U.S. Health Authorities Report Reduction In Rotavirus Disease After The Introduction Of Pentavalent Rotavirus Vaccine RotaTeq(R)

Main Category: Immune System / Vaccines
Also Included In: GastroIntestinal / Gastroenterology;  Infectious Diseases / Bacteria / Viruses
Article Date: 10 Jul 2008 - 4:00 PDT

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Findings from the U.S. Centers for Disease Control and Prevention (CDC) show that rotavirus disease was dramatically reduced in the United States from November 2007 through May 2008 compared to previous years. The findings were published in the CDC's Morbidity and Mortality Weekly Report on the 26th June.1

RotaTeq®, Merck & Co. Inc.'s and Sanofi Pasteur MSD's pentavalent oral rotavirus vaccine was introduced in February 2006 in the U.S. and was the only rotavirus vaccine used during this period.*

"Although these data are preliminary, as a paediatrician, I am excited about the marked reduction in rotavirus disease we saw this season which coincided with increasing uptake of RotaTeq®," comments Mary Allen Staat, M.D., M.P.H., professor of Paediatrics at the University of Cincinnati, and a member of the Infectious Disease Division at Cincinnati Children's Hospital Medical Center, one of the primary CDC rotavirus surveillance sites.

In one analysis in the CDC report, the percentage of tests that were positive for rotavirus in the 2007-2008 rotavirus season was lower than in the previous 15 years. Only 18% of samples tested were positive during the peak of rotavirus season in April 2008, compared with a median of 41% (range 31-46%) at the peak of previous (from July 1991 until June 2006).†

In the second analysis, the data showed a marked reduction in hospitalisations and accident and emergency (A&E) department and clinic visits due to rotavirus gastroenteritis during 2008 compared with 2006 and 2007. Among those children who presented to hospitals, A&E departments or outpatient clinics in the three counties in the US included in the analysis with acute gastroenteritis, 207 patients had rotavirus gastroenteritis in 2006; 259 in 2007; and only 18 in 2008. The overall proportion of faecal samples from these children that tested positive for rotavirus was approximately 51% in 2006; 54% in 2007; and only 6% in 2008.‡

"These data are very promising. They suggest that rotavirus vaccination could also be beneficial for infants in Europe," says paediatrician and vaccine expert Prof. Markus Rose from Frankfurt University Childrens' Hospital, Germany. "This has also been recognised by two major European paediatric societies which have urged that parents and children have full access to rotavirus vaccination, so we can start reducing the significant health and socio-economic burden of rotavirus disease."

Rotavirus is a major cause of severe dehydration due to vomiting and diarrhoea leading to children being hospitalised for gastroenteritis in Europe§.2,3 Five rotavirus types (G1, G2, G3, G4, G9) cause more than 98% of paediatric rotavirus diseases in Europe.4,5

RotaTeq® is the only pentavalent rotavirus vaccine offering efficacy against the five major disease-causing virus types (G1, G2, G3, G4, G9) and to have demonstrated high sustained protection up to three years after vaccination.

* Further monitoring and investigation will assess to what extent the observed reduction in rotavirus disease reported by the CDC is related to the use of RotaTeq®.
† These results were based on data from the National Respiratory and Enteric Virus Surveillance System, a network of U.S. laboratories of which 70 were included in the 2007-2008 analysis.
‡ These results were based on data from the New Vaccine Surveillance Network, which conducts population-based surveillance for rotavirus gastroenteritis among children less than 3 years of age in three counties in the U.S.
§ European Union member states (except Romania and Bulgaria)

More about rotavirus gastroenteritis

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.6

Rehydration 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, a seemingly mild form of the disease can become life-threatening7,8 and require hospitalisation for intravenous re-hydration.

By the age of five, almost every child will experience an episode of rotavirus gastroenteritis.9 Among European children aged 5 or younger, about 200 to 250 die every year from rotavirus disease10, while it is estimated that 87,000 (one in 54) are hospitalised due to rotavirus gastroenteritis, over 700,000 (one in seven) require a doctor's visit and 3.6 million experience an episode of rotavirus gastroenteritis.11

As rotavirus is highly contagious and relatively resistant to its environment,6, 12, 13 vaccination is recognised as the only effective control measure to have a significant impact on the burden of severe paediatric rotavirus gastroenteritis.7, 14

More about RotaTeq®

RotaTeq® (pentavalent** rotavirus vaccine, live, oral) is a fully liquid and ready-to-use vaccine with three doses, indicated in the European Union for the active immunisation of infants from the age of six weeks for prevention of gastroenteritis due to rotavirus infection.15

In clinical trials, RotaTeq® has shown to prevent 98%†† to 100%‡‡ of severe paediatric rotavirus gastroenteritis due to the rotavirus types G1, G2, G3 and G4.16, 17, 18, 19 The vaccine also reduced related hospitalisation and A&E department visits due to rotavirus types G1, G2, G3 & G4 by 94.5%§§ and to the rotavirus type G9 by 100%.*** 18, 19

RotaTeq® provided high sustained efficacy (94%†††) in reducing hospitalisations and emergency room (ER) visits due to rotavirus gastroenteritis (RVGE) in children after up to three-years of follow-up.20

As of March 2008, RotaTeq® has been approved in 80 countries around the world, including the member states of the European Union, and more than 17 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.

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. http://www.spmsd.com

** G1, G2, G3, G4, P1[8]
†† 95% CI [ 88.3, 100]
‡‡ 95% CI [13 ,100]
§§ 95% CI [91.2 ,96.6]
*** 95% CI [67.4,100]
††† 95% CI [ 91.3, 95.9]

References

1. MMWR report, vol. 57, June 25, 2008, early release. See here. (last accessed 27 June 2008)

2. 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.

3. Giaquinto C et al., Clinical Consequences of Rotavirus Acute Gastroenteritis in Europe, 2004-2005: The REVEAL Study. J Infect Dis 2007, 195 [suppl1]: S26-35

4. 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.

5. Van Damme.P et al., Distribution of Rotavirus Genotypes in Europe, 2004-2005: The REVEAL Study. J Infect Dis 2007, 195[Suppl 1], S17-S25.

6. Raebel MA, Ou BS. Rotavirus disease and its prevention in infants and children. Pharmacotherapy 1999;19(11):1279-1295.

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

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

9. See here accessed 07 May 2008

10. Parashar UD, Glass RI. Rotavirus vaccination in Europe: the time has finally arrived. J Pediatr Gastroenterol Nutr 2008 ; 46:S21-23,.

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

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

15. RotaTeq®, Summary of Product Characteristics 2008.

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., Efficacy of RotaTeq® to reduce any severity and severe rotavirus disease in Europe. Poster presentation International Congress of Paediatrics (ICP), Athens, 25-30 August 2007.

19. 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.

20. Vesikari T and al. Efficacy of the pentavalent rotavirus vaccine, RotaTeq®, against hospitalisations and emergency departments visits through the third year of life: the Finnish extension study.( Abstract) 13th International Congress for Infectious Diseases (ICID), in Kuala Lumpur (Malaysia), 19-22 June 2008.

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