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Published on: January 28, 2019
Intussusception among infants given an oral rotavirus vaccine
T V Murphy1, P M Gargiullo, M S Massoudi
1Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. tvmurphy@cdc.gov
Insights
The tetravalent rhesus-human reassortant rotavirus vaccine (RRV-TV) is linked to an increased risk of intussusception in infants. This study found a causal relationship, highlighting the need for safer rotavirus vaccines.
Area of Science:
- Pediatric Gastroenterology
- Vaccinology
- Epidemiology
Background:
- Intussusception is a serious intestinal obstruction where a segment of bowel prolapses into another.
- Nine infant cases of intussusception post-RRV-TV vaccination prompted this investigation.
Purpose of the Study:
- To assess the potential association between the rhesus-human reassortant rotavirus vaccine (RRV-TV) and intussusception in infants.
- To determine if RRV-TV vaccination increases the risk of intussusception in infants aged 1 to 12 months.
Main Methods:
- A case-control study was conducted across 19 states, analyzing infants hospitalized between November 1998 and June 1999.
- Infants with intussusception were matched with four healthy controls by age and birthplace.
- Vaccination status was verified by healthcare providers.
Main Results:
- The study analyzed 429 infants with intussusception and 1763 controls.
- A statistically significant increased risk of intussusception was observed 3-14 days after the first RRV-TV dose (OR 21.7).
- An estimated 1 case of intussusception per 4670-9474 vaccinated infants was calculated.
Conclusions:
- A strong causal association exists between RRV-TV vaccination and intussusception in healthy infants.
- The findings underscore the urgent need for rotavirus vaccines with enhanced safety profiles.
Background:
Intussusception is a form of intestinal obstruction in which a segment of the bowel prolapses into a more distal segment. Our investigation began on May 27, 1999, after nine cases of infants who had intussusception after receiving the tetravalent rhesus-human reassortant rotavirus vaccine (RRV-TV) were reported to the Vaccine Adverse Event Reporting System.
Methods:
In 19 states, we assessed the potential association between RRV-TV and intussusception among infants at least 1 but less than 12 months old. Infants hospitalized between November 1, 1998, and June 30, 1999, were identified by systematic reviews of medical and radiologic records. Each infant with intussusception was matched according to age with four healthy control infants who had been born at the same hospital as the infant with intussusception. Information on vaccinations was verified by the provider.
Results:
Data were analyzed for 429 infants with intussusception and 1763 matched controls in a case-control analysis as well as for 432 infants with intussusception in a case-series analysis. Seventy-four of the 429 infants with intussusception (17.2 percent) and 226 of the 1763 controls (12.8 percent) had received RRV-TV (P=0.02). An increased risk of intussusception 3 to 14 days after the first dose of RRV-TV was found in the case-control analysis (adjusted odds ratio, 21.7; 95 percent confidence interval, 9.6 to 48.9). In the case-series analysis, the incidence-rate ratio was 29.4 (95 percent confidence interval, 16.1 to 53.6) for days 3 through 14 after a first dose. There was also an increase in the risk of intussusception after the second dose of the vaccine, but it was smaller than the increase in risk after the first dose. Assuming full implementation of a national program of vaccination with RRV-TV, we estimated that 1 case of intussusception attributable to the vaccine would occur for every 4670 to 9474 infants vaccinated.
Conclusions:
The strong association between vaccination with RRV-TV and intussusception among otherwise healthy infants supports the existence of a causal relation. Rotavirus vaccines with an improved safety profile are urgently needed.
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