On March 22^nd, 2024 the FDA issued an Emergency Use Authorization (EUA) authorizing the emergency use of PEMGARDA (pemivibart) for the pre-exposure prophylaxis of COVID-19 in certain adults and children.

Pemivibart is a monoclonal antibody that inhibits SARS-CoV-2 from attaching to host cells.

Pemivibart may only be used by healthcare providers for pre-exposure prophylaxis of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg):

·         Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SAR-CoV-2 and

·         Who 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.

Medical conditions or treatments that may result in moderate to severe immune compromise and inadequate immune response to COVID-19 vaccination are listed on pages 3 and 4 of the pemivibart Fact Sheet for healthcare providers.

Pemivibart is not authorized for treatment of COVID-19 or for post-exposure prophylaxis of COVID-19.

Pemivibart is not a substitution for vaccination in individuals for whom COVID-19 vaccination is recommended. In individuals who have recently received a COVID-19 vaccine, pemivibart should be administered at least two weeks after vaccination.

Pemivibart can cause serious side effects including anaphylaxis. Other side effects include infusion-related reactions, infusion site reactions, common cold, viral infection, flu-like illness, tiredness, headache, and nausea.

Pemivibart is given as a 60 minute intravenous (IV) infusion approximately every 3 months. Patients who receive pemivibart will be monitored during the infusion and for 2 hours after the infusion to monitor for adverse drug reactions.

For more information, please see the links below for the Pemivibart Fact Sheets and the FDA letter of authorization.