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Suspension of Recommendation for HPV vaccines in Japan since 2013

August 12, 2017


Roles of HPV vaccines

Human papillomavirus (HPV) causes more than 99 percent of cervical cancer. Persistent infection with certain types of HPV can lead to specific cancer such as cervix, anus, vagina, vulva, penis, mouth, or sinuses. In Japan, HPV infection leads to cervical cancer in about 10,000 women every year and 2,700 women die of cervical cancer every year. World Health Organization (WHO) recommends HPV vaccines in adolescents more than 9 years of age to prevent infection with types of HPV known to cause cervical cancer. It is clear that these vaccines significantly reduce the number of women who develop cervical pre-cancer. It is estimated that mortality rate of cervical cancer could be reduced by 70 to 80% if they are available diffusely on targeted population throughout the nation.

Government’s Decision to Suspend Recommendation of HPV Vaccines

There were two types of vaccines (Gardasil and Cervarix) available to prevent infection with types of HPV known to cause cervical cancer in Japan. In 2009, the Ministry of Health, Labour and Welfare (MHLW) started to approve HPV vaccines. The vaccination rate rapidly rose up to 70%. However, more than 30 cases of adverse effects were reported by mass media with emphasis in 2013, which led to viewpoint switching into not recommending these HPV vaccines by MHLW. The causal association between those reported adverse effects and vaccination had not been proved either epidemiologically or scientifically. The Representative of Japan Cervical Cancer Sufferers Organization announces and advocates complete withdrawal of HPV vaccines in Japan as well as victim’s compensation. WHO raised concern about case reports of pain syndromes in Japan because those reports did not show scientific causalities. These vaccines could be still available at government expense but the vaccination rate dramatically decreased to only 1 percent of targeted girls in 2016.

Increased Risk of HPV Infection Estimated Unless Encouraging Resumption

It was concerned that risk of HPV type 16/18 infection at the age of 20 would noticeably increased among girls born between 2000 and 2003 compared to other age groups (Fig A). This negative effect was estimated to be worse if resuming encouragement was extended until 2020. However, MHLW has not changed their policy yet in 2017 although the Japan Society of Obstetrics and Gynecology released statement of resumption of HPV vaccines encouragement.Graph1

How to resume HPV vaccines encouragement

Japan Medical Association issued guidelines for treating affected subjects with any symptoms after administering HPV vaccines in 2015. Those victims after HPV vaccination should be cared comprehensively even if the causality is not proved epidemiologically. Resumption of HPV vaccination is awaited to minimize the risk of cervical cancer in young girls and women in Japan because of recent evidence to support non-causality between HPV vaccination and presumed pain syndrome.