The FDA is expanding its Zika guidelines, now recommending that risk reduction measures be implemented outside areas of active local transmission.
The initial guidance, issued in February, called for areas with active Zika virus transmission to test all whole blood and blood component donations for Zika virus or to use pathogen-reduction devices. If this isn’t possible, the agency recommended blood centers in those areas to stop blood collection and instead obtain blood from areas free of active virus transmission.
The revised guidance recommends all U.S. states and territories screen blood and blood components using a test authorized for use under the FDA’s investigational new drug application, or a licensed test, when that becomes available. Pathogen-reduction devices may also be used for plasma and some platelet products, the agency said.
The 11 states considered close to areas of local transmission, or at higher risk for mosquito-borne cases, are expected to comply with the new guidelines within four weeks. All other states have 12 weeks to do so.
The first local transmission of Zika in the U.S. was reported last December in Puerto Rico. Further cases of local transmission were reported in American Samoa and the U.S. Virgin Islands, followed by cases reported in Florida in July this year.
“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in an FDA statement. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”
A number of players are working on Zika diagnostic tests, including Siemens, LabCorp and Harvard University’s Wyss Institute. Meanwhile, on the vaccine side, there has been a veritable rush of interest, with Pennsylvania-based Inovio Pharma taking its candidate into a second trial and big pharmas Sanofi and GlaxoSmithKline looking into different approaches.
- here's the FDA statement