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FDA issues guidance to protect US blood supply from Zika virus

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To prevent Zika virus blood transmission in the United States, the FDA is recommending the deferral of blood donations from individuals who have recently traveled to areas with active Zika virus transmission, who may have been exposed to the virus, or who have confirmed Zika virus infection, according to a news release.

“The FDA has critical responsibilities in outbreak situations and has been working rapidly to take important steps to respond to the emerging Zika virus outbreak,” Luciana Borio, MD, the FDA’s acting chief scientist, said in the release. “We are issuing this guidance for immediate implementation in order to better protect the U.S. blood supply.”

The FDA recently issued the guidance due to reports of transfusion-associated cases outside the U.S. and current scientific evidence that suggests flaviviruses such as Zika are likely transmitted through blood. The guidance extends to asymptomatic travelers returning from Zika-endemic countries since 80% of individuals who become infected are asymptomatic. To date, there have been no reports of Zika virus entering the U.S. blood supply.

Individuals at risk for Zika virus infection should be deferred from donating blood for 4 weeks in areas without active Zika transmission, according to the FDA. At-risk individuals include those who experienced Zika virus infection symptoms during the past 4 weeks, individuals who had sexual contact with a person who traveled to or resides in an area with active transmission over the past 3 months, and individuals who traveled to areas with Zika transmission during the past 4 weeks.

The FDA recommends only using whole blood and blood components for transfusion that are collected in areas of the U.S. without active transmission.

Blood collection agencies in areas with active transmission may continue to collect and prepare platelets and plasma using an FDA-approved, pathogen-reduction device. The establishments are urged, however, to update donor education materials with information on Zika virus signs and symptoms. The FDA also advises such establishments to ask potentially exposed donors to abstain from donating blood.

“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release.

The FDA plans to issue similar guidance for donations of human cells, tissues and cellular and tissue-based products, according to the release.