EYECARE: Coronavirus BRIEFING: Crisis Response Tactics New Monoclonal Authorized to Prevent COVID in Immunocompromised People By Staff Monday, March 25, 2024 6:09 AM The FDA issued an emergency use authorization (EUA) for pemivibart (Pemgarda) 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. Head over to MedPage Today to read more about it.