FDA clears COVID-19 monoclonal antibody combination for all children

03 December 2021

1 min read


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The FDA has extended the authorization for emergency use of bamlanivimab plus etesevimab for the treatment of mild to moderate COVID-19 in all pediatric patients, including newborns, who are at risk of progressing to serious disease.

The updated authorization also allows bamlanivimab and etesevimab to be administered together for post-exposure prophylaxis for the prevention of 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 of severe COVID-19, including children and newborns, have an option for post-exposure treatment and prevention. Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk of severe COVID-19 and this authorization meets the medical needs of this vulnerable population ”, Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the statement.

The FDA has previously granted the two EUA monoclonal antibodies for the treatment of COVID-19 in patients 12 years of age and older weighing at least 88 pounds.

A clinical trial examined 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 of bamlanivimab and etesevimab when used in combination include nausea, dizziness, and rash.

“Although today’s authorization includes post-exposure prevention of COVID-19 in children, this treatment option does not replace vaccination. Vaccines remain our best tool in the fight against the virus and there is an approved COVID-19 vaccine for children 5 years and older, ”Cavazzoni said in the statement.


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