Glaxo H1N1 Vaccine Approved

GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine.  The FDA approved the supplemental biologics license application (sBLA), which was filed as a strain change supplement to Glaxo’s FluLaval seasonal flu vaccine. This means that Glaxo can now market its swine flu vaccine for use in adults to prevent influenza.  
 
The company has already received an order for 7.6 million doses of its swine flu vaccine from the United States Department of Health and Human Services. This order is a part of the US Government’s intention to secure about 250 million doses to help fight the swine flu pandemic.
 
The current outbreak of swine flu pandemic can prove to be a big opportunity for vaccine manufacturers. In addition to Glaxo, other major players in this field include Sanofi-Aventis (SNY), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN).
 
In fact, several companies including Sanofi Pasteur, the vaccine division of Sanofi-Aventis, Novartis Vaccines and Diagnostics Limited, the vaccine and diagnostics arm of Novartis, MedImmune LLC, a subsidiary of AstraZeneca and CSL Limited of Australia, have already received approval from the FDA for their swine flu vaccines.
 
Glaxo intends to start shipping its vaccine in December and expects to provide all the doses by year-end. We expect the company’s vaccine segment to post strong revenues in the fourth quarter of 2009. In addition to strong influenza product sales, the company has made significant progress in expanding its vaccine product portfolio. The approval of cervical cancer vaccine Cervarix in the US and Japan, H1N1 vaccine Pandemrix in Europe, and the H1N1 vaccine in the US should all help drive vaccine segment revenue.

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