FDA Published Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World
October 10, 2017
As part of a notice recently issued by the FDA, the regulator clarified that the Travel Notice Posting Dates table, maintained by the CDC and used by tissue banks to identify areas with active transmission risk of Zika virus (ZIKV) in other countries as part of the donor risk assessment process, HAS NOW BEEN ARCHIVED for historical purposes. Epidemiological data about ZIKV needed for the identification of risk areas for donor eligibility assessment purposes can now be found on the updated Blood & Tissue Safety web page of the CDC. The updated page maintained by the CDC shows a world map of areas with risk of Zika. Information related to the identification of ZIKV risk areas in the United States can be found in the first section of the Blood & Tissue Safety web page titled "Areas with Zika Virus Transmission Risk in the Continental US". The data will continue to be defined at the county level within a state, including risk start and end dates, as listed on the CDC web page for Blood and Tissue Safety.
Tissue banks are advised to follow these steps when screening HCT/P donors:
- Access the CDC web page for Blood and Tissue Safety.
- For domestic travel evaluation, check the data in the first section of the page titled "Areas of Active Zika Virus Transmission Risk in the Continental United States". It will continue to be defined at the county level within a state. To screen HCT/P donors, do not use other CDC web pages or maps for evaluating travel within the United States.
- For evaluating travel to areas outside of the continental United States, as of September 28, 2017, use the new links to a world map and to a table of "Areas with Interrupted Transmission." Residence in, or travel to a country or territory identified on the world map page, is considered a risk factor for ZIKV as described in FDA's current guidance for HCT/P donors.
The CDC web page for Blood and Tissue Safety should be monitored frequently for any updates.
HCT/Ps recovered prior to posting this announcement should have been screened for travel to other countries and territories using the table of Travel Notice Posting Dates, which has now been archived for historical purposes. However, HCT/P establishments may want to consider this new information regarding potential risk related to travel outside of the continental United States, as well as new information regarding estimated introduction of ZIKV, and evaluate whether this affects their practices. Estimated introduction of ZIKV and substantive risk of exposure in North America, South America, Central America, and the Caribbean is January 1, 2014. As for Africa and Asia, scientific evidence confirms ZIKV presence in some African and Asian countries for decades, in some cases dating back to the 1950's. Therefore, the possibility of mosquito-borne ZIKV transmission to travelers may have started before the travel notice dates originally posted on the Blood and Tissue Safety web page. Prior to potential use, establishments may also wish to take into consideration the type of HCT/P and the risk factors for potential ZIKV infection in recipients.
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. At this time, the potential risk to previously recovered HCT/Ps, including semen, is believed to be small enough that no formal regulatory action is required by the FDA. 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 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.
Note: This bulletin contains data related to scientific studies used as references in the original announcement issued by the FDA. The detailed list of references is available upon request.