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Predicting Human Aluminium Exposure from Vaccinations Using a Physiologically-Based Toxicokinetic Model.

Karin Weisser1, Niklas Hartung2, Gaby Wangorsch1

  • 1Division Safety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines), Paul-Ehrlich-Straße 7, 63225 Langen, Germany.

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|April 27, 2026
PubMed
Summary
This summary is machine-generated.

Aluminium (Al) adjuvants in vaccines are safe for infants and adults. Model predictions show vaccine-related Al exposure remains within normal body levels, ensuring safety for recommended vaccination schedules.

Keywords:
adjuvantsaluminiumcomputer simulationtoxicokineticsvaccination

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Area of Science:

  • Toxicology
  • Pharmacokinetics
  • Immunology

Background:

  • Aluminium (Al) compounds are widely used as vaccine adjuvants to enhance immune responses.
  • Concerns persist regarding the safety of Al exposure from vaccines, particularly in infants.
  • Limited human toxicokinetic data necessitates model-informed risk assessment for vaccine-associated Al.

Purpose of the Study:

  • To predict aluminium (Al) exposure from vaccinations using a physiologically-based toxicokinetic model.
  • To assess Al exposure in infants, children, and adults following recommended vaccination schedules.
  • To evaluate the contribution of vaccine-derived Al to the overall body burden.

Main Methods:

  • A physiologically-based toxicokinetic model was employed.
  • Predicted Al exposure from intramuscular injections of Al-adjuvanted vaccines.
  • Incorporated continuous oral background Al exposure from dietary intake.
  • Simulated exposure across age groups from neonates to 50-year-old adults.

Main Results:

  • Transient, moderate increases in plasma and tissue Al concentrations predicted in infants during the first two years of life.
  • Predicted increase in brain Al content was 4%, remaining within normal levels.
  • Marginal increases in Al levels observed in children and adults after vaccination.
  • Vaccinations contributed negligibly to the overall Al body burden by age 50.

Conclusions:

  • Vaccine-derived Al exposure, based on toxicokinetic predictions, is considered safe for infants, children, and adults.
  • Current vaccination schedules with Al-adjuvanted vaccines do not lead to unsafe Al accumulation.
  • The developed model is a valuable tool for predicting Al exposure from vaccinations.