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Contact: Regulatory Affairs Division
This fact sheet has been updated to reflect implementation, on May 15 2006, of blood donor screening measures to reduce the theoretical risk of transmission of Simian Foamy Virus and possibly other yet unidentified simian viruses by transfusion.
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Foamy viruses are a family of retroviruses commonly found in non-human primates (monkeys, chimpanzees, baboons and macaques), but also in cows, cats and other animals. To date, no diseases or health conditions have been identified with foamy viruses in either humans or animals.
Retroviruses have RNA, rather than DNA, as their genetic material. When a retrovirus infects a cell, its genome is incorporated into the host cell's DNA, which ultimately leads to the production of more viruses.
SFV is a type of foamy virus found in non-human primates. About 70-90% of non-human primates born in captivity have SFV. Animals with SFV do not display symptoms or become ill.
The precise mode of transmission of SFV is not well understood, but there is no evidence that SFV can be transmitted from one person to another. Blood samples taken from spouses of workers in the United States and Canada who have acquired SFV have shown no evidence of SFV infection, suggesting that transmission through sexual or less intimate contact does not occur easily. However, as with other types of retroviruses, it is possible for the virus to be spread through body fluid contact including contact with infected blood and saliva. A study undertaken recently by the Public Health Agency of Canada has shown that SFV can be transmitted through blood transfusion in monkeys. However, there is no evidence of transmission of SFV from blood donated by a small number of individuals infected with the virus, although the number of cases studied remains small.
In light of uncertainty regarding health effects associated with SFV and the potential risk posed by other yet unidentified simian viruses, Health Canada is taking precautionary measures to protect Canada's blood supply.
On May 15, 2006 Biologics and Genetic Therapies Directorate issued Directive D2006-01 to all licensed Canadian blood establishments involved in the manufacture of blood and blood components for transfusion, asking them to implement blood donor screening measures to reduce the theoretical risk of transmission of simian viruses. To this end, an additional question will be added to the donor screening questionnaire.
No. To date, there is no documented health risk in this case that warrants the notification of those recipients. In addition, there is no approved test that can be offered to recipients of blood products from deferred donors.
All donors that report having ever taken care of or handled monkeys or their body fluids on a regular basis in their job, regardless of the type of monkey or type of exposure, will now be excluded from donation. Donors of plasma used for further manufacturing are excluded from the directive.
Both Héma-Québec (HQ) and Canadian Blood Services (CBS) have indicated that deferral of donors with occupational exposure to non-human primates or their body fluids would have minimum impact on the blood supply. There is no documented health risk that warrants the recall of previously collected products.
Health Canada is the federal authority that regulates the safety, efficacy and quality of drugs, including whole blood and blood components used in Canada. As a regulator and based on available evidence, Health Canada may from time to time ask regulated establishments to make changes to their activities to reduce real or theoretical risks. The SFV blood donor deferral is one such time. Similar action was taken regarding variant Creutzfeld-Jakob Disease.
Please address additional questions to:
Manager, Blood Establishment Regulatory Unit
Blood, Tissue, Organs and Vaccines Regulatory Affairs Division
Centre for Policy and Regulatory Affairs
Biologics and Genetic Therapies Directorate