Pandemic 2009 Influenza Update: US FDA Approves GSK's Pandemic H1N1 Vaccine

Main Category: Swine Flu
Also Included In: Immune System / Vaccines;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 12 Nov 2009 - 2:00 PST

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GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The approval of the sBLA, which was filed as a strain change supplement to GSK's FluLaval seasonal flu vaccine, allows the company to manufacture a flu vaccine for use in adults to prevent influenza caused by the 2009 pandemic H1N1 influenza A strain.

The United States Department of Health and Human Services has placed an order to fill 7.6 million doses of unadjuvanted H1N1 pandemic vaccine from GSK, which will contribute to the approximately 250 million doses secured by the US government. The vaccine will be produced in multi-dose vials from bulk vaccine manufactured at GSK's facility in Quebec, Canada. GSK expects to begin shipping vaccine in December and to provide all 7.6 million doses by the end of the year.

Globally, GSK manufactures both adjuvanted and unadjuvanted vaccines to protect against pandemic H1N1 influenza. GSK will supply a vaccine containing a standard dose (15 ug) of inactive influenza virus antigens without an adjuvant for use in the United States. Clinical trials for both GSK's adjuvanted and unadjuvanted vaccines are ongoing in North America, Europe and Japan.

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.

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.

Source: GlaxoSmithKline