The U.S. Biomedical Advanced Research and Development Authority (BARDA) agreed to fund the manufacture by Sanofi Pasteur of an inactivated Zika vaccine for Phase II development.
The company in July entered into 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) 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 evp 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 that are essential in fighting this public health concern.”