FDA expands authorization for COVID-19 treatment to pediatric patients, including newborns

In Feb. 2021, the U.S. Food and Drug Administration (FDA) authorized monoclonal antibody treatment for adults and children 12 and older weighing 88 pounds who have tested positive for COVID-19 and are at high risk of severe disease or hospitalization. The treatment includes the drugs bamlanivimab and etesevimab to be administered together.

On Dec. 3, 2021, the agency expanded emergency use of bamlanivimab/etesevimab to include all patients at risk of severe disease, including newborns. “Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Cavazzoni noted treatment is not a substitute for vaccination, which is our best tool to fight against the virus. COVID-19 vaccines are authorized for everyone age 5 and older.

According to the FDA announcement, monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens, such as viruses. Bamlanivimab and etesevimab 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.   

Under the EUA, the manufacturer (Eli Lilly and Company) provides fact sheets for health care providers and patients, parents and caregivers that include dosing instructions, potential side effects and drug interactions.  

If you have questions about these therapies, please contact your doctor.