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BWP Report on viral safety of plasma-derived and urine-derived medicinal products with respect to Zi

The virus safety of plasma-derived medicinal products is based on a combination of several safety measures, i.e. donor selection, testing and efficient virus inactivation/removal steps applied at manufacture, see EMA guideline on plasma-derived medicinal products.

ZIKV RNA has been detected in the urine from infected persons, with the possibility that the RNA load may be higher than found in blood and the virus may be detectable in urine for a longer period than in blood. Medicinal products such as urokinase and hormones are produced from large pools of urine. It was noted that some manufacturers (i.e. for hormone preparations) collect their urine starting material from South America (Argentina). There is no regular health check at each donation of urine and given the high number of asymptomatic infections or persons with non-specific symptoms due to ZIKV-infection, the possibility that ZIKV may enter the urine pools cannot be excluded.

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