The US FDA has accepted a supplemental Biologics License Application (sBLA) for Merck’s Enflonsia (Merck is known as MSD outside the United States and Canada). The application is to protect against respiratory syncytial virus (RSV) in children under two years of age. The application is to expand its indication to include protecting children under two years of age from the respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD). It is specifically for those under two who are at increased risk for severe RSV disease through their second RSV season. Enflonsia is approved in more than 40 countries worldwide, including the US, Canada, the EU, China and Japan, for use in infants during their first RSV season.