FDA Approves GSK’s H1N1 Vaccine

GlaxoSmithKline (GSK) today announced that the 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 H1N1 influenza A strain.

The US 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 H1N1 influenza. GSK will supply a vaccine containing a standard dose (15ug) of inactive influenza virus antigens without an adjuvant for use in the US. Clinical trials for both GSK’s adjuvanted and unadjuvanted vaccines are ongoing in North America, Europe and Japan.