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news.Baxter International, a diversified healthcare company, has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for the marketing authorization of Celvapan, the first cell culture-based H5N1 pandemic vaccine, in the EU.
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The positive opinion precedes the licensure 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 clinical trial that demonstrated vaccines for two different H5N1 virus strains were well tolerated and generated a functional immune response.
Hartmut Ehrlich, vice president of bioscience global R&D at Baxter, said: “We are very pleased to receive the European Medicines Agency’s positive opinion for Celvapan. This is another step towards our goal of supplying a safe and effective vaccine to protect the population against a possible influenza pandemic.”