Pharmacy

Pemivibart (Pemgarda) Granted Emergency Use Authorization

November 7, 2024

On August 26, 2024, the Food and Drug Administration (FDA) authorized pemivibart (Pemgarda) to help prevent COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kilograms (about 88 pounds). This authorization is for preventing COVID-19 before someone is exposed to the virus. It’s not for treatment.

It’s authorized for individuals who meet the following conditions:

Not currently infected with SARS-CoV-2 and haven’t had a known recent exposure to an individual infected with SARS-CoV-2.
Have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

Limitations of Use

Pemivibart is not for treating COVID-19, or for preventing it after someone has been exposed to the virus.
Pemivibart is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to pemivibart is less than or equal to 90%. See the FDA’s fact sheet for health care providers regarding SARS-CoV-2 variant susceptibility data for pemivibart.
Pre-exposure prophylaxis with pemivibart isn’t a substitute for vaccination. Individuals recommended for the COVID-19 vaccine, including individuals with moderate to severe immune compromise, should receive the vaccine.
For individuals who recently received a COVID-19 vaccine, pemivibart should be administered at least two weeks after vaccination.

Pemivibart isn’t a substitute for a COVID-19 vaccination. People who are moderately or severely immunocompromised should receive a COVID-19 vaccine according to the recommended schedule.

The general use of EUA drugs is considered not covered unless otherwise required by federal and/or state regulation. Pemivibart isn’t FDA-approved to prevent or treat any disease or condition, including COVID-19. Pemivibart is considered a not covered drug. For more information, see the FDA’s Frequently Asked Questions on the Emergency Use Authorization for Pemgarda (pemivibart) for Pre-exposure Prophylaxis (PrEP) of COVID-19.