August 31, 2020
31 August 2020
The international media has recently released information regarding President Trump announcement of the FDA authorising the emergency use of plasma drawn from patients who recovered from COVID-19 to treat COVID-19 patients. This move, that must be distinguished from a research or monitored use authorisation (i.e, use outside of a clinical trial but with mandatory reporting), generated surprise within the scientific community as, to date, the evidence that it may be an effective treatment is still being studied. Questions were subsequently raised about the potential use of COVID-19 convalescent plasma (CCP) in the EU.
Plasma from recovered COVID-19 patients contains anti-SARS-CoV-2 antibodies. Transfusion of such plasma may be beneficial to patients suffering from COVID-19. Available clinical data is encouraging, in particular when convalescent plasma is administered early on in the course of disease. However, proof of safety and efficacy is still pending on the successful completion of ongoing randomized trials as well as careful evaluation of all other available clinical data stemming from CCP use within monitored use.
Plasma is collected by blood establishments and after testing and several other procedures, provided to hospitals for transfusion. In Europe, plasma collection and its use for transfusion are regulated at European level by the European Blood Directives, which is separate from the European Medicinal regulations.
In the EU, the decision to provide CCP for transfusion is a competence of national health authorities within Member States. The European Commission through several of its Directorate Generals provide extraordinary funds, guidance, IT tools and support – more details here.
Twenty blood establishments from EU Member States have indicated to the European Blood Alliance that they have or will be implementing CCP programmes at national level. Since the beginning of the crisis, EBA is actively engaged in promoting CCP collection and evaluation by its members, in close interaction with DG Santé of the European Commission. EBA is presently collecting numbers on the volume of CCP collected and transfused, for future analysis of the European situation regarding CCP. In addition, all 27 Member States and the UK and their blood establishments are invited to provide their CCP data through the EU CCP database developed jointly by the European Commission and EBA, a tool that will allow pooling resources for research on CCP.
DG Research and Innovation of the European Commission is also funding a research project on CCP, coordinated by the EBA: “SUPPORT-E Supporting high quality evaluation of COVID-19 convalescent plasma throughout Europe”. The project will support high quality clinical evaluation of CCP, achieve a consensus on the appropriate use of CCP in the treatment of COVID-19 across EU Member States, promote best practices regarding convalescent plasma use in the current health crisis as well as in subsequent crisis involving novel pathogens.
CCP is a promising treatment for COVID-19 patients and European blood establishments are actively researching its potency so as to provide robust evidence for policy makers to base their decisions regarding CCP as a treatment option for COVID-19. The EU is united in this endeavour through collaboration among EU Member States, and common research initiatives.
Pierre Tiberghien, President of EBA – Pierre.Tiberghien (at) europeanbloodalliance.eu
Catherine Hartmann, Executive Director – c.hartmann (at) europeanbloodalliance.eu
Tel: +32 2 8806216