Sanofi Forms Zika Vaccine Research PactBy
Sanofi and its vaccines global business unit, Sanofi Pasteur, have formed a collaboration with the Oswaldo Cruz Foundation, via Bio-Manguinhos/Fiocruz, the foundation’s immuno-biological technology institute, and the Walter Reed Army Institute of Research (WRAIR), a US Department of Defense Laboratory headquartered in Silver Springs, Maryland, for Zika vaccine development. The Oswaldo Cruz Foundation is a Rio De Janeiro, Brazil-based science and technology health institution and is a part of the Brazilian Ministry of Health.
This collaboration follows the earlier signing in July 2016 of an agreement between WRAIR and Sanofi Pasteur to conduct research and development of a Zika vaccine using WRAIR’s inactivated-virus vaccine technology (ZPIV). Under that earlier agreement, Sanofi Pasteur will create a clinical development and regulatory strategy while WRAIR will share data related to the development of immunologic assays designed to measure neutralizing antibody responses following natural infection and vaccination with ZPIV. WRAIR will also share biologic samples generated during non-human primate studies and biologic samples generated from human safety and immunogenicity studies using ZPIV.
WRAIR is providing its ZPIV candidate to Sanofi Pasteur to produce cGMP-compliant clinical material to support Phase II testing, optimize the upstream process to improve production yields, and characterize the vaccine product. WRAIR, along with the US National Institute for Allergy and Infectious Diseases, will sponsor and support a series of Phase I trials.
Under the current agreement, Fiocruz, WRAIR and Sanofi Pasteur intend to combine their expertise in the development of the Zika vaccine. Fiocruz’s activities will complement WRAIR and Sanofi Pasteur’s activities.
In September 2016, 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 fund Sanofi’s manufacture of the inactivated Zika vaccine for Phase II development. BARDA awarded Sanofi a $43.2 million grant.
Building on the WRAIR partnership, areas of collaboration with Fiocruz could include process development, vaccine characterization, epidemiological studies, and preclinical and clinical evaluation of a vaccine as well as clinical assay optimization.