New Model Developed by Food and Drug Administration May Help Develop Zika Vaccines, Therapy
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New Model Developed by Food and Drug Administration May Help Develop Zika Vaccines, Therapy

The spread of the virus and its association with neurological disorders created need for animal models

November 18, 2016

Scientists at the Food and Drug Administration (FDA) have developed a new mouse model that may assist in the development of vaccines and therapeutics for the Zika virus.

The new study describes a neonatal mouse model providing a platform that could improve and expedite future studies attempting to understand Zika's pathology, or its causes and effects.

The spread of the virus, as well as its link with more cases of neurological disorders and complicated congenital syndromes like microcephaly in infants and Guillain-Barré Syndrome in adults, has generated an urgent need for animal models in order to study Zika's pathology. An improved understanding of the impact and long-term consequences of the infection in mice may assist scientists' attempts to figure out how to fight the virus in humans. Although past research showed that only those mice whose immune systems are compromised are susceptible to Zika infection, this study indicates that neonatal mice whose immune systems are otherwise healthy can also be infected.

Daniela Verthelyi, Chief of the Laboratory of Immunology at the FDA, led its development of the new model. "There are many unanswered and essential questions about how the Zika virus works, including the long-term impact," she said. "This mouse model gives researchers a new tool to study and understand how the Zika virus replicates and spreads in the body, which we hope will provide these critical answers."

The new model uses a mouse strain known as C57BL/6. The researchers discovered that neonatal mice in this strain can be infected with Zika and develop neurological symptoms 12 days after being infected. These mice recover eventually, so the model gives scientists the opportunity to study the long-term effects of Zika as well as another method to carry out early exploration of experimental vaccines and therapeutics for the virus.

This mouse model is only one of several research projects that the FDA is conducting in its comprehensive effort to combat Zika. Other examples include initiatives for understanding how effective technologies are that reduce pathogens (e.g. viruses) in blood, evaluating the efficacy of storing red blood cells on virus infection, adding to the FDA's database of samples infected with the virus that are necessary for developing diagnostic devices, and exploring how long Zika persists in body tissues.

"The FDA considers the public health response to the Zika virus epidemic to be a top priority. We stand ready to use our expertise and authorities to the fullest extent to help facilitate the development and availability of products that may help mitigate emerging infectious disease threats, such as the Zika virus. The FDA's regulatory science research program is an essential component of the national response to emerging infectious diseases," said Luciana Borio, M.D., Acting Chief Scientist at the FDA. "Helping to advance the approaches scientists can use to understand the Zika virus will ultimately assist in speeding the development and availability of the tools needed to combat it."

The agency is also working in other areas besides research initiatives in response to the emerging Zika outbreak. It is focusing on protecting the U.S. 's supply of blood and human cells, tissues and cellular and tissue-based products, encouraging the development of diagnostic tests to assist healthcare professionals detect and diagnose Zika infection, and evaluating the safety and effectiveness of any investigational vaccines and therapeutics currently in the stages of early development.