Thomas S et al. Safety profile of plasma for fractionation donated in the United Kingdom, with respect to variant Creutzfeldt-Jakob disease (Vox Sang 2023)

Key facts

• Fifteen authors. First author Thomas S signed for the Joint UK Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee and last author Knight R for the UK National CJD Research and Surveillance Unit in Edinburgh. Other affiliations are the Department of Health and Social Care, the European Blood Alliance, Wageningen University, CSL Behring (Bern and Haywards Heath), the Marketing Research Bureau, Epodin, IPFA, PPTA, and all four UK blood services: NHS Blood and Transplant, the Welsh Blood Service, the Scottish National Blood Transfusion Service and the Northern Ireland Blood Transfusion Service
• Published in Vox Sanguinis 118(5):345-353, doi 10.1111/vox.13416, PMID 36880992, online 7 March 2023 and in the May 2023 print issue. It is indexed as a review, is not open access and has no PMC copy. The registry record lists no funder and no conflict of interest statement
• The abstract states that UK donor plasma has not been fractionated since 1999, when it was set aside as a precaution during the vCJD outbreak, and that vCJD case numbers ended far below the predictions of the 1990s
• Its main safety argument is that, allowing for incubation, more than 40 million UK blood components have been issued since leucodepletion was introduced in 1999 with no reported case of transfusion transmitted vCJD
• It records that the UK government authorised immunoglobulin manufacture from UK plasma in February 2021, and that the United States, Australia, Ireland and Hong Kong had lifted deferrals of blood donors with a UK residence history after their own reviews found no significant difference in risk
• The supply case is explicit: Europe relies on imported plasma, mainly from the United States, demand for plasma medicines is rising, and industry and patient groups argue UK plasma would bring immediate benefit to patients and make the European supply more resilient
• The conclusion is that UK plasma is safe for fractionation and that blood regulators and operators should revise guidance on deferring donors who lived in or were transfused in the UK
• The UK decision it refers to was announced by the Department of Health and Social Care on 25 February 2021. The Commission on Human Medicines advised, after an MHRA evidence review, that UK plasma could be used for immunoglobulins with risk controls such as donor to patient traceability, with each product reviewed by the MHRA and UK patients served first. The release dates the original ban to 1998 and says NHSBT then collected about 350,000 litres of plasma a year, of which about 100,000 litres were used for transfusion
• An MHRA press release of 26 June 2023 extended this to albumin on Commission on Human Medicines advice, keeping leucodepletion, deferral of higher risk donors and traceability, and noting no reported transfusion transmitted vCJD since leucodepletion began in 1999
• In May 2024 the EMA CHMP adopted revision 3 of its reflection paper, which no longer asks for exclusion of donors with a cumulative year or more in the UK between 1980 and 1996 from plasma for fractionation, using reasons that match this review: no transfusion transmitted vCJD in the UK since 1999 and a faster than expected fall in vCJD cases
• Europe PMC lists seven citing records as of 17 October 2026. They include a follow-up letter by Thomas and NHSBT and DHSC colleagues in Vox Sang in July 2023 arguing UK plasma could quickly improve the supply of plasma medicines in Europe, an Australian Red Cross Lifeblood report on donations gained after Australia dropped its UK-donor deferral in July 2022, a Hema-Quebec and Canadian Blood Services narrative review of observed and modelled vCJD transfusion risk, and the German Arbeitskreis Blut statement S 27 on vCJD donor exclusion published in 2025
• The Australian report found that over the first six months after its deferral was removed, 32,358 newly eligible donors with UK residence gave 67,914 donations, 8.4 percent of all collections, more than modelling had forecast
• In March 2025 the UK government reported that NHS patients had begun receiving immunoglobulin and albumin made from UK donor plasma, with NHSBT having collected 250,000 litres since 2021 and a target of 25 percent immunoglobulin self-sufficiency by the end of 2025

Timeline

1. 1998UK ban on fractionating domestically collected plasma introduced as a vCJD precaution, per UK government releases; the review dates the last fractionation to 1999.
2. 2021UK government lifts the ban for immunoglobulins on Commission on Human Medicines advice after an MHRA review.
3. 2021ECDC risk assessment of vCJD risk from blood and plasma products made from UK donations.
4. 2023Review published online in Vox Sanguinis.
5. 2023Print issue, Vox Sang volume 118 issue 5.
6. 2023MHRA announces UK plasma may be used for albumin.
7. 2023Follow-up letter by Thomas and NHSBT and DHSC colleagues on the European supply benefit published online.
8. 2024CHMP adopts reflection paper revision 3, dropping the UK-stay exclusion for plasma for fractionation.
9. 2025First NHS patients receive medicines made from UK donor plasma.