Increasing cases of microcephaly and Guillain-Barre syndrome apparently associated with Zika virus disease have led WHO to declare the current outbreak in Latin America a public health emergency of international concern.
There are no existing medical countermeasures to prevent or treat Zika on the market today, and many diagnostic tests are still in the early stages of development. Of those diagnostic tests commercially available, very few have undergone regulatory premarket assessment. Quality-assured, safe and effective diagnostics are therefore a top priority in our medical response. In addition, these tests will need to be able to identify individuals infected with Zika virus as opposed to other diseases with similar symptoms caused by flaviviruses (dengue and yellow fever, for example).
Leveraging lessons learned from the Ebola epidemic in West Africa, WHO is laying the ground for a medical response to the crisis. The Department of Essential Medicines and Health Products has issued an expression of interest call to manufactures and product development partnerships who have developed in vitro diagnostic tests for Zika. Interested parties can submit their products to the WHO Emergency Assessment and Listing procedure by 31 March 2016. To fast-track the availability of reliable testing tools, WHO and independent experts will review product submissions as soon as possible for acceptable quality, safety and performance levels.
The Emergency Use Assessment and Listing Procedure is designed to evaluate products during public health emergencies of international concern, such as the current Zika epidemic. The procedure was developed during the West Africa Ebola outbreak. Once a product has been listed under the procedure, UN agencies, NGOs and countries can procure the product with confidence.
WHO is working in parallel on establishing regulatory support to accelerate assessment and approval of future clinical trials for potential vaccines and treatments for Zika Virus Disease.