bamlanivimab/etesevimab – Emergency use authorization expansion
On September 16, 2021, the FDA announced the emergency use authorization approval (EUA) of Eli Lilly’s bamlanivimab/etesevimab, in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in individuals who are at high risk for 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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination and
- Have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention 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.