Plasma obtained from UK patients is “acceptably safe” for use in immunoglobulin products, if certain risk mitigation measures are implemented, according to the UK Commission on Human Medicines.
Manufacturers have been unable to use UK plasma to make immunoglobulin medicines since 1999, when it was its use banned due to the potential for iatrogenic transmission of the prions that cause variant Creutzfeldt–Jakob disease (vCJD). Since then, plasma for immunoglobulin and similar products has been imported, mostly from the US.
“Due to limitations in the supply of immunoglobulin products caused by the need to import plasma in the UK, long-term measures had to be implemented in the NHS to prioritize supply of these products to patients with the highest clinical need. The COVID-19 pandemic is placing further pressures on supply,” the UK Medicines and Healthcare products Regulatory Agency (MHRA) wrote.
MHRA considered lifting the ban for COVID-19 convalescent plasma last year. CHM, which advises the government on medicinal products, recommended waiting until more information was available, leading MHRA to do a deep dive into the evidence and present its findings to the commission.