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European paediatric societies support rotavirus vaccination of EU infants

The European Society for Paediatric Infectious Disease (ESPID) and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) have announced their support for the vaccination of EU infants against rotavirus

The European Society for Paediatric Infectious Disease (ESPID) and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) have announced their support for the vaccination of EU infants against rotavirus.

Represented by the ESPID-ESPGHAN Rotavirus Expert Group, both entities announced during the 25th ESPID congress in Porto on 1 May, the development of evidence-based guidelines to advise physicians on the effective and safe use of rotavirus vaccines in Europe, providing a frameworki for rotavirus vaccination programmes at a national level.

The group also presented the "Clinical Practice Guidelines for the Management of Gastroenteritis in Children in Europe" at the ESPID congress. According to these guidelines, gastroenteritis is an extremely common problem in childhood, and rotavirus is responsible for the most severe cases.

"Rotavirus is the most common cause of severe dehydration due to vomiting and diarrhoea in children worldwide and in Europe," commented Professor Pierre Van Damme, of the Centre for the Evaluation of Vaccination, in Belgium, and member of the ESPID-ESPGHAN Rotavirus Expert Group. "Vaccination is recognised as the only effective control measure to have a significant impact on the incidence of severe rotavirus gastroenteritis in children," he added.

The two sets of guidelines are the result of work completed by members of ESPID and ESPGHAN and supported by European experts in paediatrics, infectious diseases, virology, epidemiology, gastroenterology and public health.

Evidence-based guidelines for the use of rotavirus vaccines in Europe
During the ESPID meeting, the ESPID-ESPGHAN Rotavirus Expert Group issued summaries of evidence-based guidelines for the use of rotavirus vaccines in the EU.

The guidelines state that the available rotavirus vaccines are effective, generally well-tolerated and can reduce the burden of rotavirus disease in the region, and that both rotavirus vaccines can be used to control and prevent severe rotavirus gastroenteritis.

The group also stated that rotavirus vaccination could be incorporated into all EU vaccination schedules and can be administered separately or concomitantly with inactivated infant vaccines. They recommend that the first dose should be administrated between six and 12 weeks of age, and that the full schedule should be completed by six months.

The safety profile of the available rotavirus vaccines has been demonstrated in large clinical trials, including more than 130,000 infants; half of them receiving placebo and half getting the vaccines. The Expert Group recommended that continued post-marketing monitoring for serious adverse events should be in place for rotavirus vaccination.

The rotavirus vaccination guidelines are the result of a systematic review by the Rotavirus Expert Group together with the Polish Institute of Evidence-based Medicine, using an evidence-based medicine approach. The review covered all the available literature for rotavirus gastroenteritis and the two rotavirus vaccines in the EU before 31 January 2007.

Marketed rotavirus vaccines
Merck & Co's pentavalent RotaTeq is an oral, fully liquid and ready-to-use vaccine with three doses, indicated for the active immunisation of infants from the age of six weeks for prevention of gastroenteritis due to rotavirus infection.

The vaccine provides protection against the five predominant disease-causing rotavirus types. It is the only vaccine to offer direct efficacy against the rotaviruses, which cause more than 98 per cent of infections in the EU.

RotaTeq has been shown to prevent 98 per cent to 100 per cent of severe rotavirus gastroenteritis due to the rotavirus types G1, G2, G3 and G4. The vaccine also reduced related hospitalisation and accident and emergency department visits due to the different types of the virus by 94.5 per cent. Hospitalisation and accident and emergency department visits due to rotavirus type G9 were reduced by 100 per cent. RotaTeq has already demonstrated protection up to two years after completion of vaccination, covering the peak age for rotavirus infections in infants.

The tolerability and efficacy of RotaTeq have been evaluated in a large scale clinical program, including the largest rotavirus vaccine trial ever conducted, the Rotavirus Efficacy and Safety Trial (REST),which enrolled more than 70,000 infants worldwide with 43 per cent (31,000) coming from Europe.

RotaTeq obtained its EU marketing authorisation in June 2006 and is now available in Austria, Germany, Greece, Finland, France, Spain and Portugal and will be launched in the other EU countries in the short-term.

Competing vaccines
RotaTeq will compete with GlaxoSmithKline Biologicals' (GSK Bio) established two-dose Rotarix vaccine, which received EU Commission approval in February 2006. Rotarix was first launched in Mexico in 2005 and has already been licensed in a total of 33 countries. GSK Bio submitted a registration file for Rotarix to the European Medicines Agency (EMEA) in December 2004.

By 2010, the potential market for rotavirus vaccines is estimated to be between GBP 1bn to GBP 1.3bn worldwide. The EU accounts for 20 per cent of the total market, according to GSK.

2nd May 2007

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