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On March 22nd, 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. 

Pemivibart Resources

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