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FDA Issues Recommendations to Reduce the Risk of Zika Virus Transmission Through Blood and Tissue Products

December 30, 2021

The U.S. FDA announced new safety recommendations to reduce the risk of transmission of the Zika virus through human cell and tissue donations. The guidance addresses donations of products from both living and deceased donors, including donors of bone marrow, stem cells, and gestational tissues.

The new guidelines state:

  • Living donors should be considered ineligible if they were diagnosed with Zika virus infection, were in an area with active Zika virus transmission, or had sex with a male with either of those risk factors within the past six months. Donors of any gestational tissues should be considered ineligible if they have had any of the aforementioned risk factors at any time during the pregnancy.
  • Deceased donors should be considered ineligible if they were diagnosed with Zika virus in the past six months.

The six-month deferral period was determined based on limited data on the disease. Zika virus has been detected in tissues and bodily fluids after the virus is no longer detectable in the blood stream, and has been detected in semen for up to 10 weeks after the onset of symptoms.

The U.S. FDA has also prioritized the development of blood donor screening and diagnostic tests to identify Zika infection, evaluate the safety and efficacy of vaccines, and review technology that can suppress populations of mosquitoes that carry the virus.

The Zika virus outbreak has now reached 36 countries and territories, primarily in the Americas after the first outbreak in Brazil in 2015, according to the CDC.

Sources: U.S. FDA press release, March 1, 2016.


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