3 December 2021 - Today, the U.S. FDA revised the emergency use authorisation of bamlanivimab and etesevimab (previously authorised for paediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorise bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger paediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. 

This revision also authorises bamlanivimab and etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all paediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalisation or death.

Read FDA press release