GSK to manufacture A H1N1 influenza vaccine

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GSK is committed to supporting governments and health authorities around the world to respond to the emergence of the new A (H1N1) influenza strain.

Since the outbreak, the company has been in continuous discussions with governments and public health authorities, including the WHO, the US Centers for Disease Control and Prevention, the US Department of Health and Human Services and the European Centre for Disease Prevention and Control to help develop appropriate options to respond to the emergence of the new A (H1N1) influenza strain.

GSK expects to manufacture a candidate A (H1N1) adjuvanted influenza vaccine once virus seed is made available by the WHO. The first doses of the vaccine are expected to be available four to six months later, subject to regulatory approval.

The vaccine will comprise antigen of the recently isolated A (H1N1) 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.

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).

The new candidate vaccine will require regulatory approval. In 2008, GSK received a European licence fora pandemic vaccine based on a ?mock-up’ dossier. This approval, which was based on data involving the H5N1 influenza strain, is expected to enable faster registration of this new A (H1N1) influenza vaccine and is currently being discussed with European regulatory authorities.

To date, GSK has received interest from several governments aiming to stockpile the new candidate adjuvanted vaccine as a precautionary measure. These include:

Supplying the UK Government with 60 million doses of the candidate A (H1N1) adjuvanted influenza vaccine.

The French Government intend to purchase 50 million doses of the candidate A (H1N1) influenza vaccine.

The Government of Belgium intend to purchase 12.6 million doses of the candidate A (H1N1) influenza vaccine in order to stockpile and to protect, when needed, the total Belgian population.

An agreement with the Government of Finland to supply 5.3 million doses of H1N1 antigen, which is expected to be used in conjunction with the government’s existing stockpile of GSK’s adjuvant system.

GSK has made substantial investments to expand capacity for its adjuvant system. As part of the company’s commitment to maximising global manufacturing capacity of a pandemic vaccine, GSK is ready to engage in discussions with companies and governmental agencies that can combine the adjuvant system with alternatively sourced antigen.

GSK is committed to addressing the needs of developing countries with use of this candidate adjuvanted vaccine. GSK will convert its intended donation to the WHO of 50 million doses of H5N1 pre-pandemic vaccine to the new candidate A (H1N1) adjuvanted influenza vaccine once production begins.

In the future, as capacity increases, GSK will supply the candidate A (H1N1) adjuvantedinfluenza vaccine to developing countries under a tiered-pricing policy based on World Bank classifications and GAVI eligibility.

Source: GlaxoSmithKline, USA

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