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FDA authorizes bamlanivimab and etesevimab antibody therapy for post-exposure prophylaxis for COVID

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eMediNexus    20 September 2021

The US Food and Drug Administration (FDA) revised the emergency use authorization (EUA) for bamlanivimab and etesevimab, given together, to include emergency use as post-exposure prophylaxis for COVID-19 in adults and children, aged >12 years weighing at least 40 kg, who have a high risk for progression to severe disease, including hospitalization or death.

Bamlanivimab and etesevimab, given together, are not authorized for use as pre-exposure prophylaxis to prevent COVID-19. The monoclonal antibody therapy can only be used as post-exposure prophylaxis for people:

  • Who have a high risk for progression to severe COVID-19, including hospital admission or death, and
  • Who have not been fully vaccinated or who are may not develop an adequate immune response to complete vaccination (such as those with immunocompromising conditions, including people taking immunosuppressive medications), and
  • Who have been exposed to an individual infected with SARS-CoV-2 in line with the CDC’s close contact criteria, or
  • Who have a high risk of exposure to an infected individual owing to the occurrence of the infection in others in the same institutional setting (such as nursing homes or prisons)… (DG Alerts)

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