Hemophilus Vaccine Study in Finland Proves a Causal Relationship Between Vaccines and Diabetes

(published Autoimmunity 35:247-253,2002)

     Dr. J. Bart Classen discovered it would be possible to study the effect of Hemophilus B immunization on the incidence of IDDM  using data from a large clinical trial  in Finland.  Dr. J. Bart Classen and D.C. Classen initiated and funded a collaboration with Dr. Tuomilehto in Finland. All children born in Finland between October 1st, 1985 and August 31st, 1987, approximately 116,000 were randomized to receive 4 doses of the HiB vaccine (PPR-D, Connaught) starting at 3 months of life or one dose starting at 24 months of life. Classen and Classen calculated the incidence of IDDM in both groups through age 10 and in an group which did not receive the HiB vaccine, a cohort which included all 128,500 children born in Finland in the 24 months prior to the Hemophilus vaccine study. Immediately following the completion of these two arms all children born in Finland over a two year period were randomized to receive 3 doses of the old PPR-D HiB vaccine or 3 doses of a newer HbOC HiB vaccine. The data supports  published findings that the immunization starting after 2 months of life is associated with an increased incidence of IDDM. Rises in diabetes have been seen in the UK and USA following the introduction of the hemophilus vaccine (see HIB)

    Proof that the hemophilus vaccine causes diabetes is summarized in the graphs and tables below. Data from the clinical trial (Figures 1 A and 1B) shows distinct clusters of diabetes caused by the hemophilus vaccine. The cases of diabetes caused by the vaccine occur in clusters starting approximately 38 months after immunization and lasting approximately 6-8 months. In these time frames the relative risk exceeds 2, meaning that the majority of cases of diabetes are caused by the vaccine. The clustering effect in the graphs below is very significant since the delay between immunization and the development of diabetes is identical to the delay reported by several independent groups between the detection of autoantibodies to insulin secreting pancreatic islet cells and the development of diabetes (see Journal of Pediatric Endocrinology and Metabolism 16 (4):495-507, 2003)

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Further support for a causal relationship is demonstrated in Figures 2 and 3 below. Figure 2 shows the incidence of diabetes in the underlying population in Finland had been stable in the 5-9 year old population but rose after routine hemophilus immunization in a predictable manner based on the clinical trial.   Figure 3  shows the hemophilus vaccine causes diabetes in mice.

Children received 4 doses (3,4,6,18 months) or 1 dose (26 months) of the Hemophilus influenza B vaccine and were followed from birth through age 9 of life (10th birth day) for the development of IDDM.The graph shows a cluster of cases of diabetes caused by the hemophilus vaccine occurring 36-42 months after immunization starting at 3 months of life.

Figure 1B.

Children received 1 dose (26 months) or 0 doses of the Hemophilus influenza B vaccine. Children were followed from birth through age 9 of life (10th birth day).The graph shows a cluster of cases of diabetes caused by the vaccine occurring 40 months after the hemophilus vaccine is given.

The yearly incidence of IDDM in Finland in children age 5 through age 9 of life from 1982 through 1996 is tabulated in 3 year averages. The incidence of IDDM in the unvaccinated and vaccinated group in the clinical trial is compared to the underlying incidence of IDDM in Finland prior to HiB vaccinated children reaching age 5. The incidence of IDDM in Finland rose after the vaccinated children reached age 5 (1994-1996) and the incidence in Finland equaled that in the vaccinated group from the clinical trial. This shows the incidence of diabetes in Finland rose after wide spread use of the hemophilus vaccine, in a way predicted by the clinical trial.

All female NOD mice were injected intrapertioneally with hepatitis B vaccine injected on day 3 of life and intramuscularly on day 28 of life. The "vaccinated" group (n=40) received additional doses of the DTaP, hemophilus, and inactivated polio vaccines on weeks 10, 16, 22. Mice in the "control" group (n= 37) were injected with saline intramuscularly on weeks 10, 16, 22. Mice for followed for the development of IDDM from week 10 to week 32.The data shows there were more cases of diabetes, fewer diabetes free mice, in the group receiving the hemophilus vaccine.

   The graph above shows that there is a dosing effect, with the highest incidence of diabetes in the group receiving 4 doses of vaccine followed by the group receiving 1 dose.

    The data is tabulated below.

 
           4 DOSES           1 DOSE            0 Dose
Population 59,024            56,921            128,532
       

           Cases Cumulative  Cases  Cumulative Cases    Cumulative
           IDDM  Incidence   IDDM   Incidence  IDDM     Incidence
                 100,000            100,000             100,000
Age
0 to 7     154   261         135    237        266      207**
0 to 10    235   398         214    376        437      340    

0 to 5     98    166         83     146        180      140
0 to 2     21    36          21     37         33       26
5 to 10    137   232         131    230        257      200
2 to 7     133   225         114    200        233      181
2 to 5     77    130         62     109        147      114
5 to 7     56    95          52     91         86       67
       

**The results are statistically significant at 7 years of life    

(7 years was the primary, prospective endpoint of the study).      

 	The graphs below shows A rise in diabetes was seen in both children under 5 and over 5.  
       

    The data below shows that the incidence of diabetes in Finland had been constant in children 5 through 9 years of age for approximately 10 years. The incidence of IDDM rose dramatically in this population when the Hemophilus vaccinated children entered this age group. This supports a causal relationship between the vaccine and IDDM.

    The effect of Hemophilus vaccine on insulin dependent diabetes (IDDM) appears to be huge. Over 24,000 children may develop IDDM from the Hemophilus vaccine over a 10 year period in the US. The actual number may be even larger since the data from Finland was derived from studying a weak, early generation Hemophilus vaccine and newer vaccines may be more diabetogenic. The incidence of IDDM has increased in Finland as these new vaccines have been added to the immunization schedule (see above).