Updated Information about the Risk of ZIKA Virus Transmission via Cells and Tissues

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

On February 28, the FDA announced in its CBER News the latest changes regarding the safety of blood and tissue products with regard to the transmission of the Zika virus. Reference is made to the website of the Center for Disease Control and Prevention (CDC). The information provided there by the CDC for blood and tissue collection establishments on the epidemiological situation regarding the Zika virus (ZIKV) has changed. This concerns the risk assessment for areas outside the USA. Using a newly developed method, a world map has been produced which uses colouring to assign areas to four different hazard categories:

• Country or area with current Zika outbreak (red),
• Country or territory with previous or current reports of Zika transmission (purple) transmitted by mosquitoes,
• Country or area with the vector and without reported mosquito-borne zika transmission (yellow),
• Country or area without mosquitoes spreading Zika (green).

Regardless of this, the FDA's "Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products", which were last updated in May 2018, continue to apply to the testing of donors of HCT/Ps. Accordingly, stay or travel to areas with increased risk of Zika transmission (red and purple) or sexual contact with a man who lives or has travelled in such an area still count as factors in determining donor fitness.

The table previously listed on the CDC page, which lists areas where a ZIKV transmission was previously reported but later classified as interrupted, is no longer listed on the page. However, it remains available for the history of the data. On the current map, these areas have been shaded purple.

Further information on the risk assessment of travel within the USA can be found on the CDC website in the section "Areas at increased risk for Zika virus transmission through blood or tissue donation in U.S. states". There is currently no increased risk listed within the USA.

Further details can be found directly on the page "Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World".