EMA Publishes Reflection Paper on vCJD and Plasma-Derived Medicinal Products

June 04, 2024

The European Medicines Agency (EMA) published a recommendation paper on May 31 that lifts the recommendation to exclude donors who spent a cumulative year or more in the United Kingdom between 1980 and 1996 from donating plasma for fractionation due to the risk of variant Creutzfeldt-Jakob disease (vCJD).

This decision is based on the decline in vCJD cases, the absence of a new wave of cases and the use of risk-reducing factors specific to plasma-derived medicinal products, such as prion reduction during manufacture. The last known UK case of vCJD was reported in 2016, and no transfusion-transmitted infections have been reported from the UK since 1999.

Additional information about CJD and vCJD is available on the AABB website