Biomedical Advanced Research and Development Authority (BARDA) has agreed to a proposal by Sanofi Pasteur 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 disclosed its partnership with the Walter Reed Army Institute of Research (WRAIR) for 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 phases 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.
Sanofi Pasteur has developed and provided several vaccines against flaviviruses, such as yellow fever, dengue, and Japanese encephalitis.