Key TakeawaysThe Food and Drug Administration (FDA) has extended its emergency use authorization (EUA) for the combination of twomonoclonal antibody drugsto treat COVID-19 in all children, including newborns.The combination of drugs—bamlanivimab and etesevimab—is authorized to treat mild-to-moderate COVID in children who are at high risk of becoming severely sick.The combination of drugs can also be used as a preventive treatment in children who have been exposed to COVID and are at high risk for developing severe illness.The Food and Drug Administration (FDA) hasextended 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 treatmentwas authorizedfor use in children aged 12 and over and in adults in February 2021.Ina 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.“FDA Advisory Committee Recommends Merck COVID-19 Antiviral PillHow the Drugs WorkBamlanivimab and etesevimab are neutralizingmonoclonal antibodiesthat 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 combinationcan 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 DoMonoclonal 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.How Vaccine Makers Are Tackling the Omicron VariantDosageAccording 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.3 Parents on Why They Got Their Kids VaccinatedSide Effects and ContraindicationsSerious 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 treatmentmay help prevent severe illness, hospitalization, and deathfrom 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-19According 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 living with obesity.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 VaccinationTreatment 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.”More People Are Turning to COVID Monoclonal Antibody TreatmentsIn the FDA’s statement (and thepatient 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.“What This Means For YouA combination of two monoclonal antibodies, bamlanivimab and etesevimab, has been authorized for use as a treatment for COVID-19 in children, including newborns. However, the treatment is not a substitute for vaccination which provides the best protection against COVID.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 ourcoronavirus news page.
Key TakeawaysThe Food and Drug Administration (FDA) has extended its emergency use authorization (EUA) for the combination of twomonoclonal antibody drugsto treat COVID-19 in all children, including newborns.The combination of drugs—bamlanivimab and etesevimab—is authorized to treat mild-to-moderate COVID in children who are at high risk of becoming severely sick.The combination of drugs can also be used as a preventive treatment in children who have been exposed to COVID and are at high risk for developing severe illness.
Key Takeaways
The Food and Drug Administration (FDA) has extended its emergency use authorization (EUA) for the combination of twomonoclonal antibody drugsto treat COVID-19 in all children, including newborns.The combination of drugs—bamlanivimab and etesevimab—is authorized to treat mild-to-moderate COVID in children who are at high risk of becoming severely sick.The combination of drugs can also be used as a preventive treatment in children who have been exposed to COVID and are at high risk for developing severe illness.
The Food and Drug Administration (FDA) hasextended 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 treatmentwas authorizedfor use in children aged 12 and over and in adults in February 2021.
Ina 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.”
FDA Advisory Committee Recommends Merck COVID-19 Antiviral Pill
How the Drugs Work
Bamlanivimab and etesevimab are neutralizingmonoclonal antibodiesthat 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 combinationcan 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.
How Vaccine Makers Are Tackling the Omicron Variant
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.
3 Parents on Why They Got Their Kids Vaccinated
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 treatmentmay help prevent severe illness, hospitalization, and deathfrom 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 living with obesity.
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.”
More People Are Turning to COVID Monoclonal Antibody Treatments
In the FDA’s statement (and thepatient 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.”
What This Means For YouA combination of two monoclonal antibodies, bamlanivimab and etesevimab, has been authorized for use as a treatment for COVID-19 in children, including newborns. However, the treatment is not a substitute for vaccination which provides the best protection against COVID.
What This Means For You
A combination of two monoclonal antibodies, bamlanivimab and etesevimab, has been authorized for use as a treatment for COVID-19 in children, including newborns. However, the treatment is not a substitute for vaccination which provides the best protection against COVID.
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 ourcoronavirus news page.
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