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  1. Safety & Availability (Biologics)

Important Information for Blood 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 for 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 based on retrospective analysis. The potential increased risk currently impacts 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. This designation continues through the present. In addition, following retrospective analysis CDC has now identified 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 purpose of blood and tissue safety intervention was not met during that 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 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 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.

In February 2016, the FDA issued “Recommendations for Donor Screening, Deferral and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Guidance:  Guidance for Industry,” and recommended that blood should not be collected in areas with active transmission of ZIKV, or from travelers to such areas, until testing for ZIKV or pathogen reduction was implemented. In August 2016, the FDA issued “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry,” recommending testing for ZIKV or use of a pathogen-reduction technology. This guidance recommended immediate testing in states and territories with one or more locally acquired cases of ZIKV. Nationwide testing was phased in rapidly over a 12-week period.

Considerations
The FDA’s current guidance contains recommendations regarding ZIKV and the blood supply. As a precaution, blood establishments may wish to consider whether to take additional measures to address the possibility of increased risk of ZIKV from certain blood components that were collected in these three counties prior to the implementation of blood donor screening tests for ZIKV. 

The FDA is not recommending “lookback” tracing to recipients of blood components collected in Miami-Dade, Broward and Palm Beach counties since June 15, 2016. Although a potential risk of ZIKV transmission from these donations has been identified, the risk is considered very low.

Regarding ZIKV untested and non-pathogen-reduced blood components, blood establishments that collected donations in Miami-Dade, Broward and Palm Beach counties since June 15, 2016 may wish to consider whether to quarantine undistributed, in-date blood components (i.e., frozen plasma and frozen red blood cells) and whether to notify consignees to quarantine such blood components so that they will not be transfused.

Regarding ZIKV untested and non-pathogen-reduced blood components, blood establishments that are contacted by a donor who reports residence in or travel to Miami-Dade, Broward and Palm Beach counties since June 15, 2016 may wish to consider whether to quarantine undistributed, in-date blood components from the donor (i.e., frozen plasma and frozen red blood cells) and whether to notify consignees to quarantine such blood components so that they will not be transfused.