European Commission authorises first vaccine to protect older adults from RSV infection

The European Commission has authorised Arexvy, the first vaccine to protect adults aged 60 years and older, against the lower respiratory tract disease caused by RSV. This decision marks an important step and has been particularly awaited in light of the increased RSV infections in the EU last winter. The vaccine Arexvy, which is now authorised throughout the EU, will help strengthen the immune response to the virus. The authorisation follows a stringent evaluation under EMA's accelerated assessment mechanism. Considering that prevention of RSV infection in the elderly population is of major public health interest, the Commission accelerated the authorisation of the vaccine.

On 31 October 2022, the Commission already authorised in the EU the monoclonal antibody Beyfortus (nirsevimab) for the prevention of lower respiratory tract disease in new-born babies and infants during their first RSV season (i.e., when there is a higher risk of RSV infection).

RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover within one to two weeks, but RSV can be serious in vulnerable people, including older adults and those with lung or heart disease and diabetes. In Europe, RSV causes an estimated 250,000 hospitalisations and 17,000 in-hospital deaths every year in people aged 65 years and older.

This is our first authorised RSV vaccine, and we hope it will prevent some of the problems we encountered last winter. The COVID pandemic clearly showed the need for decisive action to better prepare the EU for emerging health threats. This is a core principle of the strong European Health Union we are building. In view of the threat posed by RSV, we have today authorised as a matter of priority the first vaccine to protect the EU's older citizens against an important health threat. I now encourage Member States to quickly build on this authorisation and define national vaccination strategies so that those most at risk can access them in the coming months ahead of the next autumn season

Stella Kyriakides, Commissioner for Health and Food Safety