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The FDA issued an as COVID-19 pre-exposure prophylaxis in immunocompromised individuals who are unlikely to mount a sufficient immune response following vaccination, the agency announced on Friday.

A long-acting monoclonal antibody, pemivibart is specifically authorized for people ages 12 years and older (and weighing 40 kg or more) with moderate-to-severe immune compromise either because of a medical condition or due to immunosuppressant medications. Pemivibart is given as a single intravenous infusion and is not for use as post-exposure prophylaxis or in people currently infected with SARS-CoV-2.

The EUA was based on immunobridging data involving other human monoclonal antibodies against SARS-CoV-2 demonstrating that pemivibart may be effective for COVID prevention.

"Serum neutralizing antibody titers of Pemgarda were consistent with the titer levels associated with efficacy in prior clinical trials of adintrevimab and certain other monoclonal antibody products," the FDA stated.

According to the EUA, individuals who would qualify for the antibody include those undergoing active treatment for cancer (including those receiving CAR T-cell therapy or stem cell transplant); patients with hematologic malignancies associated with poor responses to COVID vaccines regardless of their treatment status; solid-organ transplant recipients; those with moderate-or-severe primary immunodeficiency; people with advanced or untreated HIV; and those on high-dose corticosteroids, B-cell depleting agents, and other immunosuppressants.

No long-acting monoclonal antibody has been available for preventing COVID infection in individuals with moderate-to-severe immune compromise since the agency pulled the EUA for tixagevimab-cilgavimab (Evusheld) in January 2023 -- the move followed data showing the combination was unlikely to be sufficiently active against circulating SARS-CoV-2 variants. At the time, the CDC that immunocompromised individuals receive the latest COVID booster (if they had not already), wear a well-fitting high-quality mask in public, maintain distance in crowded areas, and improve indoor ventilation.

Pemivibart is administered at a dose of 4,500 mg over a 60-minute infusion, with repeat dosing every 3 months recommended if ongoing protection is needed.

FDA cautioned that anaphylaxis occurred in 0.6% of clinical trial participants who received pemivibart. Therefore, patients should be monitored for 2 hours after the infusion is finished, and pemivibart should be administered in settings where health providers have immediate access to medications to reverse severe allergic reactions and can alert EMS if necessary.

Other potential side effects noted in the include infusion-related reactions, fatigue, nausea, and headache.

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