BARDA Grants Help Build Global Flu Vaccine Manufacturing Capacity

October 14, 2010

The US Department of Health and Human Services? (HHS) Biomedical Advanced Research and Development Authority (BARDA) is providing three sets of grants totaling $10.4 million to help the World Health Organization (WHO) strengthen developing countries? ability to produce flu vaccines, potentially reducing the global threat from influenza.

The US Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) is providing three sets of grants totaling $10.4 million to help the World Health Organization (WHO) strengthen developing countries’ ability to produce flu vaccines, potentially reducing the global threat from influenza.

The grants provided to the WHO will be used to assist developing countries with pandemic influenza vaccine manufacturing infrastructure, training on influenza vaccine manufacturing, and the development and distribution of certain technologies for pandemic influenza vaccines.

BARDA awarded a $6.4 million grant to the WHO as part of an ongoing international cooperative agreement in the Initiative for Vaccine Research. This funding will support requests to the WHO from developing countries to expand regulatory systems, construct and validate vaccine manufacturing facilities, and transfer new technology for recombinant or cell-based influenza vaccines.

Through this WHO initiative over the past five years, $40 million in US funding has been used to develop vaccine manufacturing infrastructure in 10 countries: Egypt, India, Indonesia, Vietnam, Brazil, Mexico, Russia, Romania, Serbia, and Thailand.

The second set of grants supports training on cutting-edge manufacturing techniques for WHO grantees. NC State University’s Biotechnology and Education Center received $861,000, and Utah State’s Center for Integrated Biosystems received $322,000, to train selected personnel from manufacturers in developing countries. Trainees will receive hands-on instruction in US Food and Drug Administration good manufacturing practices in vaccine production technology. These practices can be taken back and implemented by manufacturers in their native countries.

The third set of grants supports developing adjuvants and technology transfer to produce adjuvants. Adjuvant use has been shown to reduce the amount of protein needed for flu vaccine to be effective, so the adjuvanted vaccines made in these countries could serve a greater number of people. The Infectious Disease Research Institute in Seattle received $790,000, and the University of Lausanne in Switzerland received $1.8 million to develop adjuvants and other technologies that can be transferred without the restriction of intellectual property rights.

In addition to the three grants, BARDA also has awarded a three-year contract for $56.94 million to Sanofi Pasteur (Lyon, France). The contract allows Sanofi Pasteur to manufacture pandemic influenza vaccine at full capacity year-round.

The contract affords rapid response and production of a strain-matched pandemic influenza vaccine in the event of a declared pandemic. The contract covers the year-round availability of sufficient eggs and other essential supplies to support production of interpandemic or pandemic influenza vaccine at the company's full production capacity. The year-round supply also enables Sanofi Pasteur to collaborate with the US government to develop vaccines against other potential pandemic virus strains as they are identified.

Sanofi Pasteur received its first year-round egg supply contract from HHS in 2004 and has been under contract since that time. This new contract provides for an additional three years of supply.