(WEHT) — In a recent media release, the FDA announced they’ve expanded authorization of two monoclonal antibodies for COVID-19 treatment. They say these antibodies are for treatment and post-treatment of younger pediatric patients and newborns.
The bamlanivimab and etesevimab antibodies were previously authorized for pediatric patients aged 12 and older weighing at least 40 kilograms (around 88 pounds). They add the new revision also authorizes the antibodies to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death.
According to officials, the two antibodies administered together were studied in a clinical trial of 125 pediatric patients, all with at least one risk factor for severe COVID-19, to evaluate the safety and pharmacokinetics of treatment in pediatric patients.