Updated Risk Assessment of Variant Creutzfeldt-Jakob Disease (vCJD) Risks for Recipients of Blood and Plasma-Derived Products in the United States

• Activity Number: 78
• Type: Contributed
• Date/Time: Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
• Sponsor: Section on Risk Analysis
• Author(s): Steven Anderson*+ and Hong Yang and Richard Forshee and Mark Walderhaug
• Companies: FDA and FDA and FDA and FDA
• Keywords: Variant Creutzfeldt-Jakob disease ; Blood ; transfusion ; hemophilia ; Factor VIII ; risk assessment

Abstract

The identification of 4 cases of transfusion-transmitted vCJD (the human counterpart of 'mad cow' disease) and 1 case in a hemophiliac in the UK prompted the US FDA to re-evaluate vCJD risks for recipients of plasma-derived products in the US. Our updated risk assessment assumes all persons are equally susceptible to vCJD and estimates risk for plasma-derived Factor VIII (pdFVIII) recipients. For severe hemophilia patients at highest risk the model estimated annual mean exposure to be ~7 x 10-8 iv ID50 (~1 in 270,000) with the lower prevalence (4 per million) assumption, and ~1 x 10-4 iv ID50 (~1 in 12,000) with higher prevalence (1 per 4,225) assumption. Due to limited data and knowledge of vCJD, the model estimates are uncertain but suggest the risk is small, and donor deferral and manufacturing processes greatly reduce the risk.