Importation of plasma and use of apheresis platelets as risk reduction measures for variant Creutzfeldt‐Jakob disease: The SaBTO review

Abstract

Following recognition that blood, blood components, tissues and organs donated by infected donors could transmit infectious prions causing variant Creutzfeldt‐Jakob Disease (vCJD), several risk reduction measures were introduced in the UK. The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) established a working group to review the measures in place. Factors considered included: ethical issues around the current provisions and potential changes; operational issues for blood establishments and hospitals; a review from the Advisory Committee on Dangerous Pathogens (ACDP) showing the downward trend in the estimated number of future cases of vCJD; and cost‐effectiveness. The working group recommended that the current vCJD risk reduction measures for individuals born after 1995 or with thrombotic thrombocytopenic purpura (TTP) could be withdrawn. After consultation with stakeholders, SaBTO accepted these proposals which allow more equal provision of components, less operational complexity and risk, and more resources to be deployed elsewhere in the NHS. The potential saving on plasma will be £500 m and moving to using pooled platelets in additive solution for all recipients will bring potential savings of £280 m over the next 50 to 60 years. There could be small number of additional clinical cases of vCJD: 1–2 (<1–14; 95% CI) from plasma and 3–4 (<1 to 45; 95% CI) from platelets. Local and national guidelines will still be applied for managing individual conditions. UK Ministers for Health accepted SaBTO's recommendations on 9 Sept 2019 and implementation began immediately. This paper describes the review and rationale leading to these recommendations.

Risk of variant Creutzfeldt–Jakob disease in a simulated cohort of Canadian blood donors

“…The estimated risk to recipients appears minimal, and epidemiological data on vCJD are reassuring. Indeed, there has been no suspected transfusion‐transmission case of vCJD since 1999 [5], possibly (in part) because of the implementation of universal leukodepletion in the UK (also in 1999) [8]. Furthermore, the vCJD epidemic has considerably waned since the early 2000s, with fewer than five cases reported worldwide between 2015 and 2021 [2].…”

“…Blood services have, thus, implemented measures to mitigate the risk of transfusion transmission of vCJD. In the late 1990s and early 2000s, many resource‐rich countries adopted universal leukodepletion [7, 8] to reduce the risk of vCJD [9–11] and other immune and infectious complications resulting from blood transfusion [12, 13]. Given the unclear performance of available blood screening tests and potential logistical problems, several jurisdictions have also implemented donor deferral criteria based on time spent in high‐risk countries, such as the UK, France and Ireland.…”

“…Blood services have, thus, implemented measures to mitigate the risk of transfusion transmission of vCJD. In the late 1990s and early 2000s, many resource-rich countries adopted universal leukodepletion [7,8] to reduce the risk of vCJD [9][10][11] and other immune and infectious complications resulting from blood transfusion [12,13].…”

“…Given this limitation and the waning vCJD epidemic, an increasing number of countries (e.g., the UK, the United States [US] and Australia) are reassessing the need for donor deferral [8, 14, 15], often using risk simulation models. However, no such evaluation has been conducted in Canada, where blood donors who have resided in high‐risk countries are still indefinitely deferred from donating blood.…”

Current advances in 2022: A critical review of selected topics by the Association for the Advancement of Blood and Biotherapies (AABB) Clinical Transfusion Medicine Committee

“…The UK's Advisory Committee on the Safety of Blood, Tissues, and Organs and Medicines and Healthcare Products Regulatory Agency mathematically modeled risk of variant Creutzfeldt‐Jakob disease infection through blood transfusion 12,13 . After evaluating these data, the FDA provided updated guidance 14 .…”