During the public health emergency for COVID-19, the U.S. Food and Drug Administration (FDA) issued guidance for the use of convalescent plasma to treat COVID-19. Recently, it has been recommended that COVID-19 convalescent plasma be provided to immunocompromised individuals who are at high risk of severe disease and death. As monoclonal antibodies have become ineffective, the use of convalescent plasma has increased. Now, as the public health emergency for COVID-19 is set to expire on May 11, 2023, some of the FDA guidance documents will concurrently expire. The guidance, however, for COVID-19 convalescent plasma will remain in effect at least until November 7, 2023—180 days after the end of the public health emergency. This will give the FDA additional time to finalize revised guidance for COVID-19 convalescent plasma. Thus, clinicians may continue to treat hospitalized patients and patients who are immunocompromised with convalescent plasma and to enroll patients in randomized controlled trials.
References:
- FDA Regulatory Information. Investigational COVID-19 Convalescent Plasma. Guidance for Industry. March 13, 2023.
- Bloch EM, Focosi D, Shoham S, Senefeld J, Tobian AAR, et al. Guidance on the Use of Convalescent Plasma to Treat Immunocompromised Patients With Coronavirus Disease 2019 (COVID-19), Clinical Infectious Diseases, 2023;, ciad066
