A group of Japanese physicians is asking the Japanese government to reconsider its position on the human papillomavirus (HPV) vaccine, citing that the incidence of HPV infection will rise if the current trend continues.
The Japanese government withdrew its support for the HPV vaccine in 2013 and has not reinstated it.
The comments come from Yusuke Tanaka, MD, and five colleagues from the Department of Obstetrics and Gynecology at Osaka University Graduate School of Medicine, Japan, andwere published in the July issue of The Lancet Oncology.
The authors explain that HPV vaccinations became available in Japan for girls aged 13 to 16 years with public aid in 2010 and subsequently also became routine for those aged 12 to 16 years, beginning in April 2013.
However, just 2 months later, the Japanese governmentwithdrew its recommendation for the HPV vaccine, citing concerns from the public about adverse effects.
The Japanese Ministry of Health, Labor, and Welfare did not suspend use of the HPV vaccine but instead instructed local governments not to promote it while analyses were being conducted about adverse effects, which include long-term pain and numbness.
As a result of that action, say Dr Tanaka and coauthors, the rate of newly vaccinated girls in fiscal year 2013 dropped from the routine rate of approximately 70% per year to 1.1% in 12-year-old girls and to 3.9% in 13-year-old girls.
The authors note that the International Federation of Gynecology and Obstetrics (FIGO) Gynecologic Oncology Committee and the FIGO subcommittee for Cervical Cancer Prevention released a statement in August 2013 that supported the safety of HPV vaccination. Two years later, the Japan Society of Obstetrics and Gynecology issued its own statement, noting that “the current situation in Japan should be evaluated based on scientific evidence.”
However, the Ministry of Health, Labor, and Welfare of Japan has declined to reinstate their previous recommendation for HPV vaccines.
The authors emphasize that if the current situation continues in Japan, “there is concern that disparities might occur in the incidence of HPV infections and result in future highly preventable cervical and other HPV-related cancers, depending on an unfortunate year of birth.”
If vaccination were to rapidly resume this year for girls aged 12 to 16 years, for example, the rate of HPV 16/18 infection by age 20, for women born in 2000–2003, would only slightly increase.
However, they note that it is highly unlikely that this will happen in 2016.
Instead, they predict that if vaccine “encouragement” is not reinstated until 2020, girls who are born between 2000 and 2003 will have a noticeably high HPV 16/18-positivity rate compared with those born in other years.
Additionally, if the vaccine recommendation doesn’t begin again until 2020, some girls may also become sexually active during this time period, thus further increasing the rate of HPV infection.
“In other words, this year is the last chance to minimize the potential risk of HPV infection for Japanese girls,” they say.
Guidelines Issued for Chronic Symptoms
Last year, medical authorities in Japan issued guidelines to healthcare professional for evaluating and managing symptoms, including chronic pain, that appear to be associated with the HPV vaccine. The guidelines were edited and approved by the Japan Medical Association and the Japanese Association of Medical Sciences.
Since then, a class action lawsuit has been initiated on behalf of girls and young women who are still experiencing symptoms after receiving the HPV vaccination. The suit is directed against the Japanese government, which launched the national vaccination program, and the two manufacturers of the vaccines: Merck & Co (Gardasil) and GlaxoSmithKline (Cervarix).
Chronic symptoms after HPV vaccination have also been reported in other countries, and some have been documented in the medical literature.
Last year the European Medicines Agency (EMA) announced that a task force found no causalitybetween the vaccination and two sets of chronic symptom syndromes. This has also been the message from the Centers for Disease Control and Prevention.
However, some clinicians and scientists have questioned the validity of the EMA report, and now anofficial complaint has been filed by the Nordic Cochrane Center.
Coauthors Yutaka Ueda and Tadashi Kimura received lecture fees from GlaxoSmithKline/Japan Vaccine (the manufacturer of the HPV vaccine Cervarix). Dr Ueda also received a lecture fee, research fund, and consultation fee from Merck Sharp & Dohme (the manufacturer of the HPV vaccine Gardasil) and research funding from the Japan Agency for Medical Research and Development. The other authors have disclosed no relevant financial relationships.
Lancet Oncol. 2016;17:868-869. AbstractGo to source