Suspension of Recommendation for HPV vaccines in Japan since 2013

by

cervarix_1703 

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.

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6 Responses to “Suspension of Recommendation for HPV vaccines in Japan since 2013”

  1. canadan33 Says:

    Thank you very much form your interesting blog on a public health topic that I previously was unaware of in Japan. It seems amazing to me that a small group campaign with an agenda to suspend the use of this potentially life saving vaccine in young girls could be so powerful as to sway the ministry of health to completely withdraw recommending and funding this vaccine for use. Once again we see the power of the media, politics and the uninformed to effect public health policy without the benefit of sound epidemiological and scientific due process. It is very unfortunate to think that Japan may once again see the numbers of cases of cervical cancer rise and deaths as well as a direct result of this poorly thought out government reaction.
    Thank you again for your interesting blog. I will continue to follow this story in the news

  2. childhealthandpolicy Says:

    Has the pain syndrome been widely reproduced outside of Japan? These are brands of HPV vaccine that we are using for years in the US and most of our adverse effects are related to uncommon presyncope or syncope. This is one of those times in which I wish national governments used more international data.

    Fascinating story from both a medical and public health perspective that I will now be following.

  3. etjuhn Says:

    Thank you Naohiisse for the post.

    The impact of the mass media on this health policy is concerning, and I’d have to agree with everyone’s comments on this post. It seems the media was somehow able to convince policy makers without scientific evidence, and I wonder if any particular individual or group was leading the charge against the HPV vaccines. It seems that elements from more traditional media advocacy strategies were used here, especially as the mass media had an ability to influence key decision makers (MHLW). It would be interesting to find out if any groups or organizations had funded for advertisements against HPV in the country, or if decentralized communication channels were the primary means for the media coverage. From my experience, many of the social marketing healthcare campaigns I’ve come across attempt to educate me with evidence based medicine focusing on a particular patient, and the narrative can be quite compelling. I wonder if this type of strategy took place in convincing both the public and policy makers to not support the vaccines. Also, I wonder if any professional organizations (such as Japanese OB-GYN’s) have advocated against the MHLW decision.

  4. dsomaiya2 Says:

    Thank you for this post!
    This adds to my dilemma as a practicing OB-
    Gyn in the US. I have bought into the data shown to me and the recommendation of my College that HPV vaccine is a good thing and decreases cervical cancer mortality by 70-80%. I actively encourage HPV vaccination in my practice. However as much as I hate to say this, the concerns raised by the Japanese and more strongly by the Indians( see below) make me want to re-examine the evidence. India unfortunately represents one eight of the world’s population and and a fourth of all cervical cancer related deaths. And the Indian oncologists raise a vaiid point about extrapolation of data in the “intent to treat” population of primary caucasian subjects to the rest of the developing world.

    http://journal.sajc.org/article.asp?issn=2278-330X;year=2013;volume=2;issue=4;spage=193;epage=197;aulast=Gupta

    http://www.journal.sajc.org/article.asp?issn=2278-330X;year=2014;volume=3;issue=1;spage=94;epage=95;aulast=Gupta

  5. taitok Says:

    Thank you Naohiisse for the posting an important point. It is a shame that Japan is not able to start HPV vaccination. Although Japanese Ob/Gyn and pediagric academic societies support universal HPV vaccination and conclude that there is no scientific evidence of relation between these neurological reactions and vaccination, the negative campaigns from mass media were so strong that the majority of Japanese citizen believe HPV vaccination is dangerous. To move forward, in my opinion, we need to accurately perform impact assessment of not having HPV vaccines in Japan (without HPV vaccination, around 3,000 women die every year in Japan). In addition, we can use mass media for positive campaign as well bcause we already know that the evidence that HPV causes neurological sequelae is very poor by data from many countries. It is a so long way to get the coverage back in Japan, but we have no choice but move forward !

  6. yosukesugiyama Says:

    Thank you very much for raising the issue, and I agree that the effectiveness of HPV vaccination must be widely discussed again in Japan to obtain the collective immunology against HPV.
    In particular to Japanese society, I believe there are three problems we need to address to solve this type of problems.
    Firstly, the quality of the media which is sometimes not addressing the issue appropriately and just focusing on the emotional aspect of the problem, i.e. in this case, overreacting to the concerns over the side-effect, although it was not scientifically proved.
    Secondly, lack of health literacy among the population, caused by the too generous national health insurance systems which also made them indifferent in the cost effectiveness of the interventions as a whole.
    Based on the clear scientific evidence to support the efficacy of the HPV vaccination, MHLW and patient groups should organize a campaign with support of international institutions. Patient groups also need to learn the way to lobby the legislators more influentially.

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