The benefits and risks of bacille Calmette-Guérin vaccination among infants at high risk for both tuberculosis and severe combined immunodeficiency: assessment by Markov model

Introduction Quantitative benefit-risk models (qBRm) applied to vaccines are increasingly used by public health authorities and pharmaceutical companies as an important tool to help decision makers with supporting benefit-risk assessment (BRA). However, many publications on vaccine qBRm provide insufficient details on the methodological approaches used. Incomplete and/or inadequate qBRm reporting may affect result interpretation and confidence in BRA, highlighting a need for the development of standard reporting guidance. Objectives Our objective was to provide an operational checklist for improved reporting of vaccine qBRm. Methods The consolidated standards of reporting quantitative Benefit-RIsk models applied to VACcines (BRIVAC) were designed as a checklist of key information to report in qBRm scientific publications regarding the assessed vaccines, the methodological considerations and the results and their interpretation. Results In total, 22 items and accompanying definitions, recommendations, explanations and examples were provided and divided into six main sections corresponding to the classic subdivisions of a scientific publication: title and abstract (items 1-2), introduction (items 3-4), methods (items 5-15), results (items 16-17), discussion (items 18-20) and other (items 21-22). Conclusions The BRIVAC checklist is the first initiative providing an operational checklist for improved reporting of qBRm applied to vaccines in scientific articles. It is intended to assist authors, peer-reviewers, editors and readers in their critical appraisal. Future initiatives are needed to provide methodological guidance to perform qBRm while taking into account the vaccine specificities.

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“…(…) A total of 107 subjects were interviewed in the survey. (Example based on Clark and Cameron [52]).…”

Section: Examplementioning

confidence: 99%

“…Most importantly, the lifetime horizon approach would not have affected the most important outcome in the model, namely those threshold values for severe combined immunodeficiency (SCID) incidence, which alter the decision to use BCG for a given risk of tuberculous infection in the population. (Example based on Clark and Cameron [52]).…”

Section: Examplementioning

confidence: 99%

Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-Risk Models Applied to Vaccines (BRIVAC)

et al. 2020

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“…For the measurement of health burden, composite burden of disease (BoD) measures—such as the disability‐adjusted life‐years (DALY) measure—have been developed . To date, there has been limited assessment of the population‐level health burden of AEFI using BoD measures . Although selected safety aspects of vaccination have a long history of investigation, studies are often limited to rates or risk estimates.…”

Section: Introductionmentioning

confidence: 95%

“…3 To date, there has been limited assessment of the population-level health burden of AEFI using BoD measures. 4,5 Although selected safety aspects of vaccination have a long history of investigation, studies are often limited to rates or risk estimates. A comprehensive estimate of the population-level health burden of events associated with vaccination and the extent of the AEFI burden relative to the disease being prevented through vaccination would be useful contributions to current knowledge.…”

mentioning

confidence: 99%

Methodology for computing the burden of disease of adverse events following immunization

McDonald

Nijsten

Bollaerts

et al. 2018

Pharmacoepidemiology and Drug

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PurposeComposite disease burden measures such as disability‐adjusted life‐years (DALY) have been widely used to quantify the population‐level health impact of disease or injury, but application has been limited for the estimation of the burden of adverse events following immunization. Our objective was to assess the feasibility of adapting the DALY approach for estimating adverse event burden.MethodsWe developed a practical methodological framework, explicitly describing all steps involved: acquisition of relative or absolute risks and background event incidence rates, selection of disability weights and durations, and computation of the years lived with disability (YLD) measure, with appropriate estimation of uncertainty. We present a worked example, in which YLD is computed for 3 recognized adverse reactions following 3 childhood vaccination types, based on background incidence rates and relative/absolute risks retrieved from the literature.ResultsYLD provided extra insight into the health impact of an adverse event over presentation of incidence rates only, as severity and duration are additionally incorporated. As well as providing guidance for the deployment of DALY methodology in the context of adverse events associated with vaccination, we also identified where data limitations potentially occur.ConclusionsBurden of disease methodology can be applied to estimate the health burden of adverse events following vaccination in a systematic way. As with all burden of disease studies, interpretation of the estimates must consider the quality and accuracy of the data sources contributing to the DALY computation.

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“…Clark et al developed a Markov model to predict the benefits and risks of BCG among high-risk aboriginal infants in Canada who are at high risk of SCID. The model predicted that the risks outweigh the benefits if the annual risk of tuberculosis was 0.1% and the rate of SCID was higher than 4.2 per 100 000 19 Applying this model for Saudi Arabia will predict more risks than benefits since the TB rate in Saudi Arabia is 0.018% and the SCID rate is high.…”

mentioning

confidence: 99%

Bacille Calmette-Guérin Vaccination in Saudi Arabia: Benefits versus Risks

Al-Jumaah

Hajjar

Mousa

2012

Annals of Saudi Medicine

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The benefits and risks of bacille Calmette-Guérin vaccination among infants at high risk for both tuberculosis and severe combined immunodeficiency: assessment by Markov model

Cited by 12 publications

References 56 publications

Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-Risk Models Applied to Vaccines (BRIVAC)

Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-Risk Models Applied to Vaccines (BRIVAC)

Methodology for computing the burden of disease of adverse events following immunization

Bacille Calmette-Guérin Vaccination in Saudi Arabia: Benefits versus Risks

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