Recent updates regarding variant Creutzfeldt-Jakob disease risk assessments and impact on blood and plasma collection in Europe

The emergence of the variant Creutzfeldt-Jakob disease (vCJD) in the 1990s resulted in the introduction of several safety measures worldwide aimed to reduce the risk of transmission of  vCJD by transfusion of blood components or administration of plasma-derived medicinal products (PDMPs). These measures included also the deferral of blood and plasma donors deemed to be at risk of being infected and transmitting the disease.

In consideration of recent vCJD risk assessments and their impact on blood and plasma collection, the European Blood Alliance (EBA) issues the following statement:

• Increasing plasma collection by not for profit  blood establishments in Europe is a priority for the European Blood Alliance (EBA), to safeguard the supply of safe PDMPs and blood components for patients in Europe while preserving donor health.
• The United Kingdom (UK) health authorities have undergone modeling risks analysis regarding the variant Creutzfeldt-Jakob disease (vCJD) risk in the UK, and have concluded that plasma collected in the UK to manufacture immunoglobulin is acceptably safe^[1] and can therefore recommence^[2].
• Furthermore, updated risk analysis regarding the vCJD risk performed by the health authorities in Australia^[3] and in the USA^[4] have recently resulted in the removal in both countries of the deferral rules regarding blood and plasma donations by donors having lived in the UK, Ireland and France (as well as, for the USA, by donors previously transfused with blood components issued in the UK, Ireland and France). Earlier, risk analysis performed by the Irish health authority also resulted in the abrogation of deferral rules regarding blood donors having lived in the UK^[5].
• EBA notes the change in deferral criteria in countries in which these risk analyses have been performed and calls on all European stakeholders to assess the analyses, with a view to perform a similar risk analysis and, where pertinent, to consider updating their own deferral criteria regarding blood and plasma donation.

[1] Critical risk assessment report: use of UK plasma for the manufacture of immunoglobulins and vCJD risk – GOV.UK (www.gov.uk)

[2] Ban lifted to allow UK blood plasma to be used for life-saving treatments – GOV.UK (www.gov.uk)

[3] McManus H, Seed CR, Hoad VC, Kiely P, Kaldor JM, Styles CE, Yang H, Law M, Gosbell IB. Risk of variant Creutzfeldt-Jakob disease transmission by blood transfusion in Australia. Vox Sang. 2022 May 24. doi: 10.1111/vox.13290. Epub ahead of print. PMID: 35609012.

[4] Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components | FDA

[5] Irish Blood Transfusion Service. vCJD. Available here

See all EBA Position papers