Intussusception among Infants Given an Oral Rotavirus Vaccine

Murphy, Trudy V.; Gargiullo, Paul; Massoudi, Mehran S.; Nelson, David B.; Jumaan, Aisha O.; Okoro, Catherine A.; Zanardi, L; Setia, Sabeena; Fair, Elizabeth; LeBaron, Charles W.; Schwartz, Benjamin; Wharton, Melinda; Livingood, John R.

doi:10.1056/nejm200102223440804

Cited by 892 publications

(487 citation statements)

References 28 publications

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“…17 Another example is the increased risk of intussusception with rotavirus vaccines. 18 It has been estimated that for about half the drugs on the market, serious ad-verse events were not detected until after the drug received regulatory approval. 19 Relying on preapproval safety evaluation is insufficient to detect increasingly rare events.…”

Section: Discussionmentioning

confidence: 99%

Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs

et al. 2008

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Although efforts to revamp the drug-safety system have been directed at strengthening postmarketing surveillance, strategies for the preapproval stage may be useful. One strategy would be to require larger sample sizes in preapproval safety databases. To evaluate the potential benefits and costs of this approach, we developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided in a postapproval population. We found that the potential to limit adverse events can be an important consideration in sample-size determinations for preapproval trials. Requiring larger preapproval databases could be a cost-effective means of reducing adverse events in postapproval populations. M o s t i n d u s t ry-s p o n s o r e d c l i n i c a l t r i a l s of new drugs are powered to detect differences on the primary efficacy endpoint that will drive regulatory approval. Detection of adverse drug events (ADEs) is rarely considered when sample-size calculations are undertaken for clinical trials. Thus, the statistical power to detect ADEs is inherently a by-product of considerations of efficacy. w 3 6 0 5 A u g u s t 2 0 0 8 D r u g S a f e t y

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Section: Discussionmentioning

confidence: 99%

Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs

et al. 2008

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“…These trials yielded good efficacy against severe rotavirus disease in the US (80%) and Finland (91%), leading to the introduction of RRV-TV in the routine childhood immunization schedule in the US. Due to these encouraging results, RRV-TV was licensed and introduced in the US; however, RRV-TV was subsequently withdrawn by the manufacturer from the US after a post licensure association was uncovered between the vaccine and a rare adverse event, intussusceptions [59,66].…”

Section: Rhesus-human Reassortant (Rrv-tv; Rotashield)mentioning

confidence: 99%

“…Several review articles have presented excellent overviews on rotavirus genomic diversity and importance of development of rotavirus vaccine [52,59,66,82]. The objective of this article is to review the distribution of rotavirus serotypes/genotypes derived from globally collected data between 1973 and 2010 and the present vaccine strategies with special focus on India.…”

Section: Introductionmentioning

confidence: 99%

Rotavirus Infection: A Perspective on Epidemiology, Genomic Diversity and Vaccine Strategies

Mukherjee

Chawla‐Sarkar

2011

Indian J. Virol.

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“…In most instances, properly controlled studies have disproved the relationships. But certain vaccines have been associated with severe side-effects, as illustrated by the rare, but serious side-effect of intestinal intussusception due to the orally administered, rhesus-reassortant rotavirus vaccine, which resulted in the withdrawal of this vaccine from the US market by the manufacturer [19].…”

Section: Adequate Evidence Of Vaccine Safetymentioning

confidence: 99%

Evaluation of vaccines against enteric infections: a clinical and public health research agenda for developing countries

Clemens

2011

Phil. Trans. R. Soc. B

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Enteric infections are a major cause of morbidity and mortality in developing countries. To date, vaccines have played a limited role in public health efforts to control enteric infections. Licensed vaccines exist for cholera and typhoid, but these vaccines are used primarily for travellers; and there are two internationally licensed vaccines for rotavirus, but they are mainly used in affluent countries. The reasons that enteric vaccines are little used in developing countries are multiple, and certainly include financial and political constraints. Also important is the need for more cogent evidence on the performance of enteric vaccines in developing country populations. A partial inventory of research questions would include: (i) does the vaccine perform well in the most relevant settings? (ii) does the vaccine perform well in all epidemiologically relevant age groups? (iii) is there adequate evidence of vaccine safety once the vaccines have been deployed in developing countries? (iv) how effective is the vaccine when given in conjunction with non-vaccine cointerventions? (v) what is the level of vaccine protection against all relevant outcomes? and (vi) what is the expected population level of vaccine protection, including both direct and herd vaccine protective effects? Provision of evidence addressing these questions will help expand the use of enteric vaccines in developing countries.

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Intussusception among Infants Given an Oral Rotavirus Vaccine

Abstract: 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.

Cited by 892 publications

References 28 publications

Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs

Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs

Rotavirus Infection: A Perspective on Epidemiology, Genomic Diversity and Vaccine Strategies

Evaluation of vaccines against enteric infections: a clinical and public health research agenda for developing countries

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