HPV vaccine drug injury is a case in which symptoms suspected of being adverse reactions appeared in a wide range of areas, including the motor, cognitive, autonomic, and emotional systems, after HPV (human papillomavirus) vaccination. By June 2024, 4,073 cases (including 2,385 serious cases) of adverse reactions after HPV vaccination had been reported, and a lawsuit is currently underway against the government and pharmaceutical companies, mainly by victims. Currently, a lawsuit is underway against the government and the pharmaceutical companies, mainly by the victims.
| 2009 | Bivalent Vaccine for Cervical Cancer Approved |
| 2010 | Municipal public subsidies begin Damage occurred |
| 2011 | Tetravalent Vaccine for Cervical Cancer Approved |
| 2013 | Formation of the National Cervical Cancer Vaccine Victims Liaison Group The Immunization Law makes the vaccine a routine vaccination, and three months later, local governments are notified to temporarily withhold active vaccination recommendations. |
| 2016 | Launched lawsuits against the state and pharmaceutical companies. |
| 2022 | HPV vaccine recommendation resumed |
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1. what is HPV vaccine
HPV vaccine is a vaccine to prevent infection with human papillomavirus (HPV), which is involved in the development of many diseases, including cervical cancer, anal cancer, vaginal cancer, and condyloma acuminatum. In Japan, it is also called “cervical cancer vaccine.
In 2008, the “Expert Committee for the Conquest of Cervical Cancer” was established by medical experts and began to make recommendations to society and the government regarding cervical cancer. In 2009, the Japanese Society of Obstetrics and Gynecology, the Japanese Society of Pediatrics, and the Japanese Society of Gynecologic Oncology jointly issued a “Statement on the Promotion of Human Papillomavirus (HPV) Vaccination”.
Against the backdrop of the medical community’s efforts, in 2010 the government launched the “Urgent Promotion Program for Vaccination against Cervical Cancer,” a public subsidy program for HPV vaccination, and later in April 2013 the HPV vaccine became a routine vaccination due to the revision of the Immunization Law. The recommended recipients in Japan are girls aged 11-14 years who are assumed to be prior to sexual contact, since infection of the cervix is mainly caused by sexual contact, and the vaccine was administered three times over a period of about 6 months.
2. Frequent occurrence of damage and lack of understanding by doctors
After the HPV vaccine became a routine vaccination in 2013, it began to become clear that women who had received the HPV vaccine were experiencing a wide range of health problems, including fever, general pain, memory loss, menstrual abnormalities, sensitivity to light, sound, and smell, and neurological disorders. The health hazards were widely reported by the mass media, and perhaps in part due to heightened social anxiety about the HPV vaccine, the Ministry of Health, Labor and Welfare decided to temporarily suspend the recommended vaccination.
The victims sought medical treatment for their health problems after receiving the HPV vaccine, but were faced with a lack of understanding from many doctors. Some victims were forced to give up their studies and jobs because there was no treatment for their symptoms.
In the case of damage caused by vaccinations, relief is provided by the Adverse Reactions to Drugs Relief System and the Immunization Law. However, in the case of damage caused by HPV vaccination, doctors initially considered the women’s complaints as fraudulent and were uncooperative in preparing the application forms. In fact, such adverse events had been occurring even before the introduction of routine vaccination in 2013, and in March 2013, the “National Cervical Cancer Vaccine Victims Liaison Group” was established.
In 2016, the victims will seek relief and file lawsuits against the government and pharmaceutical companies in four district courts across Japan. In January 2014, the Ministry of Health, Labor, and Welfare’s Subcommittee on Vaccines and Immunization proposed the “psychosomatic reaction” theory, which states that symptoms were caused by pain and anxiety at the time of vaccination. On the other hand, in September of the same year, a research team from the Foundation for Research and Development of Intractable Diseases proposed the theory of “human papillomavirus-associated neuroimmunopathic syndrome (HPV vaccine-associated neuroimmunopathic syndrome)” that HPV vaccination causes an excessive immune response, which in turn causes symptoms. The team reported the “human papillomavirus-associated neuroimmunopathic (HANS) theory” that HPV vaccination causes an excessive immune response, resulting in symptoms, and called for a follow-up survey of all inoculated patients.
3. Resumption of regular vaccination and bashing of victims
In November 2021, during the HPV vaccine lawsuit, the suspension of recommended vaccinations was lifted by the MHLW for the first time in about eight years. Research results showing no statistical difference in symptoms between the vaccinated and non-vaccinated groups were published, and calls for the resumption of HPV vaccination recommendations gradually increased. In addition, the plaintiffs were accused of being “anti-vaccine” and ridiculed as being “anti-vaccine” because the lawsuits were a stumbling block to the resumption of recommended vaccinations. The HPV vaccine lawsuit shares similarities with the Iressa drug lawsuit in that the victims of the drug lawsuit are blamed by the public, and the social phenomenon of victims who raise their voices being blamed also awaits verification.
References
- National Plaintiffs for HPV Vaccine Drug Injury Litigation, 2023, “About HPV Vaccine Drug Injury Litigation” (retrieved February 11, 2025, from http://hkr.o.oo7.jp/yakugai/forum/forum25-data/HPV_2023.pdf).
- Kawanishi, M. et al. (eds.), 2023, Illustrated Medication Injury and Adverse Effects (Revised 3rd ed.), Nanzan-do.
- Taneda, Hiroyuki, 2023, “‘Cervical Cancer Vaccine’ Post-Inoculation Adverse Events or Health Damage,” in Yaku-yo Harmful What – New Sociology of Drug Harm, Minerva Shobo.