The U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab monoclonal antibodies (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.

This revision also authorizes bamlanivimab and etesevimab, 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. 

“Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention.”

But this therapeutic option is not a substitute for vaccination. 

What are monoclonal antibody and how it works?

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens, such as viruses. Bamlanivimab and etesevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.

Treatment:

Treatment of mild-to-moderate COVID-19 in adults and pediatric patients, including neonates (babies who are four weeks old or younger), with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death

For treatment of COVID-19, bamlanivimab and etesevimab should be administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset

Limitations of Authorized Use

Use in Patients Who Are Hospitalized or Who Require Oxygen Due to COVID-19

• Bamlanivimab and etesevimab are not authorized for use in patients 2 years and older who are hospitalized due to COVID-192

• Bamlanivimab and etesevimab are not authorized for use in patients, regardless of age, who: require oxygen therapy and/or respiratory support due to COVID-19, OR o require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity

Post-Exposure Prophylaxis (Prevention):

For use as post-exposure prophylaxis for prevention of COVID-19 in adult and pediatric individuals, including neonates, who are at high risk of progression to severe COVID-19, including hospitalization or death, and are:

·        not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example,

·        individuals with immunocompromising conditions including those taking immunosuppressive medications) and have been exposed to an individual infected with SARS-CoV-2 or

·        who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes and prisons).

For post-exposure prophylaxis, bamlanivimab and etesevimab should be administered together as soon as possible following exposure to SARS-CoV-2.

Limitations of Authorized Use

• Post-exposure prophylaxis with bamlanivimab and etesevimab is not a substitute for vaccination against COVID-19

• Bamlanivimab and etesevimab are not authorized for pre-exposure prophylaxis for prevention of COVID-19

Doctors Liked to Read More