FDA

• The U.S. FDA issued an emergency use authorization (EUA) for the emergency use of pemivibart (Pemgarda) for pre-exposure prophylaxis of COVID-19 disease in adults and adolescents (12 years of age and older, weighing at least 40kg)
  • Subjects should NOT be currently infected with SARS-CoV-2, and have not had recent exposure to an individual infected with SARS-CoV-2 and
  • Subjects have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications and are considered unlikely to mount an adequate immune response to COVID-19 vaccination.
• Pemivibart is NOT authorized for:
  • The treatment of COVID-19 disease
  • Post-exposure prophylaxis in subjects exposed to someone infected with SARS-CoV-2