On behalf of America’s Blood Centers (ABC) and our member blood centers, we applaud your efforts to maintain a safe and robust blood supply by ensuring that testing requirements and donor deferrals are evidence-based.
The determination that Zika virus (ZIKV) is no longer a relevant transfusion-transmitted infection (RTTI) recognizes the evolving knowledge surrounding the virus, which currently indicates a “low reported incidence and prevalence in the potential blood donor population.” From the time FDA and blood centers quickly acted to respond to an evolving Zika outbreak in the U.S. until today, when the data highlights that ZIKV is no longer a RTTI, the FDA’s willingness to continue to examine the evidence and modify recommendations based on the current best data is laudable. We believe such a model of consistent review based on the most current data is applicable for all RTTI’s and encourage FDA to continue such a process, next with blood donor screening for Hepatitis B Surface Antigen (see attached).