FDA Requires All US Blood Donations Be Tested for Zika Virus

FDA Blood Guidances Update

In mid-February, the US Food and Drug Administration (FDA) first issued blood collection recommendations for states and territories with active Zika virus transmission, urging blood establishments to test Whole Blood and blood components for the virus using pathogen-reduction devices, or cease collection in those regions altogether and acquire these components from uninfected areas. On Friday, August 26, 2016, the FDA amended its blood collection guidance, stating that all blood donation in US states and territories be tested for Zika virus infection, to ensure the safety of the nation’s blood supply.

Earlier this month, reports from Brazil confirmed that two female patients were infected with the Zika virus through blood transfusions. These individuals did not experience any symptoms of the virus, and have not reported any Zika-related complications. Now, the FDA recommends “universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.” According to the new guidance, individual units of blood should be tested using blood screening tests authorized by the FDA under an investigational new drug application, or when it becomes available, a licensed blood screening test. This guidance has already been implemented in infected areas in Florida, as well as in Puerto Rico and other affected territories, and has proven successful in identifying contaminated blood components.

Luciana Borio, MD, the FDA’s acting chief scientist stated in a press release, “As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary… We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

Active transmission in Palm Beach County has not been confirmed; however, door-to-door outreach, targeted testing, and vector control measures are being implemented in Palm Beach, as well as Pinellas and Miami-Dade counties, where active Zika transmission has been confirmed and is on the rise. As a precautionary measure, the Centers for Disease Control and Prevention has added Palm Beach county to its list of areas at risk for active Zika transmission.

The FDA is working diligently to advance methods to control Zika virus transmission. Today, they granted Emergency Authorization for Roche’s LightMix Modular Zika virus assay test. Furthermore, in early August the government agency approved a genetically modified mosquito, OX513A, created by a British company, Oxitec Ltd, to be released in Key Haven, Florida, as a means of Zika vector control.

Zika in Singapore

Unfortunately, Zika has not been confined to the western hemisphere, but has been spreading across the globe, with Singapore recently reporting 41 locally-transmitted cases of Zika infection in residents and construction workers in Aljunied Crescent/Sims Drive. Of the total infected individuals, 34 have fully recovered. The first case was admitted to the Communicable Diseases Center at Tan Tock Seng Hospital on August 26 where testing confirmed Zika infection. Localized transmission is believed to be contained in the Aljunied Crescent/Sims Drive area; however, the Singapore Ministry of Health (MOH) suspects the following areas are likely to experience active Zika transmission in the coming months: Khatib Camp, Sembawang Drive, as well as the hometowns of the infected workers, including Kranji Road, Chiat Place, Senoko South Road, Toh Guan Road East, and Lorong 101 Changi.

The MOH suspects there are more cases of Zika infection than currently reported, since only 20% of infected individuals present with symptoms, and since the vector population is most likely infected. Currently, the National Environmental Agency is undergoing intense vector control operations. The MOH urges individuals living or working in areas designated with active Zika transmission, especially pregnant women, monitor their health, looking for signs and symptoms of Zika infection.