In the ongoing fight against Zika, the Biomedical Advanced Research and Development Authority (BARDA) has chosen to support Takeda Pharmaceutical Company’s Zika vaccine development, promising as much as $312 million in potential funding.
According to the press release:
Initial funding from BARDA, which is a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, is for $19.8 million to cover the vaccine development through Phase 1, with potential funding of up to $312 million if ASPR/BARDA exercises all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application (BLA) in the U.S.
Under this arrangement, Takeda said that the cash boost will help the company to develop an “inactivated, adjuvanted, whole Zika virus vaccine.” The vaccine will be manufactured at Takeda’s Hikari, Japan facilities.
The objectives of the first stage of the work, according to the press release, include:
- Developing and producing the investigational vaccine and completing pre-clinical studies
- Submission of an Investigational New Drug Application (IND) to the FDA
- Execution of a Phase 1 clinical trial
Takeda has a pipeline of other vaccines as well, including those for dengue, norovirus, and polio.
“This Zika vaccine program joins our work in dengue, norovirus, our partnership with the Japanese Government on pandemic influenza, and the recently announced partnership with the Bill & Melinda Gates Foundation to help eradicate polio,” said Dr. Rajeev Venkayya, Corporate Officer and President of the Global Vaccine Business Unit at Takeda. “These efforts to develop a vaccine against the Zika virus reinforce Takeda’s commitment to the health of people everywhere, including the most vulnerable populations that are threatened by Zika.”
“In the latest set of figures released by the U.S. government, around 50 cases of locally transmitted Zika infections have been reported in Florida, with most people having no symptoms or mild illness,” said Fierce Biotech in one report.
WHO declared the Zika outbreak to be a Public Health Emergency of International Concern on February 1,2016, and on February 8, 2016 the CDC elevated its “Zika response efforts to its highest response level, Level 1.”
According to the CDC, Zika can be transmitted:
- Through mosquito bites
- From mother to child
- Through sex
- Through blood transfusion
- Through laboratory exposure
There are currently no vaccines for Zika that are commercially available. As a result, the public is currently being encouraged to avoid travel to high-risk areas and to practice safe sex in order to avoid sexual transmission of the disease.
Inovio Pharmaceuticals and the U.S. NIH have already begun human trials for other vaccine candidates, Reuters reports.
Filed Under: Drug Discovery