The FDA on Dec. 3 revised the emergency use authorization of Eli Lilly's COVID-19 monoclonal antibodies bamlanivimab and etesevimab for all children who are at high risk for severe COVID-19, including newborns.
In February, the FDA granted emergency use authorization for the administration of bamlanivimab and etesevimab together in patients ages 12 and older who are at high risk for severe COVID-19 or hospitalization. In September, the agency revised its emergency use authorization to allow the treatment to be used as a post-exposure prophylaxis for COVID-19 in high-risk patients.
The latest revision allows the antibodies to be administered to all pediatric patients who have a positive COVID-19 test and are at high risk for progression to severe COVID-19. It also allows all at-risk pediatric patients to receive the antibodies as a post-exposure prophylaxis for COVID-19.
The revision was based on a clinical trial involving 125 pediatric patients, all with at least one risk factor for severe COVID-19.