– Funds will be used for phase II development and manufacturing –
Paris, France – September 26, 2016 – Sanofi and its vaccines global business unit Sanofi Pasteur announced today that the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services has agreed to a proposal to fund the manufacture of an inactivated Zika vaccine for phase II development. Sanofi Pasteur committed to researching and developing a vaccine to prevent Zika in February, shortly after the World Health Organization declared an emergency.
In July 2016, Sanofi Pasteur announced a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate. The BARDA funding is to take WRAIR’s Zika purified inactivated virus (ZPIV) vaccine into phase II development with manufacturing and characterization of the vaccine product as well as optimization of the upstream process to improve production yields.
Sanofi Pasteur is in the process of creating a clinical development and regulatory strategy while WRAIR and the National Institute of Allergy and Infectious Diseases (NIAID)–part of the U.S. National Institutes of Health (NIH)—are conducting a series of phase I ZPIV trials. Beyond the funding provided by BARDA for the two phase I/II clinical trials, there is an option in the contract that BARDA can exercise for continuing support through Phase III industrial and clinical development.
“Given the devastating effects that this infectious disease can have on babies of infected mothers and the fact that the disease appears to rapidly spread, Sanofi Pasteur decided to get involved early on” said David Loew, Sanofi Executive Vice President and Head of Sanofi Pasteur. “We are very pleased that the U.S. government is committed to working with us to develop a Zika vaccine. Based on this collaboration, we can bring together resources and expertise which are essential in fighting this public-health concern.”
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public-health medical emergencies. The project has been funded with Federal funds from BARDA under Contract HHSO100201-6000039C.
Sanofi Pasteur has developed and provides several vaccines against flaviviruses, such as yellow fever, dengue, and Japanese encephalitis. It developed its first yellow fever vaccine in 1979 and has since sold more than 400 million doses; it is licensed in more than 100 countries around the world. In 2010 Sanofi Pasteur licensed its first vaccine against Japanese encephalitis, which is now licensed in 14 countries with more than 1.5 million doses sold to date. Both yellow fever and Japanese encephalitis vaccines are licensed in endemic countries as well as other countries for travelers. Sanofi Pasteur’s newest flavivirus vaccine is licensed for the prevention of dengue fever in several endemic countries; Dengvaxia® was first licensed in Mexico, the Philippines and Brazil late last year and picked up six more licensures so far this year in El Salvador, Costa Rica, Paraguay, Guatemala, Peru and Indonesia.