HPV vaccine in Japan

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Human papillomavirus (HPV) vaccines in Japan refers to the development, approval, rollout, suspension, and reinstatement of human papillomavirus vaccination programs, as well as associated scientific, legal, and social responses. The vaccine was first approved in Japan in 2009 and incorporated into the national routine immunization schedule in 2013. However, in June 2013, the Ministry of Health, Labour and Welfare (MHLW) suspended proactive recommendations due to reports of adverse events. [1] Vaccination rates subsequently dropped below 1%. After years of scientific review, international pressure, and domestic advocacy, recommendations were resumed in 2022. [2]

Contents

Following the resumption of proactive recommendation in 2022, HPV vaccination coverage in Japan showed a marked recovery. A 2025 population-based study from Osaka City documented over 18,000 girls receiving at least one dose, with uptake influenced by socioeconomic and geographic factors. [3]

This page outlines the development and public health implications of HPV vaccination policy in Japan.

Early development and implementation

In December 2008, a parliamentary group titled “Lawmakers’ Association for Promoting Public Health through Vaccination”—commonly known as the Vaccine Promotion Parliamentary League—was established to promote disease prevention, reduce morbidity rates, and improve public health through the use of vaccines. [4]

Cervarix (GlaxoSmithKline) was approved in October 2009 and released in December. [5] Gardasil (Merck/MSD) was approved in July 2011 and released in August. [6] [7]

Routine vaccination for girls in Grade 6 through Grade 10 was incorporated into the Immunization Act on April 1, 2013. [8]

In Japan, the standard HPV vaccination schedule consists of three doses. However, for individuals up to age 14, only two doses of the 9-valent HPV vaccine (Gardasil 9) are required. [9]

Political discourse

In a 2013 session of the National Diet, Upper House member Michiko Ueno expressed concern regarding HPV vaccine promotion, stating that the government may not have provided sufficient consideration to sexual education in relation to administering the vaccine to girls in their early teens. [10] Fellow Councillor Eriko Yamatani also opposed public vaccination, arguing that it "presupposes sexual experience in early adolescence," and claimed that regular medical checkups alone could prevent nearly 100% of cervical cancer deaths. [11]

Suspension and litigation

In June 2013, Japan’s Ministry of Health, Labour and Welfare suspended its proactive recommendation for the HPV vaccine following media reports of alleged adverse events. [12] The suspension was widely reported internationally. [13]

On June 14, 2013, the MHLW suspended proactive recommendation due to reports of chronic pain and other symptoms. [14] Although routine vaccination remained available, uptake dropped below 1%.

In Tokyo’s Suginami Ward, a junior high school student reported difficulty walking for over a year following vaccination. The ward initially declined compensation but reversed its decision after public criticism. [15]

In Japan, suspending proactive vaccine recommendations has been a recurring public health strategy in response to safety concerns. This approach was previously applied to other vaccines, including the measles-mumps-rubella (MMR) vaccine in the early 1990s and the Japanese encephalitis vaccine between 2005 and 2010, following reports of adverse events. [16]

These suspensions typically involved halting individualized outreach, such as sending vaccination vouchers or reminders, while continuing to offer the vaccine upon request. Although the suspension of proactive HPV vaccine recommendations from 2013 to 2021 followed this established pattern, its unusually long duration and the scale of its impact on public health outcomes—particularly the projected excess cases and deaths from cervical cancer—have drawn significant attention from researchers and policymakers. [17]

On June 14, 2013, the MHLW suspended proactive recommendation due to reports of chronic pain and other symptoms. Although routine vaccination remained available, uptake dropped below 1%.

In a 2019 interview, former MHLW official Tokumasa Shoubayashi stated that the suspension of proactive recommendation was primarily influenced by media coverage. He attributed the decline in public trust to Japan’s prevailing “zero-risk” mindset and suggested that without a shift in public opinion, resuming recommendation would be difficult to justify. [18]

Gender Disparities in Vaccine Policy

In Japan, the HPV vaccine was officially introduced under the name *“cervical cancer vaccine”*, a framing that emphasized its relevance to women’s reproductive health. This naming may have contributed to public perceptions that the vaccine was exclusively a women’s issue, potentially influencing media narratives and policy decisions.

Hanako Jimi, a pediatrician and member of the House of Councillors, criticized the prolonged suspension of proactive HPV vaccine recommendations. In a 2021 interview, she stated: “If this were a prostate cancer prevention vaccine, even with some hesitation, it would likely have been reinstated within a year.” [19]

Kanako Inaba, an obstetrician-gynecologist and representative of the advocacy group *Minpapi!*, expressed similar concerns. At a press conference following the submission of a citizen petition, she remarked: “Over the past eight years, sufficient evidence has accumulated regarding the vaccine’s efficacy and safety. There is no longer any reason for the government to delay. If this were a disease causing penile loss in men in their 20s to 40s, would the government have left it unaddressed for so long?” [20]

lawsuits

In 2016, the National Liaison Association of Cervical Cancer Vaccine Victims filed lawsuits in four district courts. As of May 2023, there were 117 plaintiffs: 92 received Cervarix and 25 received Gardasil. [21] [22]

Legal proceedings related to alleged adverse events from the HPV vaccine have been ongoing in Japan since 2016. The lawsuits, filed by individuals claiming long-term health effects, target both the national government and pharmaceutical companies. After years of expert testimony and plaintiff hearings across multiple district courts, a final ruling is currently scheduled for April 2027. [23]

Under Japanese law, the responsibility for implementing routine vaccinations lies with local municipalities. For diseases classified as Category A under the Immunization Act (Japan), municipalities are legally obligated to promote vaccination among eligible individuals and their guardians. “Proactive recommendation” refers to targeted outreach efforts such as sending postcards or screening forms directly to households prior to the standard vaccination period, encouraging timely uptake of the vaccine. [24] [25]

Inappropriate Responses by Local Governments During Suspension of Proactive Recommendation

During the suspension of proactive HPV vaccine recommendation, some local governments reportedly responded in ways that discouraged potential recipients. For example, individuals were told that “vaccination is not recommended,” that “there are side effects,” and even asked whether a - pre-vaccination screening form was truly necessary given that “not even 0.01% of people choose to get vaccinated.” Such remarks caused hesitation among those who wished to receive the vaccine. Other accounts include being warned strongly about adverse reactions—prompting questions like “Are you really going to get it?”—in a manner perceived as obstructive. In one case, a recipient requested that - pre-vaccination screening form be sent to a friend’s address in time for the vaccination deadline, but it was delivered too late. These experiences were reported to physicians by affected individuals. [26]

Scientific controversy

In March 2016, a research team led by Dr. Shuichi Ikeda reported that 80% of patients with neurological symptoms shared the HLA-DPB1*0501 gene type. [27] Mouse experiments suggested autoantibody deposition in the hippocampus.

In June 2016, Shinshu University established an external investigation committee in response to a whistleblower report alleging research misconduct. [28]

In November, the committee concluded that “it cannot be denied that information suggesting the mouse experiment results were scientifically proven has spread throughout society.” The experiment did not observe the condition of NFκ-βp50-deficient mice after HPV vaccination, but instead extracted serum from vaccinated mice and applied it to brain tissue of naïve mice. The experiment used only one serum sample per group, and in subsequent replication attempts, no reaction was observed in any brain tissue samples. The committee requested that Professor Ikeda conduct a new experiment starting from the initial vaccination stage using scientifically validated knockout mice, and to publish the results. Additionally, concerns were raised about a designated professor (referred to as Professor B), who had collected serum from multiple mice but reported results based only on a single sample (n=1), calling into question the research integrity. The committee concluded by stating that “a serious reflection is required for having caused public confusion.” [29]

In 2016, Dr Ikeda and colleagues published a mouse study in Scientific Reports suggesting that combined administration of an HPV vaccine and pertussis toxin caused neurological damage in mice. [30] The paper attracted media attention in Japan and was cited by vaccine-hesitant groups. However, the methodology was criticized as lacking reproducibility and having inadequate controls. [31] In May 2018, Scientific Reports formally retracted the article, citing methodological flaws. [32] Japan’s Ministry of Health, Labour and Welfare and medical societies also stated that this animal study did not provide evidence of causality in humans. [33]

On November 24, 2016, the Ministry of Health, Labour and Welfare (MHLW) issued a statement saying, “Due to Professor Ikeda’s inappropriate presentation, a situation has arisen that misled the public. We consider his social responsibility to be significant and deeply regret the matter.” The ministry further stated, “The research results presented by the Ikeda team do not provide any evidence that the symptoms observed after HPV vaccination were caused by the vaccine itself.” [34]

Dr. Ikeda filed a defamation lawsuit against journalist Riko Muranaka and the magazine Wedge. The court ruled in favor of Ikeda. Nobel laureate Tasuku Honjo submitted an expert opinion criticizing the scientific basis of the study. [35] [36] [37] 　He publicly addressed the HPV vaccine issue during a press conference in Stockholm, calling the situation in Japan “outrageous and serious.” [38] He also met with the Minister of Health to urge the resumption of proactive HPV vaccine recommendation. [39] Honjo later stated that although he explained the issue to journalists, his comments were repeatedly rejected by editorial desks. [40]

Following the court ruling, Muranaka announced her intention to appeal, stating that she viewed the lawsuit not only as a legal challenge but also as an opportunity to advocate for scientific integrity and to build connections within the medical and journalistic communities. [41]

Commenting on the case, Heidi Larson, director of the Vaccine Confidence Project at the London School of Hygiene & Tropical Medicine, emphasized that the outcome should not be interpreted as a validation of Dr. Ikeda’s scientific claims. She noted that the ruling was based on issues of tone and expression, rather than scientific merit. [42]


In 2017, Japanese physician and journalist Riko Muranaka was awarded the John Maddox Prize, jointly presented by Nature and the Sense About Science foundation. The award recognized her efforts to communicate scientific evidence about the safety of the HPV vaccine in Japan, despite facing public hostility, professional backlash, and legal threats. Muranaka’s reporting challenged widespread misinformation and highlighted the consequences of Japan’s prolonged suspension of proactive vaccine recommendations, including the projected rise in cervical cancer cases and deaths. [43] [44]

International commentators noted that Japan’s suspension had broader implications. Okita (2020) analyzed the suspension as a case study in the intersection of science, ethics, and policy, concluding that political decisions departed significantly from scientific consensus. [45]

International and domestic consensus

Scientific review: Nagoya City study

IIn 2015, the city of Nagoya commissioned a large-scale survey to investigate potential adverse symptoms following HPV vaccination. The study, led by Professor Sadao Suzuki of Nagoya City University, targeted approximately 70,000 young women born between April 1994 and April 2001, comparing symptom prevalence between vaccinated and unvaccinated groups. A peer-reviewed study analyzing the survey data concluded that there was no statistically significant difference in the frequency of reported symptoms—such as chronic pain, motor dysfunction, or memory impairment—between the vaccinated and unvaccinated cohorts. [46] [47] [48]

the World Health Organization’s Global Advisory Committee on Vaccine Safety

In December 2015, the World Health Organization’s Global Advisory Committee on Vaccine Safety (GACVS) issued a statement explicitly criticizing Japan’s continued suspension of proactive recommendation for the HPV vaccine. The committee noted that Japan had not resumed recommendation despite expert consensus that no causal link existed between the vaccine and reported symptoms. GACVS warned: “Political decisions based on weak evidence may hinder access to safe and effective vaccines and cause real harm.” [49]

Japan was the only country named in the statement, marking an unusually direct rebuke from an international health authority. [50]

This international appeal was intended to urge the Japanese government to resume proactive recommendation and align with global scientific consensus.

The Lancet also described the situation as an "HPV vaccination crisis in Japan". [51]

In August 2016, a group of senior Japanese medical experts—including the presidents of the Japan Medical Association and the Japan Association of Obstetricians and Gynecologists—submitted a letter to the Director of the Health Bureau at the Ministry of Health, Labour and Welfare. The letter included signatures from 341 researchers from over 50 countries who had participated in EUROGIN 2016 (European Research Organization on Genital Infection and Neoplasia). The statement warned: “The symptoms reported in Japan have not been shown to be causally related to the HPV vaccine. Japan’s inappropriate policy decisions are having a negative impact on global vaccine confidence.” [52]

In April 2016, 17 Japanese medical societies issued a joint statement urging the resumption of proactive HPV vaccine recommendation. The statement cited data from the Ministry of Health indicating that only 186 individuals—approximately 0.002% of total doses administered—remained under medical care for unresolved adverse events. [53]

Epidemiological study by Sofue Group

In response to public concern over adverse events following HPV vaccination, the Ministry of Health, Labour and Welfare commissioned a large-scale epidemiological study led by Dr. HirokazuSofue at the Osaka Center for Cancer and Disease Prevention. The study aimed to evaluate the prevalence of reported symptoms among vaccinated and unvaccinated adolescent girls across Japan. The researchers found that symptoms such as chronic pain, motor dysfunction, and cognitive complaints were not significantly more frequent among vaccinated individuals compared to unvaccinated controls. In fact, similar symptom patterns were observed in both groups, suggesting that the reported conditions may not be causally linked to the vaccine itself but rather reflect broader psychosocial or developmental factors. The study emphasized the importance of establishing specialized clinical systems to assess and manage post-vaccination symptoms, regardless of causality, and contributed to the scientific basis for Japan’s resumption of proactive HPV vaccine recommendation in 2022. [54]

Approval for male vaccination

On December 4, 2020, the MHLW approved Gardasil for use in males. [55] [56] [57]

In Japan, the approved indications include prevention of anal cancer, precancerous lesions, and genital warts. Internationally, the vaccine is also approved for oropharyngeal cancer, and G7 countries have adopted gender-neutral vaccination policies. [58]

Gender-inclusive vaccination efforts

In September 2023, Tokyo Governor Yuriko Koike stated during a session of the Tokyo Metropolitan Assembly that HPV vaccination for males could help prevent male-specific cancers and contribute to herd immunity when administered to both sexes. She announced that the Tokyo Metropolitan Government would consider financial support for municipalities implementing such programs. [59]

Tokyo also indicated its intention to urge the national government to accelerate consideration of routine HPV vaccination for males, while simultaneously exploring support for municipalities that had already begun subsidizing such programs. In its fiscal year 2024 budget request, the Tokyo Metropolitan Bureau of Social Welfare and Public Health allocated approximately ¥380 million for municipal subsidies related to male HPV vaccination. [60]

In January 2024, following the governor’s budget review, Tokyo announced its policy to cover half the cost of HPV vaccination for boys in grades 6 through 10 (ages roughly 12–16), provided that local municipalities offer financial assistance. [61] [62]

Resumption and recovery (2022–2024)

In Japan, the HPV vaccine is classified as a Category A disease under the Immunization Act (Japan), and Article 9 of the Act stipulates that eligible individuals and their guardians have a "duty to make efforts" to receive the vaccination. Although the government continued routine vaccination, it suspended proactive recommendations in June 2013 following reports of adverse reactions. However, as no specific safety concerns were identified, proactive recommendations resumed in November 2021. [63]

The decision was reported internationally, including in Lancet Oncology. [64]

A petition calling for free vaccination for university-aged women who missed the opportunity due to the suspension of proactive recommendations gathered approximately 13,000 signatures in a single day. [65] In response, the government decided to offer catch-up vaccinations to affected cohorts until March 2025. [66] Furthermore, those who receive their first dose by March 2025 will be eligible to complete the series free of charge during fiscal year 2025. [67]

In June 2023, the National Cancer Center Japan published the “2023 Fact Sheet on the Prevention of Cervical Cancer and Other HPV-Related Cancers.” The report highlighted that Japan’s cervical cancer mortality rate remains higher than in other developed countries, and emphasized the effectiveness and safety of HPV vaccination and screening. The Center recommended both measures as essential components of prevention. During the press conference, officials acknowledged the inadequacy of past countermeasures and expressed regret for the lack of public communication during the suspension of proactive vaccine recommendations. [68] [69]

Proactive recommendation resumed in April 2022. That year, 540,681 individuals received their first dose. [70]

In fiscal year 2024, total first-dose recipients rose to 1,513,862, including 430,000 routine and 1,080,000 catch-up recipients. The routine coverage rate reached 82.2%, the highest since the vaccine’s introduction. [71]

Controversy over MEXT's Educational Guidance

In November 2022, Japan’s Ministry of Education, Culture, Sports, Science and Technology (MEXT), through its Medical Education Division, sent a notice to universities with faculties of medicine, pharmacy, and related fields. The notice included a request letter from a citizens’ group that claims symptoms reported after HPV vaccination constitute “drug-induced harm,” and encouraged institutions to conduct classes on pharmaceutical injury based on this material. [72] A MEXT official later stated that the ministry had not been directly informed by the Ministry of Health, Labour and Welfare (MHLW) about the updated status of the HPV vaccine, which had resumed proactive recommendation earlier that fiscal year. Although the HPV Vaccine Parliamentary League of the Liberal Democratic Party requested a correction, MEXT’s follow-up notice in December 2022 did not retract the original guidance. Instead, it added a clarification that the request letter from the citizens’ group should be treated as supplementary material, without changing the ministry’s treatment of the claims regarding HPV vaccine-related harm. [73]

Social media and public discourse

On September 25, 2024, the terms "HPV vaccine" and "cervical cancer" trended on X (formerly Twitter) in Japan. Users shared vaccination experiences and praised one another. Obstetricians and vaccine advocates welcomed the change. [74]

Journalist Eito Suzuki posted courtroom observations from the HPV vaccine litigation on X in August 2024, receiving over 18 million impressions. His reporting highlighted that plaintiffs had pre-existing conditions and psychosocial challenges prior to vaccination. Some had been diagnosed with HANS (Health Anxiety Neuro-Syndrome) and certified for compensation by the PMDA, leading some to abandon cognitive behavioral therapy. [75] [76]

A 10-year analysis of Japanese-language social media posts by Kyoto University researchers found that discussions about vaccine safety peaked in 2015 and declined thereafter, while discourse on vaccine effectiveness increased. The study concluded that targeted public health interventions are needed to address lingering vaccine hesitancy. [77]

Media coverage and civic perspectives

Journalist Naoko Iwanaga of BuzzFeed Japan documented the experiences of mothers navigating HPV vaccine decisions amid government silence and media confusion. Her reporting highlighted the lack of individualized notifications, the emotional burden of vaccine hesitancy, and the role of misinformation in shaping public perception. [78] Iwanaga also covered the defamation lawsuit against Dr. Riko Muranaka, noting the chilling effect on scientific journalism and the broader media silence that followed. The work of Dr. Riko Muranaka received international attention and was cited in discussions about vaccine communication and public trust. [79] Iwanaga’s reporting was widely circulated among healthcare professionals and policy advocates in Japan, and she later stated that her coverage of HPV vaccine issues contributed to her departure from a major newspaper. [80]

Minpapi (short for “Minna de shirou HPV project”) is a non-profit initiative founded in 2017 by gynecologist Kanako Inaba. The organization aims to promote accurate public understanding of HPV infection and vaccination through physician-supervised articles, social media outreach, and policy advocacy. Minpapi has collaborated with municipalities, media outlets, and digital platforms to address gaps in vaccine awareness, especially among young women who missed routine vaccination due to the suspension of proactive recommendation. [81] In 2023, Minpapi partnered with the Florence Group to launch a campaign titled “HPV vaccine for boys too,” offering free vaccinations to boys aged 9–18 in selected clinics. The initiative highlighted gender disparities in vaccine access and called for public funding of male vaccination. [82]

A 2021 study published in *Vaccine* by researchers including Takahiro Kinoshita and Michael R. Reich of Harvard Kennedy School analyzed the decline in HPV vaccine confidence in Japan. The authors attributed the drop in coverage to a combination of sensationalized media reports, delayed government response, and erosion of public trust. They emphasized that rebuilding vaccine confidence requires transparent communication and stronger engagement between health authorities and the public. [83]

Vaccination coverage by birth cohort

225,993 girls were vaccinated for the first round of routine vaccination in 2022, and the vaccination rate was 42.2%. [a] The Osaka University Graduate School of Medicine and Faculty of Medicine reported the first vaccination rate and cumulative first vaccination rate for each year of birth in 2022 at a meeting of the Ministry of Health, Labor and Welfare. [84]

Subsequent studies documented a rebound in uptake. [85]

Human Papillomavirus Vaccination by Birth Fiscal Year in Japan [86] [87] [88] [89]
HPV vaccine in Japan

Annual Number of First-Time HPV Vaccine Recipients in Japan (Routine and Catch-Up)

In Japan, HPV vaccine coverage once dropped below 1% following the suspension of proactive recommendations in June 2013. After the resumption of recommendations in November 2021, the first half of fiscal year 2022 saw approximately 160,000 individuals complete their first dose of routine vaccination, resulting in a coverage rate of 30.1%. [90]

Including catch-up vaccinations, the total number of first-dose recipients reached 540,681 in fiscal year 2022, [91] 668,012 in fiscal year 2023, [92] and 1,513,862 in fiscal year 2024. [93]

Annual Number of First-Time HPV Vaccine Recipients in Japan (Routine and Catch-Up)
HPV vaccine in Japan

Regional Study

In 2025, Oka and colleagues published a population-based cross-sectional study analyzing HPV vaccination uptake in Osaka City, Japan. [3] The study examined cumulative vaccination coverage among 185,373 girls born between fiscal years 1997 and 2010, using neighborhood-level socioeconomic indicators and access metrics. As of 2022, 18,688 girls in Osaka City had received at least one dose of the HPV vaccine. Uptake was higher in areas with lower deprivation and greater access to vaccination facilities. The authors found significant associations between vaccination rates and both the Area Deprivation Index (ADI) and proximity to medical providers, suggesting that socioeconomic and geographic factors influenced recovery in coverage following the resumption of proactive recommendation.

Long-term consequences of HPV vaccine hesitancy in Japan

Multiple studies have estimated that the suspension of proactive HPV vaccine recommendations in Japan will result in more than 20,000 excess cases of cervical cancer and over 5,000 excess deaths among women born around the year 2000. [94] [95] [96]

Notes

  1. ↑ In Japan’s HPV vaccination program, “implementation rate” refers to the proportion of girls who received the vaccine within the 13-year-old cohort. However, due to delayed uptake among older girls—especially those in their first year of high school—the number of doses administered can exceed the size of the target cohort, resulting in implementation rates over 100%. This differs from “vaccination coverage rate,” which tracks uptake within birth-year cohorts regardless of timing.

References

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  3. 1 2 Oka, Emiko (2025). "Area Socioeconomic Status, Vaccination Access, and Female Human Papillomavirus Vaccination". JAMA Network Open. 8 (3): e250747. doi:10.1001/jamanetworkopen.2025.0747 . Retrieved 2025-09-20.
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