Zika Virus and Blood Donations - Current Recommendations of the FDA

Recommendation

23-26 April 2024
Berlin, Germany

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Currently, the Zika Virus and its possible infection risks are in the focus of public and media attention. The virus, normally a mosquito-transmitted infection related to dengue, yellow fever and West Nile virus, known since 1947, was found in Africa and Asia and did not begin to spread widely in the Western Hemisphere until last May, when an outbreak occurred in Brazil.

With the new knowledge that it can be spread by sexual contacts and with the strong suspicion that it effects Microcephaly with babys when pregnant women are infected, the Zika Virus has gained increasing importance.

Therefore, the US FDA has reacted to the possible risks of transmission by blood and blood components with a new "Guidance for Industry: Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus" published on 16 February 2016. Amongst the new findings, the guidance refers to the following data:

"Two instances of possible transfusion-transmission have been described in media announcements in Campinas, Brazil (Refs. 20, 22). In French Polynesia, 3% of samples from asymptomatic blood donors contained detectable ZIKV RNA during the outbreak in French Polynesia in 2013-14, indicating the likelihood of transmission by blood transfusion (Refs. 9, 23, 24). For these reasons, measures should be taken to prevent transfusion-transmission."

The Guidance document should provide blood establishments that collect Whole Blood and blood components with recommendations for donor screening, donor deferral and product management to reduce the risk of transfusion-transmitted Zika Virus (ZIKV). The recommendations apply to the collection of Whole Blood and blood components intended for transfusion but not to the collection of Source Plasma. 

More details about FDA/CBERs current thinking can be found in the Guidance for Industry: Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus"