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Date: Mon, 28 Oct 2002
Posted by: Lois Levitan (lcl3@cornell.edu)

1. FDA Guidance to Blood Industry on West Nile Virus (Oct 25, 2002)
2. Agency (FDA, CDC, etc) Workshop Nov 4-5 on Development of Donor Screening Assays for WNV

(1)
FOOD & DRUG ADMINISTRATION: FINAL GUIDANCE TO BLOOD INDUSTRY ON WEST NILE VIRUS
October 25, 2002   [Consumer Inquiries: 888-INFO-FDA; Media Inquiries: 301-827-6242]

The Food and Drug Administration (FDA) today issued guidance designed to protect the safety of the blood supply against West Nile Virus (WNV). This guidance for industry provides recommendations for assessing the suitability of potential donors and for the proper handling of blood products from donors known or suspected to have WNV infections.

The guidance applies to whole blood and blood components intended for transfusion and for use in further manufacturing. It is intended to reduce the risk of WNV through transfusions, particularly in geographical areas where human cases are occurring. FDA is issuing the guidance for immediate implementation.

The guidance provides detailed information to help blood establishments decide which potential donors should be deferred; it also sets forth recommendations about the retrieval and quarantine of blood and blood products from donors who develop WNV illness or infection after donation or are suspected of having WNV infections.

In addition, the guidance describes circumstances in which blood collectors should consider notifying transfusion services of proven or likely WNV infection in a donor so that hospitals can trace recipients of blood components from the affected donor.

Finally, the guidance advises industry to encourage donors to report any illness suggestive of WNV (e.g. fever and flu-like symptoms) within 2 weeks of blood donation if WNV infection is circulating in the community.

The guidance builds on existing blood safety regulations that require blood establishments to defer donors who are not in good health. Since approximately 20 percent of persons with WNV have symptoms ranging from mild symptoms to fever and other flu-like symptoms, donor screening procedures already in place should identify these people. FDA reminded the blood industry of these existing provisions in an alert on August 17, 2002, which was updated October 3.

No additional screening questions are being recommended. Currently there is no practical method to distinguish between the vast majority of donors who may have received mosquito bites from uninfected mosquitoes from the small number who may be infected.

Because no screening tests are currently available for WNV, these recommendations for donor deferral and product retrieval are especially important. FDA is working with industry to facilitate the development and review of possible donor screening tests for WNV. FDA is organizing a scientific workshop on WNV testing on November 4 and 5 in Bethesda, MD.

Recommendations in the new guidance for donor deferral include deferring a potential donor with a medical diagnosis of WNV until 14 days after the condition is resolved and at least 28 days from the onset of symptoms or diagnosis, whichever is later. If a person is asymptomatic and did not have recent WNV symptoms, having a positive antibody test result alone would not be grounds for deferral.

For donors who report symptoms suggestive of WNV infection when cases are known to be occurring in the community, it is recommended they be deferred from donating for 28 days from the onset of illness or 14 days after the condition is resolved, whichever is the later date.

Recommendations are also given in the guidance to quarantine and retrieve any unused components if a donor later reports a medical diagnosis of WNV or if a blood donor is associated with a potential case of transmission to a transfusion recipient. FDA does not recommend these measures when donors report only mild cold symptoms without fever, or if donors only report receiving mosquito bites. In the case of plasma derivatives, such as Factor VIII, quarantine and retrieval are not recommended because the viral reduction processes have been shown to inactivate viruses similar to WNV.

FDA reminds potential donors that donating blood carries no risk of acquiring WNV. In situations where blood transfusion may be life-saving, the benefits of blood transfusion outweigh the risk of WNV infection. Bites from mosquitoes carrying WNV remain, by far, the most common means of transmission. The guidance can be found on FDA's website at http://www.fda.gov/cber/gdlns/wnvguid.htm.

[This press release is posted at http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01166.html.]

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(2)
WORKSHOP ON DEVELOPMENT OF DONOR SCREENING ASSAYS FOR WEST NILE VIRUS
November 4 and 5, 2002
[Workshop Registration Information: http://www.fda.gov/cber/meetings/wnv110402.htm]

Workshop Goals and Objectives

FDA's Center for Biologics Evaluation and Research, in cooperation with the Centers for Disease Control and Prevention, the National Heart, Lung, and Blood Institute, NIH, and the Health Resources Services Administration, is sponsoring a public workshop entitled " Development of Screening Assays for West Nile Virus". The workshop will focus on scientific issues related to the development of tests that are suitable for screening donors for West Nile Virus (WNV). WNV is an arthropod-borne virus that belongs to the Japanese encephalitis complex of flaviviridae. WNV is transmitted primarily in birds through mosquito bites while humans are incidental hosts. The ongoing epidemic of WNV infections has raised concern that WNV can be transmitted through blood transfusions. At present, transmission of WNV by blood transfusion has not been proven. However, during this year's WNV outbreak there were several cases of encephalitis in patients who had received blood transfusions. In addition, WNV has been confirmed in epidemiological surveys in the case of 4 organ recipients from a single organ donor. There are no tests available to screen blood and organ/-tissue donors for WNV nor is the data available about the stability of WNV in such tissues. FDA is holding a workshop to review current developments in WNV transmission in the U.S. and to explore strategies to address issues related to the development of donor screening tests and the utility of virus inactivation methods.

The goals and objectives of this workshop are to review and discuss the following:

1.Current status of WNV pathogenicity and epidemiology in the U.S.
2.Methodologies suitable for screening of WNV in donors.
3.Prospective studies for establishing the transmission to recipients of blood, or human cells, tissues, and cellular or tissue based products (HCT/Ps).
4.Development of WNV screening assays for future large-scale implementation in the donor screening setting.
5.Issues relevant to the implementation of WNV tests.
6.FDA's expectations for licensure of WNV test.
7.Strategies for inactivation of WNV.

Location:
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Phone: 301-657-1234

Workshop Committee:
Hira Nakhasi, FDA chairperson [other names deleted]

Preliminary Agenda

The workshop will take place from 8:00 a.m. to 5:00 p.m. on both days. On the first day, the workshop will deal with the topics of WNV pathogenicity and epidemiology, methodologies suitable for screening WNV in blood and tissue/organ donors, studies on transmission through human cells, tissues and cellular or tissue based products, and development of WNV screening assays for future large-scale implementation in donor screening setting. On the second day it will focus on the prospective studies for establishing the transmission to recipients of blood, issues relevant to implementation of WNV tests, FDA's expectation for licensure of WNV test, and strategies for inactivation.

Registration

There is no registration fee for this meeting; however, seating space is limited and early registration is recommended. On-site registration will be limited to space available on the days of the workshop beginning at 7:30 a.m. Complete the attached registration form in this announcement and mail, fax or e-mail it to: Joseph Wilczek, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: wilczek@cber.fda.gov

Overnight Accommodations

A block of rooms has been reserved for participants requiring overnight accommodations at the Hyatt Regency Bethesda. Contact the hotel directly and refer to the FDA workshop to receive a discounted room rate of $150.00/night plus tax. There are only a limited number of rooms available at the discounted rate.

For Program Information Contact

Joseph Wilczek
Program Coordinator
Food and Drug Administration
Office of Blood Research & Review
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-302
Rockville, MD 20852
Phone: 301-827-6129
Fax: 301-827-2843
e-mail: wilczek@cber.fda.gov

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