Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
7638804 | Journal of Trace Elements in Medicine and Biology | 2018 | 7 Pages |
Abstract
FDA regulations require safety testing of constituent ingredients in drugs (21 CFR 610.15). With the exception of extraneous proteins, no component safety testing is required for vaccines or vaccine schedules. The dosing of aluminum in vaccines is based on the production of antibody titers, not safety science. Here we estimate a Pediatric Dose Limit that considers body weight. We identify several serious historical missteps in past analyses of provisional safe levels of aluminum in vaccines, and provide updates relevant to infant aluminum exposure in the pediatric schedule considering pediatric body weight. When aluminum doses are estimated from Federal Regulatory Code given body weight, exposure from the current vaccine schedule are found to exceed our estimate of a weight-corrected Pediatric Dose Limit. Our calculations show that the levels of aluminum suggested by the currently used limits place infants at risk of acute, repeated, and possibly chronic exposures of toxic levels of aluminum in modern vaccine schedules. Individual adult exposures are on par with Provisional Tolerable Weekly Intake “limits”, but some individuals may be aluminum intolerant due to genetics or previous exposures. Vaccination in neonates and low birth-weight infants must be re-assessed; other implications for the use of aluminum-containing vaccines, and additional limitations in our understanding of neurotoxicity and safety levels of aluminum in biologics are discussed.
Keywords
CEDJECFAHEDNOAELLOAELPDLMRLATSDRAluminumAgency for Toxic Substances and Disease RegistryMinimal risk levelHuman equivalent doseRegulatory elementsPTWINeurotoxinsProvisional Tolerable Weekly IntakeNo observed adverse effect levelVaccinesNeonatal vaccinationLowest observed adverse effect leveljoint expert committee on food additives
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
James Lyons-Weiler, Robert Ricketson,