Monoclonal Antibody Receives Emergency Use Authorization for Preventing COVID-19 in High-Risk Patients

Pemivibart, a long-acting antispike monoclonal antibody, is likely to be most beneficial in immunosuppressed patients at excess risk for severe COVID-19.

Although severe COVID-19 has become less common than early in the pandemic, immunosuppressed patients remain at excess risk for poor outcomes. In late 2021, the FDA granted emergency use authorization (EUA) to the monoclonal antibody combination Evusheld for primary prevention of COVID-19 in immunosuppressed patients; however, this approval was withdrawn in early 2023 as Evusheld was no longer effective against most circulating variants. Before the EUA of pemivibart (PEMGARDA), no agents were available for primary prevention.

Patient Population

Pemivibart is authorized under this EUA for preexposure prophylaxis of COVID-19 in people aged ≥12 years and weighing ≥40 kg with moderate-to-severe immunosuppression and likelihood of insufficient res…

Author

Daniel Kaul, MD

Disclosures

Grant/Research SupportNobelpharma; Pfizer

Leadership Positions in Professional SocietiesAmerican Society of Transplantation (Program Committee)

Daniel Kaul, MD

Disclosures

Grant/Research SupportNobelpharma; Pfizer

Leadership Positions in Professional SocietiesAmerican Society of Transplantation (Program Committee)

Monoclonal Antibody Receives Emergency Use Authorization for Preventing COVID-19 in High-Risk Patients

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Patient Population

Author