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.”