GlaxoSmithKline (GSK) announced that the Board of Health in Mexico approved recently for marketing in Mexico a new vaccine, Rotarix/EE, for the prevention of gastroenteritis caused by rotavirus infection.

Rotarix is an oral, two-dose, live attenuated vaccine developed from a single human strain designed to provide broad protection against multiple rotavirus strains and to provide early protection before the onset of rotavirus illness. The vaccine works by stimulating the body to mimic the immune response to natural rotavirus infection, which protects against the subsequent development of moderate to severe rotavirus disease.

More than 70,000 infants have been enrolled in the global clinical development program, with studies conducted in Europe, the US, Latin America and Asia to evaluate the safety and efficacy of Rotarix.
These studies demonstrate that Rotarix is an effective, safe and well-tolerated vaccine.

Rotarix has been designed to fit in with a country's existing infant vaccination schedules with both doses given before 6 months of age.

Rotarix has shown up to 90 per cent efficacy against severe rotavirus-related gastro-enteritis in the first year of life, as defined by the well established and widely used Vesikari 20-point scale, and up to 84 per cent efficacy in the second year of life against severe rotavirus-related gastro-enteritis. In addition, Rotarix was 86 per cent effective in preventing hospitalisations due to rotavirus-related gastro-enteritis.

Rotarix has demonstrated protection against different circulating strains of rotavirus when compared to the original strain of the vaccine.

"We are delighted that Mexico has become the first country in the world to approve Rotarix, an important new vaccine to prevent severe rotavirus-related gastro-enteritis in infants worldwide," said Jean Stephenne, President and General Manager of GSK Biologicals.

Rotarix has been in development at GSK Biologicals since 1997 when it was in-licensed from AVANT Immunotherapeutics.

Rotavirus infection is the leading cause of severe diarrhoea and vomiting in infants and young children between 3-24 months worldwide. If untreated, the virus can rapidly kill, as the sickest children become dehydrated from 10 to 20 episodes of diarrhoea in a single day. Globally, rotaviruses account for approximately 138 million cases of infantile gastroenteritis each year and it was recently reported that rotavirus is responsible for approximately 440,000 deaths per year. The majority of which occur in the Indian subcontinent, sub-Saharan Africa and South America.