The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a favourable opinion for the vaccine Arexvy on 26 April 2023. The vaccine product from GlaxoSmithKline Biologicals S.A. is intended for use in adults aged 60 years and older to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV) infection. The European Commission followed this recommendation on 6 June 2023 and granted a marketing authorisation for Arexvy.
Arexvy contains a genetically modified version of the RSV fusion protein (F) in a stabilised prefusion form (RSVPreF3). This protein is essential for an RSV infection to occur. The version of the protein contained in the vaccine acts as an antigen against which antibodies are formed by the immune system to protect against infection. The vaccine also contains the adjuvant AS01E, which enhances the immune response to the vaccine.
Arexvy was assessed by the CHMP at EMA under its accelerated assessment mechanism because prevention of RSV infections in the elderly population is considered to be of great public health interest.
The CHMP's favourable opinion is based on data from a randomised, placebo-controlled trial of 25,000 adults in 17 countries. The results showed protection of about 83% against lower respiratory tract disease (LRTD) for six months.
The most commonly reported vaccine reactions that subsided within about 10 days were headache, fatigue, muscle pain, joint pain, and pain at the injection site. The clinical trial is still ongoing and will serve to more accurately determine the efficacy of a single dose of Arexvy over several seasons, the need for booster vaccination, and the safety profile.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover within one to two weeks, but RSV can lead to a severe disease progression in high-risk individuals. People at risk include older adults and individuals who suffer from lung disease, heart disease, or diabetes. In Europe, RSV infections result in an estimated 250,000 hospitalisations and 17,000 hospital deaths each year in people aged 65 and over.
Updated: 28.04.2023
