The European Commission has granted approval of Rotarix in the European Union (EU), allowing active vaccination of infants from the age of 6 weeks, against the highly contagious rotavirus. Rotarix will be the first vaccine available to children in Europe for the prevention of gastroenteritis caused by rotavirus, a GSK release said.
Rotavirus disease causes hospitalisation of 87,000 babies and over 700,000 visits to the doctor each year in Europe1. In total an estimated 3.6 million of the 23.6 million children under 5 years of age suffer from rotavirus gastroenteritis (RVGE) in the EU each year.
Rotarix is a two-dose, oral vaccine that is administered at approximately two and four months of age to offer early protection against RVGE before the peak incidence of disease at 6-24 months. Rotarix can be co-administered with all infant vaccines within the routine infant vaccination schedules across Europe. Rotarix has already been licensed in 33 countries and 1.4 million doses of the vaccine have been distributed since its first launch in Mexico in 2005.
"Rotavirus causes great discomfort for children, with diarrhoea and vomiting continuing for several days, which can lead to severe dehydration, and if left untreated can be fatal. The availability of a safe and effective vaccine, like Rotarix, is exciting news for physicians as it will not only prevent these distressing symptoms that many children suffer, but will also help to reduce the burden on healthcare resources needed in treating outbreaks of the disease," commented Prof. Dr. Timo Vesikari, University of Tampere, Finland.
Rotavirus is the leading recognised viral cause of diarrhoea-related illness among infants and young children, with 95 per cent of children worldwide experiencing an episode by the time they reach 3-5 years of age, irrespective of race or socioeconomic status. Due to the large number of hospitalisations and outpatient visits, there is a high economic burden associated with RVGE. According to a recent study, the total cost in France is €28 million per year.
The high infection rate of rotavirus makes it difficult to control the spread of the disease. Therefore, vaccination is recognised as the only control measure to have a significant impact on the incidence of severe RVGE and is considered the optimum first line strategy for disease prevention.
The global clinical development program has proven that Rotarix protects against the most common circulating strains (G1 and non-G1 rotavirus strains) including the globally emerging G9 strain. The vaccines safety was shown in a recent trial that demonstrated that Rotarix caused fewer serious adverse events (SAEs) compared to placebo. The safety analysis of this trial also showed that there is no attributable risk for intussusception, a complication which was observed with a previous marketed vaccine.
Rotarix has been developed by GlaxoSmithKline Biologicals since 1997. Rotarix strain RIX4414 derives from the strain 89-12, which was originally developed by Dr Richard Ward at the Children's Hospital of Cincinnati, and which was in-licensed from Avant Immunotherapeutics. It is the first licensed attenuated human rotavirus oral vaccine conferring protection against severe rotavirus diarrhoea with data also showing efficacy against emergent strains. The vaccine is highly immunogenic and can be co-administered with all major infant vaccinations including oral polio vaccine.
In addition to the European license, an additional 33 licenses have been granted worldwide (16 Latin American countries including Brazil; Philippines and Singapore being the first Asian countries). Rotarix received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the Scientific Committee which evaluates the quality, safety and efficacy of medicinal products in the European Union on December 15, 2005. The European Marketing Authorisation from the European Commission announced today will make Rotarix the first rotavirus vaccine available to children in Europe. Furthermore, Rotarix has been filed for approval in 75 countries. Rotarix is not approved in the US yet, however GSK is in late stage development discussions with the FDA regarding licensure of Rotarix for the US market.
Recently, Brazil, Panama and Venezuela included, for the first time, the rotavirus vaccine in their national official vaccination calendars. As part of the government's paediatric immunization program, vaccination with Rotarix will be available free at public health clinics in those countries.