As already reported on 25 February, the FDA published a new Guidance for Industry for immediate implementation: "Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus". The agency therefore determined that prior public participation is not feasible or appropriate and did not seek for public comments. Following this publication, the FDA received several questions from blood establishments. With a new Q&A document "Questions and Answers Regarding “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry”, the FDA wants to provide answers to these questions to assist blood establishments in implementing the recommendations of the February 2016 guidance.
The document includes answers to more than 20 common questions, some more general, e.g.
Question: Does FDA recommend that blood establishments ask donors specific questions regarding sexual contact with someone who travelled to an area with active transmission of Zika virus (ZIKV)? Answer: In areas without active transmission of ZIKV, we do not recommend asking donors a specific question with respect to sexual contact, although blood establishments may elect to do so. In these areas, we recommend that the donor educational materials instruct donors to self-defer for 4 weeks after the last sexual contact with a man who has been diagnosed with ZIKV or who travelled to or resided in an area with active transmission of ZIKV in the 3 months prior to that instance of sexual contact. In areas with active transmission of ZIKV, we recommend adding a question to the donor history questionnaire to assess donors for a history of sexual contact in the past 4 weeks with a man who has been diagnosed with or had symptoms suggestive of ZIKV in 3 months prior to that instance of sexual contact, in addition to providing information in the donor educational materials.
Other questions address detailed recommendations of the guidance document more specifically:
Question: Why does the guidance recommend a 4 week deferral for sexual contact with a man who has been diagnosed with ZIKV, had symptoms suggestive of ZIKV or who travelled to an area with ZIKV in the 3 months prior to that instance of sexual contact? Answer: Sexual transmission of ZIKV has been reported from men to their sexual partners. The maximum time ZIKV may persist in semen is currently unknown, but has been shown to be more than 60 days. This deferral will help to ensure that the virus has not been transmitted to the sexual partner of the at-risk male.