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FORT BELVOIR, Va. - The team of researchers and program managers at the Defense Threat Reduction Agency (DTRA) that has worked to counter the threat of the Ebola Virus Disease (EVD) welcomed the announcement of the U.S. Food and Drug Administration’s (FDA) approval of the vaccine, Ervebo ®, to the pharmaceutical company Merck & Co., Inc. Dec,19 2019.
The approval of the vaccine represents the culmination of nearly two decades of efforts by a host of teams from across the public and private sectors such as DTRA and Merck, international partners in North America, Europe and Africa, and non-governmental and international organizations. The World Health Organization (WHO) describes EVD as a rare but severe hemorrhagic fever. EVD has killed thousands over the course of outbreaks, primarily in sub-Saharan Africa, since it first appeared in the 1970s.
DTRA, a Department of Defense (DoD) combat support agency that identifies and combats biological threats as part of its mission to counter weapons of mass destruction (WMD), began its work on the vaccine in 2014 during an especially deadly outbreak in West Africa. The outbreak made clear the danger EVD posed to U.S. national security interests abroad, as well as to the U.S. domestic population in the event of a pandemic. To counter the threat, DTRA quickly initiated a strategy to get a vaccine approved. The combat support agency coordinated a series of investment efforts and partnerships to deliver a baseline platform for a viable vaccine candidate to mitigate the spread of the deadly disease.
“DTRA’s agile contracting, and well-placed contacts throughout government, academia, and industry allowed DTRA to form partnerships and guide development of this vaccine from the early stages of development, through crucial preclinical, and critical phase 1 clinical safety trials to the actual phase 2 clinical efficacy trial that demonstrated effectiveness of this vaccine during the outbreak,” said L. Revell Phillips Ph.D., a member of DTRA’s research and development team.
DTRA’s pioneering approach started with a contract to BioProtection Systems, a small biotech company. DTRA and BioProtection Systems partnered with Public Health Agency Canada, who began developing the vaccine in 2001, to accelerate its development. With these three teams working together, the vaccine progressed to a series of nonclinical and clinical studies conducted at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) and Walter Reed Army Institute of Research (WRAIR) defense laboratories.
As the effort evolved, DTRA leveraged its USAMRIID partner’s research capacity, resulting in international partnering agreements with the WHO. DTRA also coordinated with teams across the U.S. government as development of the vaccine progressed. The efforts of this research and development consortium produced viable data that would be transitioned to next-level partners.
“We exercised our ability to develop partnerships for a relevant need, which was critical in transitioning medical countermeasures to our advanced developers at the speed of relevancy,” said U.S. Army Maj. Jeffrey Froude, DTRA’s program manager for the EVD Vaccine.
Froude explained that DTRA bolstered its research and development investments through two key U.S. governmental partners. First, DTRA worked closely with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), for advanced trials and manufacturing activities. Second, DTRA teamed with the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) for the task of immunoassay development. For that development effort, JPEO-CBRND’s, office of the Joint Program Manager for CBRN Medical took the lead.
Following several years of coordinated research and development efforts by the coalition of partners, the promising vaccine candidate transitioned to next-level partners BARDA and Merck for more advanced human clinical trials and product manufacturing of the EVD vaccine.
“This vaccine’s rapid progress is a testament to the power of partnerships among government agencies and with the private sector,” said BARDA director Rick Bright, Ph.D.
Next-level partner BARDA and Merck, served as the transition point to conduct more advanced human clinical trials and product manufacturing on the Ebola vaccine with the Joint Program Executive office (JPEO) providing a testing capability that allowed Merck to test human and non-human primate samples. The Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical (JPM-CBRN), U.S. Army Col. Ryan Eckmeier, stated that this “interagency partnership from the beginning was critical to advancing this vaccine product.”
Merck’s expertise with licensing and manufacturing was instrumental in advancing the vaccine. The pharmaceutical giant partnered with the WHO, United Nations International Children's Emergency Fund, and Gavi Vaccine Alliance, among others, to strategize on how to best implement future public health preparedness and response efforts against EVD.
“We share in this achievement, and thank you all personally for your amazing support over the last five years,” said Beth-Ann G. Coller, PhD, executive director of Merck’s vaccine team in a note to the DTRA team. “This has truly been a journey and one that we are proud to have shared with our colleagues in DoD. Without the early and continued support of DTRA we would not be here today.”
DTRA continues to leverage its successful partnerships as the agency works to develop future countermeasures. DTRA and BARDA have active partnering agreements to develop vaccine and therapeutic medical countermeasures to address a diverse range of viral and bacterial infectious disease threats. Efforts will use a similar model to the one that supported development and approval of the EVD vaccine.
“As DTRA moves forward to new challenges, we will leverage continued utilization of the Ebola vaccine model, using a diverse range of ways that we can work with our academic, international, interagency and industrial partners through grants, contracts and other transaction authorities,” said Froude. “We have a proven paradigm on how to efficiently advance medical countermeasures working with our U.S. government partners in these endeavors.”
| Date Taken: | 01.13.2020 |
| Date Posted: | 01.13.2020 10:41 |
| Story ID: | 358923 |
| Location: | FORT BELVOIR, VIRGINIA, US |
| Web Views: | 446 |
| Downloads: | 1 |
This work, DTRA contributes to historic Ebola vaccine effort, by Darnell Gardner, identified by DVIDS, must comply with the restrictions shown on https://www.dvidshub.net/about/copyright.
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