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Influenza HA Vaccine

The Ministry of Health, Labour and Welfare (MHLW) is now trying to approve the imported vaccines for new strain of influenza (A/H1N1).

Although the article 14-3 of the Act on Pharmaceutical Affairs allows the Minister of Health to specially approve the production and sales of drugs under certain conditions, it shall be an exceptional scheme for urgent and emergency situations, such as highly lethal and infectious diseases occurs.
The MHLW does not provide citizens with correct information including the followings: the number of inpatients or dead is limited (i.e., most of the symptoms are mild) despite the fact that more than 540,000 persons are presumed to be infected; or the efficacy of vaccines is expected to be limited.

We have strong objection to applying this article to the imported vaccines for the new strain of flu (A/H1N1). We desire that more scientific and citizen-oriented discussion will be held on new flu policy including the issue on vaccinations.
We therefore submitted a request to the MHLW on September 13, 2009 as follows:

< Our Request Outline >

1. Special Approval for Imported Vaccines
Draft proposal by the MHLW premises that the Minister will give special approval to the imported vaccines based on the article 14-3 of the Act on Pharmaceutical Affairs. However, the prevalence of the new flu in Japan so far suggests that seriousness and danger of the new flu does not overweigh those of the seasonal flu. In addition, we must say that the efficacy of vaccines is extremely limited. Further more, the need to urgently import vaccines at the expense of ensuring safety is hardly found, given that the safety of the imported vaccines is unknown. The imported vaccines do not fall under the requirements provided by the article 14-3 of the Act for special approval.

2. Remedies for Damage to Health
No-fault compensation scheme should be introduced. However, the scheme is the second best strategy effective only after certain damage to health occurs. The best strategy shall be the provision of the vaccines safest possible. In addition, the government is trying to introduce no-fault compensation with corporate immunity in order to use the imported vaccines, which we think confuses the orders of things. The corporate immunity shall not be introduced.

3. Ensuring Voluntariness in Taking Vaccinations and Providing Correct Information
In order to ensure that people take vaccinations with his/her own will they should be provided with correct information, including the efficacy and limitation of the vaccines, risks, and the seriousness of the new flu. Almost all patients reveal only slight symptoms, and especially for healthy people, most of the cases are cured naturally. The rate of serious cases and death is not high, as compared with seasonal flues. This information should be widely disseminated.
In addition, the vaccines’ "efficacy rate," which is written on reference materials, does not correctly reflect past studies and overemphasizes the efficacy. Therefore, explanation based on these materials is not proper.


  • YAKUGAI Ombudsperson
  • Tie-up Group

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