Rotavirus Vaccine and Health Care Utilization for Diarrhea in U.S. Children

Cortes, Jennifer; Curns, Aaron T.; Tate, Jacqueline E.; Cortese, Margaret M.; Patel, Manish; Zhou, Fangjun; Parashar, Umesh D.

doi:10.1056/nejmoa1000446

Cited by 154 publications

(119 citation statements)

References 16 publications

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“…RV5 and RV1 were recommended for routine vaccination of US infants in 2006 and 2008, respectively, 4 and their use has resulted in an annual decline of ∼40 000 gastroenteritis hospitalizations in 2008 and 2009 in US children, with an annual reduction of about $140 million in treatment costs. 5 Recent postlicensure studies from Australia and Mexico have demonstrated a transient increased risk of intussusception during the first week after the first dose of both RV5 and RV1, at an estimated excess risk of ∼1 to 2 cases per 100 000 vaccinated infants. 6,7 Postlicensure studies in the United States have not documented an increased risk of intussusception with RV5, but available data are insufficient to confidently exclude a risk as small as seen in international settings.…”

Section: Discussionmentioning

confidence: 99%

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Intussusception After Rotavirus Vaccines Reported to US VAERS, 2006–2012

et al. 2013

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BACKGROUND: In 2006 and 2008, 2 new rotavirus vaccines (RotaTeq [RV5] and Rotarix [RV1]) were introduced in the United States. METHODS: We assessed intussusception events reported to the Vaccine Adverse Event Reporting System from February 2006 through April 2012 for RV5 and from April 2008 through April 2012 for RV1. For RV5, we conducted a self-controlled risk interval analysis using Poisson regression to estimate the daily reporting ratio (DRR) of intussusception comparing average daily reports 3 to 6 versus 0 to 2 days after vaccination. We calculated reporting rate differences based on DRRs and background rates of intussusception. Sensitivity analyses were conducted to assess effects of differential reporting completeness and inaccuracy of baseline rates. Few reports were submitted after RV1, allowing only a descriptive analysis. RESULTS: The Vaccine Adverse Event Reporting System received 584 confirmed intussusception reports after RV5 and 52 after RV1, with clustering 3 to 6 days after both vaccines. The DRR comparing the 3- to 6-day and the 0- to 2-day periods after RV5 dose 1 was 3.75 (95% confidence interval = 1.90 to 7.39). There was no significant increase in reporting after dose 2 or dose 3. Over all 3 doses, the excess risk of intussusception was 0.79 events (95% confidence interval = –0.04 to 1.62) per 100 000 vaccinations. From the sensitivity analyses, we conclude that under a worst-case scenario, the DRR could be 5.00 and excess risk per 100 000 doses could be 1.36. CONCLUSIONS: We observed a persistent clustering of reported intussusception events 3 to 6 days after the first dose of RV5 vaccination. This clustering could translate to a small increased risk of intussusception, which is outweighed by the benefits of rotavirus vaccination.

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Section: Discussionmentioning

confidence: 99%

“…This is substantially lower than the number of diarrhea hospitalizations prevented annually (∼40 000) since rotavirus vaccine introduction. 5,23 …”

Section: Figurementioning

confidence: 99%

Intussusception After Rotavirus Vaccines Reported to US VAERS, 2006–2012

et al. 2013

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“…The MarketScan commercial database is representative of the commercially insured population in the United States and has been published widely in a variety of therapeutic areas focusing on epidemiology and outcomes research. 22,23 The MarketScan commercial database used in this study is de-identified and fully compliant with the Health Insurance Portability and Accountability Act of 1996; thus, this study was exempt from the review and approval of an institutional review board.…”

Section: ■■ Methodsmentioning

confidence: 99%

The Prevalence of Opioid-Related Major Potential Drug-Drug Interactions and Their Impact on Health Care Costs in Chronic Pain Patients

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et al. 2014

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“…RV vaccines are highly effective, with efficacy between 57% and 87% against severe RV-associated diarrhea, and higher efficacy in industrialized countries [3]. Since vaccine introduction, hospitalization rates due to RV gastroenteritis in children under 5 years have decreased by 65-84% in Europe, in Australia by 71%, and in the USA by 60-75% [4][5][6]. However, RV vaccines remain underutilized globally -as of April 2016, only 85 countries (44%) included routine vaccination in their national program (http://www.who.int/immunization/monitoring_surveillance/ data/en/, accessed 5 May 2016).…”

Section: The Impact Of Rv Vaccine Introductionmentioning

confidence: 99%