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Rotavirus vaccination does not increase long-term risk for intussusception
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Despite a slightly increased risk for intussusception shortly after rotavirus vaccination, infants who received either of the two available vaccines in the United States were not at increased risk for the condition after 2 years, according to a report published in the Journal of the Pediatric Infectious Diseases Society.
The first available vaccine against rotavirus — RotaShield (Wyeth Laboratories) — was introduced in the U.S. in 1998 but was pulled from the market in 1999 because of a potential risk for intussusception. Beginning in 2006, two other rotavirus vaccines were licensed and recommended for routine immunization of U.S. infants: the pentavalent RotaTeq (Merck) and the monovalent Rotarix (GlaxoSmithKline).
Rachel M. Burke, PhD, MPH, an epidemiologist in the Division of Viral Diseases at the CDC, and colleagues wrote that although post-licensure studies of the two available vaccines have demonstrated a short-term risk for intussusception, the long-term risks have not been assessed.
The researchers analyzed administrative claims data from the Truven Health MarketScan Commercial Claims and Encounters Database, focusing on commercially insured U.S. children born on or after Jan. 1, 2006, and who were followed up for 2 years.
Their analysis included 1,858,827 children. Intussusception was identified in 544 of these children, and 385 had the intussusception code in the first diagnostic position. Nearly three-quarters of cases (74.6%; n = 406) occurred in children aged younger than 12 months. After 2 years, the risk for intussusception was 0.044% (95% CI, 0.040%-0.048%). The greatest risk for intussusception, the researchers wrote, occurred between approximately age 2 and 12 months.
According to the researchers, of the 1,349,221 children who survived and were followed until at least 8 months of age, 67.2% were fully vaccinated against rotavirus, 12.5% were partially vaccinated and 20.3% were unvaccinated. Crude and adjusted HRs were comparable between the groups and nonsignificant, they said. For example, the adjusted HRs were 0.79 (95% CI, 0.57-1.09) for fully vaccinated children and 0.89 (95% CI, 0.66-1.19) for partially vaccinated children.
“The benefits of rotavirus vaccination already have been estimated to outweigh the increased short-term risk for intussusception,” Burke and colleagues wrote. “The results of our study provide additional data to support the long-term safety profile of the vaccines and support continued rotavirus vaccination in the U.S.” – by Katherine Bortz
Disclosures: The authors report no relevant financial disclosures.
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