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• W2045746585 abstract "Type 1 diabetes and vaccinations has been a subject for investigations without clear conclusions. The increase in the frequency of type 1 diabetes in recent years has been paralleled by an increase in vaccination frequency. It is therefore of outmost importance that conclusions regarding this association are based on clear and reproducible results. For reader information, the number of type 1 diabetes cases in the unvaccinated groups (0–9 years: 153 cases; 10–19 years: 183 cases) was chosen by the authors not be presented in the published article but are those figures obtained in the study and used for the calculations of hazard ratios according to the same persons. The authors answered in general terms, but their arguments did not explain the significant discrepancy in the critical age group 10–19 years. Using their cut-off limits for age groups about 11% is still not reported (62 cases in the study) when compared with the SWEDIABKIDS registry. The authors give new information, not clearly presented in the article. The spans of age at diagnosis were in fact 0–12 and 10–22 years, respectively, although the groups were named 0–9 and 10–19 years. They explain the estimated contradictory data with this circumstance, but no numerical explanation is given. I have therefore recalculated the number of type 1 diabetes cases taken into account the author's explanation with a successive rightward shift in age at diagnosis during the 27-months study period including an initial 9 months lag-phase between 1st January and 1st October 2009. Data used for the estimations are presented in the Table 1. In the younger age group, 0–9 years (0–12), the number of cases was close to that reported in the SWEDIABKIDS registry (−1% corresponding to −4 cases). The methodology used in the article captures in principal all cases compared with the quality registry in this age group. However, one would expect slightly more cases by actively searching for cases as in the article study compared with the voluntary passive reporting used for the SWEDIABKIDS registry. A significant discrepancy remained, however, in the age group 10–19 years (10–22). Using modest extrapolation values in favour of the article, there are 62 type 1 diabetes cases not reported in the study corresponding to about −11% of the study population. This is a great difference corresponding to a whole average age-class. Lack of retrieved patients in this age group in the study is difficult to understand. One would expect more cases in the study than in the registry. Therefore, the discrepancy may be substantially larger than −11%. If there was no lag-phase in the study, the discrepancy would be even larger. The huge size of the sample, comprising 64% of the Swedish children aged 0–19 years, is representative for the whole population; it requires extraordinary deviation in the remaining Swedish population not investigated to balance the figures (34% higher incidence in 10–19 years). The cases not retrieved in the study could easily switch the outcome between Pandemrix and type 1 diabetes from ‘no association’ (HR 1.23, 1.00–1.51 95% CI) into a clear statistical significant association. The distribution of the missing 62 cases between vaccinated and nonvaccinated adolescents is crucial. If the inter-relationship is preserved, there will be a statistical significant association between Pandemrix and type 1 diabetes by expanding the cohort with 62 more cases. This age group cover the most sensitive period in life to get type 1 diabetes. The elevated HR of 1.23 would correspond to about 190 cases in the country caused by Pandemrix during the 27-months follow-up period which is twice the number of narcolepsy cases in this age group. This is consistent with Rawshani et al. who recently reported an increased incidence in the same age group (10–19 years) of about 10 per cent between the year before the vaccination campaign started (2008) and the year after (2010). The authors’ conclusion: ‘…, we found no convincing evidence of a risk increase for selected neurological or immune-related diseases, except narcolepsy, in Pandemrix-vaccinated compared with unvaccinated individuals.’ is challenged by the discrepancy between the study and the register in type 1 diabetes cases and therefore questioned. An effect of Pandemrix vaccination is suggested already by the current data and if the missing cases as compared with the register are added, there will be a statistical significant association if the inter-relationship of type 1 diabetes cases is preserved between vaccinated and unvaccinated individuals. The reported hazard ratio corresponds to as much as about 190 extra cases of type 1 diabetes due to Pandemrix vaccination in the sensitive age group 10–19 years, and the issue is therefore too important to be neglected but must be investigated further. It is therefore necessary to identify all individual cases in the study and the registry and add all the missing unvaccinated and vaccinated cases to the study when recalculating the hazard ratio and the confidence interval. The issue is therefore considered unresolved. No conflict of interest to declare." @default.
• W2045746585 created "2016-06-24" @default.
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• W2045746585 date "2015-01-26" @default.
• W2045746585 modified "2023-10-18" @default.
• W2045746585 title "Retracted: Response on the author's reply to the Letter to the Editor: Contradictory data on type 1 diabetes in a recently published article ‘Risks of neurological and immune-related diseases, including narcolepsy, after vaccination with Pandemrix’" @default.
• W2045746585 doi "https://doi.org/10.1111/joim.12327" @default.
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