- May 12, 2021: Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection, and Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components” - FDA has determined Zika virus (ZIKV) is no longer an RTTI under FDA’s regulations because, as discussed further in the guidance, the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential donor population. Accordingly, FDA withdrew the guidance titled, “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018.
- On February 28, 2019, FDA published a web page: Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World - CDC has changed information on its Blood and Tissue Safety webpage used to communicate epidemiological information about ZIKV to the blood and tissue collection community. The webpage includes a world map of areas with risk of Zika for other countries and territories outside of U.S. states. A new process has been developed to indicate risk for these areas that assigns one of four categories. FDA considers countries and territories outside the U.S. states categorized as “Red” (current outbreak) or “Purple” (any prior or current reports of mosquito-borne Zika transmission) as areas with increased risk of ZIKV transmission.
On March 13, 2017, the Centers for Disease Control and Prevention (CDC) announced that based on a retrospective analysis of Zika virus (ZIKV) infections they identified a potential increased risk to blood and tissue safety, including semen, in Florida’s Miami-Dade, Palm Beach, and Broward counties dating back to June 15, 2016. While Miami-Dade County is the only part of Florida currently (July 29, 2016 to present) designated by CDC as an area of active ZIKV transmission for the purposes of blood and tissue safety intervention, people in this part of Florida regularly travel within and between these three counties and may not recognize that they have been in an area of active ZIKV transmission. This information has been added to CDC’s webpage used to communicate epidemiological information about ZIKV to the blood and tissue collection community.
The potential increased risk to blood and tissue safety, and particularly to semen, in this area due to CDC’s announcement is considered to be very low. However, as a precaution, the Food and Drug Administration is informing establishments that collect tissues (i.e., human cell, tissues, and cellular and tissue-based products – HCT/Ps) and blood components of the potential increased risk, so they may consider whether and how this new information impacts their practices.
Specifically, the FDA has shared the following:
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 their practices. Establishments may wish to take both donors and 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.
Also see the FDA’s communication to tissue establishments: Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Zika Virus (archived)
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 the 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.
For more information on the FDA’s current guidance to industry to reduce the risk of ZIKV transmission by blood components and tissue products please see:
- Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products (March 2016) (PDF, 76 KB)
- Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry (August 2016) (PDF, 279 KB)
- FDA approves first test for screening Zika virus in blood donations (October 5, 2017)