The rapid, pandemic spread of Zika virus (ZIKV) spurred an international public health emergency in 2015. Cases of ZIKV infection have now been reported in 85 countries or territories¹; in 72 of those locations, no such cases had been reported previously. The association of ZIKV with severe teratogenic effects,² its persistence in whole blood,³ and four possible cases of transmission of ZIKV by blood transfusion in Brazil^4-6 have raised questions about a potential risk to the blood supply. In February 2016, the Food and Drug Administration (FDA) recommended that collection of donated blood cease in areas in the United States in which ZIKV was active, unless blood testing or pathogen-reduction methods could be implemented.⁷ At the time, no vectorborne cases of ZIKV infection had been reported in the continental United States; however, an epidemic was under way in the U.S. territories, most notably in Puerto Rico and the U.S. Virgin Islands. An unprecedented response from both blood-collection centers and industry (i.e., commercial manufacturers of donor screening tests) followed; within 6 weeks after the FDA guidance was issued, blood-donation screening began in Puerto Rico with the use of a newly developed, high-performance nucleic acid test for ZIKV under an investigational new drug application. In August 2016, the FDA expanded its earlier guidance to include blood-donation screening throughout the continental United States. Consequently, all donated blood in the United States is now screened for ZIKV. In this issue of the Journal, results of the screening of more than 4,000,000 U.S. blood donations for ZIKV during a 15-month period in 2016 and 2017 are reported.⁸

The current U.S. strategy for ZIKV screening comes at a cost with an unclear gain. Although concerns about blood safety are vital, is it appropriate and possible to reverse blood-donation screening for ZIKV in the United States in light of emerging data? Addressing this question requires that we understand the variables that contributed to the decision to implement blood-donation screening along with the reasons to consider whether those variables remain relevant.

…continue reading ‘Revisiting Blood Safety Practices Given Emerging Data about Zika Virus’

Image: By NIAID – Zika Virus, CC BY 2.0, https://commons.wikimedia.org/w/index.php?curid=49179070

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