HPV Vaccine Adverse-Effects Class-Action Suit Planned in Japan

Zosia Chustecka

April 01, 2016

In Japan, lawyers acting on behalf of girls and young women who still have symptoms, including pain disorders, after vaccination against human papillomavirus (HPV) are now planning a class-action suit against the Japanese government, which launched a national vaccination program, and the two manufacturers of the vaccines — Merck & Co (Gardasil) and GlaxoSmithKline (Cervarix).

"Many victims are still suffering from side effects..., which include overall pain and disorders of perception, movement, and memory," said lawyer Masumi Minaguchi, a representative from the planned lawsuit's defense team. He was speaking at a news conference in Tokyo on Wednesday March 30, according to a report in The Japan Times.

There are currently 12 plaintiffs, aged from 10 to 20 years, and the lawyers are looking for more to join in, so they intend to publicize the issue in seminars planned for April and May. The team plans to file the lawsuit sometime after June at four district courts, in Fukuoka, Nagoya, Osaka, and Tokyo, according to the report.

In Japan, the health ministry began recommending that girls between the ages of 12 and 16 be vaccinated against HPV to protect against cervical cancer in April 2013, after the National Diet revised the Preventive Vaccination Law. However, the ministry halted the recommendations in June 2013 following a number of cases involving reported adverse effects.

The report notes that, according to health ministry figures, an estimated 2.59 million had received injections of Cervarix by the end of 2014, with 2022 people reporting adverse effects, and an estimated 790,000 people had been given Gardasil, with 453 reporting adverse effects.

Last year, the Japanese Ministry of Health and Welfare put into place a scheme specifically to manage the symptoms after HPV vaccinations, with guidance for health professionals and special centers around the country to deal with these cases.

As previously reported by Medscape Medical News, the issue of adverse effects, symptoms, and pain syndromes after HPV vaccination has also been reported in many other countries, including the United States.

Last year, this issue was investigated by the European Medicines Agency (EMA), which concluded that evidence does not support that the vaccines cause complex regional pain syndrome or postural orthostatic tachycardia syndrome. However, researchers from Denmark, where many of these cases were first reported, said that the EMA investigation was "not valid," as it relied mostly on published cases, and the Danes launched their own independent study in November 2015.

In the United States, the health authorities say there is no problem.

"HPV vaccines have an excellent safety record," Tom Shimabukuro, MD, MPH, MBA, deputy director of the Immunization Safety Office at the Centers for Disease Control and Prevention (CDC), told Medscape Medical News last year.

The vaccine has been in use for nearly a decade. The first, the quadrivalent HPV vaccine (Gardasil), was licensed in the United States in 2006, followed by the bivalent HPV vaccine (Cervarix), which was licensed in 2009, and the nine-valent HPV vaccine (Gardasil 9), which was licensed in 2014.

"Approximately 79 million doses of HPV vaccines have been distributed for use in the United States, and no causal association or links between HPV vaccines and atypical or unusual pain syndromes or autonomic dysfunction have been identified in either prelicensure clinical trials or postlicensure safety monitoring conducted by CDC," Dr Shimabukuro said.

"Most side effects to HPV vaccines are mild and go away on their own, like pain and redness from the shot. Occasionally, patients might faint after receiving HPV, or any injectable vaccine," he noted.


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