Presumptive Transfusion Transmissions of vCJD: Introduction to Consideration of Current FDA-recommended Safeguards FDA TSE Advisory Committee 16 th Meeting.

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Presumptive Transfusion Transmissions of vCJD: Introduction to Consideration of Current FDA-recommended Safeguards FDA TSE Advisory Committee 16 th Meeting Silver Spring MD 14 October 2004 David M. Asher, MD Laboratory of Bacterial, Parasitic & Unconventional Agents Division of Emerging & Transfusion-Transmitted Diseases Office of Blood Research & Review Center for Biologics Evaluation & Research United States Food & Drug Administration address:

History of TSEs and FDA Blood Safety Policies 1978: Manuelidis & al detected CJD agent in guinea pig blood buffy coat. 1983: Kuroda, Gibbs detected GSS (“fCJD”) agent in mouse blood—highest concentration, buffy coat present: TSE agents in blood confirmed Hamster scrapie, mice BSE, sheep BSE & nat’l scrapie, chimps GSS 1983: FDA requested withdrawal of CJD- implicated blood components. 1987: FDA recommended deferring donors Rx with pit-hGH, later other donors at increased TSE risk: Dura mater allograft, family history of CJD 1995: FDA encouraged precautionary voluntary withdrawals of CJD-implicated (post-donation info) blood products

History of TSEs and FDA Blood Safety Policies 1998/1999: FDA no longer recommended withdrawal of plasma derivatives from pools with “CJD-implicated” donor:  No epidemiological evidence of transmission  Preliminary evidence that processing of plasma reduced TSE infectivity  Cannot screen for preclinical sporadic CJD (Many pools must contain plasma from donors who will get CJD.)  Withdrawals contributed to shortages of some products  FDA continued to recommend retrieval:  Components from CJD-implicated donors  Plasma derivatives from pool with vCJD-implicated donor (has not occurred in USA) 1999: FDA recommended precautionary geographic vCJD deferral (donors  6 mo in UK )

History of TSEs and FDA Blood Safety Policies 2002: FDA recommended enhanced precautionary geographic vCJD deferrals. 2003: UK reported a case of presumptive transfusion- transmitted (TT) vCJD non-leukoreduced RBC in one of a small cohort of recipients—“TMER” Study. July 2004: UK reported a 2 nd TT vCJD case (first PRNP-129-met/val heterozygote). July 2004: UK appendix (and tonsil) PrP sc survey suggested >200 persons/million in UK ?incubating vCJD Sept 2004: UK notified certain recipients of plasma derivatives that they were at increased risk of vCJD.

Final Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) & Variant Creutzfeldt- Jakob Disease (vCJD) by Blood and Blood Products Jan 9, Phase I (for implementation by May 31, 2002)  Indefinitely defer all donors who -have any form of CJD or are at increased risk of CJD  (no change from previous FDA guidance) -spent  3 mo in UK from Jan 1, 1980 to Dec 31, 1996  or who ever had blood transfusion in UK from 1980 to present  or who ever injected UK bovine insulin prepared in or after spent  5 yr in France from Jan 1, 1980 to the present -spent  6 mo on US military bases from Jan 1, 1980 to end of 1990 north of Alps or end of 1996 south of Alps

Final Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) & Variant Creutzfeldt- Jakob Disease (vCJD) by Blood and Blood Products Jan 9, Phase II (for implementation by October 31, 2002)  Indefinitely defer all donors of Whole Blood but not donors of Source Plasma who spent  5 yr in Europe from Jan 1, 1980 to the present (including time in spent in UK and France 1980-present)  Exempt from deferral are  Donors of Source Plasma who spent any period of time in Europe except UK and France  Donors of plasma/serum to manufacture CBER- approved non-injectable products (specially labeled)

PrP sc in Appendix (&Tonsils): Association with vCJD (Hilton DA et al. Brit Med J 2002; 325: , J Pathol 2004;203: ) Estimated UK prevalence of abnormal PrP in lymphoid tissues 1 st survey: ~120/million (95% CI 0.5 – 900/million) 2 nd survey: ~237/million (95% CI /million) *1 yr, 2 yr,10 yr (neg) before onset of symptoms; 3 yr, 4 yr, 11 yr (neg) before death Postmortem vCJD19/20 Preclinical vCJD*2/3 1 st Surgical Survey1/ nd Surgical Survey3/12,674

1st Probable Transfusion-Transmitted Case of vCJD in UK (UK Parliament 17 Dec 2003; CA Llewelyn & al. Lancet 2004;363: ) March 1996 Clinically healthy young blood donor donated Whole Blood to the UK National Blood Service. Packed RBC—not leukoreduced—were transfused into a 63 yr-old surgical patient (later found to be PRNP met129-homozygous). About March 1999 Donor developed signs of variant CJD, later died; vCJD confirmed by autopsy. UK Transfusion Medicine Epidemiology Review (TMER) enrolled recipient (with 49 other recipients of vCJD-implicated labile blood components from 16 donors later Dx with vCJD—13 now living >5yr. December 2003 The recipient died age 69; postmortem diagnosis was typical vCJD. The recipient's age-adjusted food-borne risk of vCJD estimated by UK authorities to have been ~ 1:15,000 to 1:30,000.

2 nd Probable Transfusion-Transmitted Case of vCJD in UK (Peden AH & al. Lancet 2004;264: ) 1999 Clinically healthy young blood donor donated Whole Blood to the UK National Blood Service. Packed RBC—not leukoreduced—were transfused into an older surgical patient (later found to be PRNP met/val-129-heterozygous) Donor developed signs of variant CJD 18 mo later, died in 2001; vCJD confirmed by autopsy. UK Transfusion Medicine Epidemiology Review (TMER) enrolled recipient (with 49 other recipients of vCJD-implicated labile blood components from 16 donors later Dx with vCJD—13 now living >5yr) The recipient died of ruptured abdominal aortic aneurism. No history of dementia and CNS, tonsils and appendix were normal. PrP sc was present in several areas of spleen, cervical lymph node. The recipient's age-adjusted food-borne risk of vCJD estimated by UK authorities to have been ~ 1:15,000 to 1:30,000.

Some Implications for Public Health of Recent Findings Regarding vCJD vCJD was transmitted by transfusions of non-LR RBC. PRNP-129-MV (probably VV) genotype did not convey absolute resistance to infection with the BSE agent, at least after adaptation to humans and IV exposure. A second wave of vCJD cases in PRNP-129-MV (? and VV) persons in UK is possible, perhaps smaller than the first wave but of unknown magnitude. A recent survey of PrP sc in tonsils and appendices of normal surgical patients in UK estimated a rate of 237 infected people per million people in UK; that estimate may be low (uncertain when appendix becomes positive). The number of persons in the UK—possibly in other BSE countries— potentially having vCJD agent in blood may be significant. BSE geographic-based blood donor deferral policies have been prudent and justifiable.

FDA Policies to Reduce Risk of Transmitting vCJD by Blood Products Reduce risk that donor was exposed to BSE agent  Dietary exposure: Residence in BSE country (or military base importing beef from UK)  Other exposure: Use of UK bovine insulin Reduce risk that donor was exposed to vCJD agent of human origin  Transfusion in UK after 1980

FDA Charge & Questions for TSEAC  FDA seeks advice from the Transmissible Spongiform Encephalopathies Advisory Committee on whether recent information regarding variant Creutzfeldt-Jakob disease warrants consideration of additional safeguards for FDA- regulated human blood and blood products. 1.Are the measures currently recommended by FDA to reduce the risk of transmitting CJD and vCJD by blood products still justified? 2.Do the recent scientific data on vCJD warrant consideration by FDA of any additional potentially risk- reducing measures for blood and blood products? 3.If so, please comment on the additional risk-reducing measures that FDA should consider at this time.