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Japan eyes promotion of HPV vaccines as early as FY 2022 while damages lawsuits go on

The Central Government Building No. 5 that houses the Health, Labor and Welfare Ministry is seen in this file photo. (Mainichi/Kimi Takeuchi)

TOKYO -- A health ministry panel recommended on Oct. 1 that Japan actively resume promoting human papillomavirus (HPV) vaccines -- a move that is expected to greatly boost the country's low vaccination rate. However, women who sustained health damage after being vaccinated are staunchly opposed to the move, saying it could lead to further harm, and lawsuits are continuing in district courts across the country.

    HPV can cause cervical cancer, which causes about 2,800 deaths per year in Japan. A vaccination program targeting girls from the sixth year of elementary school to the first year of high school began in April 2013. But immediately afterward, there was a stream of reports suggesting side effects from pain to motor disorders, and the Ministry of Health, Labor and Welfare was forced to alter course.

    In June that year, a ministry expert panel noted a clear increased rate of persistent pain and judged that a causal relationship between vaccinations and the health problems could not be denied. It said that until appropriate information could be provided to the public, vaccinations should not be actively recommended. The ministry halted active promotion of vaccinations after just three months.

    People can still get HPV vaccinations free of charge, but because the shots are not being actively promoted, the vaccination rate is far lower than it was before. Between fiscal 1995 and 1998 the vaccination rate exceeded 70%, but among those born from fiscal 2002 onward -- the age bracket eligible for vaccinations when active promotion was suspended -- the rate is under 1% percent.

    Eight years have passed since promotion ceased, and the death rate for cervical cancer has been rising. Discussion on resuming active recommendation began following the accumulation of scientific views on the efficacy and safety of the vaccines. At the Oct. 1 meeting of the expert panel at the health ministry, findings by a Swedish team showing vaccinations were effective in preventing cervical cancer were reported. In a survey conducted between 2006 and 2017 on 1.67 million women between the ages of 10 and 30, the rate of cervical cancer among those who got the shot was 47 per 100,000, while for those who hadn't been vaccinated, the rate was 94 per 100,000. For the group that was vaccinated, the risk of developing cervical cancer was 63% lower, while for those who were vaccinated before the age of 17, the rate was 88% lower.

    Regarding side effects of HPV vaccinations, the package insert accompanying the vaccine Cervarix, which is used for regular vaccinations, states that the rates of hives and dizziness following inoculation range from 1% to less than 10%, while paresthesia at the injection site and fatigue over the entire body were reported in less than 1% of cases.

    Major studies conducted in Europe and the United States failed to find a clear causal relationship between long-term fatigue and autoimmune diseases reported as health damage from the injections. Furthermore, a survey by the city of Nagoya found no significant difference in the rate of symptoms between those who had been vaccinated and those who hadn't.

    There were no dissenting opinions among the members at the Oct. 1 expert meeting, which concluded that there were no factors to hinder resuming vaccination promotion. A health ministry official commented, "A certain part of the population was followed for a certain amount of time, and papers with a high level of evidence were presented to the expert committee. At this stage, there are no autoimmune disorders or other such symptoms shown to be causally linked to the vaccine." The ministry wants to resume actively promoting vaccinations as early as fiscal 2022.

    However, women who suffered health problems after getting HPV shots have filed lawsuits demanding that their health be restored. On Oct. 1, the same day as the health ministry panel meeting, the plaintiffs and their legal representatives held a news conference. Masumi Minaguchi, a joint representative of the legal team, commented, "The premise of the discussion (by experts at the ministry) is divorced from the seriousness of side effects and the fact that the treatment system is badly lacking."

    The lawsuits allege that vaccinations were responsible for side effects including memory and motor disorders. A total of 130 women and girls aged from their 10s to 20s, who were in grades ranging from the sixth year of elementary school to their first year of high school when they were vaccinated, have filed lawsuits in four district courts, including in Tokyo and Osaka, against the government and pharmaceutical firms for compensation. Meanwhile, the government and pharmaceutical companies have denied a causal relationship and are fighting the lawsuits.

    According to the lawyers' group, an average of 13.72 people per million have been granted medical fees under the relief system provided by the Pharmaceuticals and Medical Devices Agency for health damage from vaccinations, on the grounds that a causal relationship cannot be denied. This is more than 20 times the rate for measles and rubella, and based on the comparatively higher rate, the legal team says the risk of side effects should be properly evaluated.

    One 24-year-old woman from Mie Prefecture, who developed higher brain dysfunction after being vaccinated when she was in her third year of junior high school, says she still experiences headaches and pain over her whole body.

    "For a long time, I've wanted my body back how it was," she said. "There is still no treatment method, and people's health has been damaged, but there are schools and workplaces that unfairly treat the conditions as 'feigned illnesses.' I want them to listen to our voices."

    (Japanese original by Sooryeon Kim, Takuya Murata, and Ai Yokota, Lifestyle and Medical News Department)

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