Innovation New Jersey
  • Home
  • Our Coalition
    • Contact Us
  • News
  • Resources
    • State Supports
    • Federal Supports
    • Higher Ed Supports
  • Join Us

Innovation News

Everything Innovation. Everything New Jersey.
Follow us and stay connected.

HHS Awards $ 19.8 Million to Takeda to Accelerate Development of a Zika Vaccine

9/9/2016

0 Comments

 
Washington, DC — The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) on September 1 announced it will provide an initial $19.8 million over the next 18 months to Takeda Vaccines, Inc. of Deerfield, Illinois, a subsidiary of the Takeda Group headquartered in Japan, to develop a Zika vaccine for use in the United States.
 
Under the contract, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide funding to complete studies that should enable the company to file an Investigational New Drug application with the U.S. Food and Drug Administration.
 
If the application is approved, the first clinical (human) trials of the vaccine could begin next year.
 
The contract initially provides funding and technical assistance for process development, preclinical studies, toxicology testing, and a Phase 1 clinical trial to demonstrate safety and determine whether the experimental vaccine stimulates an immune response in people.
 
If this work is successful and additional funds are made available, ASPR’s BARDA also could sponsor Phase 2 and 3 clinical trials as well as large-scale manufacturing work needed for the company to apply to the FDA to license the vaccine.  With this additional work, BARDA would have provided up to a total of $311 million through 2022.
​“To help protect people from Zika in the U.S. and abroad, we are aggressively pursuing the development of promising vaccine candidates around the world,” said Dr. Richard Hatchett, acting director of BARDA.
 
“Successfully combating this virus,” Dr. Hatchett continued, “will take a global collaborative effort to protect people from the threat Zika poses to public health.  This partnership with Takeda is an example of our efforts to engage the private sector, including large pharmaceutical companies, to develop Zika vaccines and innovative diagnostic tests.”
 
The vaccine is made from an inactivated (killed) whole Zika virus formulated with an adjuvant, a substance that enhances the body’s immune response.
 
Using adjuvants in vaccine can reduce the amount of vaccine antigen needed to stimulate an immune response. Antigen is the component of the vaccine that stimulates the person’s immune system to protect against a virus.
 
Needing less antigen in each dose of vaccine means more doses of vaccine could be made available.
 
The selection of an inactivated vaccine is based on years of research that have led to several effective inactivated vaccines for related flaviviruses, including Japanese encephalitis and tick-borne encephalitis. Inactivated vaccines are more stable than live vaccines and can be given to special populations including people with immunocompromised conditions.
 
Takeda is the largest pharmaceutical company in Japan and Asia and is one of the top 20 pharmaceutical companies in the world. The company has vaccine programs for dengue, Chikungunya, norovirus, polio and pandemic influenza. Manufacturing of the Zika vaccine will occur at Takeda’s facilities in Hikari, Japan. The company also is developing its Zika vaccine for use outside of the United States.
 
This new vaccine development project is part of ASPR/BARDA’s comprehensive integrated portfolio approach for advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats.
 
In addition to emerging infectious diseases, these threats include pandemic influenza, chemical, biological, radiological, and nuclear agents, and antimicrobial resistant pathogens.
 
0 Comments



Leave a Reply.

    Do not miss a single innovative moment and sign up for our newsletter!
    Weekly updates


    Categories

    All
    3D Printing
    Academia
    Acquisitions
    Aerospace
    Agriculture
    AIDS
    Algae
    Alumni
    Animals
    Architecture
    Astrophysics
    Autism
    Awards
    Big Data
    Bioethics
    Biofuel
    Biomedical
    BioNJ
    Bioterrorism
    Bit Coins
    Brain Health
    Business
    Camden
    Cancer
    CCollege
    Cellular
    Centenary
    Chemistry
    ChooseNJ
    Climate Change
    Clinical Trials
    Cloud Tech
    Collaboration
    Computing
    Congress
    Coriell
    Council On Innovation
    Crowdfunding
    Cybersecurity
    DARPA
    Defense
    Degree
    Dementia
    Dental Health
    DOC
    DOD
    DOE
    Drew
    Drones
    Drug Creation
    Einstein's Alley
    Electricity
    Energy
    Engineering
    Entrepreneurship
    Environmental
    FAA
    Fairleigh Dickinson
    FDA
    Federal Budget
    Federal Government
    Federal Labs
    Federal Program
    Finance
    Food Science
    Fort Monmouth
    Fuel Cells
    Funding
    Genome
    Geography
    Geology
    Global Competition
    Google
    Governor Christie
    Grant
    Hackensack
    HackensackUMC
    Healthcare
    Health Care
    HHS
    HINJ
    Hospitals
    Immigration
    Incubator
    Infrastructure
    International
    Internet
    Investor
    IoT
    IP
    IT
    Jobs
    Johnson & Johnson
    K-12
    Kean
    Kessler
    Legislation
    Logistics
    Manufacturing
    Medical Devices
    Med School
    Mental Health
    Mentor
    Microorganisms
    Molecular Biology
    Montclair
    NAS
    Neuroscience
    Newark
    New Jersey
    NIFA
    NIH
    NIST
    NJBDA
    NJBIA
    NJ Chemistry Council
    NJCU
    NJDOLWD
    NJEDA
    NJEDge
    NJHF
    NJII
    NJIT
    NJMEP
    NJPAC
    NJPRO
    NJTC
    Nonprofit
    NSF
    OpEd
    Open Data
    OSHE
    OSTP
    Parasite
    Patents
    Paterson
    Patients
    Perth Amboy
    Pharma
    POTUS
    PPPL
    Princeton
    Prosthetics
    Ranking
    Rare Disease
    R&D Council
    Report
    Resiliency
    Rider
    Robotics
    Rowan
    Rutgers
    SBA
    Seton Hall
    Siemens
    Smart Car
    Smart Cities
    Software
    Solar
    Space
    SSTI
    Startup
    State Government
    STEM
    Stevens
    Stockton
    Subatomic
    Supports
    Sustainability
    Taxes
    TCNJ
    Teachers
    Telecom
    Therapy
    Thermodynamics
    Transportation
    Undergraduate
    USEDA
    Verizon
    Video Game
    Virtual Reality
    Water
    WHO
    William Paterson
    Women In STEM
    Workforce Development

Home   Coalition   News   Resources   Events   Join Us
Picture
Innovation New Jersey Coalition
222 West State Street
Suite 302
Trenton, NJ 08608
732-729-9619