EMA publishes reflection paper on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products

In this reflection paper, the recommendation that donors who have spent a cumulative period of 1 year or more in the UK between the beginning of 1980 and the end of 1996 should be excluded from donating plasma for fractionation due to the risk of variant Creutzfeldt-Jakob disease (vCJD), is no longer required. 

This decision is based on the decline of vCJD cases and the absence of a new wave of cases as well as on the risk-reducing factors specific to plasma-derived medicinal products, such as prion reduction during manufacture. 

In January 2023, ECDC published its guidance, vCJD in donors of blood and plasma having temporarily resided in or visited the United Kingdom, focusing on blood and plasma for transfusion. In this guidance, ECDC agrees with the conclusions of modelling studies regarding a very low risk of transmission of vCJD through blood transfusion and recommends that each country assess the local risk of transmission of vCJD via transfusion and balance the risk against supply needs in the country. 

Both agencies will continue to work closely to provide timely and evidence-based guidance to support effective risk management and ensure the safety of the European population.