FDA approves GlaxoSmithKline's pandemic H1N1 vaccine

LONDON and PHILADELPHIA — GlaxoSmithKline announced Nov. 10 that the Food and Drug Administration has approved a supplemental biologics license application for its unadjuvanted H1N1 influenza 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 H1N1 influenza A strain.  

The U.S. Department of Health and Human Services has placed an order to fill 7.6 million doses of unadjuvanted H1N1 vaccine from GSK. 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. Clinical trials for both vaccines are ongoing in North America, Europe and Japan.