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**STATEMENT OF THE AMERICAN ASSOCIATION OF BLOOD BANKS**

**BEFORE THE BLOOD PRODUCTS ADVISORY COMMITTEE**

**Simian Foamy Virus Transmission by Blood and Blood Products**

**December 13, 2001**

**Presented by Kay R. Gregory, MS, MT(ASCP)SBB**

**Director, Regulatory Affairs**

The American Association of Blood Banks (AABB) is the professional
society for over 8,000 individuals involved in blood banking and
transfusion medicine and represents approximately 2,000 institutional
members, including blood collection centers, hospital based blood banks,
and transfusion services as they collect, process, distribute, and
transfuse blood and blood components and hematopoietic stem cells. Our
members are responsible for virtually all of the blood collected and
more than 80 percent of the blood transfused in this country. For over
50 years, the AABB\'s highest priority has been to maintain and enhance
the safety and availability of the nation\'s blood supply.

Thank you for your attention to this interesting matter. Human infection
with foamy viruses is not new, and was first described in a
nasopharyngeal cancer derived cell line 30 years ago.^1,2,3^ Although
there is no convincing evidence of any disease association with human
infection^3,4^, the number of infected persons studied and the average
duration of follow up are inadequate to prove they are not pathogenic
under some circumstances. We would like to note that Simian Foamy Virus
(SFV) is being studied as "a safe, efficient alternative to current
onco- and lentiviral vectors for gene transfer in cells from a broad
spectrum of lineages across species boundaries."^5^

Foamy viruses are ubiquitous in captive primate populations, and present
in many other animal genera (infections in man appear to represent rare
zoonotic events^3^). SFV does not appear to be pathogenic. Of interest
in this regard is the evidence that the putative hepatitis viruses, TT,
GBV, and SEN, are either nonpathogenic or uncommonly so. Actually, GBV
infection seems to have a beneficial impact on the course of HIV
infection,^6,7^ reminding us that all viral infections may not be
dangerous.

The AABB supports careful and expeditious inquiry into the prevalence of
SFV infection in selected populations, including blood donors, and
longitudinal analysis of the impact of such infections where identified.
Epidemiological and laboratory studies of primate workers in comparison
with appropriately matched controls for unique patterns of illness will
provide useful information.

Newer technologies allow us to detect, with greater and greater
sensitivity, more and more infectious agents. Concerns about the
potential pathogenicity of these agents will challenge us repeatedly. We
are ready to join the public health authorities in studies that may help
clarify whether these less well known agents represent a risk for
transfusion recipients. We applaud the monitoring activities that are
taking place. At the same time, we would like to emphasize that
available data on SFV suggest action regarding blood donors is not
currently appropriate.

Thank you for the opportunity to comment.

References:

1\. Achong B, Mansell PWA, Epstein MA, et al. An unusual virus in
cultures from a human nasopharyngeal carcinoma. J Natl Cancer Inst
1971;46:299-307.

2\. Heneine W, Switzer WM, Sandstrom P, et al. Identification of a human
population infected with simian foamy viruses. Nature Med 1998;4:403-7.

3\. Meiering CD, Linial ML. Historical perspective of foamy virus
epidemiology and infection. Clin Microbiol Rev 2001;14:165-76.

4\. Schweizer M, Turek R, Hahn H, et al. Markers of foamy virus
infections in monkeys, apes, and accidentally infected humans:
appropriate testing fails to confirm suspected foamy virus prevalence in
humans. AIDS Res Hum Retroviruses 1995;11:161-70.

5\. Mergia A, Chari S, Kolson DL, et al. The efficiency of simian foamy
virus vector type-1 (SFV-1) in nondividing cells and in human PBLs.
Virology 2001;280:243-52.

6\. Xiang J, Wunschmann S, Diekema DJ, et al. Effect of coinfection with
GB virus C on survival among patients with HIV infection. N Engl J Med
2001;345:707-14.

7\. Tillmann HL, Heiken H, Knapik-Botor A, et al. Infection with GB
virus C and reduced mortality among HIV-infected patients. N Engl J Med
2001;345:715-24.