November 17, 2016  |  FDA Medical Countermeasures Initiative Update

FDA research to help speed development of Zika virus vaccines and therapeutics

Neonatal mouse model provides a new platform for Zika virus research

A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in PLOS Pathogens, is the description of a neonatal mouse model that provides a platform for potentially improving and expediting studies to understand the causes and effects (pathology) of the Zika virus.

"There are many unanswered and essential questions about how the Zika virus works, including the long-term impact," said Daniela Verthelyi, MD, PhD, FDA’s Chief of the Laboratory of Immunology, who led the agency's development of the new animal model. "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." 

Read the full press release 

Related Information

• Zika (PRVABC59) Infection Is Associated with T cell Infiltration and Neurodegeneration in CNS of Immunocompetent Neonatal C57Bl/6 Mice (PLOS Pathogens article) 
• Zika virus response updates from FDA
• Zika virus diagnostic development

Extramural research spotlight:  How to Steward Medical Countermeasures and Public Trust in an Emergency Broadly distributing meaningful and timely risk and benefit information concerning medical countermeasures (MCMs) in an emergency is essential to increasing voluntary and proper use of recommended countermeasures, and ultimately improving public health outcomes—saving lives. An extramural research project conducted by the UPMC Center for Health Security sought to better prepare public health communicators to get MCM risk and benefit information to the public how and when they need it. Project summary, from UPMC Full PDF report (9.8 MB), from UPMC  More about this project, from FDA The views, opinions, and/or findings contained in this report are those of the authors and not necessarily those of the FDA.

EUA Updates On November 15, 2016, in response to CDC's request, FDA concurred(PDF, 155 KB) with the modification to the CDC algorithm for results confirmation of the Zika MAC-ELISA as outlined in the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection(revised). The Instructions for Use and Fact Sheets remain unchanged by this request. Additional technical information - also see from CDC: Updated Laboratory Guidance - Frequently Asked Questions On November 3, 2016, FDA amended and reissued (PDF, 529 KB) the Ebola virus diagnostic EUA initially authorized on February 24, 2015, to transfer ownership of the ReEBOV™ Antigen Rapid Test EUA from Corgenix Inc. to Zalgen Labs, LLC.  Additional technical information On October 31, 2016, in response to altona Diagnostics GmbH's request, FDA concurred (PDF, 129 KB) with the revision to add the MagNA Pure 96 Instrument (Roche) and the NucliSENS® easyMAG® Instrument (bioMérieux) and their respective extraction chemistry/reagents as authorized extraction methods under the EUA of the RealStar® Zika Virus RT-PCR Kit U.S. issued on May 13, 2016. Additional technical information

Guidance and information for industry

• FDA is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. To ensure that the Agency considers your comments in this review, submit comments by January 9, 2017.Also see the Pharmaceutical Users Software Exchange (PhUSE) SDSP template(PDF, 74 KB) (November 8, 2016)

Events

• November 17-18, 2016: FDA will hold a public advisory committee meeting of the Blood Products Advisory Committee in Silver Spring, MD - on November 18, 2016, the Committee will meet in open session to hear an informational session on Zika virus and blood safety in the United States
• New! December 5, 2016: Public workshop - The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance (Rockville, MD and webcast) - register by November 28, 2016
• New! December 7, 2016: Public workshop - The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program (Bethesda, MD and webcast) - register  by November 23, 2016
• New! February 2, 2017: Ninth Annual Sentinel Initiative Public Workshop  (Washington, DC and webcast) - register  before February 2, 2017 (no on-site registration)

In case you missed it

• FDA research - Study of antibody responses to an investigative Ebola vaccine may guide development and evaluation of effective countermeasures - Scientists at FDA have demonstrated novel immune system targets on Ebola virus and identified the major type of vaccine-triggered antibodies that neutralize the virus. The findings also demonstrate that selection of the appropriate assay may be important for evaluating effective vaccines against the Ebola virus. Also see the Nature Medicine article (November 2, 2016)
• From NIH - Testing of investigational inactivated Zika vaccine in humans begins - first of five planned clinical trials to test ZPIV vaccine and Antibody protects against fetal disease in mouse model of Zika infection - NIH-funded research may aid treatment, vaccine development (November 7, 2016)