FDA Issues New Blood Transfusion Guidance Aimed at Reducing Zika Spread

The risk of blood transmission is considered likely based on the most current scientific evidence of how Zika virus and similar viruses are spread.

Officials with the Food and Drug Administration (FDA) this week 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.

“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 a prepared statement. “We are issuing this guidance for immediate implementation in order to better protect the blood supply.”

While there have been no reports to date of Zika virus entering the US blood supply, the risk of blood transmission is considered likely based on the most current scientific evidence of how Zika virus and similar viruses are spread and recent reports of transfusion-associated infection outside of the United States. Furthermore, about 4 out of 5 of those infected with Zika virus do not become symptomatic. For these reasons, the FDA is recommending that blood establishments defer blood donations from individuals in accordance with the new guidance.

In areas without active Zika virus transmission, FDA officials are recommending that donors at risk for Zika virus infection be deferred for 4 weeks. Individuals considered to be at risk include: those who have had symptoms suggestive of Zika virus infection during the past 4 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 3 months, and those who have traveled to areas with active transmission of Zika virus during the past 4 weeks.

FDA officials are recommending that whole blood and blood components for transfusion be obtained from areas of the United States without active transmission. Blood establishments may continue collecting and preparing platelets and plasma if an FDA-approved, pathogen-reduction device is used. The guidance also 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.

Following the issuance of these recommendations, FDA officials are also intending to issue a guidance that will address appropriate donor deferral measures for human cells, tissues, and cellular and tissue-based products (HCT/Ps), given recent reports of sexual transmission of the virus.