Zika, a flavivirus, is transmitted by Aedes mosquitoes, most commonly by A. aegypti. This same vector, in addition to A. albopictus, transmits dengue (another flavivirus) and chikungunya (an alphavirus). Other modes of Zika virus transmission include intrauterine, perinatal, and sexual routes. AABB works closely with the FDA, CDC, and the Council of State and Territorial Epidemiologists to continually assess the latest scientific information and develop appropriate tools and policies.
On March 13th, 2017, The Centers for Disease Control and Prevention (CDC) released epidemiological information on Zika virus (ZIKV). CDC released both current and retrospective data to provide additional information on the identified potential increased risk to HCT/Ps and active areas of ZIKV transmission. In addition to historical transmission summaries, CDC noted that Broward and Palm Beach counties are listed as areas of potential increased risk to blood and tissue safety. Miami-Dade County and Cameron County (TX) are current areas of active ZIKV transmission. Full information, including travel notices, can be found on the CDC website. The FDA noted that HCT/P establishments may want to consider this information. FDA noted, HCT/Ps from living donors appear to have an increased risk of ZIKV transmission, such as HPC’s, peripheral or cord blood, reproductive and gestational tissues. Additionally, consideration should be given to the recipient population with women of child-bearing age, immunocompromised, individuals seeking assisted reproductive technology and treatments to conceive.
AABB submitted comments to FDA regarding the six month donor deferral recommended in the final guidance “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products.”
AABB HPC Donor History Questionnaire Task Force updated its donor history documents for HPC, Apheresis and HCP, Marrow donors and HPC, Cord Blood to incorporate FDA recommendations for donor screening.
The FDA publishes a FDA final guidance, “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products,” with recommendations for human cells, tissues, and cellular and tissue based products (HCT/Ps) collected in areas with active Zika virus transmission and areas without active Zika virus transmission. The recommendations were to be implemented by April 1st, 2016 through a combination of self-deferral and donor history screening.