FDA Grants Fast Track Designation to Takeda's Zika Vaccine Candidate


The FDA grants Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted whole Zika virus vaccine candidate.

The US Food and Drug Administration (FDA) has granted Fast Track designation to Takeda’s Zika virus vaccine candidate, TAK-426.

This announcement comes on the heels of the Centers for Disease Control and Prevention (CDC) reporting an increase in birth defects linked with Zika virus infection in the United States. Once considered a mild infection when first discovered in 1947, the virus has been linked with devastating microcephaly in newborns as well as Guillain-Barré Syndrome in adults. In the report, investigators determined that in 2016, 3 out of every 1000 live births in 15 US states and territories had a birth defect that could be associated with a Zika virus infection in the mother.

“Microcephaly appears to be the tip of the iceberg; there’s so much more” when it comes to Zika-related complications, keynote speaker Annelies Wilder-Smith, MD, PhD, DTM&H, MIH, FAMS, FACTM, professor of infectious diseases, Vaccine Preventable & Emerging Infectious Diseases Laboratory, Lee Kong Chian School of Medicine, Nanyang Technological University, in Singapore, said during her presentation at the First International Zika conference. There are also “spontaneous abortion, stillbirths, epilepsy, visual problems, hearing loss,” and even severe dysphasia. In addition, Dr. Wilder-Smith listed problems that may not be witnessed until later on, such as: "mental retardation, psychotic disorders, [and] learning difficulties,” among others.

The CDC and the World Health Organization have provided recommendations for protecting oneself against the virus, as well as those for pregnant women, such as avoiding travel to areas of the world where Zika is endemic and using daytime protection against mosquitoes.

“Of course, you can reduce landing and biting rates with personal protection, like spraying mosquito repellant and wearing long-sleeves, etc.,” Dr. Wilder-Smith told Contagion ® in an interview. “But we have not seen any data that good personal protection, indeed, also translates to less disease.”

There is currently no vaccine against the Zika virus. Medications such as acetaminophen can be provided to treat fever and pain symptoms

“We recognize the public health threat posed by the Zika virus,” Laurence De Moerlooze, PhD, Global Zika Program lead, said in Takeda’s press release. “As soon as Takeda received funding from Biomedical Advanced Research and Development Authority (BARDA), we mobilized a team and prioritized development of this vaccine candidate, initiating a phase 1 trial within 15 months of contract signature… 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.”

Currently, Takeda’s vaccine candidate is being assessed in a phase 1 trial dubbed ZIK-101 under a US Investigational New Drug application. The candidate will proceed to phase 2 development if initial data yielded by the phase 1 study proves favorable.

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