The FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis of COVID-19 in certain adults and adolescents.

Pemgarda is authorized for individuals:

  • who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2;
  • and who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

View the Fact sheet for Healthcare Providers for Emergency use Authorization of Pemgarda here.

View the Fact Sheet for Patients, Parents, and Caregivers Emergency Use Authorization of Pemgarda here.

View Frequently Asked Questions on the Emergency Use Authorization for Pemgarda for Pre-exposure Prophylaxis (PrEP) of COVID-19 here.

For more information about all Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products, see the resources available on the FDA’s Emergency Use Authorization webpage.