Rotavirus vaccine

Dr. Laura Sauvé (biography and disclosure)

What is the issue

Burden of rotavirus: Rotavirus causes up to 40% of childhood gastroenteritis; virtually all children will have at least one episode by age 5, with at least 1 in 20 visiting the emergency department.  IMPACT has demonstrated that we have at least 450 cases per year of rotavirus leading to hospitalization in Canadian children’s hospitals. In addition to these hospitalizations, there is considerable burden on families and outpatient physician visits.  Worldwide, rotavirus is a major killer of children, causing up to 5% of deaths of children under the age of 5 years. Most severe rotavirus happens prior to the age of 2 years with the first episode; subsequent episodes are less likely to be severe.

A question I get asked frequently

Should I recommend the rotavirus vaccine & how safe is it? The rotavirus vaccine was funded as part of the public health care system in British Columbia in 2012.  There are two oral, live attenuated vaccines, Rotarix® (Glaxo-Smith-Kline) and Rotateq® (Merck).  Rotarix® has been chosen for the public health program in BC.  Questions that arise are (1) is it worth vaccinating against rotavirus? and (2) is it a safe vaccine – specifically, is it associated with intussusception like the Rotashield vaccine in the 1990s? Prior to 2012 in BC, uptake has been minimal.

Vaccine effectiveness & efficacy: In very large clinical trials, both vaccines were shown be highly efficacious at preventing severe rotavirus gastroenteritis, rotavirus-related emergency department visits and hospitalizations.  In 2007, with approximately half of American infants being vaccinated against rotavirus, surveillance in the United States showed a decrease of more than 50% of rotavirus diarrhea in all ages of children (not just those vaccinated).

Vaccine safety: Both rotavirus vaccine products have been shown to be safe and well tolerated.  A previous vaccine (Rotashield®, Wyeth) was linked to an excess risk of intussusception, so investigators, policy makers and physicians have been quite cautious.  With much larger than usual phase three Rotavirus vaccine trials and post-marketing surveillance, there has been no significant concern about excess cases of intussusception. While small numbers of Rotarix® vaccine trial participants (<5%) reported gastrointestinal upset, fever, or irritability, the proportion was the same in the placebo groups.  In the Rotateq® vaccine trials, there was a small, statistically significant increase in vomiting (15% vs. 14%) and diarrhea (24% vs. 21%).  The trials did not find any increased rates of severe adverse events.  Since both vaccines are live attenuated oral vaccines, there is some fecal excretion of the vaccine strain of rotavirus, but poses little danger to contacts (including immunocompromised contacts).

What I recommend (practice tip) to GPs in managing this problem?

The bulk of the evidence suggests that both rotavirus vaccines are safe and effective. They should be given as recommended by BCCDC at 2 and 4 months of age, with the other routine immunizations.  The information sheet for health practitioners (link added) suggests giving it at the beginning of a visit, while the child is happy. The vaccine is really sweet, so one could also give it around the time of the shots, as an adjunct pain relief. The first dose must be given between 6 and 20 weeks. The second dose must be given between 10 weeks and 8 months of age (minimum 1 month after dose 1).

Rotavirus vaccines can prevent important morbidity for young infants, and the associated physician visits, emergency department visits, hospitalizations and related parental stress and missed work days due to rotavirus infection.

References (Note: Article requests might require a login ID with CPSBC or UBC)

1. BC Centers for Disease Control. Section IIA – Immunization Schedules. Communicable Disease Control Immunization Program.  Available at http://www.bccdc.ca/dis-cond/comm-manual/CDManualChap2.htm
2. Immunize BC. Rotavirus Vaccine Program in British Columbia Information for Health Care Providers. February 2012. Available at http://immunizebc.ca/sites/default/files/graphics/hcp_qa_rotavirus_final-feb_9_2012.pdf
3. Le Saux N, Bettinger JA, Halperin SA, Vaudry W, Scheifele DW; for Members of the Canadian Immunization Monitoring Program, Active (IMPACT). Substantial morbidity for hospitalized children with community-acquired rotavirus infections. 2005-2007 IMPACT surveillance in Canadian hospitals. Pediatr Infect Dis J. 2010 Sep;29(9):879-82. (View article with CPSBC or UBC)
4. Le Saux N, Bettinger J, Déry P, Embree J, Vaudry W, Halperin SA, McDermid A, Booth TF, Coyle D. The hidden costs and characteristics of childhood rotavirus emergency visits in Canada. Pediatr Infect Dis J. 2012 Feb;31(2):159-63. (View article with CPSBC or UBC)
5. National Advisory Committee on Immunization (NACI).  Updated Statement on the use of Rotavirus Vaccines. Canada Communicable Disease Report  2010 Jul;36 (ACS-4). (View article)
6. Salvadori M, Le Saux N, Canadian Paediatric Society, Infectious Diseases and Immunization Committee. Recommendations for the use of rotavirus vaccines in infants. Paediatr Child Health. 2010;15(8):519-523 (View article)

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Rotavirus vaccine

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