Critical risk assessment report: use of UK plasma for the manufacture of immunoglobulins and vCJD risk
The Commission on Human Medicines (CHM) has concluded that the risk of vCJD cases arising from the use of UK plasma for the manufacture of immunoglobulin medicinal products would be negligible.
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On 8 October 2020, the CHM deliberated on whether the removal of the ban would pose a risk of increased transmissions and clinical cases of vCJD. The CHM concluded that the risk of vCJD cases arising from the use of UK plasma for the manufacture of immunoglobulin medicinal products would be negligible. The CHM also noted the clinical need for immunoglobulin products for patients with immunodeficiency and certain autoimmune conditions.
The CHM advised that UK-sourced plasma is acceptably safe for the manufacture of immunoglobulin medicinal products provided the following risk-mitigation measures are adhered to:
- All relevant risk-mitigation measures already in place for blood components for transfusion (the use of leucodepletion, deferral of high-risk donors and traceability between donor and recipient) should be applied to UK-sourced plasma for the manufacture of immunoglobulins.
- Manufacturers should be required to submit an application to vary the terms of their existing licences to introduce the use of UK-sourced plasma. The product-specific risk assessment and an evaluation of the prion reduction capacity of the product manufacturing process, will be required. Each product will need to be individually reviewed and evaluated by the MHRA, and advice sought from the CHM’s Clinical Trials, Biologicals and Vaccines Expert Advisory Group and CHM.