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Vaccine of rota virus

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rotavirus vaccine efficacy safety

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Rotavirus Vaccine

Overview

Rotavirus is the leading cause of severe gastroenteritis in infants and young children worldwide. Two live, oral, attenuated rotavirus vaccines were licensed in 2006 and are now in wide use globally:
FeatureRV1 - Rotarix (GlaxoSmithKline)RV5 - RotaTeq (Merck)
TypeMonovalent (human strain G1P[8])Pentavalent (5 bovine-human reassortants: G1, G2, G3, G4, P1A[8])
Doses2 doses3 doses
Schedule2 and 4 months of age2, 4, and 6 months of age
Minimum age for 1st dose6 weeks6 weeks
Maximum age for 1st dose14 weeks, 6 days14 weeks, 6 days
Min. interval between doses4 weeks4 weeks
Maximum age for last dose8 months, 0 days8 months, 0 days
RouteOralOral
  • Red Book 2021, p. 1004-1006
  • Park's Textbook of Preventive and Social Medicine, p. 269

History - The Withdrawn Vaccine

A prior rotavirus vaccine called Rotashield (multivalent, live attenuated) was used in the US in 1998-1999 but was withdrawn due to a significant association with intussusception. - Yamada's Textbook of Gastroenterology, p. 2952

Efficacy

  • Both vaccines are highly effective in preventing severe rotavirus disease in high-income countries.
  • In low-income countries, efficacy is lower but both vaccines still reduce the incidence of severe disease by approximately 50-60%.
  • Despite lower efficacy, vaccines save more lives in low-income countries because of the higher baseline disease burden and mortality.
  • After rotavirus vaccine introduction, sustained declines in diarrhoea deaths were observed in Mexico, Latin America, and Europe. - Yamada's Textbook of Gastroenterology, p. 2956

Key Administration Rules

  1. Same product preferred - The series should be completed with the same product whenever possible.
  2. If product unknown - If any dose was RV5 or the product is unknown, administer a total of 3 doses.
  3. Concurrent vaccines - Can be given simultaneously with other childhood vaccines.
  4. Regurgitation - If the infant spits out or vomits the dose, do not repeat it.
  5. Breastfeeding - Breastfed infants follow the same schedule as non-breastfed infants.
  6. Preterm infants - Can be immunized at the same chronological age (at least 6 weeks postnatal) if clinically stable.

Contraindications

  • Severe allergic reaction (anaphylaxis) to a prior dose or vaccine component
  • SCID (Severe Combined Immunodeficiency) - live vaccine virus can cause prolonged, severe gastroenteritis
  • History of intussusception
  • Infants exposed in utero to biologic response modifiers (BRMs) - avoid for the first 12 months after last in utero BRM exposure (exceptions: certolizumab, and likely infliximab)

Special Populations

  • HIV-exposed/infected infants - Should receive rotavirus vaccine regardless of CD4+ count, per standard schedule.
  • Immunocompromised household contacts - Highly immunocompromised individuals should avoid handling diapers of recently vaccinated infants for 4 weeks post-vaccination.
  • Latex allergy - The tip caps of RV1 (Rotarix) prefilled applicators may contain natural rubber latex; these infants should preferentially receive RV5 (RotaTeq), whose dosing tubes are latex-free.
  • Infants with prior rotavirus gastroenteritis - Should still complete the vaccine series per standard schedule.

Intussusception Risk

There is a potentially higher risk of intussusception when the first dose is given to infants older than 12 weeks (14 weeks, 6 days is the absolute maximum). This is why:
  • Rotavirus vaccines should not be used in catch-up vaccination campaigns where exact infant age may be uncertain.
  • Vaccination should not be initiated after 14 weeks, 6 days of age. - Park's Textbook, p. 269
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