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HHS entered into a $43.18 million contract with Sanofi Pasteur for the development of a Zika vaccine candidate.
The United States Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) announced on Sept. 26, 2016 a contract with Sanofi Pasteur of Swiftwater, Pennsylvania to develop an inactivated vaccine candidate to prevent the Zika virus infection. Under a $43.18 million contract through June 2022 with Pasteur, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) is providing funding and technical assistance to support the advanced development of a candidate Zika vaccine whose development was initiated at the Walter Reed Army Institute of Research (WRAIR).
The advanced development for the vaccine will be conducted by Sanofi Pasteur and will include further process development, scale-up, production of clinical trial material, and two Phase I/II clinical trials that are targeted to begin in the first half of 2018. Work on the vaccine candidate began this past March as a collaborative effort between WRAIR, BARDA, and the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases. WRAIR has signed a cooperative research and development agreement with Sanofi Pasteur to transfer aspects of the early stage process development and manufacturing to accelerate the development of this vaccine.
If Sanofi Pasteur’s work is successful at meeting data-driven milestones and additional funds are made available, the contract includes an option for up to an additional $130.45 million to fund Phase III clinical trials needed for the company to submit a license application to FDA.
The vaccine is made from an inactivated whole Zika virus formulated with an adjuvant. The selection of an inactivated vaccine is based on years of research that have led to several effective inactivated vaccines for related flaviviruses, including Japanese encephalitis and tick-borne encephalitis, HHS said in a press announcement. Inactivated vaccines for various viral pathogens are often more stable than live, attenuated vaccines.