FDA Releases Guidance on Zika Virus
The Food and Drug Administration has released a new guidance, "Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus,” offering recommendations for blood collection institutions regarding Zika virus. The guidance includes two sets of recommendations: one for areas without active transmission of Zika virus, and one for areas with active transmission of Zika virus. The guidance refers blood collection institutions to the
CDC website to stay informed about areas with active transmission of Zika virus infection.
For areas without active transmission of Zika virus, FDA recommends blood donors with a history of Zika virus infection — or those who exhibit signs and symptoms of Zika virus infection within two weeks of returning from an area with active transmission of Zika virus — should self-defer for four weeks after the resolution of symptoms. In addition, donors who have had sexual contact with a man who has been diagnosed with Zika virus infection, or with a man who has traveled to an area with active transmission of Zika virus, should self-defer for four weeks after the last sexual contact. FDA also recommends updates to the Donor History Questionnaire to reflect the recommendations in the new guidance. FDA recommends that all blood collection institutions in areas without active transmission of Zika virus infection implement the new recommendations as soon as possible, but no later than four weeks from today.
For areas with active transmission of Zika virus infection, FDA recommends that whole blood and blood components be obtained from areas of the United States without active transmission of Zika virus to fill orders. Exceptions can be made if blood collection institutions implement pathogen reduction technology for platelets and plasma using an FDA-approved pathogen reduction device, or collect blood components locally and test blood donations with an FDA-licensed blood donor screening test for Zika virus infection, when available. In areas with active transmission of Zika virus infection, blood collection institutions should implement FDA’s recommendations immediately for blood to be transfused to at-risk recipients, particularly pregnant women. All other recommendations should be implemented as soon as possible, but no later than two weeks from today.
AABB members are urged to carefully review the new FDA guidance for additional recommendations. AABB will update AABB
Association Bulletin #16-03 on Zika, dengue and chikungunya viruses in light of the new FDA guidance document. In addition, the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terror, in coordination with the Department of Health and Human Services, the Centers for Disease Control and Prevention and FDA, is actively assessing possible needs to provide blood to affected areas.