FDA Issues Guidance to Protect Blood Supply from Zika Virus

In February, the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus or have had a confirmed Zika virus infection. Specifically, in areas with active Zika virus transmission, FDA recommends that whole blood and blood components for transfusion be obtained from areas of the U.S. without active transmission. However, blood establishments may continue collecting and preparing platelets and plasma if an FDA-approved, pathogen-reduction device is used. In addition, the guidance recommends blood establishments update donor education materials with information about Zika virus signs and symptoms and ask potentially affected donors to refrain from giving blood. In areas without active Zika virus transmission, FDA recommends that donors at risk for Zika virus infection be deferred for four weeks. Individuals considered to be at risk include those who have had symptoms suggestive of Zika virus infection during the past four weeks, those who have had sexual contact with a person who has traveled to or resided in an area with active Zika virus transmission during the prior three months, and those who have traveled to areas with active transmission of Zika virus during the past four weeks.

While there have been no reports to date of Zika virus entering the U.S. blood supply, the risk of blood transmission is considered likely based on the most current scientific evidence of how Zika virus and similar viruses (flaviviruses) are spread and recent reports of transfusion-associated infection outside of the U.S. It is also a concern because four out of five individuals infected with Zika virus do not become symptomatic. “Based on the best available evidence, we believe the new recommendations will help reduce the risk of collecting blood and blood components from donors who may be infected with the Zika virus,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

Due to recent reports of sexual transmission of Zika virus, FDA also intends to issue a guidance that will address appropriate donor deferral measures for human cells, tissues and cellular and tissue-based products.