ArticleDrug safety2018
Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database.
Article in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Real-world evidence of autoimmune hepatitis following COVID-19 vaccination: A population-based pharmacovigilance analysis.Frontiers in pharmacology · 2023Article
- Booster dose of COVID-19 mRNA vaccine does not increase risks of myocarditis and pericarditis compared with primary vaccination: New insights from the vaccine adverse event reporting system.Frontiers in immunology · 2022Article
- Comment on "Central Demyelinating Diseases After Vaccination Against Hepatitis B Virus: A Disproportionality Analysis Within the VAERS Database".Drug safety · 2018Article
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHepatitis B (HB) vaccination programs were set up worldwide in the early 1990s. Despite their major focus on reducing the burden of HB infection, they have seldom achieved the targeted population coverage in most countries, including the USA, with around 24.5% of adults being vaccinated against HB. Among proposed reasons for this is the persisting doubt about a possible link between HB vaccination and the occurrence of cases of multiple sclerosis (MS).
objectiveOur objective was to evaluate a potential safety signal between MS and HB vaccination. We conducted a disproportionality analysis (DPA) using the cases reported to the Vaccine Adverse Event Reporting System (VAERS).
methodsWe calculated the proportional reporting rate (PRR) and reporting odds ratio (ROR) of MS having occurred within the 120 days following HB immunization in adults aged 19-49 years when compared with other vaccines using the reports recorded in the VAERS database. Both ratios were estimated globally and then according to the origin of reports (USA vs. non-USA). We then performed a sensitivity analysis using a broader category of demyelinating events.
findingsMS cases following HB vaccination were more likely to originate from outside the USA and to be reported before 2000 than those associated with other immunizations. All computed ratios were found to be statistically significant, with PRRs ranging from 3.48 to 5.56 and RORs ranging from 3.48 to 5.62. When considering the geographical origin, similar RORs were obtained for both US and non-US cases.
conclusionIn VAERS, MS cases were up to five times more likely to be reported after an HB vaccination than after any other vaccination. Since DPA is mainly suited for hypothesis generation, further studies evaluating the nature of the link between MS and HB vaccination would be of considerable importance.
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Registered trials
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