Sanofi and its vaccines global business unit Sanofi Pasteur, announced today that it has agreed to Principles of Collaboration with the Oswaldo Cruz Foundation– by means of its Immuno-biological Technology Institute known as Bio-Manguinhos/Fiocruz-and the Walter Reed Army Institute of Research (WRAIR)–a United States Department of Defense Laboratory-regarding Zika vaccine development. This collaboration follows the signing this past summer of a Cooperative Research and Development Agreement (CRADA) between WRAIR and Sanofi Pasteur to conduct research and development of a Zika vaccine using WRAIR’sinactivated-virus vaccine (ZPIV) technology.
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 1 trials.
Last month 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 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, PhD, 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.”
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, Dengvaxia®, is licensed for the prevention of dengue fever in 12 endemic countries to date, including Brazil.