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The US Food and Drug Administration (FDA) has granted fast track designation to TAK-426, a candidate vaccine for Zika virus.
TAK-426 is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate being developed by Takeda Pharmaceutical Company Limited with the aid of federal funding.
TAK-426 is currently being studied in a phase 1 trial, ZIK-101 (NCT03343626).
This randomized, placebo-controlled, double-blind trial was designed to evaluate the safety and immunogenicity of TAK-426 in 240 male and female subjects between the ages of 18 and 49.
The trial is taking place in the continental US and US territories. It is being conducted under a US Investigational New Drug application.
Takeda says that, if initial data from ZIK-101 are supportive, the company will work to progress into phase 2 development as soon as possible.
Takeda’s Zika program is supported by federal funds from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services (contract No. HHSO100201600015C).
“We recognize the public health threat posed by the Zika virus,” said Laurence De Moerlooze, PhD, lead of the global Zika program at Takeda.
“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.”
About fast track designation
The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines with the potential to treat serious or life-threatening conditions and address unmet medical needs.
The fast track process allows for more frequent interactions with the FDA, rolling reviews of a product application, and eligibility for priority review if relevant criteria are met. The FDA’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months. 
The US Food and Drug Administration (FDA) has granted fast track designation to TAK-426, a candidate vaccine for Zika virus.
TAK-426 is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate being developed by Takeda Pharmaceutical Company Limited with the aid of federal funding.
TAK-426 is currently being studied in a phase 1 trial, ZIK-101 (NCT03343626).
This randomized, placebo-controlled, double-blind trial was designed to evaluate the safety and immunogenicity of TAK-426 in 240 male and female subjects between the ages of 18 and 49.
The trial is taking place in the continental US and US territories. It is being conducted under a US Investigational New Drug application.
Takeda says that, if initial data from ZIK-101 are supportive, the company will work to progress into phase 2 development as soon as possible.
Takeda’s Zika program is supported by federal funds from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services (contract No. HHSO100201600015C).
“We recognize the public health threat posed by the Zika virus,” said Laurence De Moerlooze, PhD, lead of the global Zika program at Takeda.
“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.”
About fast track designation
The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines with the potential to treat serious or life-threatening conditions and address unmet medical needs.
The fast track process allows for more frequent interactions with the FDA, rolling reviews of a product application, and eligibility for priority review if relevant criteria are met. The FDA’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The US Food and Drug Administration (FDA) has granted fast track designation to TAK-426, a candidate vaccine for Zika virus.
TAK-426 is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate being developed by Takeda Pharmaceutical Company Limited with the aid of federal funding.
TAK-426 is currently being studied in a phase 1 trial, ZIK-101 (NCT03343626).
This randomized, placebo-controlled, double-blind trial was designed to evaluate the safety and immunogenicity of TAK-426 in 240 male and female subjects between the ages of 18 and 49.
The trial is taking place in the continental US and US territories. It is being conducted under a US Investigational New Drug application.
Takeda says that, if initial data from ZIK-101 are supportive, the company will work to progress into phase 2 development as soon as possible.
Takeda’s Zika program is supported by federal funds from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services (contract No. HHSO100201600015C).
“We recognize the public health threat posed by the Zika virus,” said Laurence De Moerlooze, PhD, lead of the global Zika program at Takeda.
“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.”
About fast track designation
The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines with the potential to treat serious or life-threatening conditions and address unmet medical needs.
The fast track process allows for more frequent interactions with the FDA, rolling reviews of a product application, and eligibility for priority review if relevant criteria are met. The FDA’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.