Table 1.
Timeline of the policies and events related to HPV vaccines in Japan.
2009 | October | The bi-valent HPV vaccine was licensed. |
2010 | November | Subsidies from local and national governments for an HPV vaccination program for girls 13–16 commenced. |
2011 | July | The quadra-valent HPV vaccine was licensed. |
2013 | April | The national immunization program for girls aged 12–16 years commenced |
June | The VARRC ruled that “It is necessary to determine the frequency of pain occurrence whose relationship can be undeniably linked to HPV vaccination. HPV vaccination should not be actively recommended until proper information can be provided to the public.” The VARRC announced the suspension of its recommendation for vaccination (Notification by the Director-General of the Health Service Bureau of the MHLW). | |
2014 | January and July | The VARRC evaluated the pathogenesis and causal relationship of the “diverse symptoms” reportedly experienced after HPV vaccination. The reported chronic pain and motor impairment were regarded as functional physical symptoms (a form of functional somatic syndrome). |
2015 | August | The “Guide for the Management and Treatment of Symptoms that Occur after HPV Vaccine Injection” was published. An organization of cooperative medical institutions from all 47 prefectures agreed to provide treatment for any girl suffering from symptoms after HPV vaccination in any community throughout Japan. The MHLW announced three measures for patients with symptoms, mainly of pain or movement disorders. |
September | The result of the adverse events follow-up survey was released. The suspension of governmental recommendation was continued. The MHLW and the Ministry of Education, Culture, Sports, Science, and Technology issued their “Improvement of the Consultation and Support System for Persons with Symptoms after HPV Vaccination”. Relief (subsidies for medical expenses, etc.) based on the Immunization Law and the Pharmaceuticals and Medical Devices Agency Law, was implemented | |
November | Symptom consultation services were established in the health and education departments of each prefecture. | |
December | The VARRC evaluated the safety and efficacy of HPV vaccines in Japan and abroad. | |
2017 | April | The conclusions of a nationwide epidemiological survey by a research team designated by the MHLW were reported to the VARRC (Key finding: Unvaccinated girls had a similar number of “diverse symptoms”). |
November | The VARRC evaluated all available information on the safety and efficacy of the HPV vaccine in Japan and abroad and expressed its commitment to continue to provide close support to patients who presented with any of the diverse symptoms. The VARRC discussed ways to better inform the public about the HPV vaccine. | |
2018 | January | An extensively revised informational leaflet was released by the MHLW to better inform the public about the HPV vaccine. |
2019 | August | The VARRC reported the results of a survey on the provision of HPV vaccine information. |
2020 | July | The “Parliamentary Association for the Resumption of Recommendation of HPV Vaccination” submitted a petition to the MHLW. The 9-valent HPV vaccine was licensed in Japan. |
October | MHLW’s ‘Leaflet to Inform the Public about the HPV Vaccine’ was revised. | |
December | The quadra-valent HPV vaccine was approved to prevent anal cancer for males. | |
2021 | August | “Parliamentary Association for the Resumption of Recommendation of HPV Vaccination” submitted a petition to the MHLW again. The Japanese Society of Obstetrics and Gynecology submitted a petition to the MHLW to extend the period of routine vaccination. |
Abbereviations: human papillomavirus, HPV; Vaccine Adverse Reactions Review Committee, VARRC; Ministry of Health, Labor, and Welfare, MHLW.