The U.S. Food and Drug Administration (FDA) began a series of actions this week designed to combat the emerging threat of Zika virus and to mitigate its spread throughout the U.S. and the world.
The FDA began with important steps to help protect the safety of the blood supply. One of the first steps the agency took was ensuring that individuals who had traveled to areas of concern were deferred from donating blood. This step also included requiring areas of concern, like Puerto Rico, to obtain whole blood and blood components from areas of the U.S. without active virus transmission unless a blood donor screening test for Zika virus was used. Due to a shortage of available tests, the FDA worked closely with developers in a highly-accelerated time frame to make an investigational test for blood screening.
The virus also has a high risk of spreading from human cells, tissues, and cellular and tissue-based products. Due to this risk, the FDA issued guidance recommending that donors of these biological products be considered ineligible if they were diagnosed with the Zika virus, 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.
There are currently no vaccines available for Zika virus, however, the FDA is currently making the development and availability of vaccines one if its highest priorities to mitigate any potential long-term outbreaks. Inovio Pharmaceuticals announced that it will begin evaluating the first investigational Zika virus vaccine in a Phase I clinical study.