Regulatory considerations on authorization of the use of convalescent plasma (PC) to address the COVID-19 emergency, 22 April 2020

Abstract

Since the last century, passive immunization has been used for the prevention and treatment of some human infectious diseases. The serum of convalescent patients is the treatment of choice in cases of Argentine Hemorrhagic Fever. In addition, it was use during outbreaks of Ebola in Africa and also during the SARS and MERS outbreaks, as no other therapeutic options existed. Experience to date with the use of convalescent plasma for the treatment of COVID-19 is limited, but preliminary results indicate potential usefulness. Several controlled clinical trials are underway, to collect more quality scientific evidence to confirm the safety and efficacy of this intervention. In this context, the recommendations foresee its use under experimental conditions within the regulatory framework of each country. Moreover, there are challenges for large-scale collection, processing, and distribution of plasma from convalescent patients to meet potential clinical needs. Some published guidance exists for the collection and use of plasma from convalescent patients in infectious disease cases and Ebola outbreaks and even in the current COVID-19 situation.