Background
FDA’s August 2020 CJD guidance describes CJD and vCJD:
- Creutzfeldt-Jakob disease (CJD): A rare, invariably fatal degenerative brain disease belonging to a group of diseases known as transmissible spongiform encephalopathies (TSE). TSEs, also referred to as prion diseases, are characterized by the presence and long incubation period of an infectious agent that attacks the brain. There are three main types of CJD: sporadic (classic), iatrogenic and familial CJD. Sporadic CJD accounts for approximately 85-95% of cases, with an estimated annual incidence of one case per 1,000,000 worldwide.
- “No transfusion-transmitted cases of CJD have been described to date, and the risk remains theoretical.”
- Variant CJD (vCJD): Distinct from CJD, vCJD is a prion disease related to bovine spongiform encephalopathy (BSE), commonly referred to as “mad cow disease.” vCJD, the human form of the disease, is thought to be acquired from eating contaminated beef products. BSE was first recognized in the United Kingdom in 1985 and subsequently spread to many European countries. The incidence of vCJD in the United Kingdom peaked at 29 cases in 1999 and has decreased each year since.
- Among a study of 178 vCJD cases in the United Kingdom, 18 were individuals who donated blood components that were traced to 67 recipients.
- Four documented vCJD cases in this cohort were likely transfusion-transmitted.
Refer to FDA's August 2020 CJD guidance for detailed information on FDA's statements on current risk of transfusion transmission, and significant updates to the deferral requirements.
Refer to the Blood Donor History Questionnaire webpage and flowcharts for assistance with donor eligibility.
