The US Biomedical Advanced Research and Development Authority (BARDA) has selected Japanese company Takeda Pharmaceutical’s Vaccine Business Unit to develop a vaccine to support the Zika response within the US and other affected regions worldwide.
BARDA is a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services.
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The authority will initially provide $19.8m to cover the vaccine development through Phase I, with potential funding of up to $312m in case ASPR / BARDA exercises all options to take the vaccine through Phase III trials.
The World Health Organisation declared the Zika outbreak to be a Public Health Emergency of International Concern on 1 February this year.
On 8 February, the Centres for Disease Control and Prevention (CDC) elevated its Zika response efforts to Level I.
Takeda Pharmaceutical global vaccine business unit corporate officer and president Dr Rajeev Venkayya said: “Working with BARDA, Takeda is deploying its world-class expertise and capabilities in vaccine development for emerging infectious diseases, and our outstanding team and manufacturing facilities in Hikari, Japan.
“This Zika vaccine programme 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.”
As part of an agreement signed with ASPR / BARDA and the Japanese Government, Takeda will develop an inactivated, adjuvanted, whole Zika virus vaccine.
Under the first stage of the work, the company will develop and produce the investigational vaccine and complete pre-clinical studies.
In addition, an investigational new drug (IND) application will be submitted to the US Food and Drug Administration and a Phase I clinical trial is to be executed.
The vaccine will be manufactured at Takeda’s facilities in Hikari, Japan.
