FDA authorizes COVID-19 monoclonal antibody combination for all children
The FDA expanded the emergency use authorization of bamlanivimab plus etesevimab for the treatment of mild to moderate COVID-19 in all pediatric patients, including newborns, who are at risk for progressing to severe disease.
The updated authorization also allows for bamlanivimab and etesevimab to be administered together for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients at risk for severe COVID-19, according to an agency press release.
“Now all patients at high risk of severe COVID-19, including children and newborn babies , have an option for treatment and post-exposure prevention. Children under 1 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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release.
The FDA previously granted the two monoclonal antibodies EUA for treatment of COVID-19 in patients aged 12 years 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. Results revealed that the treatment was effective. Possible adverse events associated with bamlanivimab include hypersensitivity and anaphylaxis, and possible reactions of bamlanivimab and etesevimab when used in combination include nausea, dizziness and rash.
“While today’s authorization includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination. Vaccines remain our best tool in the fight against the virus and there is a COVID-19 vaccine authorized for children 5 years of age and above,” Cavazzoni said in the release.
Read more about