Abstract
Nagoya City introduced free HPV vaccination in 2010 and in April 2013 the Ministry of Health, Labour and Welfare included the HPV vaccine in the National Immunization Program. However, in June 2013, the Ministry suspended proactive recommendation of the vaccine after unconfirmed reports of adverse events. To investigate any potential association between the vaccine and reported symptoms, Nagoya City conducted a questionnaire-based survey.Participants were 71,177 female residents of Nagoya City born between April 2, 1994 and April 1, 2001. The anonymous postal questionnaire investigated the onset of 24 symptoms (primary outcome), associated hospital visits, frequency, and influence on school attendance.Totally, 29,846 residents responded. No significant increase in occurrence of any of the 24 reported post-HPV vaccination symptoms was found. The vaccine was associated with increased age-adjusted odds of hospital visits for “abnormal amount of menstrual bleeding” (OR: 1.43, 95% CI: 1.13–1.82), “irregular menstruation” (OR: 1.29, 95% CI: 1.12–1.49), “severe headaches” (OR: 1.19, 95% CI: 1.02–1.39), and chronic, persisting “abnormal amount of menstrual bleeding” (OR 1.41, 95% CI: 1.11–1.79). No symptoms significantly influenced school attendance and no accumulation of symptoms was observed.The results suggest no causal association between the HPV vaccines and reported symptoms.
Highlights
Cervical cancer is the fourth most common cancer among women worldwide, with about 528,000 new cases and 266,000 deaths in 2012[1]
The results suggest no causal association between the human papillomavirus (HPV) vaccines and reported symptoms
Nagoya City, with a population of approximately 2,300,000 and located in the center of Japan, initiated a fully financed HPV vaccination program to encourage vaccination of girls born between April 2, and April 1, 1998 and in the first and second year of junior high school
Summary
Cervical cancer is the fourth most common cancer among women worldwide, with about 528,000 new cases and 266,000 deaths in 2012[1]. Following unconfirmed reports of unusual post-vaccination symptoms, the Japanese Ministry of Health, Labour and Welfare (MHLW) suspended its proactive recommendations for the vaccine in June 2013 [7] and instructed local health authorities to stop promoting the use of the vaccine until the suspected adverse events had been investigated. This led to a rapid and dramatic decrease in vaccination coverage, even though the HPV vaccines were freely available for the target age-group [8,9]
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