Pemgarda Receives Emergency Use Authorization

On March 22, the FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

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.

For more information about Pemgarda and its authorization, please see the resources available on the FDA’s Emergency Use Authorization webpage.