October 4, 2016
HHS sponsors commercial manufacturing tests for Ebola vaccine
An Ebola vaccine will take the next critical steps in development under a $24.75 million contract through May 2020 between the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and BioProtection Systems Corp. (BPS) of Ames, Iowa.
“The Ebola epidemic of 2014 and 2015 was just the latest outbreak of this potentially deadly disease and we cannot predict when or where the next outbreak will occur,” explained BARDA Acting Director Dr. Richard Hatchett. “We can prevent future epidemics by acting quickly and decisively to complete development of Ebola vaccines and treatments for use worldwide. As a global public health threat and a potential bioterrorism threat, Ebola remains a priority.”
There currently are no vaccines or treatments approved for use against Ebola. The Centers for Disease Control and Prevention (CDC) recently determined that the Ebola virus can be found in semen for a year or longer after a person has recovered from the illness. The most recent case of Ebola occurred in West Africa in April of 2016. In 2014 and 2015, the Ebola epidemic in West Africa led to more than 28,000 suspected cases of the illness, more than 15,000 confirmed cases, and 11,310 deaths.
Since the 2014-2015 epidemic, BPS has worked with Merck and Co., Inc. to advance a vaccine, known as V920, through multiple clinical studies, including studies conducted among health care professionals working in West Africa. The results suggesting that V920 protected against Ebola virus infections in humans were published in July 2015.
Today’s agreement builds on previous Ebola vaccine development efforts undertaken by BPS with support from ASPR’s Biomedical Advanced Research and Development Authority (BARDA).
Under the previous ASPR contract, BPS developed a process to scale up manufacturing of V920 to produce large quantities of the vaccine. Under the agreement announced today, the company will enable the validation of those manufacturing processes to ensure commercial quantities of the vaccine can be made available for future outbreaks if needed.
The contract could be extended for up to a total of five years and $75.98 million to support additional safety studies and analyses of how well the vaccine stimulates the human immune system when produced at commercial scale. All of these efforts will support the company’s application for vaccine licensure through the U.S. Food and Drug Administration.
As a division of ASPR, BARDA takes a comprehensive integrated portfolio approach to 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.
ASPR partners with other federal agencies, in particular the National Institutes of Health, as well as private industry to develop medical products needed to mitigate the health effects of disasters and other public health emergencies. Potential products may transition from basic research and early clinical trials at NIH divisions to BARDA for support of the advanced development necessary to support approval or licensure by the U.S. Food and Drug Administration.
For example, the BARDA-sponsored work on V920 builds on product development efforts funded by the Public Health Agency Canada, The NIH National Institute of Allergy and Infectious Diseases, and the Department of Defense.
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 lead 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.
For more information on national public health and medical preparedness, visit www.phe.gov and to learn more about partnering with BARDA in public health preparedness visit www.medicalcountermeasures.gov.