Two Major European Paediatric Societies Support Rotavirus Vaccination Of Infants In Europe

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Also Included In: Pediatrics / Children's Health;  Immune System / Vaccines
Article Date: 05 May 2007 - 9:00 PDT

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The European Society for Paediatric Infectious Disease (ESPID) and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) support rotavirus vaccination of infants in Europe.

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

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.2

"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 Antwerp, 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".3, 4

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.1

Evidence-based guidelines for the use of rotavirus vaccines in Europe

During the ESPID meeting, the ESPID-ESPGHAN Rotavirus Expert Group issued summaries of their evidence-based guidelines for the use of rotavirus vaccines in Europe. The guidelines state that the available rotavirus vaccines are effective, generally well-tolerated and can reduce the burden of rotavirus disease in Europe and that both rotavirus vaccines can be used to control and prevent severe rotavirus gastroenteritis. 1

They also state that rotavirus vaccination can be incorporated into all European vaccination schedules and can be administered separately or concomitantly with inactivated infant vaccines. They recommend that the first dose should be administrated between 6 weeks and 12 weeks of age, and that the full schedule should be completed by 6 months of age.1

The good safety profile of vaccines is of great importance and has been demonstrated for the available rotavirus vaccines in very large clinical trials, together including more than 130,000 infants; half of them receiving placebo, half of them receiving the vaccines.5, 6 The Expert Group recommends that continued post-marketing monitoring for serious adverse events should be in place for rotavirus vaccination.1

The other guidelines give guidance on the use of rotavirus vaccines together with oral polio vaccines and for premature or immunodeficient infants.1 These 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.1 The review covered all the available literature for rotavirus gastroenteritis and the two rotavirus vaccines in Europe prior to 31st January 2007.

Rotavirus: an underestimated, unpredictable and unavoidable disease

In the European Union (25 member states), it is estimated that each year, 87,000 children less than 5 years of age are hospitalised due to rotavirus gastroenteritis and over 700,000 visit the doctor. In Western Europe, 1 child dies every week because of rotavirus infection.7

Virtually all children - regardless of ethnicity or nationality or how rich or poor they are - will be infected with rotavirus by two to three years of age. 3,8 The majority of them will be infected between 6 to 24 months of age at a time where they are particularly vulnerable to disease. 9,10 The typical symptoms of rotavirus disease are watery diarrhoea, vomiting, fever and abdominal pain. The severity ranges from asymptomatic forms (most of the cases) to severe forms with a dramatic loss of body fluid (dehydration) that can be fatal.9 According to the Expert group, dehydration is the main clinical feature of acute gastroenteritis and generally reflects disease severity. Rehydration is the key treatment in the UK and should be administered as soon as possible in the form of oral rehydration fluids which can be purchased from retail pharmacies.2

There are no risk factors for developing a severe case of rotavirus gastroenteritis. Overnight, a seemingly mild form of the disease can become life-threatening 9,11,4 and require hospitalisation for intravenous re-hydration.

As rotavirus is both highly contagious and resistant to its environment, there has been no real way to prevent rotavirus infection in children until now.9,12,13 Vaccination is recognised as the only control measure to have a significant impact on the incidence of severe paediatric rotavirus gastroenteritis.3,4

RotaTeq®: an easy-to-use, pentavalent rotavirus vaccine for infants providing broad direct protection against the five predominant disease-causing rotavirus types RotaTeq® is the only rotavirus vaccine that offers direct efficacy against the five rotavirus types that cause more than 98% of rotavirus diseases in Europe (G1, G2, G3, G4 and G9).14,15 In clinical trials, RotaTeq® has been shown to prevent 98%* to 100%† of severe rotavirus gastroenteritis due to the rotavirus types G1, G2, G3 and G4.6, 16, 17 The vaccine also reduced related hospitalisation and accident and emergency department visits due to rotavirus types G1, G2, G3 & G4 by 94.5%‡ and hospitalisation and accident and emergency department visits due to rotavirus type G9 by 100%.§ 6 Currently, RotaTeq ® has already demonstrated protection up to two years after completion of vaccination, thus covering the peak age for rotavirus infections in infants. 6,14

* 95% confidence interval: 88.3 to 100%
† 95% confidence interval: 13 to 100%
‡ 95% confidence interval: 91.2 to 96.6%
§ 95% confidence interval: 67.4 to 100%

Preliminary results indicate that protection starts from the first dose,18 and three doses should be given for complete protection. RotaTeq® contains the rotavirus types G1, G2, G3, G4 and P1[8] which provides protection against G9, a G-type that contains P1[8].

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% (31,000) coming from Europe. 19 In the REST study, no difference has been shown between RotaTeq® and placebo groups for the most common adverse events6, which were vomiting, diarrhoea and fever. No difference between RotaTeq® and placebo has been shown concerning serious adverse events, such as intussusception.6

RotaTeq® obtained its marketing authorisation in the European Union in June 2006. It is now available in Austria, Germany, Greece, Finland, France, Spain and Portugal and will be launched in the other European countries in due course. RotaTeq® (rotavirus vaccine, live, oral) 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.20

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofiaventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.

References

1 Van Damme P. on behalf of ESPID-ESPGHAN Rotavirus Expert Group. Evidence-based recommendations for the use of rotavirus vaccines in Europe. Centre for the Evaluation of Vaccination, Faculty of Medecine, University of Antwerp. May 2007. (abstract).
2 ESPGHAN-ESPID Working Group. Clinical Practice Guidelines for the Management of Gastroenteritis in Children in Europe. ESPID. May 2007
3 Parashar UD. et al. Global illness and deaths caused by rotavirus disease in children. Emerg Inf Dis 2003;9:565-572
4 Clark HF and Offit PA. Vaccines for rotavirus gastroenteritis universally needed for infants. Ped Ann 2004; 33(8). 537- 543.
5 Ruiz-Palacios G et al. Safety and Efficacy of an Attenuated Vaccine against Severe Rotavirus Gastroenteritis. N Engl J Med 2006;354:11-22.
6 Vesikari T et al. Safety and Efficacy of a Pentavalent Human - Bovine (WC3) Reassortant Rotavirus Vaccine. N Engl J Med 2006; 354(1):23-33.
7 Soriano-Gabarro M et al. Burden of rotavirus disease in European Union Countries. Pediatr Infect Dis J 2006;25:S7-S11.
8 Clark HF et al. Rotavirus Vaccines. In: Plotkin SA, Orenstein WA eds. Vaccines 4th Ed. Philadelphia: Saunders; 2004.p. 1327-1345.
9 Raebel MA, Ou BS. Rotavirus disease and its prevention in infants and children. Pharmacotherapy 1999;19(11):1279-1295.
10 WHO - State of the art of new vaccines Research & Development. Initiative for Vaccine Research. Geneva, April 2003.
11 Matson D.O. In: Long SS Ed. Principles and Practice of Paediatric Infectious Diseases. New York: Churchill Livingstone 2003. 1105-1108.
12 Fischer TK, Bresee JS, Glass RI. Rotavirus vaccines and the prevention of hospital acquired diarrhea in children. Vaccine 2004;22:49-54.
13 Dennehy PH. Transmission of rotavirus and other enteric pathogens in the home. Pediatr infect Dis J 2000; 19[Suppl10]: S103-5.
14 Van Damme P et al. Multicenter prospective study of the burden of rotavirus acute gastroenteritis in Europe, 2004-2005: the REVEAL study. J Infect Dis 2007, 195 [suppl1]: S4-16.
15 Santos N and Hoshino Y. Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine. Rev Med Virol 2005;15:29-56.
16 Vesikari T et al. Effects of the potency and composition of the multivalents human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. Vaccine 2006; 24: 4821-4829.
17 Block SL et al. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics 2007;119:11-18.
18 Vesikari T et al. Clinical Trials of rotavirus vaccines in Europe. Pediatr Infect dis J 2006;25(1):S42-S47.
19 RotaTeq SmPC. 2006.

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