Sanofi-Pasteur MSD's three-dose RotaTeq vaccine has been given the thumbs up in Europe to prevent rotavirus gastroenteritis in infants. The indication covers the five predominant disease-causing rotavirus types, which cover 95% of rotavirus disease worldwide and 98% in Europe, and will be used in infants from the age of six weeks.
Rotavirus is an extremely common disease in infants and young children and can prove serious, being the leading cause of hospitalisation due to gastroenteritis infection in Europe. Last month, Sanofi-Pasteur reported data from the REVEAL study showing rotavirus is responsible for about 60% of hospitalisations due to severe gastroenteritis in children aged under five. Stays in hospital ranged from about 2.5 to five days, and peaked during the winter months when hospitals are already under severe pressure from other seasonal infections.
In one clinical trial, dubbed REST, RotaTeq was shown to prevent 98% of severe rotavirus gastroenteritis – characterised by vomiting, fever, abdominal pain and watery diarrhoea - and, significantly, also cut hospitalisation and accident/emergency visits by almost 95%.
RotaTeq was developed by Merck & Co in the USA, where it was cleared for marketing in February this year and subsequently given the green light for routine immunization of all infants.
In the European Union, it is estimated that, each year, 87,000 hospitalisations and over 700,000 doctor visits of children under five years of age are due to rotavirus gastroenteritis. In total an estimated 3.6 million of the 23.6 million children under five years of age suffer from RG in the European Union each year.
GSK also markets a rotavirus vaccine, Rotarix, which began its global launch in January 2005 and received European approval in February 2006. Sanofi Pasteur MSD expects to launch its vaccine in Europe this month.
Meanwhile, Merck is planning a clinical trials programme for Rotateq in Africa and Asia as part of a bid to make the vaccine available there “as quickly as possible.” It is in the process of identifying sites and hopes to begin at least one trial by the end of the year.