The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will provide an initial $19.8 million over the next 18 months to Takeda Vaccines, Inc. of Deerfield, Ill., a subsidiary of the Takeda Group headquartered in Japan, to develop a Zika vaccine for use in the United States.
Under the contract, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide funding to complete studies that should enable the company to file an Investigational New Drug application with the U.S. Food and Drug Administration. If the application is approved, the first clinical (human) trials of the vaccine could begin next year.
The contract 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, ASPR’s BARDA also 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. With this additional work, BARDA would have provided up to a total of $311 million through 2022.
“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,” said Dr. Richard Hatchett, acting director of BARDA. “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 vaccine is made from an inactivated (killed) whole Zika virus formulated with an adjuvant, a substance that enhances the body’s immune response. Using adjuvants in vaccine can reduce the amount of vaccine antigen needed to stimulate an immune response. Antigen is the component of the vaccine that stimulates the person’s immune system to protect against a virus. Needing less antigen in each dose of vaccine means more doses of vaccine could be made available.
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. Inactivated vaccines are more stable than live vaccines and can be given to special populations including people with immunocompromised conditions.
Takeda is the largest pharmaceutical company in Japan and Asia and is one of the top 20 pharmaceutical companies in the world. The company 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. The company also is developing its Zika vaccine for use outside of the United States.
This new vaccine development project is part of ASPR/BARDA’s comprehensive integrated portfolio approach for advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to emerging infectious diseases, these threats include pandemic influenza, chemical, biological, radiological, and nuclear agents, and antimicrobial resistant pathogens.
ASPR’s BARDA partners with other federal agencies, in particular the National Institutes of Health, as well as private industry to develop medical products needed to mitigate the health effects of disasters and other public health emergencies. Potential products may transition from basic research and early clinical trials at NIH to BARDA for support of the advanced development necessary to earn FDA approval or licensure.
In April, BARDA received $85 million in reprogrammed funds. With today’s award, BARDA has obligated more than $76 million of these funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies through private sector partners. In addition, ASPR is providing Zika-positive blood samples to developers to validate the accuracy of new diagnostic tests. As of August, HHS agencies across the department have obligated $288 million of repurposed funds to support Zika response and preparedness activities.