EMA has recommended a marketing authorisation in the European Union (EU) for Beyfortus (nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in newborn babies and infants during their first RSV season (when there is a risk of RSV infection in the community).
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, especially in infants. It is the most common cause of lower respiratory tract infections, such as bronchiolitis (inflammation of the small airways in the lungs) and pneumonia (infection of the lungs) that may lead to hospitalisation or even death in newborn babies and young infants. For instance in 2015, RSV caused an estimated 33 million lower respiratory tract infections in children younger than five years globally; 3.2 million of them required hospitalisation. Approximately 59,600 children died, the vast majority (43,600) in low- and middle-income countries. Despite a decrease in the number of RSV infections during the pandemic in 2020 and 2021, a resurgence in infections is expected following the easing of COVID-19 mitigation measures. In the EU, the virus is usually more common during the winter…
