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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Variant Creutzfeldt-Jakob Disease (vCJD) and Plasma Derivatives Other than Factor VIII (pdFVIII) Questions and Answers

What is the risk of vCJD for a patient who receives a US licensed plasma-derived product other than plasma-derived Factor VIII (pdFVIII)?

The US Public Health Service, including FDA, CDC, and NIH, believes that vCJD risk from US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty. We believe that the risk of other plasma derived products including plasma derived Factor IX, is likely to be as small as or smaller than for pdFVIII.

FDA conducted a risk assessment for pdFVIII because the plasma fraction from which it is made is likely to contain more of the vCJD infectious agent, if present, than plasma fractions from which other plasma-derived products are made, such as Factor IX, (used to treat hemophilia B), albumin, and immune globulins. The FVIII-containing fraction is further processed using a variety of methods that are likely to reduce or potentially eliminate vCJD from the final pdFVIII product. Methods likely to reduce or potentially eliminate vCJD are also used in the manufacture of other plasma-derived products, including Factor IX, albumin, and immune globulins.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Rockville, MD 20852-1448