Zika No Longer a Relevant Transfusion-Transmitted Infection Risk
Previously, the U.S. FDA requires blood establishments to test blood donations for new or emerging infectious agents that may affect blood product safety if certain conditions are outlined in FDA regulations.
Specifically, if a transfusion-transmitted infection “may have sufficient incidence and/or prevalence to affect the potential donor population” and meets certain other criteria described in FDA’s regulations, then FDA may determine the transfusion-transmitted infection is a “relevant transfusion-transmitted infection” (RTTI).
Effective on May 13, 2021, the FDA has determined Zika virus (ZIKV) is no longer an RTTI under FDA’s regulations.
As discussed further below, 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.
Because ZIKV is no longer an RTTI, blood establishments may discontinue testing for ZIKV.
Licensed blood establishments that discontinue testing blood donations for ZIKV must report this change to FDA in the annual report under 21 CFR 601.12(d), noting the date testing was discontinued. Corresponding changes to the circular of information must also be reported in the annual report under 21 CFR 601.12(d).
As of April 1, 2021, the U.S. CDC reported zero (0) cases of Zika in the USA during 2021. However, Puerto Rico has confirmed seven (7) locally transmitted Zika cases in 2021.