1. Revised Recommendations for the Assessment of Donor Suitability: West Nile Virus Sharyn Orton, Ph.D. OBRR/CBER/FDA Blood Products Advisory Committee Meeting June 19, 2003

2. Background In October 2002, CBER released the final guidance for industry, “Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection”. In May 2003, a revised final guidance was released. This guidance supercedes the October 2002 release.

3. Highlights of the Current Guidance Recommendations Apply to Whole Blood and blood components intended for transfusion and blood components intended for use in further manufacturing into injectable or non-injectable products, including recovered plasma, Source Leukocytes and Source Plasma.

4. Donor Deferral  Diagnosed acute WNV illness or infection Defer for at least 28 days* from onset of symptoms or until 14 days after the condition is considered resolved, whichever is the later date. –In the absence of WNV compatible illness, an IgM positive WNV antibody test result should not be grounds for deferral. Same as previous guidance.

5. continued  Suspected acute WNV illness or infection Predonation question to ask donors about fever with headache in the week prior to donation. –If yes, defer for 28 days from the date of interview. –Implement no later than June 1; earlier if there are local reports of epizootic or human infections. –Discontinue no earlier than November 30; later if human cases are reported in November. Continue until there are 2 consecutive weeks without human cases.

6. continued Question (con’d) –Ask question annually. –Question is new from previous guidance –Rationale Donors implicated in transfusion transmitted WNV in 2002 were asymptomatic at the time of donation 9 of 14 reported symptoms compatible with WNV prior to or after donation

7. continued Fever and headache were reported by 57.1% (vs 1.8% in non-implicated donors) Survey suggested that inclusion of a question related to fever with headache in the week prior to donation would result in < 1.0% donor loss

8. continued Potential association with transfusion-related WNV transmission –Defer donor for 28 days from date of implicated donation –Same as previous guidance

9. continued Post donation information –Any donor that reports a post-donation febrile illness suggestive of WNV infection (particularly between June 1 and November 30) should be deferred for 28 days from the onset of illness or 14 days after the condition is considered to be resolved, whichever is the later date*. –Date range new from previous guidance

10. Retrieval and Quarantine*  Diagnosed WNV infection or illness in donor In-date components from relevant collections should be quarantined and retrieved prompt. Relevant collections are those occurring between 14 days prior to onset of illness and either 28 days subsequent to illness or 14 days after the condition is considered to be resolved, whichever is the later date. Same as previous guidance

11. continued  Donor associated with a potential case of transmission to a transfusion recipient A donor is considered potentially associated if a recipient of blood or transfusible blood components is diagnosed with WNV and received blood components from that donor within the 28 days prior to onset of symptoms (in the recipient).

12. continued Quarantine and retrieval of in-date components from the suspected donor collected in the period between 28 days before the suspect donation and 28 days after the suspect donation. Same as previous guidance

13. continued  Undiagnosed post-donation illness in potentially exposed individuals* Symptoms consistent with WNV infection. Current donation and any others the date back to 14 days prior to the onset of symptoms in the donor. Pooled Source Plasma, recovered plasma or Source Leukocytes already pooled for fractionation do not need to be retrieved. Same as previous guidance

14. Notification of Prior Transfusion Recipients  Diagnosed WNV illness in a donor relevant to prior donations Relevant units would be those dating from 14 days prior through 28 days after onset of illness in the donor. Establishments trace records and notify Transfusion Services. Transfusion Services notify physicians of prior recipients of blood or blood components from that donor.

15. continued  Donor likely source of transfusion transmitted WNV. Relevant units would be those dating from 28 days prior through 28 days after the date of donation that was implicated. Establishments trace records and notify Transfusion Services. Transfusion Services notify physicians of prior recipients of blood or blood components from that donor. Same as previous guidance

16. FAQ’s Does this guidance apply to autologous blood donors? The use of the question and deferral standards defined in the Guidance for autologous donors is entirely a matter for the discretion of the individual medical director. FDA recommends that the medical director at each blood bank assess the risk and make decisions about the autologous donation with the donor and the donor’s physician.

17. continued Must the blood banks make changes in their donor interview forms? As discussed in the Guidance, temporarily use of a separate printed sheet, independent of the usual donor history questionnaire will be acceptable as an interim measure, but SOPs must clearly specify how the donor will be instructed to respond and how the response will be documented [21 CFR 606.160(b)(1)(i)].

18. continued If an establishment asks blood donors the question “Have you had a medical diagnosis of WNV,” would they have to submit that as a supplement because they weren’t following the guidance specifically? FDA intentionally did not recommend that establishments specifically ask potential donors about WNV infection. If the establishment wants to also ask about WNV infection, this would be more than we recommended, and can be submitted in the next annual report.

19. Conclusion Current Guidance located at: www.fda.gov/cber/gdlns/wnvguid.htm