GlaxoSmithKline's pandemic H1N1 vaccine cleared by US FDA; firm donates 50M doses to WHO

The US Food and Drug Administration has cleared UK drug giant GlaxoSmithKline's supplemental Biologics License Application 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 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 material 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 (15mcg) of inactive influenza virus antigens without an adjuvant for use in the USA. Clinical trials for both GSK's adjuvanted and unadjuvanted vaccines are ongoing in North America, Europe and Japan, the company noted.

Separately, GSK announced that it has signed an agreement with the World Health Organization to donate 50 million doses of its adjuvanted pandemic H1N1 influenza vaccine to the WHO for distribution to developing countries most in need. GSK is working with WHO and health authorities to prepare for initial shipments of the vaccine to developing countries by the end of November.

In addition to this agreement on vaccines, GSK says it continues to have discussions with the WHO about a donation of its antiviral medicine, Relenza. A tiered-pricing policy based on World Bank classification of countries is also in effect for this antiviral, and the company is making Relenza Rotacaps and Diskhaler available at not-for-profit prices to the world's 50 least developed countries.