To accelerate development of a Zika vaccine, the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) will begin developing a vaccine using its Center for Innovation in Advanced Development and Manufacturing (CIADM) in Baltimore, Maryland.
With funding and direction from ASPR's Biomedical Advanced Research and Development Authority (BARDA), the CIADM led by Emergent BioSolutions, Inc., will conduct a variety of studies to move quickly through early stages of vaccine development and submit an investigational new drug request to FDA to begin clinical studies. To further speed development time, the CIADM will use vaccine technology similar to that used in vaccines being developed to protect against similar viruses, such as Dengue.
Over the next 30 months, BARDA will provide more than $17.9 million to Emergent with the potential for additional work for a total of approximately $21.9 million. At any stage in development, BARDA could transfer the technology to other vaccine manufacturers to utilize the technology for to produce and market the Zika vaccine.
"The threat posed by Zika presents an urgent need for vaccines and diagnostics," said Dr. Richard Hatchett, acting BARDA director. "To meet that need as quickly as possible, we need to leverage the infrastructure, experience, and expertise available within BARDA, other federal agencies, industry, and academia."
In addition to the CIADM, BARDA can call on other aspects of our National Medical Countermeasure Response Infrastructure which provide expertise in regulatory, non-regulatory, clinical, nonclinical, and manufacturing processes needed to develop a vaccine.
HHS established three CIADMs in 2012. Each center is run as a consortium with organizational experience in developing or manufacturing biological drugs and vaccines for use in public health emergencies. The centers bring together small biotech companies, academic institutions and large experienced pharmaceutical companies to develop and deliver drugs and vaccines quickly and cost effectively.
BARDA has used the CIADMs to accelerate development of therapeutics for Ebola, develop a second-generation anthrax vaccine, and manufacture experimental vaccines to protect against influenza viruses with pandemic potential.
In addition to this vaccine development, BARDA is sponsoring development of pathogen reduction technologies to reduce the risk from Zika in the blood supply. BARDA also is using its clinical studies network to collect blood samples needed to speed development of diagnostic tests.
BARDA is seeking additional proposals for products that could be used to prevent or detect Zika or other illnesses and injuries associated with public health emergencies. Visit www.medicalcountermeasures.gov to request a meeting.
The effort is part of BARDA's comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threat agents, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities' ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov