TAK-426 is currently being tested on 240 individuals.

 The FDA has given Fast Track Status to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted vaccine with whole Zika virus. The vaccine is in Phase I of clinical trials, and is currently being tested on 240 subjects in the US and Puerto Rico; the company hopes to reach Phase II as soon as possible. The program has received federal funding from BARDA.

There are currently no drugs or vaccines on the market, which have been approved to fight the mosquito-borne virus. With TAK-426 being granted Fast Track designation, the company is hoping for accelerated approval and ultimately priority review, in efforts to get the vaccine market.

“We recognize the public health threat posed by the Zika virus,” noted Laurence De Moerlooze, Ph.D., Takeda’s Global Zika Program Lead. “As soon as Takeda received funding from BARDA, we mobilized a team and prioritized development of this vaccine candidate, initiating a Phase 1 trial within 15 months of contract signature. With Fast Track designation, the ongoing support of BARDA, and the abilities of our organization, we are confident that we will continue to make expedient progress. We look forward to continuing to work closely with the FDA and BARDA, as well as other health authorities across the world, on the development of this important vaccine candidate,” he added.

Takeda is simultaneously working on a vaccine pipeline to address dengue, norovirus and polio. Zika is caused by a virus transmitted primarily by Aedes aegypti mosquitoes.