GSK Update: GSK’s Arepanrix™ H1N1 pandemic vaccine prequalified by the World Health Organization

First prequalification for an H1N1 pandemic vaccine

-  First prequalification for an H1N1 pandemic vaccine

-  Key step in ensuring the vaccine can be distributed to developing countries


Tuesday 1st December 2009, London UK

GlaxoSmithKline (GSK) today announced that the World Health Organization (WHO) has awarded prequalification for global use of Arepanrix, GSK’s adjuvanted H1N1 pandemic vaccine manufactured in Canada. This is the first prequalification for an H1N1 pandemic vaccine, and is a key step in ensuring the vaccine can be distributed to developing countries. The WHO prequalification project is a service provided by the WHO to facilitate access to medicines that meet unified standards of quality and safety.

"As H1N1 continues to spread it is critical that all people around the world have access to an effective H1N1 vaccine during the pandemic. Since the start of the H1N1 pandemic GSK has been diligently working to achieve this and the WHO prequalification is a key step in ensuring that developing countries can be supplied with Arepanrix.” said Jean Stéphenne, President of GSK Biologicals. “The WHO has indicated that developing countries may be hardest hit by the H1N1 pandemic. It is clearly our collective responsibility to ensure that we do everything possible to provide vaccine supplies to these countries.”

Earlier, in November, GSK announced that it has signed an agreement with the WHO to donate 50 million doses of its adjuvanted pandemic H1N1 influenza vaccine to the WHO for the distribution to developing countries most in need.

GSK is committed to ensuring that developing countries have access to vaccines. Today’s announcement continues GSK’s track record of seeking WHO prequalification for its life-saving vaccines. GSK was also awarded prequalification foritsvaccine against pneumococcal disease in November of 2009,its cervical cancer vaccine in July 2009 and received an extended prequalification for a vaccine against rotavirus in June 2009. Together, all four prequalifications will provide access to vaccines for major global health priorities and potentially save millions of lives over the coming years.

Further information on GSK’s development of a vaccine to protect against pandemic 2009, including explanation of the vaccine development process and background information on adjuvants is available on:

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit



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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.