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FDA grants fast track status to Takeda’s Zika virus vaccine candidate

Takeda Pharmaceutical has secured fast track designation from the US Food and Drug Administration (FDA) for its Zika virus vaccine candidate, TAK-426.

TAK-426 is a purified, inactivated, alum-adjuvanted and whole Zika virus vaccine candidate.

Zika holds capacity to induce congenital Zika syndrome (CZS), including microcephaly and other congenital brain abnormalities, in infants born to mothers infected during pregnancy.

At present, the firm’s Zika vaccine candidate is being assessed in a phase 1 trial (ZIK-101), as part of the US investigational new drug (IND) application.

ZIK-101 is a randomized, placebo-controlled and double-blind trial designed to assess the safety and immunogenicity of the firm’s investigational Zika vaccine candidate in 240 male and female subjects between the ages of 18 and 49.

The study will evaluate various dose levels of the vaccine candidate to support the expansion of Zika vaccine candidate into further studies.

Takeda is carrying out the trial in the continental U.S and the US territories.

Takeda is also working on various vaccine programs to address infectious diseases such as dengue, norovirus and polio.

The firm’s dengue vaccine candidate TAK-003 received fast track designation from the FDA. It is currently being assessed in a pivotal phase 3 efficacy study.

Takeda global zika program lead Laurence De Moerlooze said: “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.”