The Department of Health and Human Services has awarded a potential $173.6 million contract to Sanofi Pasteur for work to develop inactivated vaccine candidate that could help prevent Zika virus infection and associated birth defects.
HHS said Monday the contract has a $43.2 million base value that covers process development, scale up, clinical trial material production as well as phase one and phase two clinical trials that are scheduled to begin in 2018.
The contract contains a $130.5 million option for phase 3 clinical trials that are required to submit a license application to the Food and Drug Administration.
“This investment supports clinical trials and manufacturing of an additional Zika vaccine candidate that could help prevent Zika virus infection and the devastating birth defects that Zika virus can cause, ” said Richard Hatchett, acting director of HHS’ Biomedical Advanced Research and Development Authority.
HHS will provide funds and technical assistance to further develop the candidate Zika vaccine.
The inactivated vaccine was initially developed in March through the collaboration of Walter Reed Army Institute of Research, BARDA and the National Institutes of Health™s National Institute of Allergy and Infectious Diseases.
WRAIR will transfer aspects of the early stage process development and manufacturing to Sanofi Pasteur under a Cooperative Research and Development Agreement.
The vaccine contains an inactivated Zika virus formulated with an adjuvant, a substance that works to enhance the vaccine™s capacity to trigger an immune response.
HHS says research has shown that inactivated vaccines are safe and effective when administered to special populations such as pregnant women and people with weakened immune systems.
BARDA has obligated $128.1 million out of its $132.4 million in repurposed funds for Zika mitigation efforts that include the contract with Sanofi Pasteur.
