GlaxoSmithKline to manufacture new adjuvanted H1N1 vaccine
GSK says it will manufacture a candidate A (H1N1) adjuvanted influenza vaccine once the virus seed is made available by the World Health Organization (WHO). The first doses of the vaccine are expected to be available four to six months later, subject to regulatory approval.
GSK says it will manufacture a candidate A (H1N1) adjuvanted influenza vaccine once the virus seed is made available by the World Health Organization (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 GSK's proprietary adjuvant system AS03.
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 compared with a formulation without adjuvant. The adjuvant system helps to increase the number of vaccine doses that can be produced.
The adjuvanted vaccine has also 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 for a pandemic vaccine based on a "mock-up" dossier. This approval, 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.
GSK has received interest from several governments, including the UK, France, Belgium and Finland, which aim to stockpile the new candidate adjuvanted vaccine as a precautionary measure.
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.
As capacity increases, GSK will supply the vaccine to developing countries under a tiered-pricing policy.
The company will continue to produce its seasonal influenza vaccine for the 2009/2010 Northern Hemisphere influenza season as planned and expects to complete production of this vaccine by the end of July. The company also continues to supply seasonal vaccine for use in the Southern Hemisphere as it enters the winter season this year.