1 / 8

Alan E. Williams, Ph.D. Director, Division of Blood Applications

Donor Deferral for Transfusion in France Since 1980 Amendment to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products". Alan E. Williams, Ph.D.

aiko
Download Presentation

Alan E. Williams, Ph.D. Director, Division of Blood Applications

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Donor Deferral for Transfusion in France Since 1980Amendment to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" Alan E. Williams, Ph.D. Director, Division of Blood Applications Office of Blood Research and Review CBER, FDA TSE Advisory Committee September 18, 2006

  2. Current FDA Recommendations: vCJD –Related Donor Deferral • Guidance to Industry January, 2002 > 3 months residence/travel in U.K. 1980 - 1996 > 5 years residence/travel in Europe • For donors of Source Plasma this criterion applies only to France (5-10% consumption of UK beef) > 6 months on US military bases in Europe between 1980-1990 (N) or 1980-1996 (S) (up to 35% UK beef consumed) Transfusion in the U.K. 1980 – present Receipt of bovine insulin sourced in the U.K. after 1980

  3. TSEACOctober 14, 2004 • Review of current FDA recommendations regarding vCJD-related donor eligibility • No TSEAC recommendations for further FDA actions to protect the blood supply • Discussion: • Predictive value of donor questions to exclude TSE risk • Feasibility of deferral for history of transfusion outside of the UK

  4. TSEAC DiscussionsFebruary 8, 2005 Recent developments: • Two observed vCJD transmissions associated with transfusion • Prior donations by two recent vCJD cases in France • Donor deferral for any previous transfusion • France – 1998 • Netherlands – 2004 • UK - (2005)

  5. Estimated Donor Loss Related to History of Transfusion in UK and France • Hx tx (UK - deferral already accomplished) 0.4 x 0.05 = 2/10,000 • Hx Tx (France) 0.4 x 0.7 x 0.05 = 1.4/10,0000 • Hx Tx (any Europe, excl. UK) 0.7% x 0.05 = 3/10,000 (Source Plasma donor impact expected to be less due to younger age)

  6. TSEAC RecommendationsFebruary 8, 2005 TSEAC recommended deferral of blood donors transfused in France since 1980 (12-3-1) TSEAC did not recommend deferral of blood donors transfused elsewhere in Europe since 1980(0-15-1) TSEAC did not recommend deferral of plasma donors transfused in France (5-7-4) or other European countries since 1980 (0-16-0)

  7. Donor Deferrals for History of Transfusion - Rationale for Prudent Preventive Measures • Relative likelihood of dietary BSE exposure in France • Three presumptive cases of vCJD transmission by transfusion • Fourteen definite or probable vCJD cases observed in France • vCJD incubation period may be > 12 years and asymptomatic prionemia may be > 3 years pre-illness. • Experimental studies of prion reduction in fractionated plasma are reassuring, however not all fractionated products have been studied and observations do not necessarily reflect the blood form of the vCJD agent.

  8. Amendment (Donor Deferral for Transfusion in France Since 1980)…….(Draft Level I Guidance Published August, 2006 • FDA Recommends Deferral of donors who have received a transfusion of blood or blood components in France since 1980. • Applies to Whole Blood and blood components intended for transfusion, and blood components intended for further manufacturing into injectable products, including recovered plasma, Source Leukocytes, and Source Plasma • Implementation within six months of publication as final guidance

More Related