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The collaboration follows the signing of a cooperative research agreement between Sanofi Pasteur, Fiocruz, and WRAIR.
On Oct. 27, 2016, Sanofi Pasteur announced that it has agreed to collaborate with the Oswaldo Cruz Foundation through its immuno-biological technology institute known as Bio-Manguinhos/Fiocruz, and the Walter Reed Army Institute of Research (WRAIR) on Zika vaccine development. This collaboration follows the signing of a cooperative research and development agreement (CRADA) between WRAIR and Sanofi Pasteur to conduct research and development of a Zika vaccine using WRAIR’s inactivated-virus vaccine (ZPIV) technology.
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 to support Phase II testing, optimize the upstream process to improve production yields, and characterize the vaccine product. WRAIR-along with the United States National Institute for Allergy and Infectious Diseases (NIAID)-will sponsor and support a series of Phase I trials. Building on the WRAIR partnership, areas of collaboration with Fiocruz potentially include process development, vaccine characterization, epidemiological studies, pre-clinical and clinical evaluation of a vaccine, as well as clinical assay optimization.
In September 2016, the Biomedical Advanced Research and Development Authority (BARDA) agreed to a proposal to fund Sanofi’s manufacture of the inactivated Zika vaccine for Phase II development. Sanofi 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.
Source: Sanofi Pasteur