Baxter International Inc. (NYSE: BAX) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion for the marketing authorization of CELVAPAN, the first cell culture-based H5N1 (avian flu) pandemic vaccine, in the European Union. The positive opinion precedes the licensure of the "mock-up" vaccine, which allows CELVAPAN to be used if the World Health Organization (WHO) officially declares a pandemic. The positive opinion was based on results from a comprehensive clinical development program, including a Phase III clinical trial that demonstrated vaccines for two different H5N1 virus strains were well tolerated and generated a functional immune response.
For more information, visit http://www.medicalnewstoday.com/articles/133806.php
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