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Multicenter Study
. 2021 Dec 1;148(6):e2021051910.
doi: 10.1542/peds.2021-051910.

The Childhood Vaccination Schedule and the Lack of Association With Type 1 Diabetes

Jason M Glanz  1   2 , Christina L Clarke  1 , Matthew F Daley  1 , Jo Ann Shoup  1 , Simon J Hambidge  3 , Joshua T B Williams  3 , Holly C Groom  4 , Elyse O Kharbanda  5 , Nicola P Klein  6 , Lisa A Jackson  7 , Bruno J Lewin  8 , David L McClure  9 , Stanley Xu  8 , Frank DeStefano  10
Affiliations
Multicenter Study

The Childhood Vaccination Schedule and the Lack of Association With Type 1 Diabetes

Jason M Glanz et al. Pediatrics. .

Abstract

Objectives: Safety studies assessing the association between the entire recommended childhood immunization schedule and autoimmune diseases, such as type 1 diabetes mellitus (T1DM), are lacking. To examine the association between the recommended immunization schedule and T1DM, we conducted a retrospective cohort study of children born between 2004 and 2014 in 8 US health care organizations that participate in the Vaccine Safety Datalink.

Methods: Three measures of the immunization schedule were assessed: average days undervaccinated (ADU), cumulative antigen exposure, and cumulative aluminum exposure. T1DM incidence was identified by International Classification of Disease codes. Cox proportional hazards models were used to analyze associations between the 3 exposure measures and T1DM incidence. Adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) were calculated. Models were adjusted for sex, race and ethnicity, birth year, mother's age, birth weight, gestational age, number of well-child visits, and study site.

Results: In a cohort of 584 171 children, the mean ADU was 38 days, the mean cumulative antigen exposure was 263 antigens (SD = 54), and the mean cumulative aluminum exposure was 4.11 mg (SD = 0.73). There were 1132 incident cases of T1DM. ADU (aHR = 1.01; 95% CI, 0.99-1.02) and cumulative antigen exposure (aHR = 0.98; 95% CI, 0.97-1.00) were not associated with T1DM. Cumulative aluminum exposure >3.00 mg was inversely associated with T1DM (aHR = 0.77; 95% CI, 0.60-0.99).

Conclusions: The recommended schedule is not positively associated with the incidence of T1DM in children. These results support the safety of the recommended childhood immunization schedule.

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Conflict of interest statement

POTENTIAL CONFLICT OF INTEREST: Dr Klein receives research support from Pfizer, Merck, Sanofi Pasteur, GlaxoSmithKline, and Protein Science (now Sanofi Pasteur). All other authors have indicated they have no potential conflicts of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Cohort exclusions. a Children were excluded if they received nonstandard vaccines that are not in the ACIP schedule, such as experimental vaccines, Japanese encephalitis, rabies, or typhoid.
FIGURE 2
FIGURE 2
The risk of developing T1DM. Complete-case analysis consisted of 497 636 children, of whom 991 developed T1DM. The imputed models used all 584 171 patients and 1132 children who developed T1DM. We adjusted for sex, race and ethnicity, year and season of birth, the mother’s age at birth, birth weight, gestational age, VSD site, and number of well-child visits between 30 days and 2 years of life.
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