DTRA's commitment will enable critical nonclinical development on the vaccine candidate that IAVI is developing in partnership with Merck (known as MSD outside the United States and Canada).
DTRA's award will facilitate the vaccine candidate's clinical development path to licensure by supporting work at IAVI's Vaccine Design and Development Laboratory in Brooklyn, New York, to characterise immune responses in animals and demonstrate the safety and efficacy profile of rVSVΔG-SARS-CoV-2 vaccination in animals.
These nonclinical data will be essential to supplement the clinical data package and to inform the most effective use of the vaccine in an ongoing pandemic.
The award from DTRA comes from its Science and Technology New Initiatives, under the topic area Chemical/Biological.
In May 2020 US-based pharmaceutical company Merck (NYSE: MRK) and IAVI announced their collaboration to develop an investigational vaccine against SARS-CoV-2.
This collaboration combines the vaccine research and development capabilities of Merck and IAVI and uses the same rVSV platform that underlies Merck's Ebola Zaire virus vaccine, the first rVSV-based vaccine approved for use in humans.
The COVID-19 vaccine candidate, V590, is currently in preclinical development, and clinical studies are planned to start this year. Merck will lead regulatory filings globally. Both organizations will work together to develop the vaccine as rapidly as possible, and make it accessible globally, if approved.
Merck signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services, that provides funding support for the program.
The government of Japan announced to the World Bank/International Monetary Fund Development Committee in April 2020, in partnership with the World Bank, its commitment to contribute USD 10m to IAVI's COVID-19 vaccine development program.
Since its founding in 2008, the IAVI DDL has become one of the world's leading viral vector vaccine research and development labs, known for innovation and generation of novel vaccine design concepts.
IAVI's rVSV program at the DDL includes vaccine candidates for HIV and several emerging infectious diseases, including COVID-19.
In November 2019 DTRA awarded IAVI USD 35.7m to advance research on an rVSV vectored Marburg virus vaccine candidate.
That vaccine candidate is in preclinical development.
Another IAVI rVSV vaccine candidate for prevention of Lassa fever is in preclinical development with support from the Coalition for Epidemic Preparedness and Innovation; this candidate was recently found to have strong preclinical efficacy in animal studies, and clinical trials will begin in 2021.
IAVI's rVSV HIV vaccine candidate has been made possible by many supporters, including the Bill and Melinda Gates Foundation; the Danish Ministry of Foreign Affairs; the government of Canada; the government of Japan, in partnership with the World Bank; the Irish Department of Foreign Affairs and Trade; the Louis and Rachel Rudin Foundation; the Netherlands Ministry of Foreign Affairs; the Norwegian Agency for Development Cooperation; the Starr Foundation; the U.K Department for International Development; the US National Institutes of Health ; and through the generous support of the American people from the United States Agency for International Development (USAID).
IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions.
The Defense Threat Reduction Agency enables the Department of Defense, the United States government, and international partners to counter and deter weapons of mass destruction and improvised threat networks.
DTRA has over 2,000 uniformed military personnel and DoD civilians working on every continent except Antarctica.
The agency has thousands of global engagements in more than 100 countries and in addition to multiple locations stateside and overseas, the agency has liaisons in many embassies.
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