HHS to pay Japanese company $20 million to speed Zika vaccine
The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response announced September 1 it would disburse an initial $19.8 million over the next 18 months to Deerfield, Ill.-based Takeda Vaccines to accelerate the development of a Zika vaccine for the United States.
Takeda Vaccines is a subsidiary of the Takeda Group headquartered in Japan and one the largest pharmaceutical companies in Japan and Asia. Takeda has vaccine programs for dengue, Chikungunya, norovirus, polio and pandemic influenza. Manufacturing of the Zika vaccine will occur at Takeda’s facilities in Hikari, Japan.
Under the contract with Takeda, ASPR’s Biomedical Advanced Research and Development Authority will provide funding to complete studies expected to enable Takeda to file an Investigational New Drug application with the U.S. Food and Drug Administration.
If the application is approved, the first clinical trials of the vaccine on humans could begin next year.
“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,” Richard Hatchett, MD, acting director of BARDA, said in a statement. “Successfully combating this virus will take a global collaborative effort to protect people from the threat Zika poses to public health.”
The HHS contract with Takeda initially provides funding and technical assistance for process development, preclinical studies, toxicology testing, and a Phase 1 clinical trial to demonstrate safety and determine whether the experimental vaccine stimulates an immune response in people.
If this work is successful and additional funds are made available, HHS could sponsor Phase 2 and 3 clinical trials as well as large-scale manufacturing work needed for the company to apply to the FDA to license the vaccine.
The additional work would take the total cost to $311million through 2022.