title: Updated aluminum pharmacokinetics following infant exposures through diet and vaccination.
abstract: Aluminum is a ubiquitous element that is released naturally into the environment via volcanic activity and the breakdown of rocks on the earth's surface. Exposure of the general population to aluminum occurs primarily through the consumption of food, antacids, and buffered analgesics. Exposure to aluminum in the general population can also occur through vaccination, since vaccines often contain aluminum salts (frequently aluminum hydroxide or aluminum phosphate) as adjuvants. Because concerns have been expressed by the public that aluminum in vaccines may pose a risk to infants, we developed an up-to-date analysis of the safety of aluminum adjuvants. Keith et al. [1] previously analyzed the pharmacokinetics of aluminum for infant dietary and vaccine exposures and compared the resulting body burdens to those based on the minimal risk levels (MRLs) established by the Agency for Toxic Substances and Disease Registry. We updated the analysis of Keith et al. [1] with a current pediatric vaccination schedule [2]; baseline aluminum levels at birth; an aluminum retention function that reflects changing glomerular filtration rates in infants; an adjustment for the kinetics of aluminum efflux at the site of injection; contemporaneous MRLs; and the most recent infant body weight data for children 0-60 months of age [3]. Using these updated parameters we found that the body burden of aluminum from vaccines and diet throughout an infant's first year of life is significantly less than the corresponding safe body burden of aluminum modeled using the regulatory MRL. We conclude that episodic exposures to vaccines that contain aluminum adjuvant continue to be extremely low risk to infants and that the benefits of using vaccines containing aluminum adjuvant outweigh any theoretical concerns.
authors: Office of Biostatistics and Epidemiology, USFDA Center for Biologics Evaluation and Research, 1401 Rockville Pike, HFM-210, Rockville, MD 20852, United States. Robert.Mitkus@fda.hhs.gov
authors: Robert J
authors: RJ
authors: Mitkus
authors: David B
authors: DB
authors: King
authors: Maureen A
authors: MA
authors: Hess
authors: Richard A
authors: RA
authors: Forshee
authors: Mark O
authors: MO
authors: Walderhaug
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects*; D000535:Aluminum / Q000009:adverse effects* / Q000493:pharmacokinetics*; D006801:Humans; D014611:Vaccination / Q000009:adverse effects*
chemical_list: D000276:Adjuvants, Immunologic; D000535:Aluminum