TheÂ Department of Health and Human Services has awarded a potential $173.6 million contract to Sanofi PasteurÂ forÂ work to develop inactivated vaccine candidate that could help preventÂ Zika virus infection and associated birth defects.
HHS said Monday the contract has aÂ $43.2 million base value that coversÂ 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 containsÂ 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, ” saidÂ Richard Hatchett, acting director of HHS’ Biomedical Advanced Research and Development Authority.
HHS will provide funds and technical assistance to further develop theÂ candidate Zika vaccine.
The inactivated vaccine was initially developed in March through the collaboration ofÂ Walter Reed Army Institute of Research, Â BARDA and the National Institutes of Healthâs National Institute of Allergy and Infectious Diseases.
WRAIR willÂ transfer aspectsÂ ofÂ the early stage process development and manufacturing toÂ Sanofi Pasteur under aÂ Cooperative Research and Development Agreement.
TheÂ vaccine containsÂ an inactivated Zika virus formulated with an adjuvant, a substance that works to enhanceÂ the vaccineâs capacityÂ to triggerÂ an immune response.
HHS saysÂ research has shown that inactivated vaccines areÂ safe and effective when administeredÂ to special populations such as pregnant women and people with weakenedÂ immune systems.
BARDA has obligated $128.1 million out of its $132.4 million in repurposed funds for Zika mitigation efforts thatÂ include the contract with Sanofi Pasteur.