Giuseppe
Emeritus
[Source: Clinical Infectious Diseases, full page: (LINK). Abstract, edited.]
Intussusception Risk and Disease Prevention Associated With Rotavirus Vaccines in Australia's National Immunization Program
John B. Carlin 1,2, Kristine K. Macartney 5,6,7, Katherine J. Lee 1,2, Helen E. Quinn 5,6, Jim Buttery 1,3,4, Ruth Lopert 8, Julie Bines 1,2, and Peter B. McIntyre 5,6,7
Author Affiliations: <SUP>1</SUP>Murdoch Children's Research Institute, Royal Children's Hospital <SUP>2</SUP>Department of Paediatrics, University of Melbourne <SUP>3</SUP>Infectious Diseases Department, Monash Children's Hospital <SUP>4</SUP>Department of Paediatrics, Monash University, Melbourne<SUP>5</SUP>National Centre for Immunisation Research & Surveillance <SUP>6</SUP>Discipline of Paediatrics and Child Health, University of Sydney <SUP>7</SUP>Department of Microbiology and Infectious Diseases, The Children's Hospital at Westmead, Sydney <SUP>8</SUP>Therapeutic Goods Administration, Canberra, Australia
Correspondence: John B. Carlin, PhD, Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Road, Parkville, VIC 3052, Australia. (john.carlin@mcri.edu.au).
Abstract
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.
Key words: rotavirus vaccine ? intussusception ? vaccine surveillance - vaccine adverse events - vaccination risk-benefit
Received March 26, 2013. Accepted June 7, 2013.
? The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.
For Permissions, please e-mail: journals.permissions@oup.com.
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Intussusception Risk and Disease Prevention Associated With Rotavirus Vaccines in Australia's National Immunization Program
John B. Carlin 1,2, Kristine K. Macartney 5,6,7, Katherine J. Lee 1,2, Helen E. Quinn 5,6, Jim Buttery 1,3,4, Ruth Lopert 8, Julie Bines 1,2, and Peter B. McIntyre 5,6,7
Author Affiliations: <SUP>1</SUP>Murdoch Children's Research Institute, Royal Children's Hospital <SUP>2</SUP>Department of Paediatrics, University of Melbourne <SUP>3</SUP>Infectious Diseases Department, Monash Children's Hospital <SUP>4</SUP>Department of Paediatrics, Monash University, Melbourne<SUP>5</SUP>National Centre for Immunisation Research & Surveillance <SUP>6</SUP>Discipline of Paediatrics and Child Health, University of Sydney <SUP>7</SUP>Department of Microbiology and Infectious Diseases, The Children's Hospital at Westmead, Sydney <SUP>8</SUP>Therapeutic Goods Administration, Canberra, Australia
Correspondence: John B. Carlin, PhD, Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Road, Parkville, VIC 3052, Australia. (john.carlin@mcri.edu.au).
Abstract
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.
Key words: rotavirus vaccine ? intussusception ? vaccine surveillance - vaccine adverse events - vaccination risk-benefit
Received March 26, 2013. Accepted June 7, 2013.
? The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.
For Permissions, please e-mail: journals.permissions@oup.com.
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------