Infectious Disease

FDA approves the combination of COVID-19 monoclonal antibodies for all children

December 03, 2021

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The FDA has expanded the emergency approval of bamlanivimab plus etesevimab for the treatment of mild to moderate COVID-19 in all pediatric patients, including neonates, who are at risk of progressing to severe disease.

The updated approval also allows the co-administration of bamlanivimab and etesevimab for post-exposure prophylaxis to prevent COVID-19 in all pediatric patients at risk for severe COVID-19, according to a press release from the agency.

“Now all patients at high risk for severe COVID-19, including children and newborns, have an option for treatment and prevention after exposure. Children under 1 year of age exposed to the virus that causes COVID-19 may be at particularly high risk of severe COVID-19, and this approval addresses the medical needs of this vulnerable population. ” Patrizia Cavazzoni, MD, Director of the FDA’s Center for Drug Evaluation and Research said in the press release.

The FDA previously granted EUAs to the two monoclonal antibodies for the treatment of COVID-19 in patients 12 years of age and older who weigh at least 88 pounds.

A clinical study evaluated the safety of bamlanivimab and etesevimab when used together in 125 pediatric patients with at least one risk factor for severe COVID-19. The results showed that the treatment was effective. Possible side effects associated with bamlanivimab include hypersensitivity and anaphylaxis, and possible reactions to bamlanivimab and etesevimab when used together include nausea, dizziness and rash.

“Although today’s approval includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination. Vaccines remain our best tool in fighting the virus, and there is a COVID-19 vaccine approved for children ages 5 and up, ”Cavazzoni said in the press release.

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