Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree‐temporal scan data mining method

Li, Rongxia; Weintraub, Eric; McNeil, Michael M.; Kulldorff, Martin; Lewis, Edwin; Nelson, Jennifer C.; Qian, Lei; Klein, Nicola P.; DeStefano, Frank

doi:10.1002/pds.4397

Cited by 21 publications

(9 citation statements)

References 16 publications

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“…Early postlicensure surveillance raised the concern of a potential risk for Guillain-Barré syndrome (GBS), but subsequent evaluations have not identified an increased risk for GBS after MenACWY-D vaccination (107)(108)(109)(110). No other vaccine safety concerns have been identified in postlicensure surveillance (111)(112)(113)(114).…”

Section: Menacwy-d (Menactra)mentioning

confidence: 99%

“…Although rates of syncope and medically attended fever increased after MenACWY-D vaccination, no new safety concerns were identified. Furthermore, tree-temporal scan data mining through VSD of primary doses administered to 1.2 million adolescents aged 11-18 years during the same period identified no new or unexpected adverse events within 42 days after MenACWY-D administration (114). Several smaller studies, including…”

Section: Postlicensure Safety Monitoringmentioning

confidence: 99%

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Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

Mbaeyi¹,

Bozio²,

Duffy³

et al. 2020

MMWR Recomm. Rep.

159

154

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This report compiles and summarizes all recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) for use of meningococcal vaccines in the United States. As a comprehensive summary and update of previously published recommendations, it replaces all previously published reports and policy notes. This report also contains new recommendations for administration of booster doses of serogroup B meningococcal (MenB) vaccine for persons at increased risk for serogroup B meningococcal disease. These guidelines will be updated as needed on the basis of availability of new data or licensure of new meningococcal vaccines. ACIP recommends routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for adolescents aged 11 or 12 years, with a booster dose at age 16 years. ACIP also recommends routine vaccination with MenACWY for persons aged ≥2 months at increased risk for meningococcal disease caused by serogroups A, C, W, or Y, including persons who have persistent complement component deficiencies; persons receiving a complement inhibitor (e.g., eculizumab [Soliris] or ravulizumab [Ultomiris]); persons who have anatomic or functional asplenia; persons with human immunodeficiency virus infection; microbiologists routinely exposed to isolates of Neisseria meningitidis; persons identified to be at increased risk because of a meningococcal disease outbreak caused by serogroups A, C, W, or Y; persons who travel to or live in areas in which meningococcal disease is hyperendemic or epidemic; unvaccinated or incompletely vaccinated first-year college students living in residence halls; and military recruits. ACIP recommends MenACWY booster doses for previously vaccinated persons who become or remain at increased risk. In addition, ACIP recommends routine use of MenB vaccine series among persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease, including persons who have persistent complement component deficiencies; persons receiving a complement inhibitor; persons who have anatomic or functional asplenia; microbiologists who are routinely exposed to isolates of N. meningitidis; and persons identified to be at increased risk because of a meningococcal disease outbreak caused by serogroup B. ACIP recommends MenB booster doses for previously vaccinated persons who become or remain at increased risk. In addition, ACIP recommends a MenB series for adolescents and young adults aged 16-23 years on the basis of shared clinical decision-making to provide short-term protection against disease caused by most strains of serogroup B N. meningitidis.

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Section: Menacwy-d (Menactra)mentioning

confidence: 99%

Section: Postlicensure Safety Monitoringmentioning

confidence: 99%

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

Mbaeyi¹,

Bozio²,

Duffy³

et al. 2020

MMWR Recomm. Rep.

159

154

View full text Add to dashboard Cite

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“…In the self-controlled analysis, we used the conditional tree-temporal scan statistic [18,19]. The analysis was conditioned on the total number of events over follow-up in each cut.…”

Section: Tree-based Scan Statisticsmentioning

confidence: 99%

Data Mining for Adverse Events of Tumor Necrosis Factor-Alpha Inhibitors in Pediatric Patients: Tree-Based Scan Statistic Analyses of Danish Nationwide Health Data

et al. 2020

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Background and Objectives Tumor necrosis factor-alpha (TNF-α) inhibitors are efficacious and considered generally safe in adults. However, pediatric-specific safety evidence is scarce. The aim of this study was to screen for signals of previously unknown adverse events of TNF-α inhibitors in pediatric patients. Methods We conducted a data-mining study based on routinely collected, nationwide Danish healthcare data for 2004-2016. Using tree-based scan statistics to identify events with unexpectedly high incidence during TNF-α inhibitor use among patients with inflammatory bowel disease or juvenile idiopathic arthritis, two analyses were performed: comparison with episodes of no use and with other time periods from the same patient. Based on incident physician-assigned diagnosis codes from outpatient and inpatient visits in specialist care, we screened thousands of potential adverse events while adjusting for multiple testing. Results We identified 1310 episodes of new TNF-α inhibitor use that met the eligibility criteria. Two signals of adverse events of TNF-α inhibitors, as compared with no use, were detected. First, there were excess events of dermatologic complications (ICD-10: L00-L99, 87 vs. 44 events, risk difference [RD] 3.3%), which have been described previously in adults and children. Second, there were excess events of psychiatric diagnosis adjustment disorders (ICD-10: F432, 33 vs. 7 events, RD 2.0%), which was likely associated with the underlying disease and its severity, rather than with the treatment. The selfcontrolled analysis generated no signal. Conclusions No signals of previously unknown adverse events of TNF-α inhibitors in pediatric patients were detected. The study showed that real-world data and newly developed methods for adverse events data mining can play a particularly important role in pediatrics where pre-approval drug safety data are scarce.

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“…A study by Kulldorff et al introduced a new signal detection algorithm, the tree-based scan statistic, which, unlike other algorithms based on rate ratios or Bayesian shrinkage estimator, is based on a log-likelihood ratio-based approach and adjust for multiple-testing. [ 6 , 7 ]. Moreover, this quantitative method is suitable for handling hierarchy structured variables such as AE terminology and anatomical therapeutic chemical (ATC) classification system [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

Safety Surveillance of Pneumococcal Vaccine Using Three Algorithms: Disproportionality Methods, Empirical Bayes Geometric Mean, and Tree-Based Scan Statistic

et al. 2020

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Introduction: Diverse algorithms for signal detection exist. However, inconsistent results are often encountered among the algorithms due to different levels of specificity used in defining the adverse events (AEs) and signal threshold. We aimed to explore potential safety signals for two pneumococcal vaccines in a spontaneous reporting database and compare the results and performances among the algorithms. Methods: Safety surveillance was conducted using the Korea national spontaneous reporting database from 1988 to 2017. Safety signals for pneumococcal vaccine and its subtypes were detected using the following the algorithms: disproportionality methods comprising of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC); empirical Bayes geometric mean (EBGM); and tree-based scan statistics (TSS). Moreover, the performances of these algorithms were measured by comparing detected signals with the known AEs or pneumococcal vaccines (reference standard). Results: Among 10,380 vaccine-related AEs, 1135 reports and 101 AE terms were reported following pneumococcal vaccine. IC generated the most safety signals for pneumococcal vaccine (40/101), followed by PRR and ROR (19/101 each), TSS (15/101), and EBGM (1/101). Similar results were observed for its subtypes. Cellulitis was the only AE detected by all algorithms for pneumococcal vaccine. TSS showed the best balance in the performance: the highest in accuracy, negative predictive value, and area under the curve (70.3%, 67.4%, and 64.2%). Conclusion: Discrepancy in the number of detected signals was observed between algorithms. EBGM and TSS calibrated noise better than disproportionality methods, and TSS showed balanced performance. Nonetheless, these results should be interpreted with caution due to a lack of a gold standard for signal detection.

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Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree‐temporal scan data mining method

Abstract: As a pilot study, we demonstrated that the tree-temporal scan statistic data mining method can be successfully applied to screen broadly for a wide range of vaccine-AE associations within a large health care data network.

Cited by 21 publications

References 16 publications

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

Data Mining for Adverse Events of Tumor Necrosis Factor-Alpha Inhibitors in Pediatric Patients: Tree-Based Scan Statistic Analyses of Danish Nationwide Health Data

Safety Surveillance of Pneumococcal Vaccine Using Three Algorithms: Disproportionality Methods, Empirical Bayes Geometric Mean, and Tree-Based Scan Statistic

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