Top 5 things to know about FDA’s Zika blood guidelines

As a safety measure against the emerging Zika virus outbreak, FDA issued a new guidance recommending that individuals who have been to areas with active Zika virus transmission, who have potentially have been exposed to the virus, or have had a confirmed Zika virus infection should not donate blood.

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 (flaviviruses) are spread and recent reports of transfusion-associated infection outside of the U.S. “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,” FDA said in a statement.

Related: Top 5 things to know about Zika virus

“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.

Here are the top 5 things to know about FDA’s guidance on Zika and blood transmissions:

1. In areas without active virus transmission, FDA recommends that donors at risk for Zika virus infection be deferred for four weeks. At-risk individuals 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 3 months, and those who have traveled to areas with active transmission of Zika virus during the past 4 weeks.

2. In areas with active Zika virus transmission, FDA recommends 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.

Related: CDC: Flu reaches “epidemic” level

3. Blood banks should update donor education materials with information about Zika virus signs and symptoms and ask potentially affected donors to refrain from giving blood.

4. FDA intends 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.

5. FDA is prioritizing the development of blood screening and diagnostic tests that may be useful for identifying the presence of the virus, preparing to evaluate the safety and efficacy of investigational vaccines and therapeutics that might be developed, and reviewing technology that may help suppress populations of the mosquitoes that can spread the virus.                                                                                                     

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