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

FDA Recommended Safeguards for Minimizing Risk of vCJD from Blood Products: Deferral of donors based on risk of BSE exposure. Alan E. Williams, Ph.D. Director, Division of Blood Applications Office of Blood Research and Review CBER, FDA TSE Advisory Committee February 13, 2004.

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

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  1. FDA Recommended Safeguards for Minimizing Risk of vCJD from Blood Products: Deferral of donors based on risk of BSE exposure Alan E. Williams, Ph.D. Director, Division of Blood Applications Office of Blood Research and Review CBER, FDA TSE Advisory Committee February 13, 2004

  2. FDA Recommended Safeguards for Minimizing Risk of vCJD from Blood Products: Deferral of donors based on risk of BSE exposure • June 2, 1999 TSEAC • Guidance to Industry November 11, 1999 • Donor deferrals undertaken concurrent with a commitment to monitor the blood supply (estimated loss 2%) • Donor deferrals recommended for: • travel/residence in U.K. for >six months between 1980- 1996 • Receipt of bovine insulin sourced in the U.K. after 1980 • Product retrieval recommended if donor later discovered to have vCJD

  3. Estimation of Residual Potential Donor Exposure to BSE/vCJDAfter November, 1999 Guidance

  4. FDA Recommended Safeguards for Minimizing Risk of vCJD from Blood Products: Deferral of donors based on risk of BSE exposure • June 18-19, 2001 TSEAC • Guidance to Industry January, 2002 • Added donor deferrals for risk of BSE exposure in Europe • Tightened U.K. donor deferral • Called for implementation in two phases by 5/02 and 10/02 • Estimated 90% reduction in risk with cumulative loss of 7% of donor base

  5. FDA Recommended Safeguards for Minimizing Risk of vCJD from Blood Products: Deferral of donors based on risk of BSE exposure • Donor currently are deferred based on the following criteria: > 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 certain US military bases in Europe between 1980-1990 or 1980-1996 (up to 35% UK beef consumed) Transfusion in the U.K. 1980 – present Receipt of bovine insulin sourced in the U.K. after 1980

  6. Impact of 2001 Recommendations on US Donor Base • 1999 donor travel survey estimated 5.0% overall donor loss with higher loss in coastal areas. • Actual impact discussed at June 27, 2002 BPAC. • Geographic areas with concentrations of military donors hit hard • Observed on-site deferrals (0.1 – 3.5%) underestimated true donor loss • Blood supply has been particularly difficult to maintain over past several years.

  7. Retrovirus Epidemiology Donor Study (REDS) Participants 1998 - 2003 • ARCBS Greater Chesapeake and Potomac • ARCBS S.E. Michigan • ARCBS S. California • Oklahoma Blood Institute • Irwin Memorial Blood Center • Westat, Inc.- Coordinating Center

  8. Additional Demographic Data-Allogeneic Donors • Race/Ethnicity (Census) • Lifetime Transfusion History • Country of Birth • Level of Education

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