Monday, September 18, 2006


children's vaccine for fatal diarrhoea

A breakthrough in preventing the most common cause of childhood gastroenteritis — that kills over 100,000 children in the country alone every year — will soon be available in India with doctors and healthcare providers. GlaxoSmithKline is planning to introduce the Rotarix vaccine by the middle of next year.

Rotavirus is the leading cause for diarrhoea hospitalisation, and kills over 600,000 children a year in developing countries. Most infections occur in children under two, and 95% of children worldwide experience an episode of rotavirus disease by the time they reach three-five years of age, irrespective of race or economic status.

Sources said the company is expected to file for registration of the vaccine by the end of 2006, or the first quarter of 2007 with the authorities. GSK has already conducted clinical studies in Europe, the US, Latin America, Africa and Asia. Rotarix is an oral vaccine and is given in the first six months of life, with the first dose between six and 14 weeks of age, followed by a second dose between 14 and 24 weeks of age.

It is understood that Rotarix has an efficacy of up to 73% protection against any rotavirus diarrhoea, and up to 90% against severe rotavirus diarrhoea. Global prices are still being negotiated. It is learnt that Brazil offers it free to all children, while Glaxo sells it to the Brazilian government at $15 for two doses.

"If we get an effective vaccine at a reasonable price, it can also be included in the government's immunisation programme, especially in places where access to medical help is difficult," says Dr Nitin Verma, senior consultant pediatrics at Max Healthcare. Around 30% of the cases in the summer and monsoon months are related to rotarix-related diarrhoea and is very common in the first two years, he added.

At present, there is no effective vaccine available to treat rotavirus infections, which occurs in 80-90% of gastroenterology cases. Worldwide, Merck and GSK have been working on launching a vaccine to treat it. The disease is more devastating for children in the developing world due to lack of prompt access to treatment and hospital care.

The severity of infection ranges from symptoms of vomiting, fever and watery diarrhoea to dehydrating gastroenteritis, which can be fatal in some cases.
If untreated, the virus can kill, as the sickest children become dehydrated from 10 to 20 episodes of diarrhoea in a single day, experts say.

"Since infants have smaller body reserves and lose fluids and salts rapidly, the problem can push the child to dehydration and low salt. The vaccine should, however, be made optional as the disease is self-limiting and preventable in most cases", says Dr S Bagai, head pediatrics Rockland Hospital.

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