To build a sustainable capacity to manufacture influenza vaccine in developing countries and help reduce the global threat of influenza pandemics, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) recently announced grants totaling $15 million to two international organizations and two U.S. universities.
The awards are the latest in a program established by ASPR’s Biomedical Advanced Research and Development Authority (BARDA) in 2006 to accelerate development of locally produced influenza vaccines around the world.
The program provides cost-sharing to build vaccine manufacturing facilities that can produce influenza and other vaccines in developing countries and trains personnel from developing countries at U.S.-based universities in advanced vaccine production. The program also supports technical assistance for foreign countries to operate and regulate their facilities and to conduct clinical trials with influenza vaccines produced in the facilities.
“Making more vaccine available worldwide during pandemics makes everyone safer,” said BARDA Director Robin Robinson, Ph.D. “By enhancing the manufacturing capacity in developing countries, we strengthen the overall global pandemic response capabilities and enhance America’s health security.”
The World Health Organization (WHO) will receive $10.5 million to support its Global Action Plan for Influenza Vaccines (GAP). GAP enhances capacity to produce influenza vaccines in low-resourced nations. The BARDA funding supports H7N9-related preparedness activities, allowing manufacturers in these countries to produce H7N9 pre-pandemic influenza vaccine candidates and to evaluate vaccine safety and efficacy in clinical studies.
Over the past seven years, BARDA has provided approximately $50 million through this WHO initiative to support development of influenza vaccine manufacturing capacity in Brazil, Egypt, India, Indonesia, Kazakhstan, Mexico, Romania, Serbia, South Africa, South Korea, Thailand, and Vietnam.
This initiative has led to approval in these countries of three seasonal flu vaccines and seven 2009 H1N1 pandemic vaccines and has resulted in two vaccines being pre-qualified by the WHO for use in a pandemic. Several of the developing countries were able to respond to the 2009 H1N1 pandemic with high quality locally produced vaccines because of advances made through the program.
In addition, BARDA will provide $4.25 million to PATH, an international global health non-governmental organization. Through this grant, PATH will provide specialized technical support on-site to assist influenza vaccine manufacturers in troubleshooting and remediating any issues with their manufacturing processes and will help in advanced clinical development of influenza vaccines.
To develop and maintain a skilled global workforce capable of producing vaccines, BARDA will continue to support the biomanufacturing training program for vaccine manufacturers in developing countries. This support allows for on-site training and practical hands-on programs in biomanufacturing and current Good Manufacturing Practices.
Utah State University’s Center for Integrated Biosystems in Logan, and North Carolina State University’s Biotechnology and Education Center in Raleigh will receive $125,000 each to conduct these training programs.
BARDA’s international influenza program compliments the agency’s efforts to build influenza vaccine manufacturing capacity domestically and to develop new, faster technologies for producing a greater quantity of effective vaccines in the United States.
These international and domestic programs are 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. In addition to pandemic influenza and emerging infectious diseases, these threats include chemical, biological, radiological and nuclear agents.