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Teen girl getting intravenous infusion

CDC, FDA sign off on new product to prevent COVID in immunocompromised adolescents, adults

April 4, 2024

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Health officials have authorized a monoclonal antibody to prevent COVID-19 in immunocompromised adolescents and adults.

Pemgarda (pemivibart) from Invivyd Inc. is an intravenous infusion intended for pre-exposure prophylaxis. It works by blocking attachment of the SARS-CoV-2 virus into human cells.

The Food and Drug Administration granted emergency use authorization (EUA) for Pemgarda in late March, and the Centers for Disease Control and Prevention (CDC) announced Thursday that it recommends its use.

Pemgarda can be used for people ages 12 years and older weighing at least 40 kilograms who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and who are unlikely to mount an adequate response to vaccination. Patients should not receive Pemgarda if they are infected with SARS-CoV-2 or have had a known recent exposure.

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

Health officials say Pemgarda is not a substitute for vaccination. Immunocompromised individuals should still receive a COVID-19 vaccine according to the recommended schedule. Pemgarda should be deferred for at least two weeks after a dose of COVID-19 vaccine.

Side effects of Pemgarda may include hypersensitivity reactions, including anaphylaxis, infusion-related reactions, fatigue, nausea and headache. Pemgarda should be administered only in settings in which health care providers can immediately treat a severe hypersensitivity reaction such as anaphylaxis.

COVID-19 emergency department visits, hospital admissions and deaths are declining. They fell 21%, 14% and 17%, respectively, from March 17 to 23, according to CDC data.



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