US FDA issues Zika guidelines for human cell, tissue donations

WASHINGTON - The US Food and Drug Administration (FDA) on Tuesday issued new guidelines to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products.

Under the new guidelines, 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 umbilical cord blood, placenta, or other gestational tissues should also be considered ineligible if the women have had any of the above risk factors at any point during their pregnancy.

In addition, deceased donors should be considered ineligible if they were diagnosed with Zika virus infection in the past six months.

The recommendations came two weeks after the FDA issued similiar guidelines for reducing the risk of the Zika virus via blood transfusion in the United States.

"Though there is more to be learned about the transmission of Zika virus, given what we know about the virus at this point, which also is informed by our understanding of similar viruses, we must address the potential risk of Zika virus transmission by human cells and tissues," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

"Providing HCT/P (human cells, tissues, and cellular and tissue-based products) establishments with donor eligibility recommendations will help reduce that potential risk," Marks said.

The FDA said a deferral period of six months was chosen because of the limited data available on the length of time the virus can persist in all tissues.

"Zika virus has been detected in tissues and body fluids after the virus is no longer detectable in the blood stream, and has been detected in semen possibly up to 10 weeks after the onset of symptoms," it said. "Given the uncertainty, six months was determined to provide the appropriate level of caution."

According to the FDA, less evidence exists regarding the potential for transmission of Zika virus by HCT/Ps typically recovered from deceased donors.