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GSK to produce A (H1N1) vaccine stockpile
With the World Health Oganisation (WHO) announcing today that 40 countries have reported 9,830 cases of A (H1N1) flu, GlaxoSmithKline (GSK) said that it has orders from several governments to create a stockpile of a new A (H1N1) vaccine.
GSK expects to manufacture a candidate A (H1N1) adjuvanted influenza vaccine once virus seed is made available by the WHO. First doses of the vaccine are likely to be available four to six months later.
GSK has received interest from several governments aiming to stockpile the vaccine as a precautionary measure, including requests for 60m for the UK; 50m for France; 12.6m for Belgium and 5.3m for Finland.
The new candidate vaccine will require regulatory approval. However, registration should be expedited because in 2008 GSK received a European licence for a pandemic vaccine based on a 'mock-up' dossier. This approval was based on data involving the H5N1 influenza strain.
In clinical studies based on the H5N1 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 helps to increase the number of vaccines doses that can be produced and clinical studies show that it provides potential to offer protection even if the influenza strain changes slightly.
GSK has made substantial investments to expand capacity for its adjuvant system.
Published: 20/05/2009
Content Area: Pharmaceutical industry articlesArticle type: Healthcare news
