Zika virus infection is asymptomatic in approximately 80% of individuals, and may be transmitted for up to 6 months. Early evidence suggested that Zika virus was a transfusion transmissible illness including: detection of viremia in symptomatic and asymptomatic infections, documentation of perinatal transmission identification of Zika virus RNA in blood donations, previous demonstration of transfusion transmission of other flaviviruses and reports of probable transfusion transmission in Brazil. Because of this evidence, The Food and Drug Administration (FDA) acted decisively in 2016 to reduce the risk of transfusion transmitted Zika Virus infection.
Beginning in February 2016, FDA and CDC collaborated to recommend travel and risk factor–related deferrals for all U.S. blood donors. Until laboratory screening of blood donations or pathogen reduction technology could be implemented, FDA issued guidance recommending that blood centers in areas with active mosquito-borne Zika virus transmission cease local blood collection and import blood from U.S. areas without active transmission. Testing of blood donors for Zika became available through two separate Investigational New Drug (IND) applications granted to Roche Molecular Systems on April 3 and Hologic/Grifols on June 20, 2016. Alternatively, an FDA approved pathogen reduction device could be used for plasma and apheresis platelet products. Because of increasing reports of persons infected through travel and local transmission, FDA expanded its blood screening recommendations to include all areas of the United States on August 26, 2016.
As of December 10, 2016, Zika virus positive products from 78 donations in the continental United States and Hawaii and 353 donations in Puerto Rico have been prevented from entering the blood supply as a result of screening. To date, there have been no confirmed transfusion-transmission cases of Zika virus in the United States. However, cases of Zika virus transmission through platelet transfusions have been documented in Brazil.
Zika Virus —10 Public Health Achievements in 2016 and Future Priorities. MMWR Early Release / December 30, 2016 / 65
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Food and Drug Administration. FDA allows use of investigational test to screen blood donations for Zika virus. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm493081.htm
Food and Drug Administration. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2016. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM518213.pdf