Pemivibart (Pemgarda) Granted Emergency Use Authorization

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.