Examining a possible association between human papilloma virus (HPV) vaccination and migraine: results of a cohort study in the Netherlands

Klooster, Tessa M. Schurink-van't; Ridder, Maria A. J. de; Kemmeren, Jeanet M.; Lei, Johan van der; Dekker, Frans; Sturkenboom, Miriam; Melker, Hester E. de

doi:10.1007/s00431-014-2444-x

“…A cohort study conducted in the Netherlands identified no significant increase in the risk of migraine after immunisation with the bivalent HPV vaccine. 40 Although the study was limited by insufficient sample size and lack of power, this result was consistent with strength and limitations of this study By linking two different nationwide databases-a vaccine registry and health insurance database-our study provided results for the entire population of South Korea. 41 Using this nationwide linked database allowed us to detect associations between HPV vaccine and rare or serious diseases without losing statistical power.…”

Section: Discussionsupporting

confidence: 83%

Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study

Yoon

¹

,

Lee

²

,

Lee

³

et al. 2021

BMJ

View full text Add to dashboard Cite

Objective To evaluate the association between human papillomavirus (HPV) vaccination and serious adverse events in adolescent girls in South Korea. Design Cohort study. Setting A large linked database created by linking the Korea Immunization Registry Information System and the National Health Information Database, between January 2017 and December 2019. Participants 441 399 girls aged 11-14 years who had been vaccinated in 2017: 382 020 had been vaccinated against HPV and 59 379 had not been vaccinated against HPV. Main outcome measures Outcomes were 33 serious adverse events, including endocrine, gastrointestinal, cardiovascular, musculoskeletal, haematological, dermatological, and neurological diseases. A cohort design was used for the primary analysis and a self-controlled risk interval design for the secondary analysis; both analyses used a risk period of one year after HPV vaccination for each outcome. Incidence rate and adjusted rate ratios were estimated using Poisson regression in the primary analysis, comparing the HPV vaccinated group with the HPV unvaccinated group, and adjusted relative risks were estimated using conditional logistic regression in the secondary analysis. Results Among the 33 predefined serious adverse events, no associations were found with HPV vaccination in the cohort analysis, including Hashimoto’s thyroiditis (incidence rate per 100 000 person years: 52.7 v 36.3 for the vaccinated and unvaccinated groups; adjusted rate ratio 1.24, 95% confidence interval 0.78 to 1.94) and rheumatoid arthritis (incidence rate per 100 000 person years: 168.1 v 145.4 for the vaccinated and unvaccinated groups; 0.99, 0.79 to 1.25), with the exception of an increased risk observed for migraine (incidence rate per 100 000 person years: 1235.0 v 920.9 for the vaccinated and unvaccinated groups; 1.11, 1.02 to 1.22). Secondary analysis using self-controlled risk intervals confirmed no associations between HPV vaccination and serious adverse events, including migraine (adjusted relative risk 0.67, 95% confidence interval 0.58 to 0.78). Results were robust to varying follow-up periods and for vaccine subtypes. Conclusions In this nationwide cohort study, with more than 500 000 doses of HPV vaccines, no evidence was found to support an association between HPV vaccination and serious adverse events using both cohort analysis and self-controlled risk interval analysis. Inconsistent findings for migraine should be interpreted with caution considering its pathophysiology and the population of interest.

show abstract

“…The safety of the vaccines has continued to be monitored through population‐based vaccine safety surveillance systems, studies and follow up of trial participants . The WHO Global Advisory Committee for Vaccine Safety continues to regularly review these data and confirm safety .…”

Section: Current Knowledge About the Efficacy And Safety Of Prophylacmentioning

confidence: 99%

“…The safety of the vaccines has continued to be monitored through population-based vaccine safety surveillance systems, studies and follow up of trial participants. [10][11][12][13][14][15][16][17][18] The WHO Global Advisory Committee for Vaccine Safety continues to regularly review these data and confirm safety. 19 Failure to achieve high population coverage limits the full potential benefits gained from vaccination, which are observed in countries with successfully implemented vaccine programs.…”

Section: Current Knowledge About the Efficacy And Safety Of Prophylacmentioning

confidence: 99%

Eurogin Roadmap 2015: How has HPV knowledge changed our practice: Vaccines

Brotherton

¹

,

Jit

²

,

Gravitt

³

et al. 2016

View full text Add to dashboard Cite

This review is one of two complementary reviews that have been prepared in the framework of the Eurogin Roadmap 2015 to evaluate how knowledge about HPV is changing practices in HPV infection and disease control through vaccination and screening. In this review of HPV vaccine knowledge, we present the most significant findings of the past year which have contributed to our knowledge of the two HPV prophylactic vaccines currently in widespread use and about the recently licensed nonavalent HPV vaccine. Whereas anal cancer is dealt with in the companion mini-review on screening, we also review here the rapidly evolving evidence regarding HPV-associated head and neck cancer and priority research areas. Current Knowledge About the Efficacy and Safety of Prophylactic HPV VaccinesIt is now ten years since the first prophylactic HPV vaccine was licensed for use following extensive clinical trials. At the time of licensing, the vaccines were known to be highly efficacious in HPV-na€ ıve individuals at preventing vaccine-type HPV infection and type specific cervical disease and, for the quadrivalent vaccine, genital warts and vulvar/vaginal intraepithelial lesions. We have now direct evidence that both vaccines provide protection for close to a decade, if not longer. Large sentinel cohorts of young Nordic women and smaller cohorts from the original trials are being closely monitored to detect any loss of protection over time.

show abstract

Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase®

Chandler

¹

,

Juhlin

²

,

Fransson

³

et al. 2016

View full text Add to dashboard Cite

IntroductionA number of safety signals—complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), and chronic fatigue syndrome (CFS)—have emerged with human papillomavirus (HPV) vaccines, which share a similar pattern of symptomatology. Previous signal evaluations and epidemiological studies have largely relied on traditional methodologies and signals have been considered individually.ObjectiveThe aim of this study was to explore global reporting patterns for HPV vaccine for subgroups of reports with similar adverse event (AE) profiles.MethodsAll individual case safety reports (reports) for HPV vaccines in VigiBase® until 1 January 2015 were identified. A statistical cluster analysis algorithm was used to identify natural groupings based on AE profiles in a data-driven exploratory analysis. Clinical assessment of the clusters was performed to identify clusters relevant to current safety concerns.ResultsOverall, 54 clusters containing at least five reports were identified. The four largest clusters included 71 % of the analysed HPV reports and described AEs included in the product label. Four smaller clusters were identified to include case reports relevant to ongoing safety concerns (total of 694 cases). In all four of these clusters, the most commonly reported AE terms were headache and dizziness and fatigue or syncope; three of these four AE terms were reported in >50 % of the reports included in the clusters. These clusters had a higher proportion of serious cases compared with HPV reports overall (44–89 % in the clusters compared with 24 %). Furthermore, only a minority of reports included in these clusters included AE terms of diagnoses to explain these symptoms. Using proportional reporting ratios, the combination of headache and dizziness with either fatigue or syncope was found to be more commonly reported in HPV vaccine reports compared with non-HPV vaccine reports for females aged 9–25 years. This disproportionality remained when results were stratified by age and when those countries reporting the signals of CRPS (Japan) and POTS (Denmark) were excluded.ConclusionsCluster analysis reveals additional reports of AEs following HPV vaccination that are serious in nature and describe symptoms that overlap those reported in cases from the recent safety signals (POTS, CRPS, and CFS), but which do not report explicit diagnoses. While the causal association between HPV vaccination and these AEs remains uncertain, more extensive analyses of spontaneous reports can better identify the relevant case series for thorough signal evaluation.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-016-0456-3) contains supplementary material, which is available to authorized users.

show abstract

Examining a possible association between human papilloma virus (HPV) vaccination and migraine: results of a cohort study in the Netherlands

Cited by 8 publications

References 21 publications

Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study

Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study

Eurogin Roadmap 2015: How has HPV knowledge changed our practice: Vaccines

Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase®

Contact Info

Product

Resources

About