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Home Industry News Baxter flu vaccine marketing authorisation approved

Baxter flu vaccine marketing authorisation approved

19th December 2008

Baxter has received a positive opinion regarding the marketing authorisation for its cell culture-based avian flu vaccine, it emerged this week.

The company said the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) approved Celvapan as a pandemic H5N1 vaccine.

It based its decision on clinical development programme results, which included a phase III trial demonstrating tolerance and a functional immune response for two H5N1 virus strains.

The positive opinion allows the use of Celvapan if a pandemic was to be declared by the World Health Organisation.

Baxter said the vaccine is made using Vero cell technology – and this offers advantages compared to traditional egg-based vaccine methods.

“We are very pleased to receive the EMEA’s positive opinion for Celvapan,” added the firm’s BioScience global research and development vice-president Hartmut Ehrlich.

“This is another step towards our goal of supplying a safe and effective vaccine to protect the population against a possible influenza pandemic.”

In related news, Baxter announced last month it was raising its quarterly dividend by 20 per cent.

Chairman and chief executive officer Robert L Parkinson Jr said this represented a “strong” position financially.

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