Wednesday, December 12, 2007

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New GlaxoSmithKline vaccine to combat Rotavirus menace in Sri Lanka

Rotarix to help combat acute diarrhoea which afflicts most children under the age of 5

Rotavirus gastroenteritis, an infection that afflicts virtually every child in the world within the first five years of life and accounts for up to half the hospitalisations due to diarrhoea, can now be prevented in Sri Lanka with the launch in December 2007 of Rotarix an oral two-dose vaccine developed by GlaxoSmithKline (GSK) Biologicals, one of the world’s leading manufacturers of vaccines.


Already licensed in over 100 countries and launched in 61 of them where some 14 million doses have been distributed, Rotarix has shown up to 100 per cent efficacy in protecting infants against severe rotavirus gastroenteritis in clinical studies involving over 70,000 infants, its manufacturer told medical professionals at the formal launch of the vaccine in Colombo last week.


In Europe, where Rotarix was approved in February 2006 for vaccination of infants from the age of six weeks, the vaccine has prevented 96 per cent of hospitalisations due to rotavirus gastroenteritis (RVGE) and reduced the need for medical attention by 84 per cent. The vaccine is now included in the national immunisation programmes of USA, Australia, Brazil, El Salvador, Mexico, Panama, Venezuela and Luxembourg. The Philippines, Singapore and Thailand were the first Asian countries to license Rotarix.


“The arrival of this vaccine in our country will be a source of great relief to parents of children under the age of five, said Stuart Chapman, Managing Director of GSK (Pharmaceuticals) in Sri Lanka. “About 90 per cent of the 611,000 deaths of children annually due to rotavirus gastroenteritis occur in Asia and Africa, and it is time that steps are taken to protect our infants from this disease.”


In Sri Lanka, it is estimated that about 1000 children under the age of five die as a result of diarrhoea every year. Of these deaths, about 250 or 25 per cent are caused by rotavirus, a highly contagious strain of virus that can survive in the environment for hours on hands and for days on solid surfaces. Twenty eight per cent of cases of rotavirus gastroenteritis occur in infants below five months and 43 per cent of cases in babies between six and 11 months. Addressing participants at the launch of Rotarix in Colombo, Professor Lulu Bravo, Vice Chancellor for Research and Executive Director of the University of Philippines, Manila said the World Health Organisation (WHO) and the Global Alliance for Vaccines and Immunisation (GAVI) had made the development of Rotavirus vaccine a top priority. Citing extensive research data she said:

“Two doses of RSX 4414 have been shown to be highly effective in protecting infants against RVGE in different geographic settings.”
Rotavirus gastroenteritis manifests itself with symptoms that include vomiting, diarrhoea, fever and abdominal pain. The fever and vomiting can last up to nine days, but the diarrhoea can last for up to three weeks. Rotavirus-induced diarrhoea carries a greater risk of dehydration than childhood diarrhoea caused by other infections. Globally, 25 to 55 per cent of children under the age of five hospitalised with acute diarrhoea are infected with rotavirus.


The first live attenuated oral human rotavirus vaccine available to children in Asia, Rotarix provides immunity by mimicking natural rotavirus infection. Just two doses of the vaccine administered within the first six months of life (the first at six weeks and the second before 24 weeks) provide sustained protection against rotavirus gastroenteritis. Rotarix can be administered with other infant vaccinations without impairing the immune response to any of the co-administered antigens. The vaccine has been shown to be heat-stable, with no variation in its immunogenicity after exposure of seven days at 37°C making it suitable for mass vaccination programmes.


One of the world’s leading research-based pharmaceutical and health care companies, GlaxoSmithKline (www.gsk.com) has been present in Sri Lanka for more than 50 years and is the country’s leading pharmaceuticals and vaccines company. GlaxoSmithKline Biologicals (GSK Bio) is the centre of all GlaxoSmithKline’s activities in the field of vaccine research, development and production. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination paediatric vaccines which protect the world’s children against up to six diseases in one vaccine.