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Intussusception Risk and Disease Prevention Associated With Rotavirus Vaccines in Australia's National Immunization Program

2013; Oxford University Press; Volume: 57; Issue: 10 Linguagem: Inglês

10.1093/cid/cit520

1537-6591

John B. Carlin, Kristine Macartney, K. J. Lee, Helen Quinn, Jim Buttery, Ruth Lopert, Julie E. Bines, Peter McIntyre,

Animal Virus Infections Studies

Background. Estimates of the risk of intussusception (IS) associated with currently licensed rotavirus vaccines (RV1 [Rotarix; GSK] and RV5 [RotaTeq; Merck]) diverge. Contemporaneous introduction of both vaccines in Australia enabled a population-based assessment of risk. Methods. Confirmed cases of IS in infants aged 1 to <12 months were identified from national hospitalization databases, supplemented by active hospital-based surveillance, from July 2007 through June 2010. Vaccination histories were verified by the Australian Childhood Immunisation Register, which was also used to identify age-matched controls. Self-controlled case series and case-control methods were used to assess the risk of IS associated with both vaccines in prespecified periods after vaccination. The estimated burden of vaccine-attributable IS was compared with estimated reductions in gastroenteritis hospitalizations. Results. Based on 306 confirmed cases of IS, the relative incidence of IS in the 1–7-day period after the first vaccine dose, was 6.8 (95% confidence interval, 2.4–19.0; P < .001) for RV1, and 9.9 (95% confidence interval, 3.7–26.4; P < .001) for RV5. There was a smaller increased risk 1–7 days after the second dose of each vaccine. The case-control analysis gave similar results. We estimate an excess of 14 IS cases and >6500 fewer gastroenteritis hospitalizations in young children annually in Australia after vaccine introduction. Conclusions. We found a similarly increased risk of IS after both vaccines, but the balance of benefits and risks at population level was highly favorable, a finding likely to extend to other settings despite varying incidence of IS and potentially higher morbidity and mortality from both gastroenteritis and IS.