FDA Authorizes Monoclonal Antibody COVID Treatment for All High-Risk Children

The Food and Drug Administration (FDA) has extended the emergency use authorization (EUA) for the combination of bamlanivimab and etesevimab as a treatment for COVID-19 in all children, including newborns.

The combination treatment was authorized for use in children aged 12 and over and in adults in February 2021.

In a statement, Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said that the extension of the authorization means that "all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention."

Cavazzoni added that children under one year of age who are exposed to the virus "may be at particularly high risk for severe COVID-19" and that the authorization "addresses the medical needs of this vulnerable population."

How the Drugs Work

Bamlanivimab and etesevimab are neutralizing monoclonal antibodies that are given to patients through an intravenous (IV) infusion. The drugs are already being used to treat mild-to-moderate COVID-19 in people who have tested positive for the virus and are at high risk for developing severe illness or needing hospitalization.

The combination can also be used preventively (prophylaxis) in babies and children who have been exposed to COVID and have underlying conditions that put them at risk for developing severe illness if they get sick.

What Monoclonal Antibodies Do

Monoclonal antibodies mimic the natural antibodies that the body makes if it has been infected with the COVID virus. Bamlanivimab and etesevimab work together to target overlapping parts of the spike protein of the virus and keep it from attaching to human cells (which is how it infects them).

Andrew Pavia, MD, Chief of Pediatric Infectious Diseases at the University of Utah, told Verywell that monoclonal antibodies "have proven to be an effective therapy for people at high risk of being hospitalized or developing severe disease.“

Pavia added that previously, "children under 12 or who weighed less than 40 kilograms didn't have access to monoclonal antibodies," but with the extension of the authorization, they now will.

Dosage

According to the FDA, the combination of bamlanivimab and etesevimab was studied in a clinical trial of 125 pediatric patients (including 14 adolescent patients who received a placebo). All of the participants had at least one risk factor for developing severe COVID-19.

The patients received the same doses of the drugs as adults, except for those that weighed less than 40 kilograms/88 pounds; they received doses that were adjusted for their body weights.

Side Effects and Contraindications

Serious adverse events researchers noted with the use of bamlanivimab included hypersensitivity, anaphylaxis, and infusion-related reactions. The possible side effects of combined bamlanivimab and etesevimab included nausea, dizziness, itchiness, and rash.

While the treatment may help prevent severe illness, hospitalization, and death from COVID, it's demanding. Pavia said that the drugs must be infused at an infusion center (given through an IV) and the patient must be observed. Therefore the treatment is "not appropriate for people who have average risk.”

Why Some Children Are High Risk for COVID-19

According to Pavia, there are certain factors that put some children at a much higher risk of becoming seriously ill if they catch COVID.

For example, kids that have cancer and are undergoing chemotherapy have weakened immune systems, as do children that have had organ transplants. Kids that need breathing assistance, like a ventilator at night, are also at an increased risk, as are children who are obese.

As a preventive treatment, Pavia said that bamlanivimab and etesevimab would only be used for children at high risk who have had significant exposure to someone with COVID.

No Substitute for Vaccination

Treatment with monoclonal antibodies is not meant to replace COVID vaccines, which are safe and effective.

“The impact of monoclonal antibodies is not as great as being vaccinated in terms of protection from hospitalization or death. It is a stopgap.” said Pavia. “You really want to prevent disease rather than try and treat it.”

In the FDA's statement (and the patient education materials that accompanied it), Cavazzoni said that the treatment is "not a substitute for vaccination" and that "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.”

Still, Pavia said that it's important to get the word out about the treatment because, for kids that are at high risk, monoclonal antibody treatment needs to start as soon as possible.

This information is especially crucial for the pediatric oncology community and other areas of pediatrics with patients who are especially vulnerable. Pavia said that these high-risk children "need to be tested early and referred early if they want to be able to take advantage of monoclonal antibody therapy."

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.