Guidance for Monoclonal Antibody Use in Children with SARS-CoV-2 Infection or Exposure

Guidance for Monoclonal Antibody Use in Children with SARS-CoV-2 Infection or Exposure
Provided by the Florida Chapter of the American Academy of Pediatrics’ Emerging Infections Task Force

Tallahassee, FL (August 24, 2021) – The Florida Chapter of the American Academy of Pediatrics Emerging Infections Task Force, issued the following guidance on monoclonal antibody (mAb) use in children with SARS-CoV-2 infection or exposure.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for several monoclonal antibodies (mAbs) for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in individuals 12 years of age and older weighing at least 40 kg who are positive for the SARS-CoV-2 virus using viral testing methods, and who are at high risk for progression to severe COVID-19, including hospitalization and death. Initial data shows that mAbs reduce risk of hospitalization and death if given prior to 10 days after onset of symptoms. Patients to be considered for the infusion should not be already hospitalized or receiving increased oxygen support. The following mAb treatments are available:

  • Combination of Casirivimab and imdevimab at high risk for progression to severe COVID-19, including hospitalization and death.
  • Combination of bamlanivimab and etesevimab at high risk for progressing to severe COVID-19 and/or hospitalization.
  • Sotrovimab at high risk for progression to severe COVID-19, including hospitalization or death.

In addition, the FDA has issued an EUA for use of casirivimab and imdevimab combination in individuals 12 years of age and older weighing at least 40 kg for post-exposure prophylaxis of COVID-19 in those who are at high risk for progression to severe COVID-19, including hospitalization or death, such as those:

  • Not fully vaccinated.
  • Not expected to mount an adequate immune response to complete vaccination.
  • Exposed to an individual with COVID-19 consistent with close contact criteria per the Centers for Disease Control and Prevention (CDC).
  • At high risk of exposure to an individual infected with COVID-19 because of occurrence of COVID-19 infection in other individuals in the same institutional setting.

The most serious risk associated with administration of these medications is anaphylaxis. Most frequently identified side effects include fatigue and headache. All families and patients receiving these medications should be counseled prior to administration and with close follow up for 1-2 weeks after administration. These treatments have not been well studied in children because of the limited number of children that were included in the studies. It is expected that children should have similar side effects as adults.  Families should discuss with their physician the individual risks vs, benefits for their child.

The majority of children infected with SARS-CoV-2 are not at high risk for hospitalization and death; however, children who meet certain criteria or those with underlying medical conditions are considered high risk for complications, hospitalization, and death.  Immunocompromised and obese children are at high risk and should be considered to receive a mAb treatment. Children with other underlying conditions, such as diabetes, congenital heart disease, asthma, sickle cell disease, chronic kidney disease, chronic pulmonary disease, and other medically complex conditions should also be considered after discussion of risks and benefits of treatment with the family and patient.

About the Florida Chapter of the American Academy of Pediatrics
Through its more than 2,500 members, the Florida Chapter of the American Academy of Pediatrics promotes the health & welfare of Florida’s children and supports pediatricians & pediatric specialists as the best qualified providers of their healthcare. Learn more by visiting www.fcaap.org.

For more information:
Jamie Fortune, PR Counsel
Florida Chapter of the American Academy of Pediatrics
jamief@themooreagency.com or 850-284-5972