American Red Cross, vCJD Donor Deferral Criteria, and Blood Supply Peter L. Page, MD Senior Medical Officer Biomedical Headquarters TSEAC 06/27/02

Background 1 §March 2000: ARC initiated first vCJD deferrals §Early 2001: ARC developed vCJD geographic donor deferral criteria, based upon concern and uncertainty about upcoming evolution of epidemic, stating policy would be reconsidered as new data accrue

Background 2 §October 2001: ARC implemented its criteria §January 2002: FDA issues final guidance to take effect 06/02 and 11/02

1 Final Guidance 1/9/02 2 Albania, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Republic of Ireland, Italy, Liechtenstein, Luxembourg, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Federal Republic of Yugoslavia. 3 Germany, Italy, Netherlands, Switzerland, Austria, Belgium, Spain, Republic of Ireland, Portugal, Denmark, Luxembourg and Liechtenstein Quick-reference summary of vCJD-related geographic donor deferral criteria as of 1/9/02 AgencyIn Effect:UKFrance Europe Other Than FranceOther Countries Special Rules for US Military Base Personnel FDA11/99-5/02  6 months, None ARC11/99-9/01  6 months, None ARC10/01 forward  3 months, 1980-present  6 months, 1980-present  6 months, 1980-present, all countries Gibraltar and Falklands same as UK; Oman same as Europe Same as country in which military base resides. NOTE: This implies there is not deferral for military staff on bases in Turkey FDA 1 6/02-10/02  3 months,  5 years, 1980-present NoneGibraltar and Falklands same as UK  6 months from for Germany, UK, Belgium and Netherlands;  6 months from for Turkey, Spain, Portugal and Italy FDA 1 11/02 forward  3 months,  5 years, 1980-present  5 years, present, selected countries only 2, except Source Plasma donors Gibraltar and Falklands same as UK  6 months from for Germany, UK, Belgium and Netherlands;  6 months from for Turkey, Spain, Portugal and Italy DoDSame as FDA  6 months from for bases anywhere in Europe or Turkey Hema Quebec 9/01 forward  1 month, 1980-present  3 months, 1980-present  6 months, Western Europe only 3 None CBS10/01 forward  3 months, 1980-present  3 months, 1980-present  5 years, present, Western Europe only 3 None

Differences in vCJD geographic deferrals: Ongoing ARC and recent/upcoming FDA ARCFDA Oman included US Military bases in specified European countries Yes ‘80-present 6 months Whole country 1.3 months in UK from‘80-Present 2.Time in Europe from present 6 months (All European countries) No ‘80-‘90 or -‘96 6 months Only bases ‘80-‘96 5 years (Some European countries)

1. UK Deferral Criteria Ongoing ARC criteria:  3 months, 1980-present Recent FDA criteria:  3 months, §ARC Plan: In 11/02, change to FDA’s criteria (cut off at end of 1996) §Rationale: Food chain controls implemented in UK by 1996 are now (2002) deemed to have been effective and sufficient. §Results: l ARC consistent with FDA on this issue l Individuals’ presence in the UK after 1996, after food controls in place, would not effect eligibility

2. Rest of Europe Deferral Criteria Ongoing ARC criteria:  6 months for all countries Upcoming FDA criteria (11/02):  5 years for most countries §ARC Plan: No change §Rationale: Continuing lack of active surveillance and effective food controls in some of those countries now better appreciated §Results: l No operational change for ARC; avoid complexity of dealing with various U.S. bases

ARC Experience §Donor deferrals, and blood collections vs. goal §Blood distribution and inventory

vCJD Deferrals in October 2001 Percent Deferred re vCJD By Day  6 months UK Bovine insulin  3 months UK  6 months rest of Europe Bovine insulin 2001

vCJD Deferrals September 01– March 02 Percent Deferred By Week

Summary: vCJD Deferrals by Region and Time Time Period Number of Donors Deferred re vCJD per Month March /15 – 12/14/01*5,631 March 02 ARCFDA RangeAverage Regional Donor vCJD Deferral Rate 0.00% %0.06% 0.21% %0.88% 0.25% %0.62% 3,764 *New criteria started 10/15/01

Puerto Rico American Red Cross Blood Services Regions by Region Code and Customer Business Unit (CBU) South Central CBU Western CBU North Central CBU North Atlantic CBU

vCJD Specific Donor Deferral Rates by Region For various time periods North Atlantic North Central South Central Western Region Code CBU: 3/01≥6 months UK, in place for 12 months 10/15-12/14/01≥3 months UK, ≥6 months Europe, newly implemented 3.02≥3 months UK, ≥6 months Europe, in place for 6 months

Deferrals and Collections Deferral Rate All Donors, All Reasons By Month WB Allogeneic Collections By Month August 2000 Switch from ear to finger sample, +4.5% deferral for hemoglobin

Distribution and Inventory Average Net Daily Distribution By Month Average Daily Inventory By Month

Summary §When anticipated and planned for, new donor deferral criteria can be accommodated by increased donor recruitment efforts §After the increase in deferrals from a new measure, there is culling, and the deferral rate drops §More regular volunteer blood donations continue to be needed to prevent seasonal shortages