FDA Revises EUA for Use of Bamlanivimab and Etesevimab for Post-Exposure Prophylaxis Prevention for COVID-19

On Sept. 16, 2021, FDA revised the emergency use authorization (EUA) for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in patients 12 years of age and older who weigh at least 40 kg and are at high risk for progression to severe COVID-19, including hospitalization or death. Bamlanivimab and etesevimab are monoclonal antibodies (mAbs).

Bamlanivimab and etesevimab (administered together) are now authorized for use after exposure to the SARS-CoV-2 virus in this revision of the EUA. The mAbs are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the virus.

These mAbs may only be used when administered together as post-exposure prophylaxis for patients 12 years of age and older weighing at least 40 kg who:

• Are at high risk for progression to severe COVID-19, including hospitalization or death
• Are not fully vaccinated or who are not expected to have an adequate immune response to complete COVID-19 vaccination
• Have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria, per the CDC
• Are at high risk of exposure to an individual infected with SARS-CoV-2 in the same institutional setting (such as nursing homes)

In addition, bamlanivimab and etesevimab (administered together) remain authorized for the treatment of mild to moderate COVID-19 in patients 12 years of age and older weighing at least 40 kg 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.

Source: FDA