSV-A and RSV-B one month after receiving Abrysvo compared to pre-vaccination, and safety findings were consistent with those from previous investigations of the vaccine in other populations.
Alexandre de Germay, chief international commercial officer, executive vice president, Pfizer, said the company is “thrilled that Abrysvo is now approved in the EU to help prevent RSV in adults aged 18 and older”.
He continued: “With an indication that also includes pregnant individuals between weeks 24 and 36 gestation to help protect infants from birth up to six months of age, Abrysvo’s expanded authorisation for adults aged 18 to 59 in the EU signifies another step for public health by offering the potential to substantially reduce the burden of RSV in future seasons.”