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EU Guidance on the collection and transfusion of convalescent COVID-19 plasma

Plasma transfusion is a potentially promising therapy for COVID-19 patients that can be made widely available at relatively short notice by blood services across the EU.

The Guidance document on the collection and transfusion of convalescent COVID-19 plasma

https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/guidance_plasma_covid19_en.pdf

Search for available translations of the preceding link••• aims to facilitate a common approach across EU Member States to the donation, collection, testing, processing, storage, distribution and monitoring of convalescent plasma for the treatment of Covid-19 patients.

The guidance, which is not legally binding, was developed in collaboration with the European Centre for Disease Prevention and Control (ECDC) and is endorsed by the 27 Member State competent authorities for blood and blood components.

In collaboration with the European Blood Alliance (EBA), the European Commission (DG DIGIT) is building a database for the collection of data on donation and patient outcome. The database will go live later in April and will be open to all EU/EEA blood establishments that wish to participate, via the EBA.

This open-access database will gather data from monitored use, as well as from randomised clinical trials, and will consolidate EU evidence on the safety and effectiveness of this therapy.

Blood Services in EU/EEA countries that wish to participate in the EU donation and outcome monitoring programme should contact EBA at info@europeanbloodalliance.eu

More EBA information:

EBA – COVID-19 and blood establishments

https://europeanbloodalliance.eu/covid19-and-blood-establishment/

Background information on COVID-19 Convalescent Plasma

A treatment with a promising benefit/risk ratio

Transfusing plasma from patients that have recovered from infections has been tried in the past with some success. For COVID-19, this approach is supported by early scientific evidence and a study conducted in Hong Kong during the SARS-1 crisis (a closely related virus). This empirical evidence also indicates that associated risks are very low. In fact, the procedure is a standard plasma transfusion, where the plasma meets all criteria for safety.

In addition to direct transfusion, convalescent plasma can also be used as the starting material for later industrial manufacturing of specific immuno-globulins (medicinal products). The development of such industrially manufactured product would be enhanced by the availability of a substantial inventory of donated convalescent plasma, meeting high standards of quality and safety.

Widely available in a short time

Convalescent plasma transfusions can be made available in the short term through the existing organisational capacities in the public/NGO blood services in the EU Member States. In more than half of EU Member States, blood services are preparing for collection.

In some EU Member States the collection and supply has already started . The extensive potential donor pool, recovered COVID-19 patients, seems highly motivated to donate and help fellow citizens.

This possible therapy is also of high interest across the world, and in the US FDA is already approving individual applications for use of convalescent plasma for specific patients and is working with the American Red Cross blood centres and the Mayo Clinic to support an ‘expanded access’ programme.

Working together to follow up transfused patients across the EU

Although the plasma itself is a normal donation and blood component, the effectiveness of using it to treat patients with COVID-19 infection is unproven.

Through the collaborative efforts of the European Commission, the Member State competent authorities for blood and blood components, the European Centre for Disease Prevention and Control and the European Blood Alliance, data will be gathered and analysed in a common database so that a clear picture emerges on the usefulness of these promising transfusions. In the interests of transparency and knowledge sharing, the database will be open access.

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