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GSK launches Europe's first rotavirus vaccine

Published on 01/03/06 at 11:28am

GlaxoSmithKline has launched Rotarix in Europe, the first ever marketed vaccine against rotavirus gastroenteritis, a common but potentially lethal condition in children which causes 18,000 hospitalisations a year in the UK and many more visits to GPs.

In the developing world, rotavirus is a major killer, with half a million children dying each year because of the severe dehydration caused by diarrhoea, vomiting and fever.

The disease represents about one third of deaths from diarrhoea and about 5% of all deaths among children less than five years of age, making a vaccine a hugely important step forward for public health around the world.

One vaccine has previously been marketed in the US, Wyeth's Rotashield. Launched in 1998, a small but significant number of children given the vaccine developed a type of bowel obstruction called intussusception. Even though the link between the vaccine and the condition was not established, Wyeth voluntarily withdrew the product.

GSK has gone to great lengths to prove the safety and efficacy of its product, conducting trials in 60,000 infants, one of the largest ever carried out which have shown protection rates of up to 100% against the most severe cases of the disease.

For Rotarix to help as many children as possible in the UK and other countries - as well as realise its commercial potential - the vaccine must be included in government vaccination programmes.

GSK says it is currently in discussions with the UK government about including Rotarix in public health programmes, and said it responded to a direct call from the chief medical officer for such a vaccine in 2002.

GSK is not the only company to be launching a rotavirus vaccine this year, with Merck's Rotateq virtually neck and neck with Rotarix in reaching the market.

Merck has stolen a march on its rival in the US, however, receiving recommendation to be included in the country's childhood vaccination programme.

The products, both administered orally, differ slightly in that GSK's is a two-dose course is taken up to three months of age, while Wyeth's is a three dose course taken between the ages of six and 32 weeks.

Analysts expect the products to earn between $500-750 million in peak sales, with inclusion on vaccination programmes and educational work necessary to raise awareness and maximise uptake.

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