August 29, 2015
Declaration to Demand the Resumption of Recommendations for Human Papillomavirus (HPV) Vaccination for Cervical Cancer Prevention
Japan Society of Obstetrics and Gynecology (JSOG)
Chairperson of the Executive Board
Tomoyuki Fujii, MD, PhD
More than 2 years have passed since the Ministry of Health, Labour, and Welfare decided to suspend recommendations for HPV vaccination in June 2013. During this period, institutions led by the ministry, including the Investigative Committee on Adverse Reactions, have thoroughly collected data, performed analyses, conducted follow-up surveys, and organized discussions among specialists to address various symptoms that occurred after HPV vaccine injection. At the 8th meeting of the Investigative Committee on Adverse Reactions, which took place in February 2014, chronic pain and motor impairment were regarded as functional, physical symptoms (functional somatic syndrome)1). Furthermore, at the committee’s 10th meeting held in July 2014, the incidence of adverse events among a cumulative total of 8,898,000 females, who had been vaccinated in Japan within the period between the initiation of sales of the vaccine and the end of March 2014, was examined, and it was reported that the total number of adverse events, such as chronic pain and motor impairment, was 176; this is equivalent to 2.0 per 100,000 vaccinations2). Although subsequent studies did not provide scientific or epidemiologic evidence to confirm the causal relationship between these symptoms and HPV vaccine ingredients, the suspension of recommendations for vaccination has continued to the present, consequently decreasing the vaccination rate to nearly 0%3)4).
Under these circumstances, as the first step, the Japan Society of Obstetrics and Gynecology (JSOG) has demanded the resumption of recommendations for vaccination after promptly establishing systems to provide treatment for those actually suffering from various symptoms that occurred after HPV vaccine injection, although they do not frequently occur. For example, the JSOG completed the organization of cooperative medical institutions in all 47 prefectures to provide treatment for those suffering from symptoms after HPV vaccination in any community throughout Japan by this April, including systems for referral to advanced and specialized medical institutions (27 facilities), through cooperation with prefectural medical associations and the Ministry of Health, Labour, and Welfare5). It should also be noted that the “Guidelines for the Management and Treatment of Symptoms that Occur after HPV Vaccine Injection”6) was published by the Japan Medical Association and Japanese Association of Medical Sciences on August 19 of this year to specify important points regarding early management by physicians in charge of vaccination and community-based medical institutions, covering medical interviews, consultations, and treatment, as well as the importance of approaches to support patients’ daily lives, including rehabilitation, and communication with their families and schools. The availability of appropriate treatment systems and guidelines facilitates the establishment of environments enabling those who desire vaccination to undergo it with a sense of security.
As the second step, the JSOG has also been engaged in activities to establish systems for mutual trust-based vaccination, such as continuously helping people develop appropriate evidence-based knowledge and obtain the latest information regarding cervical cancer and the HPV vaccine, while ensuring sufficient explanations of the benefits and risks of vaccination by physicians in charge to those desiring it and their families in order to appropriately obtain their informed consent when recommendations for vaccination are resumed. In Japan, cervical cancer develops in approximately 10,000 females annually, leading to nearly 3,000 deaths each year7). The tendency for the incidence to increase is particularly marked among those in their twenties and thirties, drawing social attention to young and parenting females’ loss of fertility or life due to cervical cancer as a serious issue8). As a preventive measure against cervical cancer, cancer screening using a Pap smear test is being conducted; however, the proportion of those undergoing such examinations is limited to approximately 30 to 40% (national mean in 2013: 32.7%) in Japan9), which is lower than those in Western countries, at approximately 70 to 80%. These findings highlight the difficulty in reducing the number of deaths from cervical cancer only through cervical cancer screening. According to an interim evaluation report on the government’s Basic Plan to Promote Cancer Control Programs, published in June 2015, there are no major cancers, except for cervical cancer, showing an accelerated increase in the mortality rate10). Based on data provided at the 6th meeting of the Investigative Committee on Adverse Reactions, the total numbers of cases in which the development of cervical cancer and related death have been successfully avoided through vaccination since the sale of the HPV vaccine started in Japan are estimated at 13,000 to 20,000 and 3,600 to 5,600, respectively11). These findings indicate the necessity of considering the disadvantages of vaccination avoidance similarly based on evidence.
When focusing on global trends, the World Health Organization (WHO) and International Federation of Gynecology and Obstetrics (FIGO), after repeatedly confirming the safety and effectiveness of the HPV vaccine based on the results of the latest data analyses performed on a global scale, actively recommend HPV vaccination as a national program to prevent all cancers due to the HPV12)13). In fact, in the United Kingdom, United States, and Australia, the adoption of vaccination programs has frequently been reported to decrease the incidence of HPV infection and markedly reduce cervical precancerous lesions14)-16). On the other hand, as various symptoms observed in Japan, such as chronic pain, occur independently of vaccination in some cases, the WHO has declared its concerns over Japan’s current situation12). If the suspension of recommendations for vaccination continues without improving the current situation, young generations will be deprived of the benefits of vaccines for cancer prevention, and, consequently, Japan will become the only country continuing to show a marked increase of cervical cancer in the future.
As HPV vaccine use in combination with cervical cancer screening including Pap test is indispensable for the prevention of cervical cancer, recommendations for HPV vaccination must be resumed. While continuing to help Japanese people develop evidence-based knowledge and obtain the latest information regarding the HPV vaccine and appropriately managing symptoms after vaccination, the JSOG strongly demands the early resumption of recommendations for HPV vaccination, with the aim of eradicating cervical cancer.
1) The 8th Vaccination Sub-committee Meeting: Investigative Committee on Adverse Reactions, Health Sciences Council, Ministry of Health, Labour, and Welfare (February 26, 2014)
2) The 10th Vaccination Sub-committee Meeting: Investigative Committee on Adverse Reactions, Health Sciences Council, Ministry of Health, Labour, and Welfare (July 4, 2014)
3) Hanley SJ, et al: HPV vaccination crisis in Japan. Lancet. 2015 Jun 27;385(9987):2571.
4) Ueda Y, et al: . Japan's failure to vaccinate girls against human papillomavirus. Am J Obstet Gynecol. 2015 Mar;212(3):405-6.
6) Guidelines for the Management and Treatment of Symptoms that Occur after HPV Vaccine Injection: Japan Medical Association and Japanese Association of Medical Sciences (August 2015)
7) Center for Cancer Control and Information Services, National Cancer Center, Japan
8) Motoki Y, et al: Increasing trends in cervical cancer mortality among young Japanese women below the age of 50 years: An analysis using the kanagawa population-based cancer registry, 1975-2012. Cancer Epidemiol 2015, [Epub ahead of print] PMID: 26277329
9) Comprehensive Survey of Living Conditions: Center for Cancer Control and Information Services, National Cancer Center, Japan
10) Interim Evaluation Report on the Basic Plan to Promote Cancer Control Programs - Appendix 2: Center for Cancer Control and Information Services, National Cancer Center, Japan (June 10, 2015)
11) The 6th Vaccination Sub-committee Meeting: Investigative Committee on Adverse Reactions, Health Sciences Council, Ministry of Health, Labour, and Welfare (December 25, 2013)
12）GACVS (Global Advisory Committee on Vaccine Safety) safety uptade on HPV Vaccines Geneva,13 June 2013
13）Human papillomavirus vaccines: WHO position paper, October 2014. No. 43, 2014, 89, 465-492. http://www.who.int/wer
14) Gertig DM, et al: Impact of a population-based HPV vaccination program on cervical abnormalities: a data linkage study. BMC Med 2013;11:227-238.
15) Markowitz LE, et al: Reduction in human papillomavirus (HPV) prevalence among young women following HPV vaccine introduction in the United States, National Health and Nutrition Examination Surveys, 2003-2010. J Infect Dis 2013;208(3):385-393.
16) Pollock KG, et al: Reduction of low- and high-grade cervical abnormalities associated with high uptake of the HPV bivalent vaccine in Scotland. Br J Cancer 2014;111:1824-1830.