Updated vCJD Guidelines

In May the FDA announced that we may now remove the permanent deferral for vCJD.  This is a welcome move by the Food and Drug Administration (FDA) that will allow more people to donate and strengthen our nation’s blood supply at a critical time.

  • Variant Creutzfeldt-Jakob disease (vCJD) is the human form of what is often called Mad Cow Disease, a fatal, progressive neurological condition that was first identified in the United Kingdom 1996.
  • Despite the perceived risk, science continues to show that the transmission risk of vCJD by blood components remains only theoretical.
  • By following the best available evidence, the FDA is allowing more people to donate blood without risking the safety of our nation’s blood supply.
  • Permanent deferrals remain in place for donors with a history of receiving a human cadaveric (allogeneic) dura mater transplant and for donors who volunteer that they suspect having vCJD, CJD or another similar disease; have a blood relative diagnosed with a similar disease; or who received cadaveric pituitary human growth hormone.

The final guidance removes the recommendations to defer indefinitely blood donors for:

  • Geographic risk of possible exposure to bovine spongiform encephalopathy for time spent in the United Kingdom (U.K.) from 1980-1996 and for time spent in France and Ireland from 1980-2001, and
  • Receipt of a blood transfusion in the U.K., France, and Ireland from 1980-present.

The FDA continues to require donor deferral for the following:

  • Defer permanently a donor who volunteers that they have received cadaveric pituitary human growth hormone (hGH).
  • Defer permanently a donor who volunteers that they have been diagnosed with vCJD, CJD or any other transmissible spongiform encephalopathy (TSE) or who has a blood relative diagnosed with familial prion disease (e.g., familial CJD (fCJD), Gerstmann-Sträussler-Scheinker syndrome (GSS), or fatal familial insomnia (FFI)).
  • Defer permanently donors who receive human cadaveric dura mater allografts because such transplantation is still performed in the U.S. and presents a remote risk of iatrogenic CJD.