Tools for Practice


#151 Rotavirus Vaccine: A shot to get off the pot(ty)


CLINICAL QUESTION
What are the benefits and risks of the rotavirus vaccine?

BOTTOM LINE
In developed countries, rotavirus vaccine prevents serious diarrhea for one in 22 and reduces hospitalizations for one in 100. There does not appear to be an increase in intussusception rates. 


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EVIDENCE
  • For monovalent and pentavalent rotavirus vaccine (RV1 and RV5, respectively)   
    • Systematic Review (RV1: 29 Randomized Controlled Trials (RCTs), 101,671 infants; RV5: 12 RCTs, 84,592 infants), vaccine versus placebo in developed (western) countries.1 Statistically significant results at two years:  
      • Any rotavirus diarrhea: 
        • RV1: Relative Risk (RR) 0.33 (95% confidence interval, 0.21-0.50). 
        • RV5: RR 0.36 (95% confidence interval 0.25-0.50). 
          • Placebo rate ~9%, vaccine rate ~3%.  
          • Number Needed to Treat (NNT) ~17, either vaccine. 
      • Severe rotavirus diarrhea, NNT ~50, either vaccine. 
      • RV1 (no or too little data from RV5): 
        • Any diarrhea, NNT ~40. 
        • Any severe diarrhea, NNT ~22. 
        • Hospitalizations, NNT ~100. 
      • Mortality: No difference. 
      • Limitations: Inconsistent definition of ‘severe diarrhea’ in trials (varies from rotavirus diarrhea scales to hospitalization requiring rehydration therapy).   
    • Safety:  
      • Reactions to immunization similar between vaccine and placebo: rates were fever (38-41%), diarrhea (7-25%), vomiting (13-17%).1,2 
      • No increase in intussusception in RCTs or subsequent surveillance/observational data.1-5 
  Context: 
  • Rotavirus transmission is fecal-oral and fomites (including toys) with a 1-5 day incubation.6 
  • An estimated 80% of children have rotavirus gastroenteritis by age five.7  
    • One in 62-312 children are hospitalized for rotavirus.6 
    • Most (90%) Canadian cases occur December-April and 63% affect children <2 years old.8,9 
  • Licenced oral vaccines include: 
    • RV1 (Rotarix®; GlaxoSmithKline): Live attenuated, human monovalent rotavirus, two oral doses (two and four months). 
    • RV5 (RotaTeq®; Merck): Live human-bovine reassortment, pentavalent rotavirus, three oral doses (two, four, and six months). 
  • Publicly funded in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Prince Edward Island, Northwest Territories, and Yukon. 
  • Approximately $165-$200 per vaccine series. 
 
November 23, 2015

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Author(s):

  • Clark Svrcek MD
  • G. Michael Allan MD CCFP

1. Soares-Weiser K, MacLehose H, Ben-Aharon I, et al. Cochrane Database Syst Rev. 2012; (11):CD008521.

2. Vesikari T, Matson DO, Dennehy P, et al. NEJM. 2006; 354(1):23-33.

3. Dennehy PH, Brady RC, Halperin SA, et al. Pediatr Infect Dis J. 2005; 24(6):481-8.

4. Dennehy PH. 2006. Vaccine. 2006; 24(18):3780-1.

5. CDC. MMWR. 2007; 56(10):218-22. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5610a3.htm. Last accessed July 25, 2015.

6. Salvadori M, Le Saux N. Paediatric & Child Health. 2010; 15(8):519-23. Reaffirmed Feb. 28, 2015. http://www.cps.ca/documents/position/rotavirus-vaccines. Last accessed July 27, 2015.

7. Cortese MM, Parashar UD. MMWR Recommendations and Reports. 2009; 58(RR02):1-25. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5802a1.htm. Last accessed July 25, 2015.

8. Ford-Jones EL, Wang E, Petric M, et al. Arch Pediatr Adolesc Med. 2000; 154:586-93.

9. Le Saux N, Bettinger JA, Halperin SA, et al. Pediatr Infect Dis J. 2010; 29(9):879-82.

Authors do not have any conflicts of interest to declare.