Human papillomavirus vaccines, complex regional pain syndrome, postural orthostatic tachycardia syndrome, and autonomic dysfunction – a review of the regulatory evidence from the European Medicines Agency

2017 ◽  
Author(s):  
Tom Jefferson ◽  
Lars Jørgensen
Keyword(s):  
Human Papillomavirus ◽  
Complex Regional Pain Syndrome ◽  
Autonomic Dysfunction ◽  
Pain Syndrome ◽  
European Medicines Agency ◽  
Postural Orthostatic Tachycardia Syndrome ◽  
Papillomavirus Vaccines ◽  
Human Papillomavirus Vaccines

scholarly journals Association between quadrivalent human papillomavirus vaccination and selected syndromes with autonomic dysfunction in Danish females: population based, self-controlled, case series analysis

BMJ ◽  
2020 ◽  
pp. m2930 ◽  
Author(s):  
Anders Hviid ◽  
Nicklas M Thorsen ◽  
Palle Valentiner-Branth ◽  
Morten Frisch ◽  
Kåre Mølbak
Keyword(s):  
Human Papillomavirus ◽  
Chronic Fatigue Syndrome ◽  
Complex Regional Pain Syndrome ◽  
Autonomic Dysfunction ◽  
Case Series ◽  
Pain Syndrome ◽  
Chronic Fatigue ◽  
Postural Orthostatic Tachycardia Syndrome ◽  
Human Papillomavirus Vaccination ◽  
Fatigue Syndrome

Abstract Objective To evaluate the association between quadrivalent human papillomavirus vaccination and syndromes with autonomic dysfunction, such as chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome. Design Population-based self-controlled case series. Setting Information on human papillomavirus vaccinations and selected syndromes with autonomic dysfunction (chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome) identified using ICD-10 (international classification of diseases, revision 10) diagnostic codes from Danish nationwide registers. Participants 869 patients with autonomic dysfunction syndromes from a cohort of 1 375 737 Danish born female participants aged 10 to 44 years during 2007-16. Main outcome measures Self-controlled case series rate ratios (95% confidence intervals) of the composite outcome of chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome, adjusted for age and season, comparing female participants vaccinated and unvaccinated with the quadrivalent human papillomavirus vaccine. Chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome were also considered separately in secondary analyses. Results During 10 581 902 person years of follow-up, 869 female participants with syndromes of autonomic dysfunction (136 with chronic fatigue syndrome, 535 with complex regional pain syndrome, and 198 with postural orthostatic tachycardia syndrome) were identified. Quadrivalent human papillomavirus vaccination did not statistically significantly increase the rate of a composite outcome of all syndromes with autonomic dysfunction in a 365 day risk period following vaccination (rate ratio 0.99, 95% confidence interval 0.74 to 1.32) or the rate of any individual syndrome in the risk period (chronic fatigue syndrome (0.38, 0.13 to 1.09), complex regional pain syndrome (1.31, 0.91 to 1.90), or postural orthostatic tachycardia syndrome (0.86, 0.48 to 1.54)). Conclusions When vaccination is introduced, adverse events could occur in close temporal relation to the vaccine purely by chance. These results do not support a causal association between quadrivalent human papillomavirus vaccination and chronic fatigue syndrome, complex regional pain syndrome, or postural orthostatic tachycardia syndrome, either individually or as a composite outcome. An increased risk of up to 32% cannot be formally excluded, but the statistical power of the study suggests that a larger increase in the rate of any syndrome associated with vaccination is unlikely.

The role of human papillomavirus vaccines in cervical cancer: Prevention and treatment

2018 ◽  
Vol 122 ◽  
pp. 92-97 ◽  
Author(s):  
Giorgio Bogani ◽  
Umberto Leone Roberti Maggiore ◽  
Mauro Signorelli ◽  
Fabio Martinelli ◽  
Antonino Ditto ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cancer Prevention ◽  
Cervical Cancer Prevention ◽  
Papillomavirus Vaccines ◽  
Human Papillomavirus Vaccines ◽  
Prevention And Treatment

Post-hoc analysis from phase III trials of human papillomavirus vaccines: considerations on impact on non-vaccine types

2019 ◽  
Vol 18 (3) ◽  
pp. 309-322 ◽  
Author(s):  
Martin Ryser ◽  
Valérie Berlaimont ◽  
Naveen Karkada ◽  
Attila Mihalyi ◽  
Rino Rappuoli ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Phase Iii ◽  
Papillomavirus Vaccines ◽  
Human Papillomavirus Vaccines ◽  
Post Hoc Analysis ◽  
Phase Iii Trials ◽  
Post Hoc

scholarly journals Prophylactic immunization with human papillomavirus vaccines induces oral immunity in mice

2017 ◽  
Vol 128 (1) ◽  
pp. E16-E20 ◽  
Author(s):  
Julie Ahn ◽  
Shiwen Peng ◽  
Chien-Fu Hung ◽  
Richard B. S. Roden ◽  
Simon R. Best
Keyword(s):  
Human Papillomavirus ◽  
Papillomavirus Vaccines ◽  
Human Papillomavirus Vaccines

scholarly journals Knowledge of Cervical Cancer and Human Papillomavirus Vaccines among Child-Bearing Aged Women in Hanoi, Vietnam

2020 ◽  
Vol 21 (7) ◽  
pp. 1951-1957
Author(s):  
Nguyen Thi Ngoc Phuong ◽  
Le Thi Thanh Xuan ◽  
Le Thi Huong ◽  
Do Thi Thanh Toan ◽  
Jin Kyung Oh ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Papillomavirus Vaccines ◽  
Human Papillomavirus Vaccines ◽  
Child Bearing
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