Baxter's H5N1 vacc gets nod from CHMP
USA-based Baxter International says 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 pandemic vaccine.
The decision precedes the approval of the "mock-up" vaccine, which allows Celvapan to be used if the World Health Organization officially declares a pandemic. The positive opinion was based on results from a comprehensive clinical development program, including a Phase III trial that demonstrated vaccines for two different H5N1 virus strains were well tolerated and generated a functional immune response.
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