Jule Klotter

Children and Aluminum Safety Questions

Two recent studies examine aluminum exposure and possible safety issues that result when following the current CDC pediatric vaccine schedule. Aluminum (Al) stresses endoplasmic reticula, the organelles responsible for lipid biosynthesis, calcium storage, and protein folding and processing; they reside in most cells in the body. Endoplasmic reticulum stress can produce the unfolded protein response and can lead to autoimmune conditions and neurotoxicity. Aluminum also impairs mitochondrial function and the Golgi apparati in the kidneys, which reduces the body’s ability to excrete the metal.

Aluminum compounds, such as aluminum oxyhydroxide and aluminum hydroxyphosphate, are used in some vaccines to stimulate an immune response to the vaccine antigen. In their 2018 study, James Lyons-Weiler and Robert Ricketson state, “The dosing of aluminum in vaccines is based on the production of antibody titers, not safety science.” The federal adult dose limit is 850 μg Al/dose by assay.

In 2011, the Joint Expert Committee on Food Additives set the Provisional Tolerable Weekly Intake for Al as being 2000 μg Al/kg of bodyweight, derived from studies with adult rodents. The Agency for Toxic Substances and Disease Registry uses 1000 μg Al/kg as its Minimal Risk Level. These guideline levels are for consumed aluminum, found in foods and water, not injected aluminum. Animal experiments show that far less ingested aluminum, compared to injected, is absorbed. The only safety guideline for injected aluminum is for people with renal dysfunction, set at 4-5 μg Al/kg/day. Many premature babies have impaired kidney function.

Lyons-Weiler and Ricketson applied Clark’s rule to these guidelines. Clark’s rule is used to evaluate pediatric dosage, based on the child’s weight, when only adult recommendations are available. The Hep B vaccine, which the CDC recommends be given to all newborns, contains 250 μg Al, 17 times more aluminum than would be allowed if the dosage were adjusted for body weight using Clark’s rule.

Lyons-Weiler is senior author of a 2020 study that compares vaccine aluminum exposure and the estimated chronic Al retention caused by three different vaccine schedules: the CDC schedule, the CDC schedule when using available low- or no-aluminum vaccines, and Oregon pediatrician Paul Thomas’s “Vaccine Friendly Plan.” The authors used the Priest model to estimate Al clearance.

Priest injected a single dose of a soluble aluminum isotope into an adult male and took periodic mass spectrometry measurements over 12 years. The Priest model cannot, of course, provide direct information about Al clearance in infants who weigh considerably less than an adult and whose kidneys’ glomerular filtration rate (GFR) is less than an adult’s. Children’s GFR does not reach adult level until about age two. As the study authors explain, Priest’s model is overly optimistic about Al clearance when applied to young children. It does not account for the child’s weight, kidney function, genetic variations that may affect aluminum clearance, or synergistic toxicity with fluoride, mercury, or other toxic metals in the environment. But it is all we have right now.

Using Priest’s equation, if the Hep B vaccine is given at birth (as CDC recommends), between eight and 12 percent of the 250 μg Al in that vaccine remains in the body when a baby receives the next set of CDC-recommended vaccines at two months. The CDC schedule at age two months consists of a second dose of HepB (250 μg Al), DTaP (diphteria-tetanus-acellular pertussis; 625 μg Al) Hib (Haemophilus influenae type b; 225 μg Al), and PVC13 (pneumococcal conjugate;125 μg Al), totaling 1225 μg Al. Between eight and 12 percent of that total will be in the body when the infant receives more vaccines at age four months.

The modified CDC schedule uses a low-aluminum DTaP (330 μg Al) and ActHib, which contains no aluminum—totaling 705 μg Al for the same four vaccines. (In addition to these aluminum-containing vaccines, CDC recommends rotavirus, and inactivated polio vaccines at age 2 months.) Dr. Thomas does not recommend the hepatitis B vaccine for babies whose mothers are not infected with the virus. At age two months, he recommends the low-aluminum DTaP and ActHib (no aluminum).

At four months, babies on the CDC schedule get another dose of DTaP, Hib, and PVC13. Dr. Thomas gives second doses of low aluminum DTaP and ActHib and a first dose of PVC13. CDC recommends boosters of HepB, DTaP and PVC13 at age six months, Hib, PVC13, and a first dose of HepA (250 μg Al) at 12 months, and another dose of DTaP and HepA at 18 months.

With the CDC vaccine schedule, children receive 4925 μg Al by 18 months, compared to 3037 μg Al on the modified schedule and 1820 μg Al on Dr. Thomas’s schedule.  Using Priest’s equation, 4% of the aluminum from that first HepB vaccine remains somewhere in the child’s body tissue two years later. Given the regular introduction of more aluminum-containing vaccines during the first 18 months of life, it is easy to see that aluminum clearance and possible toxicity could be an issue for young children.

The authors “strongly recommend that the US FDA update their modus operandi to consider data from studies from injected forms of aluminum in infant mice, and that the FDA establish age-specific monthly limits of aluminum exposure in toto (all sources), including 1 or more [aluminum-contain vaccines] administered in the same month.”

Lyons-Weiler J, Ricketson R. Reconsideration of the immunotherapeutic pediatric safe dose levels of aluminum. J Trace Elements in Medicine and Biol. 2018;48:67-73.

McFarland G, et al. Acute exposure and chronic retention of aluminum in three vaccine schedules and effects of genetic and environmental variation. J Trace Elements in Medicine and Biol. 2020.

Priest ND. The biological behaviour and bioavailability of aluminium in man, with special reference to studies employing aluminium-26 as a tracer: review and study update. Royal Society of Chemistry. 2004;6:375-403.

Time-Restricted Eating and Metabolic Effects

Intermittent fasting has been studied as a way to lose weight and improve cardiometabolic health. It can take several forms such as alternate-day eating, eating during the week and fasting on the weekend (the 5:2 diet), and eating only within a four- to 10-hour time period (time-restricted fasting). A 2018 study, led by Elizabeth F. Sutton, sought to determine whether the metabolic improvements—including better insulin sensitivity, reduced glucose and/or insulin levels, improved lipid profiles, lower blood pressure, and improvements in inflammation and oxidative stress biomarkers—were due to weight loss alone or to fasting.

In looking at four previous human trials that used time-restricted fasting (TRF), Sutton et al observed that results appeared to vary according to eating time. Eating during the middle of the day reduced body weight, body fat, fasting glucose and insulin levels, insulin resistance, hyperlipidemia, and inflammation. When eating time was in late afternoon or evening, the positive effects largely disappeared and, in some cases, postprandial glucose levels, β cell responsiveness, blood pressure, and lipid levels worsened. (β cells in the pancreas make and secrete insulin and amylin.) Sutton et al attributed the difference to circadian rhythms, which regulate glucose, lipid, and energy metabolism as well as sleep: “…insulin sensitivity, β cell responsiveness, and the thermic effect of food are all higher in the morning than in the afternoon or evening, suggesting that human metabolism is optimized for food intake in the morning.” They decided to conduct a five-week randomized, crossover, controlled feeding trial to test the effect of restricted eating that started early in the day.

Eight overweight men with prediabetes were randomized to a time-restricted feeding (TRF) program during which they ate three meals within a six-hour period (with breakfast between 6:30-8:30 am, lunch three hours later, and dinner three hours after lunch) or to a control program (three meals within a 12-hour period) for five weeks. After a seven-week washout period, each participant followed the alternate pattern. They were given enough food to maintain their weight. Study staff monitored the meals to ensure that participants ate all three meals.

Time-restricted fasting improved insulin sensitivity and β cell responsiveness and lowered insulin levels; those with the highest insulin levels at baseline showed the largest reductions. However, one participant’s insulin levels actually worsened on the TRF program; this man also had a long history of overnight shift work. The authors say, “Given that circadian rhythms are altered in adults who perform overnight shift work, it will be important to determine whether some subpopulations have altered circadian rhythms and would benefit more from alternative meal timing interventions.”

In addition to insulin sensitivity, TRF produced a reduction in morning blood pressure (11 ± 4 mm Hg [systolic] and 10 ± 4 mm Hg [diastolic]) and a 14% decrease in 8-isoprostane (a marker of oxidative stress), compared to the control program

The men did not experience increased hunger during the longer TRF fast: “…on the contrary, eTRF decreased the desire and capacity to eat and increased feelings of fullness in the evening.” The participants’ main complaint involved having to eat three meals within six hours!

This study was quite small; larger trials that include women are needed. The authors also recommend that lipid levels, glucose levels, and blood pressure be measured throughout the 24-hour day.

Sutton EF, et al. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metabolism. 2018;27:1212-1221.

Another Retracted Study

Using data from the National Health and Nutrition Examination Survey (NHANES), Gayle DeLong tested the hypothesis that the human papillomavirus vaccination might be one of the factors involved in the recent decline in US birth rates. She focused on data that represents 8 million 25-to-29-year-old women living in the US between 2007 and 2014, collecting information about age, income, education, race/ethnicity, marital status, pregnancy, and whether or not the woman received the HPV vaccine (number of doses and dates). NHANES did not have consistent birth control information for the women in this age group, so she could not use that as a cofactor.

DeLong reported, “Results suggest that females who received the HPV shot were less likely to have ever been pregnant than women in the same age group who did not receive the shot.” Overall, about 35% of women who had the vaccine became pregnant at least once, compared to about 60% of the unvaccinated group. A similar disparity was found when looking just at married women: 50% of the vaccinated group had conceived compared to 75% of the unvaccinated group. This study was peer-reviewed by three researchers, and the editors of the Journal of Toxicology and Environmental Health, Part A made the study available online at no cost.

In the paper, DeLong clearly stated that this study showed an association but could not and did not prove causation. She pointed to other studies that have indicated that environmental pollutants, endocrine disrupters, and pesticides are able to decrease fertility, saying that these may also be contributors to declining rates. Multiple reports of premature ovarian failure in young women who received Gardasil (Merck’s HPV vaccine) are in the literature, however; and in January 2016, the American College of Pediatricians voiced concern about the possibility that the vaccine might affect ovarian function in some young women.

In the long-honored practice of scientific debate, A. Shibata and Y. Kataoka publicly critiqued DeLong’s study in a letter to the editor, published in Human Vaccines & Immunotherapeutics. DeLong refuted their criticisms in the same publication and offered data from Spain, Italy, the United Kingdom, Australia, and Romania. Romania, which had a very low HPV vaccine uptake, “showed a substantial increase in birth rates for all but the youngest age groups.” The other four countries, all of which have strong HPV vaccine programs, have experienced clear declines in birth rates among younger women. She concluded “The correlation between the HPV vaccine and lowered fertility could be spurious, but not for the reasons that Shibata and Kataoka offer.”

In October 2019, DeLong was informed that an investigation had been opened due to “’several public and private expressions of concern about flaws in analysis.’” She was given two weeks to respond to comments from four post-publication reviewers and did so. One of these reviewers agreed with DeLong that an open debate about the possibility that the HPV vaccine is contributing to infertility needs to take place. Nonetheless, her article, “A lowered probability of pregnancy in females in the USA aged 25-29 who received a human papillomavirus vaccine injection,” was retracted—although it will remain online “to maintain the scholarly record,” according to the editors in their statement of retraction.

In her response to the retraction, DeLong wrote: “A basic principle of medical ethics holds that if there is evidence that a treatment, drug or vaccine may be dangerous, even if that evidence is not conclusive, we must investigate those possible problems until we have settled the question one way or another.”

DeLong G. Author Response to Journal of Toxicology and Environmental Health Retraction of “A lowered probability of pregnancy in females in the USA aged 25-29 who received a human papillomavirus vaccine injection.”  December 16, 2019.

DeLong G. Letters to the editor; Response to : a possible spurious correlation between human papillomavirus vaccination introduction and birth rate change in the United States. Human Vaccines & Immunotherapeutics. 2019;15(10):2503-2504.

DeLong G. A lowered probability of pregnancy in females in the USA aged 25-29 who received a human papillomavirus vaccine injection. J Toxico and Environmental Health, Part A. 2018; 81(14).

Field SS.New Concerns about the Human Papillomavirus Vaccine. American College of Pediatricians. January 2016.

Removing Access to Sugary Beverages

Banning workplace sales of sugar-sweetened beverages (SSBs) decreased consumption of these health-harming drinks and produced improvements in waist circumference and insulin resistance among 214 study participants who worked at the University of California at San Francisco (UCSF). In 2015, UCSF stopped selling sodas, sports or energy drinks, “fruit” drinks, and sweetened bottled teas and coffees in cafeterias, vending machines, hospital food services, and retail outlets. People could still bring these types of drinks to work. Sugar intake from beverages is more detrimental to metabolic health than sugar in foods, according to meta-analyses, and considered a strong risk factor for obesity and cardiometabolic disease.

Elissa S. Epel and colleagues surveyed 2556 employees about their daily beverage intake before the ban. They then conducted a randomized study with 214 survey participants who reported drinking 12 fl oz or more of sugar-sweetened drinks each day; 109 met with a health educator for a 15-minute motivational interview in which they were given information about the sugar content of these drinks, the effect on health, and how to reduce sugar intake. The remaining 105 acted as the control.

Simply banning the sale of sugar-sweetened beverages nearly halved consumption: “They reported a mean daily intake of 1050 mL (35 fl oz) of SSBs at baseline and 540 mL (18 fl oz)”  six months after the ban began. Those who took part in the motivational interview had a significantly greater response compared to the control: a mean (SD) reduction of 25.4 [2.8] fl oz vs 8.2 [2.8] fl oz. In addition, improvements in insulin sensitivity, measured by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), correlated to SSB intake reductions, particularly in participants with higher body mass index (BMI); and mean (SE) waist circumference decreased by 2.1 (2.8) cm. Removing access to these beverages appears to be an easy way to decrease consumption.

Epel ES, et al. Association of a Workplace Sales Ban on Sugar-Sweetened Beverages with Employee Consumption of Sugar-Sweetened Beverages and Health. JAMA Intern Med. October 28, 2019.

This article was originally published in Townsend Letter, February 2020.

Published March 23, 2024

About the Author

Jule Klotter has a master’s in professional writing from the University of Southern California. She joined Townsend Letter’s staff in 1990. Over the years, she has written abstract articles for “Shorts” and many book reviews that provide information for busy practitioners. She became Townsend Letter’s editor near the end of 2016.