Rotavirus Vaccine – Canadian Paediatric Society

screen-shot-2016-10-10-at-12-37-10-am Rotavirus is a double stranded RNA. 2 outer capsid proteins, VP7, the glycoprotein (G protein), and VP4 (P protein, which refers to virus serotype). Genotypes commonly affecting humans: G1P, G2P, G3P, G4P, with G1P being the commonest in Canada.


Transmission: feco-oral, fomites (remain on objects for months)

Incubation period: 48h

Presentation: vomiting and fever may precede diarrhea.

  • First 3 months: mild presentation due to maternal
  • 3 months to 5 years: variable, mild to severe diarrhea, +/- vomiting.

Course: Resolves in 3-7 days

When is it Rotavirus Season?

Starts in November to December.

Peaks in February to March (Western Canada), March to April (Eastern Canada).

Why is prophylaxis important?

Rotavirus gastroenteritis can lead to significant dehydration, shock, death if not managed appropriately. Most severe manifestations occur with the first episode and get milder with subsequent episodes.

Mortality is rare, but morbidity and healthcare costs, are similar to AOM, uncomplicated pneumonia.

Although, only a minority require hospitalization (median of 3 days in one study), since the introduction of rotavirus immunization programs, numerous studies have demonstrated a substantial decline in rotavirus disease, rotavirus related hospitalizations particularly <1 year of age, and shortened or eliminated peak seasons.

Herd immunity was demonstrated, with significant decreases in RV gastroenteritis hospitalizations for all age groups ≤19 years and significant decreases in acute gastroenteritis hospitalizations for all age groups, including those ≥65 years of age.

Evidence for rotavirus vaccination decreasing seizure- related hospitalizations in childhood, most marked in children <2 years of age. 1) Due to reduced febrile seizures, 2) limiting direct neurologic effects of systemic rotavirus infection.

Risk Factors for Severe Illness:

  • Prematurity (possibly due to lack of maternal antibodies)
  • immunocompromised state (severe, prolonged and fatal illness)

Not risk factors for rates of hospitalizations due to rotavirus:

  • socio-economic status
  • parental marital status
  • child care attendance
  • ethnicity

Breastfeeding may be protective against symptomatic rotavirus infection.

Rotavirus gastroenteritis is considered to be more severe than gastrointestinal illness, for several reasons: 1) association with vomiting, 2) gut epithelial damage leading to significant diarrhea, 3) can be associated with viremia, leading to more severe presentations, particularly in young infants.

Diagnosis: non specific clinical features, limiting clinical diagnosis. Stool enzyme immunoassay to detect antigen. Some labs offer molecular based testing.

Rotavirus Vaccine

Two types:

  1. RotaTeq (RV5), a live, oral, pentavalent bovine human reassortant vaccine composed of five strains.
    • RotaTeq is supplied in single prefilled 2 mL tubes and given as three oral doses.
  2. Rotarix (RV1), A live-attenuated monovalent G1P1 vaccine derived from a single human strain, RIX4414.
    • Rotarix is supplied in single prefilled 1.5mL tubes and given as two oral doses.

Both vaccines are latex-free. Since both are live virus vaccines, they should be stored in a refrigerator at 2°C to 8°C, and they do not require reconstitution before administration.

No data on whether they are interchangeable or not, so it is recommended to stick to the same type. Moreover, if RV5 is given, remember to give three, rather than two, doses.

When to vaccinate: Can be started at 6 weeks. Given at same time as regularly scheduled immunizations. 2 and 4 months. A minimal interval between doses of four weeks.

However, if any dose in the series was the RV5 vaccine, a total of three doses of vaccine should be administered.

The last dose must be given before eight months, 0 days of age because of concern about intussusception when given later.

The Public Health Agency of Canada’s National Advisory Committee on Immunization (NACI) indicates that the first dose should be given before a child is 14 weeks, six days of age. However, if this first dose of RV1 was not administered before that point, a catch-up first dose can be administered up to 20 weeks of age. This does not apply to RV5.

Because Rotavirus vaccines contain sucrose, it may be helpful to administer the oral rotavirus vaccine before injectable vaccines to aid in pain reduction.

Duration of protection unknown.

Some evidence to suggest that the circulating wild-type genotypes of rotavirus may shift after universal vaccination. Vaccine efficacy has not changed substantially with shifts in wild-type genotypes.


RV1 and RV5: mall increased risk of intussusception among infants 1-7 days after receiving their 1st and 2nd Rotavirus vaccine doses. These risks were in the order of 1 to 3 excess cases for every 100,000 infants vaccinated,

In Canada, 19 case reports of intussusception following rotavirus vaccine were reported between 2011 and 2014. Fifteen of these cases occurred within 21 days of immunization, representing a rate of 0.74 cases per 100,000 doses distributed during that time period.

Advice for Parents:

Benefits of disease prevention, which are substantial, relative to the very small increased risk of intussusception. Particularly in the first week following rotavirus vaccine.

Health Care Providers:

Follow-up for all infants who have persistent vomiting, or appear to have severe abdominal pain, bloody stools and/or a high fever or who have a documented intussusception. Inquire specifically about recent Rotavirus vaccination.

Report all cases of intussusception occurring within 21 days of receiving rotavirus vaccine to local public health authorities, using the adverse event reporting system administered by the Public Health Agency of Canada (

Fecal shedding of Rotavirus vaccine virus is common (50% to 80%) in the first week following vaccination. Falls to <24% at 30 days. Shedding becomes less common with subsequent doses. The clinical significance of viral shedding and the potential for horizontal transmission are unknown, but to date there has been no reported adverse clinical effect on household members or contacts.

If there is a pregnant or immunocompromised person in the household: vaccinate infant as per the routine schedule because the indirect protection provided by preventing wild-type rotavirus infection outweighs the risk of transmitting vaccine virus.

Good hygiene practices, including the cleaning of surfaces and hand hygiene after diapering, should be emphasized.


  1. A history of intussusception/greater susceptibility to intussusception (eg, uncorrected Meckel’s diverticulum)
  2. Hypersensitivity to any of the ingredients in rotavirus vaccines
  3. Known or suspected SCID/immunocompromised state

Other important tips:

Mild illness with or without fever ==> like other vaccines, give.

If spits/regurgitates a dose = do not repeat.

If previously documented rotavirus infection: should still receive rotavirus vaccination

Preterm infants (6 weeks to 8 months) should receive rotavirus vaccine at/following discharge. Schedule is the same as for term infants.

Infants who are HIV-exposed should receive vaccine according to chronological age.


CPS Summary of Recommendations

  • Recommended for all infants except those who are immunocompromised or have a history of or a known condition that predisposes them to intussusception. Premature and immunocompromised hosts are at highest risk of severe infection.
  • Both licensed rotavirus vaccines are efficacious, but stick to the same one.
  • 2 doses, unless RV5 was used, in which case, a total of 3 doses should be administered
  • Started as early as six weeks, but usually given at 2 months
    • Usually given at two and four months of age if using RV1, with a third dose at six months if using RV5.
    • If a first dose of RV1 (Rotarix) has been delayed beyond 15 weeks, NACI recommends catch-up first dose up to 20 weeks chronological age. **does not apply to RV5.
  • Inform caregivers of slightly higher temporal risk for intussusception, especially in the week after receiving rotavirus vaccine.



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