Today, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).   

Pemgarda is authorized for individuals: 

• who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2; and 
• who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. 

FDA used an immunobridging approach to determine if Pemgarda may be effective for prevention of COVID-19. Immunobridging is based on the relationship between neutralizing antibody titers and clinical efficacy identified with other human monoclonal antibodies against SARS-CoV-2. This includes adintrevimab, a monoclonal antibody like Pemgarda, and certain other monoclonal antibodies that were previously authorized for the prevention of COVID-19. The 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 authorized initial dose of Pemgarda is 4500 mg administered as a single intravenous infusion. If ongoing protection is needed, a repeat 4500mg dose should be administered every three months.  

Possible side effects of Pemgarda include: hypersensitivity reactions (including anaphylaxis), infusion-related reactions, fatigue, nausea, and headache.  Anaphylaxis, which can be life-threatening, was reported with Pemgarda in 4 of 623 (0.6%) of participants in a clinical trial.  Pemgarda should only be administered in settings in which healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary. Individuals receiving Pemgarda should be clinically monitored during the 60-minute infusion and for at least two hours after completion of the infusion.   

For more information about Pemgarda and its authorization, please see the resources available on FDA’s Emergency Use Authorization webpage.