Sanofi Pasteur Gets US Gov’t Funding for Manufacturing Zika VaccineBy
Sanofi and its vaccines global business unit, Sanofi Pasteur, have received a $43.2 million grant from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services 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 2016, shortly after the World Health Organization declared a health emergency.
In July 2016, Sanofi Pasteur formed a research 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 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, part of the US National Institutes of Health (NIH), are conducting a series of Phase I trials. Beyond the funding provided by BARDA for the two Phase I/II clinical trials, there is an option in the contract that can exercise for continuing support through Phase III industrial and clinical development.
Sanofi Pasteur has developed and provides several vaccines against flaviviruses, such as yellow fever, dengue, and Japanese encephalitis. Sanofi Pasteur’s newest flavivirus vaccine, Dengvaxia, 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.