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Biosecurity BriefingH5N1 News: Australia Approves Vaccine; Sanofi to Donate to WHO Stockpile; HHS Contracts to Develop Rapid Diagnostic Tests By Kunal Rambhia, June 20, 2008 On June 17, 2008, CIDRAP News reported that the Australian Therapeutic Goods Administration (similar to the U.S. Food and Drug Administration) approved Panvax®, an H5N1 avian influenza vaccine developed by CSL Limited.1 According to a June 17 CSL press release, the vaccine “can be used only when an influenza pandemic has been officially declared by the Australian Government in consultation with the World Health Organization.”2 The Australian government contributed more than $7 million to the development of the Panvax® vaccine and has stockpiled an additional 1.2 million doses of a “foreign-made vaccine.”1 According to CIDRAP News, Panvax® is a split-virus vaccine that requires two doses for efficacy, and the vaccine performed well in safety and immunogenicity clinical trials. Panvax® is produced in eggs and includes an adjuvant to enhance the effect of the vaccine. It is estimated that mass production of a “precisely matched” version of the egg-based vaccine “will take 4 to 6 months after the identification of a pandemic flu strain.”1 In a related CIDRAP News report on June 16, sanofi pasteur has pledged to “give 60 million doses of H5N1 influenza vaccine over 3 years to the World Health Organization (WHO) for a planned stockpile to help poor countries in the event of an influenza pandemic.”3 This comes a year after GlaxoSmithKline (GSK) promised 50 million doses of its H5N1 vaccine (which was approved in May by the European Union for marketing) for the WHO stockpile. Like the GSK vaccine, the sanofi vaccine requires two doses. The combined total of the two donations would be enough for the WHO to vaccinate approximately 55 million people. The WHO stockpile was initiated in 2007 in response to concerns posed by “Indonesia and other developing countries about lack of access to commercial H5N1 vaccines.”3 In other news, the U.S. Department of Health and Human Services (HHS) announced that the Centers for Disease Control and Prevention (CDC) “has awarded $12.9 million for the development of low-cost influenza tests that can detect and differentiate seasonal human influenza viruses from avian influenza within three hours.”4 The HHS release indicates that new, rapid diagnostics will “be performed in a hospital or a commercial laboratory and would expedite the diagnosis of a large number of patients” for both pandemic and seasonal influenza.4 Current technologies can take up to 24 hours for accurate identification of H5N1. HHS Secretary Michael Leavitt commented that “early detection will aid in improving patient survival, overall health outcomes, and use of containment measures” during an influenza pandemic.4 Contracts for development of influenza diagnostic tests were awarded to Nanogen, Inc., and Meso Scale Diagnostics, LLC. Each company received an initial $6.5 million. However, the contracts allow funding for up to $10.4 million for Nanogen and $12.1 million for Meso Scale Diagnostics over three years. CDC and the Biomedical Advanced Research and Development Authority (BARDA) awarded the contracts jointly. References
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