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.
