Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine

Abstract

Objective. An observational safety study of the quadrivalent human papillomavirus vaccine (HPV4) in women was conducted. This report presents findings from autoimmune surveillance. Design. Subjects were followed for 180 days after each HPV4 dose for new diagnoses of 16 prespecified autoimmune conditions. Setting. Two managed care organizations in California. Outcome. Potential new-onset autoimmune condition cases amongst HPV4 recipients were identified by electronic medical records. Medical records of those with ‡12-month health plan membership prior to vaccination were reviewed by clinicians to confirm the diagnosis and determine the date of disease onset. The incidence of each autoimmune condition was estimated for unvaccinated women at one study site using multiple imputations and compared with that observed in vaccinated women. Incidence rate ratios (IRR) were calculated. Findings were reviewed by an independent Safety Review Committee (SRC).Results. Overall, 1014 potential new-onset cases were electronically identified; 719 were eligible for case review; 31-40% were confirmed as new onset. Of these, no cluster of disease onset in relation to vaccination timing, dose sequence or age was found for any autoimmune condition. None of the estimated IRR was significantly elevated except Hashimoto's disease [IRR = 1.29, 95% confidence interval: 1.08-1.56]. Further investigation of temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for autoimmune thyroid conditions. The SRC and the investigators identified no autoimmune safety concerns in this study.Conclusions. No autoimmune safety signal was found in women vaccinated with HPV4.

Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013

“…exposure to environmental toxins). The timing of the onset of symptoms, consistency or plausibility of symptoms with the known pharmacology and toxicology of the qHPV, and whether or not an alternative trigger was present were all considered [18][19][20]. Finally, all serious AEFIs were assessed for unexpectedness.…”

Immunogenicity and Safety of a 9-Valent HPV Vaccine

“…Data have shown that prophylactic HPV vaccination is generally safe and well tolerated. [32][33][34][35][36][37][38] The median age of sexual debut is in the late teens (15-19 years) in most countries. 39 Virginal adolescents (#15 years old) were not included in HPV vaccine efficacy evaluations because of low HPV exposure and ethical constraints.…”

HPV vaccines and autoimmune diseases

“…I read with great interest the article by Chao et al [1] regarding the lack of autoimmune diseases in patients who were vaccinated against HPV. I would like to comment on this report and in particular on the validity of the results and conclusions.…”

“…the development of multiple sclerosis 3 years after vaccination with either Gardasil or a hepatitis B vaccine) [1,[5][6][7][8].…”