Recommendation of the Paul-Ehrlich-Institut for the Collection and Manufacture of COVID-19 Convalescent Plasma
As the COVID-19 pandemic progresses and develops, the need for treatment options is high. One therapeutic option is the treatment with COVID-19 convalescent plasma, which is collected from patients recovered from COVID-19 and therefore contains SARS-Cov-2 specific antibodies. SARS-CoV-2 specific immunoglobulin products manufactured from RKP plasma pools offer another therapeutic option.
The therapy with convalescence plasma is discussed controversially in the scientific literature. A statement of the German Scientific Board on Blood (Arbeitskreis Blut) of 2015 on single-donor convalescence plasma summarised the state of knowledge at that time and is largely still valid today. It concluded that further clinical studies are essential to investigate the efficacy of convalescence plasma.
The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, therefore strongly recommends to carrying out treatment with COVID-19 convalescence plasma in controlled clinical trials.
For the use of COVID-19 convalescence plasma outside clinical trials and for its use as a starting material for the production of specific immunoglobulins, the following criteria should be considered. In principle, for the donor selection in order to produce COVID-19 convalescence plasma all requirements for plasmapheresis donors of the current national guidelines on haemotherapy as well as the requirements of the Paul-Ehrlich-Institut are prerequisites.
In addition, the following specific requirements apply:
- Admission to donation: 4 weeks after complete recovery from COVID-19 or 2 weeks after the last negative SARS-CoV-2 PCR diagnosis from a smear.
- The person willing to donate has tested positive for antibodies against SARS-CoV-2.
- In addition to the requirements of Section 10 of the German Medicines Act (Arzneimittelgesetz, AMG), COVID-19 convalescence plasma must be labelled as such.
The Paul-Ehrlich-Institut carefully monitors and evaluates the development of the COVID-19 pandemic. It is in continuous exchange with all relevant institutes and authorities. If new findings become available, it will adjust the guidance made here accordingly.