Zika Vaccine Candidate TAK-426 Receives FDA Fast Track Designation
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Zika vaccine candidate TAK-426, which is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.
There is currently no approved vaccine or medicine for treating the Zika virus.
Recently, the Centers for Disease Control and Prevention (CDC) reported the risk for birth defects related to the Zika virus infection in pregnant women was approximately 20% higher during 2016 than baseline data.
These CDC researchers found that babies born in 15 states and US territories reported a birth defect possibly associated with Zika virus infection in the mother.
Takeda’s Zika vaccine candidate is currently being studied in a Phase 1 trial (ZIK-101) under a U.S. Investigational New Drug (IND) application.
If initial data from ZIK-101 are supportive, Takeda will work to progress into Phase 2 development as soon as possible.
This randomized, placebo-controlled, double-blind trial is designed to evaluate the safety and immunogenicity of the vaccine candidate and will assess several dose levels to support the progression of TAK-426 into future studies.
The trial will take place approximately 15 months after Takeda Pharmaceutical received a contract and funding to develop a Zika vaccine from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).
The Zika virus can cause congenital Zika syndrome, including microcephaly and other congenital brain abnormalities, in infants born to mothers infected during pregnancy.
The Zika virus is a member of the Flaviviridae family and the genus Flavivirus. The presumptive primary vector of the virus is Aedes aegypti.
But, research has identified additional mosquitoes that spread the Zika virus. These researchers believe the Zika virus was found in wild-caught female mosquitoes Cx. coronator, Cx. tarsalis, and Ae. vexans.
"The significant increase in birth defects strongly linked to Zika virus infection is concerning, but it might represent just a portion of the full effect of congenital Zika virus infection," said CDC Director Barbara Fitzgerald, MD, in a related commentary.
According to the CDC, the Zika virus has spread in recent years to more than 84 countries, territories or subnational areas, including the U.S.
Laurence De Moerlooze, Ph.D., Global Zika Program Lead said, “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.”
The FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines for serious conditions and that fill an unmet medical need.
The Fast Track process allows more frequent interactions with the FDA, rolling reviews of the Biologic License Application (BLA), and eligibility for a priority review if relevant criteria are met.
Beyond Zika, Takeda’s dengue vaccine candidate, TAK-003, was also granted Fast Track designation and is currently being evaluated in a pivotal Phase 3 efficacy study, with initial data expected this year.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600015C.
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines.
For more information, visit Takeda.