GSK Gets Approval for H1N1 sBLA

GlaxoSmithKline received approval from the FDA for its sBLA for unadjuvanted influenza A (H1N1) pandemic vaccine. The approval, 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 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 the vaccine.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.