FDA Issues Guidance to Protect Blood Supply From Zika Virus

Disclosures

February 16, 2016

The US Food and Drug Administration (FDA) today issued detailed guidance on deferring blood donations from individuals who may harbor the Zika virus, strongly suspected of causing congenital microcephaly and Guillain-Barré syndrome.

The FDA recommendations are more expansive than safeguards announced on February 5 by the American Red Cross, which supplies about 40% of the nation's blood.

The Red Cross said that it was asking individuals who have visited areas where mosquitos are actively spreading the virus to wait 28 days before they donated blood. The FDA has broadened that deferral policy to include anyone who has had symptoms suggestive of a Zika infection in the prior 4 weeks, and anyone who has had sexual contact with a person who has traveled to, or lived in, an area of active Zika transmission in the prior 3 months.

The FDA also recommends that in areas of active virus transmission — the US territories of Puerto Rico, US Virgin Islands, and American Samoa fall in that category — healthcare facilities should obtain whole blood and blood components from areas where the virus is not actively spreading. The agency said blood establishments that use an FDA-approved pathogen reduction device may continue to collect and prepare platelets and plasma.

In addition to the aforementioned US territories, the Zika zone includes 27 other countries and territories, most of them in Latin America and the Caribbean.

"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, in a news release.

The agency noted that although it has not received any reports of the Zika virus contaminating the US blood supply, reports of transfusion-associated infection have surfaced elsewhere. The fact that only 20% of infected individuals exhibit symptoms is another reason for the recommendations on deferring blood donations, according to the agency.

FDA guidance is forthcoming on who should defer donating human cells, tissues, and cellular and tissue-based products, "given recent reports of sexual transmission of the virus," the agency said.

More information on today's announcement is available on the FDA website.

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