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Submission of ¡ÈStatement on the ¡ÆPreliminary Report of Analysis of Nagoya City Cervical Cancer Immunization Program Survey¡Ç¡É

2015-12-17

Medwatcher Japan submitted its ¡ÈStatement on the ¡ÆPreliminary Report of Analysis of Nagoya City Cervical Cancer Immunization Program Survey¡Ç¡É to the Nagoya city mayor dated on December 16th, 2015.

The outline of the statement is as follows:

1. The survey has a great significance as a fact-finding survey because of its unprecedented features including size, question items of a wide range of health changes, and inclusion of unvaccinated population as the control.

2. However, because of its fact-finding nature, the survey has a limitation to deduct the causality between vaccination and health changes by applying the method of analytical epidemiology and testing the statistical significance between vaccinated and unvaccinated groups.

3. Despite that, analysis focused on post-vaccination symptoms has not been conducted. On the other hand, between-group comparison for presence or non-presence of individual symptom was tested for statistical significance and a conclusion was made that ¡Èno symptom was significantly more frequent among vaccinated people than non-vaccinated ones¡É. However, this conclusion lacks credibility and therefore conclusion that there is no causal relationship between HPV vaccination and post-vaccination symptoms cannot be made.

4. An age-adjusted analysis was performed: before the adjustment, four symptoms were significantly more frequent in the vaccinated group, whereas, after the adjustment, it became zero and on the contrary, 15 out of 24 symptoms became significantly less frequent in the vaccinated group. These results are obviously unnatural and suggest that the adjustment was not appropriate because if there were no vaccination effects, there should have been no significant differences either.

5. Nagoya city is, therefore, required to address the followings:
(1) Based on the issues mentioned in this statement, continue analyses to find out the actual situation of post-vaccination symptoms focusing on the link between vaccination timing and onset of symptoms, frequencies of symptoms if they persist, and multilayered symptoms; compare them between vaccinated and unvaccinated groups; and perform thorough analyses from various perspectives.

(2) The survey results should be considered as a public asset because the data were obtained through public funding and citizens¡Ç voluntary cooperation. Nagoya city, therefore, is obliged to disclose and make the raw data available for private researchers so that they can investigate and verify the city¡Çs analysis results as well as HPV vaccine safety.