The European Commission has authorised Arexvy, the first vaccine to protect adults aged 60 and over, against lower respiratory tract disease caused by respiratory syncytial virus (RSV). "I now encourage Member States to build quickly on this authorisation and define national vaccination strategies so that those most at risk can access it in the coming months before the next autumn season," says EU Health Commissioner Stella Kyriakides.
The green light for the vaccine was particularly awaited in light of the increase in RSV infections in the EU last winter, it took place under the EMA's accelerated evaluation mechanism and the Commission accelerated the authorization of the vaccine considering that the prevention of RSV infection in the elderly population is of great interest for public health.
On 31 October, the Commission already authorised the monoclonal antibody Beyfortus (nirsevimab) in the EU for the prevention of lower respiratory tract diseases in newborns and infants during the first season of RSV, when there is a higher risk of infection.
Syncytial virus is a common respiratory virus that usually causes mild, cold-like symptoms, the Commission points out. Most people recover within one to two weeks. However, it can be serious in vulnerable people, including the elderly and those with lung or heart disease and diabetes. In Europe, the RSC causes about 250,17 hospitalizations and 65,<> deaths each year in people aged <> and over.