Sanofi Pasteur, Fiocruz, and WRAIR to collaborate on Zika vaccine research

The three research organizations have a history of flavivirus vaccine collaboration.

Under the Principles of Collaboration, Fiocruz, WRAIR and Sanofi Pasteur intend to combine their expertise in the fight against Zika. Fiocruz's activities will complement WRAIR and Sanofi Pasteur's activities, provide additional expertise, and increase the likelihood of successfully developing and licensing a safe and effective Zika vaccine as quickly as possible.

According to the CRADA signed by WRAIR and Sanofi Pasteur, WRAIR is providing its Zika purified, inactivated-virus vaccine (ZPIV) candidate to Sanofi Pasteur to produce clinical material in compliance with current GMP (Good Manufacturing Practices) to support phase II testing, optimize the upstream process to improve production yields, and characterize the vaccine product. WRAIR-along with the U.S. National Institute for Allergy and Infectious Diseases (NIAID)--will sponsor and support a series of Phase I trials.

Last month 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 agreed to a proposal to fund Sanofi's manufacture of the inactivated Zika vaccine for Phase II development. Sanofi Pasteur is in the process of creating a clinical development and regulatory strategy while WRAIR and NIAID are conducting the 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.

Building on the WRAIR partnership, areas of collaboration with Fiocruz could include process development, vaccine characterization, epidemiological studies, pre-clinical and clinical evaluation of a vaccine, as well as clinical assay optimization.

"Fiocruz, WRAIR, and Sanofi Pasteur have a history of collaborating," explained John Shiver, Sr. VP for R&D at Sanofi Pasteur. "It only makes sense for the pursuit of public health that we combine our expertise and resources on Zika with Fiocruz, which is ideally based in Brazil where the heart of the current Zika experience lies. We have a common goal of developing a vaccine to prevent this emerging disease threat imposed by the Zika virus."