Acute exposure and chronic retention of aluminum in three vaccine schedules and effects of genetic and environmental variation
Abstract: Like the mechanisms of action as adjuvants, the pharmacodynamics of injected forms of aluminum commonly used in vaccines are not well-characterized, particularly with respect to how differences in schedules impact accumulation and how factors such as genetics and environmental influences on detoxification influence clearance. Previous modeling efforts are based on very little empirical data, with the model by Priest based on whole-body clearance rates estimated from a study involving a single human subject. In this analysis, we explore the expected acute exposures and longer-term whole-body accumulation/clearance across three vaccination schedules: the current US Centers for Disease Control and Prevention (CDC) schedule, the current CDC schedule using low aluminum or no aluminum vaccines, and Dr. Paul Thomas’ “Vaccine Friendly Plan” schedule….
Minimum safe levels (MSLs) for aluminum (in the form of aluminum oxyhydroxide, aluminum phosphate, or aluminum potassium sulfate) are equivalent to the Pediatric Dose Limit estimated by Lyons-Weiler and Ricketson (29,773,196), based on the FDA’s limit of 850 μg of aluminum per dose for adults. Assuming an average adult weight of 60 kg and using Clark’s rule (cited in Lyons-Weiler and Ricketson) leads to a target “safe” limit of 14.2 μg of aluminum per kg of body weight as a way of calculating a body weight-adjusted Pediatric Dose Limit (PDL: Lyons-Weiler and Ricketson, 29,773,196); Fig. 1. This curve, derived by Lyons-Weiler and Ricketson, is the only available dose limit for human infants that considers body weight. As a limit, it attends to the cumulative dosage and body burden from any source if the values are known. This target limit per body weight was used along with weight distributions across the population to estimate a minimum safe level (MSL) of aluminum exposure as a function of a child’s age and weight percentile. …
Fig. 1. FDA Adult aluminum per dose limit scaled to child’s weight (Clark’s Rule) following Lyons-Weiler and Ricketson .
None of the individual vaccines violates the guidance of a maximum of 850 μg of aluminum for an adult (Table 1). However, because of multiple vaccines typically given together at 2, 4, and 6 months, the CDC schedule violates this limit even assuming an adult weight (; 29,773,196). Adjusting the safe dose limit based on a child’s weight at these ages therefore results in doses that far exceed the estimated safe limit of acute toxicity (Lyons-Weiler and Ricketson, 29,773,196)….
Applying Priest’s equation to the different schedules allows us to estimate the total aluminum in the body at different ages compared to the body-weight scaled safe limit (Fig. 2).
Fig. 2. Aluminum Content in Body over First Two Years for Three Vaccine Schedules.
The CDC schedule crosses the recommended limit of aluminum for an adult by recommending multiple vaccinations containing aluminum being delivered together. Note that on all days of injection the safe limit for a child is exceeded for all three schedules; this points to acute toxicity Fig. 2….
Fig. 3. Percent Days Over aluminum Limit (%alumTox) Birth to 7 Months and 2 Years.
“All analyses to date, including our own, use aluminum clearance rate data from adults, which likely is an overly optimistic aluminum clearance rate for neonates and infants. Most excretion of aluminum is accomplished by filtration of aluminum from the blood by the glomeruli of the kidney. Renal function in infants is not fully developed: infants’ glomerular filtration rate (GFR) is not fully online at birth.”…