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Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission in Hidalgo County, Texas

Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission in Hidalgo County, Texas

On December 19, 2017, the Centers for Disease Control and Prevention (CDC) added new epidemiological information on its Blood and Tissue Safety webpage used to communicate epidemiological information about Zika virus (ZIKV) to the blood and tissue collection community. Specifically, CDC reported that local, mosquito-borne transmission of ZIKV began in Hidalgo County, Texas on September 1, 2017.

Based on the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research’s Guidance for Industry titled Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products (March 2016), residence in or travel to, within the past six months, an area with active ZIKV transmission, as identified by CDC, and sex within the past six months with a male known to reside in or travel to an area with active ZIKV transmission, are considered ZIKV risk factors for the purpose of determining eligibility of living donors of HCT/Ps. Donors of HCT/Ps should continue to be screened as recommended in FDA’s March 2016 Guidance.

Donors of HCT/Ps recovered as of the posting of this announcement (i.e., prior to the change to CDC’s Blood and Tissue Safety webpage), should be screened for ZIKV risk factors using the current information on CDC’s Blood and Tissue Safety webpage which includes Hidalgo County, Texas as an area with active transmission of ZIKV. For HCT/Ps recovered between September 1, 2017 and the posting of this announcement, establishments should consider the new information regarding local ZIKV transmission in Hidalgo County, Texas when determining eligibility of the donor.

FDA is providing establishments with this notification of potential risk to HCT/P safety out of an abundance of caution and in the interest of providing patients and practitioners with information to make informed choices, such as decisions regarding use of cryopreserved semen for reproductive purposes.

Regarding donors, prolonged persistence of ZIKV has been observed in certain HCT/Ps such as semen, and scientific knowledge in this area continues to evolve, with studies taking place to investigate tissue tropism for ZIKV. HCT/Ps from living donors, such as donors of reproductive, gestational, and hematopoietic progenitor/stem cells from peripheral blood or cord blood, appear to have increased potential for transmission of ZIKV. 

Regarding risk to recipients, the potential populations receiving HCT/Ps from living donors may also be considered when evaluating this new information. Examples may include women of child-bearing age, including those seeking assisted reproductive technology (ART) treatments to conceive, and immunocompromised persons with whom the relevant risks and benefits can be discussed.