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 1/9/022 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

Agency In Effect: UK FranceEurope Other Than

France Other CountriesSpecial Rules for US Military Base

Personnel

FDA 11/99-5/02 6 months, 1980-1996

None None None None

ARC 11/99-9/01 6 months, 1980-1996

None None None None

ARC 10/01 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

FDA1 6/02-10/02 3 months, 1980-1996

5 years,1980-present

None Gibraltar and Falklands same as UK

6 months from 1980-1990 for Germany, UK, Belgium and Netherlands;6 months from 1980-1996 for Turkey, Spain, Portugal and Italy

FDA1 11/02 forward

3 months, 1980-1996

5 years,1980-present

5 years, 1980-present, selected countries only2, except Source Plasma donors

Gibraltar and Falklands same as UK

6 months from 1980-1990 for Germany, UK, Belgium and Netherlands;6 months from 1980-1996 for Turkey, Spain, Portugal and Italy

DoD Same as FDA

Same as FDA Same as FDA Same as FDA Same as FDA 6 months from 1980-1996 for bases anywhere in Europe or Turkey

Hema Quebec

9/01 forward 1 month,1980-present

3 months,1980-present

6 months, Western Europe only3

None None

CBS 10/01 forward

3 months,1980-present

3 months,1980-present

5 years, 1980-present, Western Europe only3

None None

Differences in vCJD geographic deferrals: Ongoing ARC and recent/upcoming FDA

ARC FDA

• Oman included

• US Military bases in specified European countries

Yes

‘80-present6 months

Whole country

1. 3 months in UK from ‘80-Present

2. Time in Europe from 1980-present

6 months(All European

countries)No

‘80-‘90 or -‘966 months

Only bases

‘80-‘96

5 years(Some European

countries)

1. UK Deferral CriteriaOngoing ARC criteria: 3 months, 1980-present

Recent FDA criteria: 3 months, 1980-1996 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:

ARC consistent with FDA on this issue 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: 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

0.00%

0.20%

0.40%

0.60%

0.80%

1.00%

1.20%

1.40%

1-Oct

3-Oct

5-Oct

7-Oct

9-Oct

11-O

ct

13-O

ct

15-O

ct

17-O

ct

19-O

ct

21-O

ct

23-O

ct

25-O

ct

27-O

ct

29-O

ct

31-O

ct

vCJD Deferrals in October 2001Percent Deferred re vCJD

By Day

6 months UK

• Bovine insulin

3 months UK6 months rest of Europe• Bovine insulin

2001

0.00%

0.20%

0.40%

0.60%

0.80%

1.00%

1.20%

9-Sep

23-S

ep7-

Oct

21-O

ct

4-Nov

18-N

ov

2-Dec

16-D

ec

30-D

ec

13-J

an

27-J

an

10-F

eb

24-F

eb

10-M

ar

24-M

ar

vCJD Deferrals September 01– March 02

Percent DeferredBy Week

2001 2002

Summary:vCJD Deferrals by Region and Time

Time Period

Number of Donors Deferred

re vCJD per Month

March 01 361

10/15 – 12/14/01* 5,631

March 02

ARC FDARange Average

Regional Donor vCJD Deferral Rate

0.00% - 0.18% 0.06%

0.21% - 1.45% 0.88%

0.25% - 1.15% 0.62% 3,764

*New criteria started 10/15/01

Deferrals and Collections

0%

2%

4%

6%

8%

10%

12%

14%

16%

Deferral RateAll Donors, All Reasons

By Month

400,000

450,000

500,000

550,000

600,000

650,000

700,000

750,000

800,000

Jan-0

0

Feb-

00

Mar

-00

Apr-00

May

-00

Jun-0

0

Jul-0

0

Aug-00

Sep-00

Oct-0

0

Nov-00

Dec-00

Jan-0

1

Feb-

01

Mar

-01

Apr-01

May

-01

Jun-0

1

Jul-0

1

Aug-01

Sep-01

Oct-0

1

Nov-01

Dec-01

Jan-0

2

Feb-

02

Mar

-02

Apr-02

Budgeted Collections Actual Collections

WB Allogeneic CollectionsBy Month

August 2000

Switch from ear to finger sample, +4.5% deferral for hemoglobin

14,000

14,500

15,000

15,500

16,000

16,500

17,000

17,500

18,000

Jan-0

0

Feb-

00

Mar

-00

Apr-0

0

May

-00

Jun-

00

Jul-0

0

Aug-0

0

Sep-0

0

Oct-0

0

Nov-0

0

Dec-0

0

Jan-0

1

Feb-

01

Mar

-01

Apr-0

1

May

-01

Jun-

01

Jul-0

1

Aug-0

1

Sep-0

1

Oct-0

1

Nov-0

1

Dec-0

1

Jan-0

2

Feb-

02

Mar

-02

Apr-0

2

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

Jan-0

0

Feb-

00

Mar

-00

Apr-0

0

May

-00

Jun-

00

Jul-0

0

Aug-0

0

Sep-0

0

Oct-0

0

Nov-0

0

Dec-0

0

Jan-0

1

Feb-

01

Mar

-01

Apr-0

1

May

-01

Jun-

01

Jul-0

1

Aug-0

1

Sep-0

1

Oct-0

1

Nov-0

1

Dec-0

1

Jan-0

2

Feb-

02

Mar

-02

Apr-0

2

May

-02

Distribution and InventoryAverage Net Daily Distribution

By Month

Average Daily InventoryBy 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