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Submission of a written request on the cervical cancer vaccine (Human Papilloma Virus or HPV vaccine)

2013-09-25

On September 25th 2013, Medwatcher Japan released a written request on the cervical cancer vaccine (Human Papilloma Virus or HPV vaccine).

In accordance with the Preventive Vaccination Act, the cervical cancer vaccine has been included in Japan's mandatory vaccination schedule since April 1st 2013.
However, on June 14th of the same year, the Ministry of Health, Labor and Welfare decided to stop strong encouragement of the vaccine following a statement from a Health Science Council meeting which announced that "due to patient complaints of persistent pain upon receiving the vaccine, the causal relationship between this and the HPV vaccine cannot be denied. As the frequency of side effects is becoming clear, the vaccine should not be actively recommended as part of the mandatory vaccination schedule until appropriate information can be supplied to the public." (Although mandatory inoculation has not been cancelled and it's still possible to receive HPV vaccine according to the mandatory vaccination schedule).

However, Medwatcher Japan believes that there are not enough rational reasons why the public should be mandatorily inoculated with the HPV vaccine and submitted a written request asking the government to withdraw the vaccine from the mandatory vaccination as promptly as possible.
The request also asks that patients who have suffered side effects through voluntary inoculation receive at least the same amount of compensation as those who experience side reactions through mandatory inoculation, and that medical institutions, professionals and those wishing to receive the vaccine should be adequately informed of the safety and efficacy of the vaccine and of any serious side effects (e.g. Guillain-Barré syndrome and acute disseminated encephalomyelitis or ADEM).

Below is an outline of Medwatcher Japan's views on the safety and efficacy of the HPV vaccine:

1 Efficacy
(1) At the present time, there has been no confirmation of effects that prevent the development of cervical cancer. The only confirmed effects are those which stop dysplasia of the mucus membrane and that only lasts a maximum of about 9.4 years.

(2) Effects have only been confirmed against high-risk HPV types -16 and -18 which are found in about 5 out of 10 Japanese female patients with cervical cancer. These effects should be considered limited.

(3) There are no effects on patients already infected with the HPV types(s) that are covered by the vaccine prior to vaccination.

(4) Apart from the HPV vaccine, there are various other preventive measures against cervical cancer (screenings, limiting the number of sexual partners, using a condom during sexual intercourse). In line with points (1) to (3) above, the HPV vaccine doesn't offer reasonable efficacy and therefore cannot be considered a key preventive measure.


2 Safety
(1) Upon receiving the HPV vaccine, a given number of people have side effects including serious autoimmune diseases such as Guillain-Barre syndrome.

(2) There is a strong possibility that the Ministry of Health, Labor and Welfare's reports on the number of side effects and their frequency in patients receiving the HPV vaccine is lower than the actual figure. This can be just the tip of the iceberg.


For more information on cervical cancer, please refer to Medwatcher Japan's "The Real Answers on the Cervical Cancer Vaccine" and "The Informed Prescriber" (April and August 2013).