On the 22nd July, the company confirmed that it had contracts in place to supply 195 million doses of its pandemic (H1N1) 2009 adjuvanted influenza vaccine and had a variety of agreements in place with the US Government to supply pandemic products worth $250 million. Since that date, nine government contracts have been signed for a further 96 million doses of the vaccine. This now brings the total number of doses ordered for GSK's adjuvanted vaccine to 291 million. Discussions continue with governments for further supplies of the vaccine.
First supplies of the vaccine will be available to governments from September onwards, with shipments expected in the second half of 2009 and early 2010. The exact pace of delivery will be dependent on capacity and the yield of the influenza strain.
To ensure that the vaccine is available to developing nations, and subject to the yield and existing contractual commitments, GSK has allocated 20% of production at its Canadian manufacturing site to developing countries from early September onwards. Included within this capacity is GSK's proposed donation of 50 million doses of the H1N1 vaccine to the WHO. Ongoing discussions with developing country governments may well lead to an increase in the percentage of output supplied to developing countries. GSK is operating a tiered-pricing policy for its vaccine, based on World Bank classification of countries and GAVI eligibility.
About the pandemic (H1N1) 2009 vaccine
Following more than ten years of investment in research and development of pandemic influenza vaccines, and the successful registration of its pre-pandemic H5N1 vaccine, the company is making rapid progress to produce the Pandemic (H1N1) 2009 adjuvanted influenza vaccine.
The vaccine will comprise antigen of the recently isolated Pandemic (H1N1) 2009 influenza strain and also contain GSK's proprietary adjuvant system AS03. An adjuvant system can be added to the antigen at time of administration. In clinical studies using the H5N1 influenza strain, an adjuvanted formulation has been shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant. The adjuvant system therefore helps to increase the number of vaccine doses that can be produced.(1) In addition, in clinical studies with the H5N1 influenza strain, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly).(2,3)
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1. Leroux-Roels et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370 (9587): 580â89.
2. Leroux-Roels I et al, Broad Clade 2 Cross-Reactive Immunity Induced by an Adjuvant systemed Clade 1 rH5N1 Pandemic Influenza Vaccine PLoS ONE 3(2): e 1665. doi:10.1371/jounal.pone.0001665
3. Baras et al. Cross-protection against lethal H5N1 challenge in ferrets with an adjuvanted pandemic influenza vaccine. PLoS ONE 2008; 3 (1): e1401.