Rotavirus Vaccine Dramatically Reduces Hospital Visits For Rotavirus Gastroenteritis

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Infectious Diseases / Bacteria / Viruses;  Immune System / Vaccines
Article Date: 14 Nov 2008 - 1:00 PST

email to a friend   printer friendly   view / write opinions   rate article

New results presented at the ICAAC/IDSA* congress in Washington show that the pentavalent oral rotavirus vaccine RotaTeq®† reduced hospitalisations and accident and emergency (A&E) department visits related to rotavirus gastroenteritis (RVGE) by up to 100%‡, consequently also avoiding the related costs§.1 The nationwide observational study, conducted in the USA by Sanofi Pasteur MSD's parent company Merck &Co. Inc., evaluated the effectiveness of RotaTeq® during winter seasons in 2007 and 2008 (eg. between Jan 1st to April 30th 2007 and the first month of the rotavirus season, Jan 2008) in 33,135 infants who received three doses of RotaTeq® and 27,954 infants who had not been vaccinated with RotaTeq®.

These data are consistent with results from the U.S. health authorities (Centers for Disease Control and Prevention (CDC))2,3, a large diagnostic laboratory in the U.S. covering approximately half of the U.S. population (Quest Diagnostics)4 and several hospitals and medical schools.5,6,7,8,9 In June 2008, the U.S. health authorities reported that rotavirus disease and related hospitalisations and A&E department visits were dramatically reduced from November 2007 to May 2008 compared to previous years.10 The data from Quest Diagnostics also suggest that rotavirus vaccination reduced the transmission of the virus to non-vaccinated infants (herd immunity).4

The data are also consistent with those from the large clinical studies during the development of RotaTeq®. In these studies, RotaTeq® prevented 98% (95% CI [ 88.3, 100]) to 100% (95% CI [13 ,100]) of severe paediatric rotavirus gastroenteritis due to the rotavirus types G1, G2, G3 and G411,12 and also reduced hospitalisations and A&E department visits related to types G1, G2, G3 & G4 by 94.5% (95% CI [91.2 ,96.6]) and G9 by 100% (95% CI [67.4,100]).12,13 Types G1, G2, G3, G4 and G9 are the major disease-causing rotavirus types and cause more than 98% of rotavirus disease in Europe.15,14

"The new observational data confirm the high efficacy of pentavalent rotavirus vaccination in real life to prevent severe rotavirus gastroenteritis demonstrated before in the clinical development. The dramatic and fast reduction of infant hospitalisation and A&E visits are very encouraging also for rotavirus vaccination in Europe. Each winter season we see the burden of rotavirus epidemics which can be particularly severe on babies and young children," says Professor Marc Van Ranst, MD PhD at the University of Leuven in Belgium. The vaccine was approved and recommended for routine vaccination of infants by the U.S. authorities in early 2006 and is today largely reimbursed by either insurance funds or through the authorities' Vaccine For Children (VFC) Programme.

"Beyond the reduced suffering of infants, these real-life figures also demonstrate the relief that rotavirus vaccination can bring to the whole family in terms of avoided anxiety, stress and leave of work. It would also considerably reduce the burden of Rotavirus Gastro-enteritis on the health care system" says Carlo Giaquinto, MD, PhD, Assistant Professor at the University of Padova in Italy.

* Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) / Infectious Diseases Society of America (IDSA)
† (pentavalent (G1,G2,G3,G4, P1[8]) rotavirus vaccine, live, oral)
‡ Combined, 0.0 vs. 3.7 events per 1,000 person-years, 95% CI [86,100]
§ $0.0 vs. approximately $10,000 per 1,000 person-years, 95 % CI [100,100]

Merck Post-Licensure Effectiveness of RotaTeq® in Preventing Gastroenteritis study details

The post-licensure vaccine effectiveness study assessed the effectiveness of RotaTeq® in the USA, through rotavirus season 2007 and 2008, by analysing data from a large, national health insurance claims database. For this analysis, the frequency of hospitalisations, emergency department visits and physician office visits associated with a physician diagnosis for rotavirus gastroenteritis were compared between two groups: 33,135 infants who received three doses of RotaTeq® and 27,954 infants who had not been vaccinated with RotaTeq®, but who had received other routine childhood vaccines according to national recommended schedules.1

REST & FES study details

The Rotavirus Efficacy and Safety Trial (REST) was a double-blind, placebo-controlled phase III clinical study of RotaTeq® that enrolled almost 70,000 infants worldwide, aged 6 to 12 weeks of age who received 3 doses, with 43% (31,000) of these infants coming from Europe.21 The Finnish Extension Study (FES): Around 21,000 infants (vaccine + placebo) from the REST study were followed up to 3 years after completion of vaccination for healthcare utilization. Parents were contacted every 12 weeks to determine whether a rotavirus gastroenteritisrelated event occurred. 17

More about rotavirus gastroenteritis

By the age of five, almost every child will experience an episode of rotavirus gastroenteritis. Among European children aged 5 or younger, about 200 to 250 die every year from rotavirus disease21. While it is estimated that 87,000 (one in 54) are hospitalised due to rotavirus gastroenteritis, over 700,000 (estimated as one in seven) require a doctor's visit and 3.6 million experience an episode of rotavirus gastroenteritis.22 As rotavirus is highly contagious and relatively resistant to its environment,23,24 vaccination is recognised as the only effective control measure to have a significant impact on the burden of severe paediatric rotavirus gastroenteritis.25,26 The typical symptoms of rotavirus infection 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.27, 28 Re-hydration is the key treatment and should be applied as soon as possible. There are no risk factors for developing a severe case of rotavirus gastroenteritis. Overnight, seemingly mild form of the disease can become life-threatening28 and require hospitalisation for intravenous re-hydration. Different rotavirus types can circulate concomitantly and in proportions that may vary from country to country and from one season to another. Thus, it is hard to predict which rotavirus type will infect a child.14 Unlike for many other childhood infectious diseases, several infections with rotavirus are needed to build protection against rotavirus disease. Successive infections usually occur with different rotavirus types. A protection of 92% required three successive rotavirus infections according to a study.29 Nearly 90 % of rotavirus gastroenteritis cases occur between three months and three years of age.19

More about RotaTeq®

RotaTeq® (pentavalent (G1,G2,G3,G4, P1[8]) rotavirus vaccine, live, oral) is an orally administered, fully liquid and ready-to-use vaccine given in 3 doses. In its clinical development RotaTeq has demonstrated a consistent level of efficacy not only across different trials; 98% to 100% of severe paediatric rotavirus gastroenteritis, but also across regions; Latin America, US and Europe, and populations; premature breastfed infants.11,12,13 30,31 Protection provided by RotaTeq covers the main risk period of RVGE that extends from 3 months to 3 years of age, with a high level of efficacy starting 14 days after the first dose and up to 3 years after the third dose. 14,15,17,18,19 As of September 2008, RotaTeq® has been approved in 87 countries around the world, including the member states of the European Union, and more than 18 million doses have been distributed worldwide. In Western Europe, it is available in Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Portugal and Spain.32

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, 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. Mast C et al. Post-Licensure Effectiveness of RotaTeq® in Preventing Gastroenteritis. 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008 (poster and abstract with updated data).

2. Boom J et al. Effectiveness of Pentavalent Rotavirus Vaccine (RV5) in US Clinical Practice. 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008 (abstract).

3. Parashar U et al. Monitoring the Uptake and Impact of the New US Rotavirus Vaccination Program. 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008 (abstract).

4. Lieberman JM et al. Decline in Rotavirus Cases in the U.S. After Licensure of a Live, Oral Rotavirus Vaccine. 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008 (abstract)..

5. Clark HF et al. Decline in Rotavirus (RV) Gastroenteritis (GE) Presenting to The Children's Hospital of Philadelphia (CHOP) After Introduction of Pentavalent Rotavirus Vaccine (PRV). 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008 (abstract).

6. Daskalaki I et al. Epidemiology of Rotavirus-Associated Hospitalizations Pre- and Post-Implementation of Immunization: North Philadelphia, 2000-2008. 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008(abstract).

7. Harrison CJ et al. Fewer 2008 Hospitalizations for Rotavirus (RV) in Kansas City, Two Years Post RV Vaccine. 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008(abstract).

8. Patel JA et al. Reduction of Severe Rotavirus Gastroenteritis Following the Routine Use of Live, Oral, Pentavalent Rotavirus Vaccine. 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008(abstract).

9. Hatch S et al. Rapid Decline in Pediatric Rotavirus Cases Following Introduction of Rotavirus Vaccine. 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008(abstract).

10. MMWR report, vol. 57, June 25, 2008, early release. See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm57e625a1.htm (last accessed 27 October 2008)

11. 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.

12. 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.

13. Vesikari T and Guarino A, J Pediatr Gastroenterol Nutr 2008;46

14. Van Damme et al. Distribution of rotavirus genotypes in Europe, 2004-2005: the REVEAL study. JID 2007:195(suppl 1) S17-S25.

15. Vesikari et al. Efficacy of the Pentavalent Rotavirus Vaccine, RotaTeq™, against Hospitalizations and Emergency Department Visits through the Third Year of Life: the Finnish Extension Study. 13th ICID. Kuala Lumpur Malaysia, June 2008 (abstract).

16. Vesikari et al. Serotype-Specific Efficacy of the Pentavalent Rotavirus Vaccine against Hospitalizations and Emergency Department Visits up to Three Years: The Finnish Extension Study. 48th ICAAC/ 46th IDSA. Washington DC USA, October 2008 (poster and abstract with updated data).

17. Dennehy P et al. Efficacy of the Pentavalent Rotavirus Vaccine, RotaTeq®, between Doses: Potential Benefits of Early Protection. PAS and ASPR Joint Meeting. Honolulu Hawaï USA, May 2008 (abstract and oral presentation).

18. Van Damme et al. Multicenter prospective study of the burden of rotavirus acute gastro-enteritis in Europe, 2004-2005: the REVEAL study. JID 2007: 195 (suppl 1) S4-S16.

19. REVEAL global report July 2007. SPMSD data in file.

20. Vesikari et al. Efficacy of RotaTeq to reduce any severity and severe rotavirus disease in Europe. 25th ICP. Athens Greece, August 2007 (poster and abstract).

21. Parashar UD, Glass RI. Rotavirus vaccination in Europe: the time has finally arrived. J Pediatr Gastroenterol Nutr 2008;46:21-23.

22. Soriano-Gabarro M. et al. Burden of rotavirus disease in European countries. Pediatr Infect Dis J 2006:25 (1):S7-S11.

23. Fischer TK, Bresee JS, Glass RI. Rotavirus vaccines and the prevention of hospital acquired diarrhea in children. Vaccine 2004;22:49-54

24. Dennehy PH. Transmission of rotavirus and other enteric pathogens in the home. Pediatr infect Dis J 2000; 19[Suppl10]: S103-5.

25. Clark HF and Offit PA. Vaccines for rotavirus gastroenteritis universally needed for infants.Ped Ann 2004; 33(8). 537-543.

26. Parashar UD. et al. Global illness and deaths caused by rotavirus disease in children. Emerg Inf Dis 2003;9:565-572

27. Clark HF and Offit PA. Vaccines for rotavirus gastroenteritis universally needed for infants. Ped Ann 2004; 33(8). 537-543.

28. Matson D.O. In: Long SS Ed. Principles and Practice of Paediatric Infectious Diseases. New York: Churchill Livingstone 2003. 1105-1108.

29. Velázquez FR et al. Rotavirus infections in infants as protection against subsequent infections. N Engl J Med 1996; 335:1022-1028.

30. Goveia M.G et al. Safety and efficacy of the pentavalent human-bovine (wc3) reassortant rotavirus vaccine in healthy premature infants. Pediatr Infect DisJ 2007. In press.

31. Goveia and al. Efficacy of pentavalent Human-Bovine (WC3) reassortant rotavirus vaccine based on breastfeeding frequency. Pediatr Infect Dis J 2008, 27(7):656-658

32. SPMSD, internal data

Sanofi Pasteur MSD is the only European company dedicated exclusively to vaccines

Sanofi Pasteur MSD