Dr. Appleby is a member of the FDA’s advisory committee that in August discussed the implications of three cases of vCJD diagnosed in North America on current recommendations for vCJD screening of donors of blood, cell, and tissue-based products.
The three individuals were long-time residents of Saudi Arabia who were likely infected with the BSE agent in beef imported from the United Kingdom to Saudi Arabia during 1980-1996. After hearing data that included detailed descriptions of the cases from public health officials, the majority of the panel voted that the available data supported the FDA’s consideration to recommend deferring donors who had spent a cumulative of 6 months or more during 1980-1996 in Saudi Arabia as U.S. military personnel or who had spent more than 5 years cumulatively in Saudi Arabia during the same time period.
Having lived in the United Kingdom for at least 3 months during 1980-1996 (considered the highest risk period for dietary exposure to BSE) is among the reasons for donor deferral under current U.S. and Canadian blood donor deferral policies. Luisa Gregori, Ph.D., of the FDA’s division of emerging and transfusion-transmitted diseases said at the meeting that donor deferral is currently the only way to protect the U.S. blood supply from transfusion-transmitted CJD and vCJD and that the current donor deferral policy in the United States would not have deferred these three individuals.
The risk of CJD transmission via a blood transfusion is theoretical, but the risk of transfusion transmission of vCJD has been demonstrated, Dr. Gregori noted.
None of the sources for this story had relevant financial disclosures.