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News 383 views update:May 21, 2008

First pre-AI pandemic vaccine approved in EU

GlaxoSmithKline (GKS) announces that the European Commission has granted marketing authorisation for its H5N1 adjuvanted pre-pandemic vaccine, Prepandrixâ„¢, in all 27 EU member states.

This is the first company to obtain a European licence for a pre-pandemic vaccine.
“This vaccine marks a significant step in the world's ability to cope with an influenza pandemic. It is testament to GSK scientists who have pioneered the approach to pre-pandemic vaccination, demonstrating our commitment to doing everything we can to help prevent the devastating effects of a pandemic and play our part in averting this potential public health crisis,” said GlaxoSmithKline CEO Jean-Pierre Garnier.
A pre-pandemic vaccine, such as Prepandrix, is produced in advance of a pandemic. Such a vaccine is based on the currently circulating H5N1 avian influenza virus. This vaccine would therefore play a critical role in pandemic preparedness planning.
“Pre-pandemic vaccination is an important strategy for addressing the current threat of a pandemic posed by H5N1,” said President and General Manager GSK Biologicals, Jean Stéphenne. “GSK welcomes the EU approval for Prepandrix and remains committed to actively work with governments on their pandemic preparedness plans to help protect against the potentially devastating impact of a pandemic.”
This vaccine is formulated with a novel proprietary adjuvant system, which is designed to achieve a high immune response at a low dose of antigen which is long-lasting and active against a broad range of H5N1 strains.
Reuters has reported that GSK has received orders for Prepandrix from several governments, including the US, Switzerland and Finland. Additionally, it was reported that in 2007, the company sold 146 mln pounds of its pre-pandemic vaccine and bulk antigen.
 
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GlaxoSmithKline (GKS)
 

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