Hot on the heels of last month’s positive European opinion for Sanofi-Pasteur MSD’s Rotateq, a unique new trial has highlighted the potential benefits of vaccination against rotavirus.

According to the REVEAL study, reported during the 7th International Rotavirus Symposium in Lisbon, Portugal, rotavirus is responsible for about 60% of hospitalisations due to severe gastroenteritis in children aged under five. Stays range from about 2.5 to 5 days, and peak during the winter months when hospitals are already under severe pressure from other seasonal infections.

Speaking at a media briefing called by Sanofi Pasteur MSD in Lisbon earlier this week, Nick Kitchen, Medical Director of the company’s UK arm, said: “In the Phase III REST study, Rotateq prevented virtually all cases of severe paediatric rotavirus gastroenteritis (PRG) and reduced hospitalisations by around 95%.”

Virtually all children under two to three years old are infected by rotavirus, the most common cause of severe dehydrating diarrhoea in children worldwide. PRG is a major killer of children in developing countries and, while deaths are rare in richer regions like Europe and the USA, REVEAL clearly shows that the infection has a major impact on already hard-pressed health services in these regions.

Set in seven European countries, REVEAL is the first prospective, epidemiological study to assess the impact of rotavirus infection across Europe during a single year. Rotavirus has been low on the public health agenda in Europe, and REVEAL’s results will undoubtedly be major food for thought for European health providers as they consider whether to add routine vaccination to current immunisation schedules.

GSK is also marketing a rotavirus vaccine, Rotarix, which began its global launch in January 2005 and received European approval in February 2006. In the same month, the US Centres for Disease Control cleared Rotateq for inclusion in routine infant vaccination schedules, and Sanofi Pasteur MSD expects to launch the vaccine in Europe around the beginning of July.

By Sue Lyon