FDA Authorizes Eli Lilly’s COVID Antibody Treatment for Children under 12

December 7, 2021

Last Friday, the FDA authorized the use of Eli Lilly’s monoclonal antibody treatment for young children, including newborns. “Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens, such as viruses. Bamlanivimab and etesevimab [which comprise Eli Lilly’s antibody cocktail] are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.”

The protocol has been available for children 12+ who were at risk of developing severe COVID-19 since February of this year, and as a post-exposure prophylaxis since September. This authorization will be available for the treatment of mild to moderate COVID-19 in all pediatric patients, who have a positive COVID-19 test and are at high risk of severe COVID-19. This includes hospitalization or death. The authorization also includes the possibility of receiving treatment as a post-exposure prophylaxis for prevention of COVID-19 in pediatric patients, who are at high risk of severe COVID-19.