Photo by Cristina Granados
Patients who take plasma-derived or urine-derived medicines do not have to worry about these products being contaminated with Zika virus, according to the European Medicines Agency (EMA).
The agency said assessments have confirmed that manufacturing processes for these medicines—which include coagulation factors, immunoglobulins, and urokinase products—successfully inactivate or remove the Zika virus.
These medicines are produced from body fluids that might be sourced in parts of the world where the Zika virus is prevalent. So regulators in the European Union (EU) sought reassurance that there is no risk of the virus contaminating the final product and thus affecting the patients taking these medicines.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) investigated the potential risk with plasma-derived medicinal products.
And the Co-ordination Group for Mutual Recognition and Decentralised Procedures—Human (CMDh) has coordinated the assessment by EU member states on the potential risk with urine-derived medicinal products.
The CHMP concluded at its meeting last week that the manufacturing processes used for plasma-derived products—including, for example, the solvent/detergent method to inactivate viruses, pasteurization, and virus filtration—inactivate or remove the Zika virus from the finished product.
The CHMP therefore concluded that no additional safety measures, such as the testing or exclusion of certain plasma donors, were necessary.
The CMDh, following an assessment of data, concluded that the manufacturing processes for urine-derived products contain complementary steps with inactivation/removal capacity for enveloped viruses, which are considered sufficient for eliminating Zika virus.
Additional safety measures, such as screening urine donors/donations or deferring donors returning from Zika-affected areas, are not considered necessary.
The findings from these assessments are available in a report from the CHMP’s Biologics Working Party.
The Biologics Working Party recommendation on plasma-derived products is in line with the guidance published in July 2016 by the European Centre for Disease Prevention and Control.
