vCJD risk from plasma very small.(NEWS FROM THE FDA)(variant Creutzfeldt-Jakob disease)(Brief article)

An FDA advisory panel agreed that a probable case of preclinical variant Creutzfeldt-Jakob disease (vCJD) attributed to a plasma product in the United Kingdom showed that the transmissibility of the disease via a plasma-derived factor VIII product is no longer theoretical.

But at a recent meeting, the FDA's Transmissible Spongiform Encephalopathies Advisory Committee voted 15-0 that this report should not change the agency's latest assessment of the risk of vCJD infection associated with plasma-derived factor VIII products licensed in the United States.

Based on an updated analysis of the risk, the FDA "continues to believe" that the risk of vCJD in patients who receive U.S.-licensed plasma-derived coagulation factor VIII products "is likely to be extremely small, although we do not know the risk with certainty."

In February, the UK. Health Protection Agency reported the case of vCJD identified in a man with hemophilia in his 70s, after he had died. Eleven years earlier, the man had been treated with factor VIII that was derived from pooled plasma in the United Kingdom, which included at least one donation from a person who had died of confirmed or probable vCJD.

The risk management strategy for vCJD includes deferring blood and plasma donors who have visited or lived in countries where the prevalence of bovine spongiform encephalopathy (BSE) is higher and donors who have received transfusions in the United Kingdom since 1980. In the United States, the three cases of vCJD that have been reported were in people who lived in the United Kingdom at the height of the BSE epidemic.

However, information on BSE in the United States is limited because of inadequate surveillance of cows, as opposed to Japan, where almost all cows are tested. Also, vCJD is not a reportable disease in many parts of the United States.

--From staff reports

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