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WHO asks Hungarian bird flu vaccine maker to help set standard

The WHO asked Hungary's Omninvest Kft, the company that said it developed the first human vaccine against the H5N1 bird flu virus, to help it create an international standard for avian influenza vaccines.

Omninvest sent blood samples from patients who participated in its H5N1 vaccine trials to the WHO, which wants to develop a standard to compare data from clinical trials worldwide, István Jankovics, who helped develop the vaccine at Hungary's National Epidemiological Institute, said in an interview yesterday. Hungarian medical authorities pronounced Omninvest's vaccine effective in October 2005. The company hasn't won approval from European or US regulators and hasn't sold a vial outside Hungary. Working with the WHO lends credibility that should make selling vaccine easier, Omninvest salesman József Kassai said. „It's not only the credibility,” said Kassai, who seeks to sell the vaccine to Russia's Chelyabinsk region, in a telephone interview. „It gives us a basis for international cooperation with everybody.” Global disease trackers are monitoring the spread of the H5N1 virus in the event it changes into a form that's infectious among people. At least 167 of the 274 people known to be infected with the bird flu have died, according to the Geneva-based WHO.
Omninvest, based in the Hungarian town of Pilisborosjenő, is racing with drugmakers such as GlaxoSmithKline Plc, Europe's largest, and Baxter International Inc. to develop and market a vaccine that will protect humans in a pandemic sparked by H5N1. Switzerland's Novartis AG today won the backing of a European Medicines Agency panel for its mock-up pandemic vaccine, following an endorsement of Glaxo's experimental product.

The Hungarian company is one of three possible sources the WHO might use for sera, the part of human blood that contains antibodies for fighting infection, said John Wood, a virologist at Britain's National Institute for Biological Standards and Control, a WHO-affiliated laboratory. The institute received samples of the Hungarian vaccine and has determined they are effective, Wood said. „We sent them the sera samples in January along with the necessary clinical certificates,” Jankovics said. Omninvest „got a reply last week, in which they confirmed our results, and asked that we issue a larger amount of sera to the WHO, so that they could create a basis for standardizing immunological studies on the virus.” Before the WHO can use a serum, it has to be tested for safety and freeze dried, Wood said. „That could take most of this year,” he said. Contributing sera to a standard-making process usually does portend any major financial gain for a company, said Michael Osterholm, director of the Center for Infectious Disease and Policy at the University of Minnesota. Indonesia, where H5N1 has killed more people than in any other country, has been working closely with Deerfield, Illinois-based Baxter. Britain last year placed a £33 million ($64.8 million) advance order for H5N1 vaccine with Baxter and Emeryville, California-based Chiron Corp. one year ago. Chiron is now part of Novartis. (Bloomberg)