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
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.