HHS awards $19.8 million for development of Zika virus vaccine

The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) recently provided Takeda Vaccines, Inc., with a grant to develop a Zika virus vaccine.

The grant, worth $19.8 million, will be spaced out over the course of the next 18 months. ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide the funding to complete studies that should allow Takeda to file an investigational new drug application with the U.S. Food and Drug Administration (FDA). If approved, the first clinical trials could begin in 2017.

“To help protect people from Zika in the U.S. and abroad, we are aggressively pursuing the development of promising vaccine candidates around the world,” Dr. Richard Hatchett, acting director of BARDA, said. “Successfully combating this virus will take a global collaborative effort to protect people from the threat Zika poses to public health. This partnership with Takeda is an example of our efforts to engage the private sector, including large pharmaceutical companies, to develop Zika vaccines and innovative diagnostic tests.”

The contract will provide funding and technical assistance for process development, preclinical studies, toxicology and testing, and a Phase 1 clinical trial to demonstrate safety and whether the vaccine stimulates an immune response in humans.

If the Phase 1 trial is successful, BARDA could sponsor Phase 2 and Phase 3 work, as well as large-scale manufacturing work needed for the company to apply to the FDA to license the vaccine. If the additional work is needed, BARDA would provide up to a total of $311 million through 2022.