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NEWS:
European regulators approve GSK's Pandemrix

 
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Mixin



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PostPosted: Thu Oct 01, 2009 8:58 pm    Post subject: European regulators approve GSK's Pandemrix Reply with quote

the firm says it expects to start shipping the vaccine to countries in Europe sometime next week.

Approval of Pandemrix is based on a 'mock-up' registration file using the H5N1 antigen that was given the nod in Europe last year after regulators considered it both effective and generally well-tolerated. However, the submission also included early results from clinical studies using the current H1N1 strain, such as data showing that just one dose of the vaccine provided a strong immune response 'which exceeds the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine', according to the firm. In addition, initial evidence suggests that the new H1N1 vaccine has a similar safety and tolerability profile as the already approved H5N1 version.

More than 9,000 patients across Europe, Canada and the US are currently taking part in 16 clinical trials designed to further assess the efficiency and safety of Pandemrix, results of which will be given to regulators as soon as they become available, GSK noted. In the meantime, its vaccine will be shipped out to countries across Europe so that governments can kick off their own immunisation programmes.

http://www.pharmatimes.com/UKNews/article.aspx?id=16670
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