Alan E. Williams, Ph.D. Director, Division of Blood Applications OBRR/CBER/FDA

1. Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection - Update - Alan E. Williams, Ph.D. Director, Division of Blood Applications OBRR/CBER/FDA Blood Products Advisory Committee July 21, 2005

2. Recent WNV Regulatory Actions • BPAC October, 2004 • Deferral extended 56 days for WNV infection (vote) • Investigate possibility of donor re-entry without ID NAT testing after suitable interval (discussion) • Fever with headache question not useful to predict WNV infection(ad hoc vote) • BPAC March, 2005 (Update) • FDA introduced concept of 90 day deferral with re-entry based on negative WNV ID NAT at 56 days • Blood establishments expressed concern about timing of WNV policy for 2005 season.

3. Recent WNV Regulatory Actions Draft Guidance for Industry: Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection. April, 2005 • Discontinuation of previously recommended “fever with headache in the past week” question • 120 day deferral for WNV infection based upon rare observation of 104 day IDT viremia. • WNV ID NAT negative test recommended during 120 day deferral for donor re-entry

4. Recent WNV Regulatory Actions • (May 2005 Guidance for Industry) Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection'' (Immediate implementation) • (June, 2005 Withdrawal of Guidance for Industry)Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection''

5. FDA Current Recommendations: • June, 2005 Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection • Discontinuation of previously recommended “fever with headache” question • 120 day deferral for WNV infection (based on 104 day WNV IDT viremia and CBER in vitro data demonstrating infective WNV in presence of WNV antibodies)

6. FDA Current Recommendations: 120 dayDonor Deferral • Donors with diagnosed or suspected acute WNV illness or infection • Presumptive WNV viremic donors • Donors with suspected post-donation WNV illness- • Donors who may have transmitted WNV infection Note: Re-entry permitted without additional testing @ 120 days, but WNV IDT NAT testing considered to be scientifically useful where possible

7. FDA Current Recommendations: Product Management Diagnosed WNV Infection or Illness in a Donor • Retrieval and quarantine of in-date products 14 days prior to onset of illness and 120 days after diagnosis or onset of illness (whichever is later)

8. FDA Current Recommendations: Product Management Donors who are potentially associated with transfusion-transmitted WNV infection - (defined as donors of “suspect” donations received by a recipient up to 120 days prior to recipient WNV infection) • Retrieval and quarantine of other donations by potentially associated donors 120 days before and 120 days after the suspect donation.

9. FDA Current Recommendations: Product Management Undiagnosed Post-Donation Illness in Potentially Exposed Individuals • Medical Director judgement regarding product quarantine and retrieval considering possibility of WNV exposure potential • When conducted, quarantine and retrieval of in-date products 14 days prior to, and 120 days after onset of donor symptoms. • Product quarantine and retrieval not recommended for pooled Source Plasma, recovered plasma, or Source Leukocytes.

10. FDA Current Recommendations: Notification of Prior Transfusion Recipients about possible WNV exposure Establishments should consider tracing records and notifying transfusion services of relevant units Relevant units are those collected 14 days prior through 120 days after the onset of diagnosed WNV illness in a donor - or - Units collected from a donor 120 days prior to 120 days after a donation from that donor is identified as the likely source of a WNV transfusion transmission.