Japan Establishes Guidelines & Special Clinics to Treat HPV Vaccine Injuries

The following news report was submitted by Meryl Nass, MD, member of AHRP Board
Vaccine injuries are real. They can be serious and often fail to respond to treatment. The most serious injuries are usually to the brain. Vaccine injuries may cause death. The US federal vaccine injury compensation program has paid out $3.18 billion dollars in compensation for vaccine injuries since the program was established in 1988.

Yet with the stoking of fears over measles and the claimed “desperate” need for vaccine mandates in 2015, these truths about vaccine injuries have been overlooked, or deliberately ignored by the media.

It is hard to believe, but but there is lack of proof that HPV vaccines actually prevent cervical cancer. When the FDA licensed Gardasil under “fast-track” authority in 2006, it did so with limited data from its manufacturer, Merck. The FDA required Merck to collect data through 2017 to determine whether Gardasil really does prevent cancer. FDA’s letter to Merck states:

“You have committed to collaborate with the cancer registries in four countries in the Nordic Region ( Sweden, Norway, Iceland, and Denmark) to assess long-term outcomes following administration of GARDASI®. In this study, approximately 5,500 subjects enrolled in Protocol 015 (one half from the placebo group that will have been vaccinated shortly after approval) will be followed for a total of 14 years.

Two major goals of this study are: 1) to assess the long-term effectiveness of GARDASIL® by evaluating biopsy specimens for presence of HPV 6/11/16/18-related incident breakthrough cases of CIN 2/3, AIS and cervical cancer, VIN 2/3 and vulvar cancer, and VaIN 2/3 and vaginal cancer; and 2) to assess whether administration of GARDASIL® will result in replacement of these diseases due to vaccine HPV types with diseases due to non-vaccine HPV types.

This study is designed to accomplish these goals as discussed in the June 6, 2006, submission to your BLA. The final protocol for this study will be submitted by December 8, 2006. Patient accrual for this study was previously completed in the context of Protocol 015. This study will be completed by December 31, 2017, (14 years from initiation of the last patient enrolled in Protocol 015 in the four Nordic countries). The final study report will be submitted by December 31, 2018…”

Furthermore, the Gardasil label explicitly notes that recipients must still have regular PAP smears (PAP smears, unlike Gardasil, have been proven to prevent cervical cancer) despite their vaccinations:

“…Limitations of GARDASIL Use and Effectiveness:• GARDASIL does not eliminate the necessity for women tocontinue to undergo recommended cervical cancer screening…”

So the vaccine may work. Or it may not. But that has not stopped many states and countries from recommending or requiring this vaccine (intended for a sexually transmitted disease) for children in junior high. Rhode Island mandated HPV vaccine for its students in July. How safe are HPV vaccines? We lack reliable data, but there are many reports of serious injuries.

Now Japan — after 358 vaccine injuries judged serious and 2,000 adverse event reports — has not only rescinded its recommendation that girls receive this vaccine, but has also established guidelines and special clinics for evaluating and treating illnesses caused by the Gardasil and Cervarix HPV vaccines.
Medscape reports:

“Japan has put in place a scheme to manage symptoms, especially generalized chronic pain, that have arisen after human papillomavirus (HPV) vaccination given to adolescents to protect against cervical cancer.

Although there have been assurances on the safety of HPV vaccination from many official medical bodies since the vaccines were first introduced — Gardasil (Merck & Co.) in 2006 and Cervarix (GlaxoSmithKline) in 2009 — there have also been persistent reports of rare cases of adverse events. These include case reports in the medical literature of complex regional pain syndrome and postural orthostatic tachycardia syndrome, as previously reported by Medscape Medical News.

In July 2015, the European Medicines Agency announced that it was conducting a safety review of HPV vaccines, which was requested by Denmark, where reports of adverse events after HPV vaccination have been widely reported in the media.

Japan withdrew its recommendation for HPV vaccine in 2013, and has not reversed that decision because of concerns from the public about adverse events, which included long-term pain and numbness, as previously reported by Medscape Medical News.

Since then, various symptoms, especially generalized chronic pain after injection, have been reported.

Last month, guidelines for the evaluation and management of symptoms that begin after HPV vaccine injection were issued to healthcare professionals. The guidelines were edited and approved by the Japan Medical Association (JMA) and the Japanese Association of Medical Sciences (JAMS).

In addition, the Japanese Ministry of Health, Labor, and Welfare has issued a list of medical institutions where people can visit when they have symptoms after HPV injection; there is at least one in each prefecture. Healthcare workers at those selected institutions are educated by the JMA. However, this does not mean other institutions cannot accept those people with symptoms. The ministry has also issued information regarding HPV vaccine-related health problems and questions, with a telephone helpline…”