The recommended childhood vaccination schedule does not increase incidence of type 1 diabetes, according to a cohort study of over half a million children.
There was no association between cumulative antigen exposure or average days unvaccinated and type 1 diabetes. Moreover, cumulative exposure to aluminum greater than 3 mg — aluminum being a common adjuvant used to elicit stronger immune responses to vaccines — was associated with decreased incidence of type 1 diabetes (adjusted HR 0.77, 95% CI 0.60-0.99), according to Jason Glanz, PhD, of Kaiser Permanente Colorado, Denver, and University of Colorado, Aurora, and colleagues.
Mean cumulative aluminum exposure in this study was 4.11 mg. Vaccines can contain up to 0.85 mg of aluminum, and children adhering to the recommended immunization schedule can be exposed to up to 6 mg of aluminum.
“The observed negative association between cumulative vaccine aluminum exposure and T1DM [type 1 diabetes mellitus] was an unanticipated result and should be examined with future research,” Glanz’s group wrote in the December 2021 issue of Pediatrics.
“To maintain public trust in the U.S. childhood immunization program, in future studies, researchers should also continue to examine the safety of the entire recommended immunization schedule relative to other health conditions that concern the public,” the authors urged.
In the past 20 years, the incidence of type 1 or type 2 diabetes among children has increased. Past studies have demonstrated that individual vaccines do not cause type 1 diabetes, but none have looked at the vaccine schedule as a whole.
Nevertheless, some parents complain that the recommended immunization schedule is too aggressive for infants. “Specifically there are beliefs that vaccine antigen exposure during infancy overwhelms the immune system and that vaccine ingredients, such as aluminum, increase the risk for autoimmune diseases,” according to Glanz and colleagues.
Approximately 10-15% of parents delay or refuse vaccines due to such concerns, according to one survey.
The recommended childhood immunization schedule for children under the age of 23 months includes eight different vaccines for a total of 23 doses. Prior to 2006, the recommended schedule included seven vaccines (rotavirus, a three-dose vaccine, was added in 2006).
Due to COVID-19, routine vaccination rates in children have plummeted. Notably, aluminum is not an ingredient in either the Pfizer or Moderna COVID-19 vaccines (the former was recently authorized for use in children 5-11 years of age).
The present retrospective cohort study was conducted with the Vaccine Safety Datalink, a CDC program that assesses the safety of vaccinations using data from eight health care systems that are a demographically representative population of the U.S.
Glanz and colleagues included children born between 2004 and 2014 who had continuous health enrollment from birth through age 23 months and at least two well visits by 12 months. Children with medical conditions that prevented vaccinations were excluded.
In the present study, 1,132 children out of over 500,000 children were identified to have type 1 diabetes, equating to approximately 25 cases per 100,000 people. In the U.S., the incidence of type 1 diabetes is approximately 22 cases out of every 100,00 children, according to the CDC.
Children with a family history of type 1 diabetes were more likely to be diagnosed with diabetes and be undervaccinated, according to the researchers.
The researchers acknowledged that incidence of type 1 diabetes is highest when children are 10-14 years of age, but this study only followed children for an average of 7 years after birth.
Disclosures
This study was funded by the CDC as part of the Vaccine Safety Datalink project.
Glanz had no disclosures.
A study coauthor reported research support from Pfizer, Merck, Sanofi Pasteur, and GlaxoSmithKline.
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