Pfizer announced that the European Commission (EC) has expanded the marketing authorisation for its Abrysvo vaccine to include adults aged 18 to 59 years.
The decision allows the vaccine to be used for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in this age group.
Abrysvo is a bivalent, unadjuvanted vaccine designed to protect against RSV-LRTD, targeting the RSV fusion protein (F) in its prefusion state.
In August 2023, the EC initially approved Abrysvo for adults aged 60 and older and for maternal immunisation to protect infants.
The expanded approval now provides the broadest indication in the European Union (EU).
It covers active immunisation of the RSV vaccine for individuals 18 and older and passive protection for infants up to six months old through maternal immunisation.
Pfizer executive vice president, chief international commercial officer Alexandre de Germay said: “We are thrilled that Abrysvo is now approved in the EU to help prevent RSV in adults aged 18 and older, which causes approximately 158,000 adult hospital admissions annually from RSV disease.
“With an indication that also includes pregnant individuals between weeks 24 and 36 gestation to help protect infants from birth up to 6 months of age, Abrysvo’s expanded authorization 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.”
The expanded EC approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
It applies to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
The expanded approval is supported by data from the Phase 3 MONeT clinical trial.
The study evaluated the safety, tolerability, and immunogenicity of Abrysvo in adults aged 18 to 59 with chronic medical conditions that increase the risk of RSV-associated LRTD.
The approval is also backed by extensive clinical trials involving thousands of vaccinated individuals in this age group, further validating the vaccine’s safety and efficacy.
