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  1. Safety & Availability (Biologics)

Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Zika Virus

Date: March 13, 2017

The Centers for Disease Control and Prevention (CDC) has added new epidemiological information to its website about Zika virus (ZIKV). This new information has implications to the blood and tissue collection community. In addition to providing information about areas with active transmission, the CDC website now includes information about areas with potential increased risk to blood and tissue safety that were identified upon retrospective analysis. The potential increased risk currently affects individuals in Florida’s Miami-Dade, Broward, and Palm Beach counties from June 15, 2016, forward due to local movement of the population within the contiguous tri-county area.

This notification of potential increased risk to blood and tissue safety, and particularly to semen, is being done out of an abundance of caution and in the interest of providing patients and practitioners with information to make informed reproductive choices. The potential risk to blood and tissues, including semen, has been deemed small enough that no formal regulatory action is required by the FDA.

Since July 29, 2016, Miami-Dade County has been designated by CDC as an area of active ZIKV transmission for the purposes of blood and tissue safety intervention. This designation continues, and the CDC webpage above should be monitored frequently for any updates or changes. In addition, based on retrospective analysis, CDC has now determined that a potential increased risk to blood and tissue safety for Miami-Dade County also existed from June 15, 2016 to July 29, 2016, although the threshold for designation as an area of active transmission for the purposes of blood and tissue safety intervention was not met during this timeframe.

Based on the movement of the population between Miami-Dade, Broward, and Palm Beach counties, CDC has also identified a potential increased risk to blood and tissue safety for Broward and Palm Beach counties that also dates back to June 15, 2016. Palm Beach County was previously identified as an area of active ZIKV transmission from August 24, 2016 to November 2, 2016 for the purposes of blood and tissue safety intervention. Although the threshold for designation as an area of active transmission has not been reached for Broward County, individuals in both Broward and Palm Beach counties have been identified as having potential increased risk due to local movement of the population within the contiguous tri-county area that includes Miami-Dade County.

Based on the Food and Drug Administration, 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 an area with active ZIKV transmission, and sex 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. 

Considerations
HCT/P establishments may want to consider the new information from CDC regarding the potential increased risk of ZIKV infection in Miami-Dade, Broward, and Palm Beach counties and whether it affects your practices. Establishments may wish to take the type of tissue donation from donors and the risk factors for potential ZIKV infection in recipients into consideration. 

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 through ongoing studies to investigate tissue tropism for ZIKV (cells and tissues that support growth of the virus). HCT/Ps from living donors, such as reproductive, gestational, and hematopoietic progenitor/stem cells from peripheral blood or cord blood, appear to have increased potential for transmission of ZIKV.

Regarding recipients, the populations that receive HCT/Ps from living donors should 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.