When the first confirmed case of Zika transmission was reported in Puerto Rico on December 31, 2015, there were no vaccine candidates for Zika. Today there are at least a dozen approaches in the US alone that are being evaluated to someday be available for general use. Diagnostic assays to help patients make informed decisions about their health are also under development.
How have so many medical countermeasures advanced so quickly to fight a threat that few people were worried about just last year?
The partners in the Public Health Emergency Medical Enterprise (PHEMCE) are an important part of that answer. Working together PHEMCE partners are making smart investments and using a strategic approach to support the development of critical medical countermeasures for use in the fight against Zika.
The PHEMCE originally was created to speed development and licensure of products that address bioterrorism threats and other major public health impacts from chemical, nuclear and radiological events. It has evolved to also help our nation better respond to newly emerging infectious diseases.
Long before travel-associated Zika cases began to trickle into the U.S. states, officials from PHEMCE partner agencies worked together to assess what was known about this obscure and rapidly emerging threat. Recognizing that a range of federal departments and agencies possess knowledge, expertise and have stakes in protecting our national health security, the PHEMCE brings together the Departments of Homeland Security, Health and Human Services, Defense, Veterans Affairs and the U.S. Department of Agriculture. When ASPR was created in 2006, it was charged with leading the PHEMCE.
The PHEMCE partners worked together on a strategic approach. They started to evaluate the status of the development of vaccines, diagnostics and blood screening technologies and efficiently collaborate on ways to respond to the threat of Zika. The PHEMCE agencies could of course each independently respond to the various needs required for the Zika response, but it is the collaboration within this Enterprise that allows for better coordination of resources, funding, and decision making, to avoid duplication and quicken the response time.
The different agencies each also bring unique expertise to the table. For example, the experience of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases and the Walter Reed Army Institute in basic and early clinical research was combined with additional expertise from ASPR’s BARDA for advanced development and industry partnerships to help determine which vaccine approaches to Zika could prove effective and were worth pursuing.
This level of coordination has been key to ensuring that the many vaccine candidates are evaluated against similar sets of criteria and take advantage of common overarching needs, like how and where to perform clinical trials to give us a more seamless transition of Zika medical countermeasures from the research and development stage to maturing into products. Several of these vaccine candidates have advanced into Phase I clinical trials, and the PHEMCE now is looking at setting up clinical trial sites for Phase II studies.
It also helped in the domain of developing commercial diagnostic assays. To date, the coordinated efforts of the PHEMCE partner agencies have resulted in six grants to commercial partners to develop diagnostic assays that can be used under of Emergency Use Authorization for patient identification and for blood screening.
The PHEMCE’s goal is to make sure the right medical products are available for the right patients at the right place and time. As simple as that goal may seem, it requires tremendous coordination among many federal partners.
In the 10 years since it was created, the PHEMCE has produced a greater national response capability, more medical countermeasures available to aid during a disaster, and a public health response structure that will help our nation deliver the materials needed during a public health emergency and boost capacity when new threats arise.
With these mechanisms in place, PHEMCE partners are better positioned to advance medical countermeasures for Zika and prepare for future threats to national health security.
