Aluminum in Vaccines

Download as pdf or txt
Download as pdf or txt
You are on page 1of 3

ALUMINUM – VACCINE RISK STATEMENT (VRS)

ALUMINUM IN VACCINES Delivering Data on Infectious Diseases & Vaccines™

What Parents Need to Know Available in other languages at


physiciansforinformedconsent.org/aluminum

1. WHAT IS ALUMINUM? 4. IS EXPOSURE TO ALUMINUM SAFE?


Aluminum is a silvery-white, moldable, and durable light The FDA has considered aluminum to be generally
metal. These qualities make it useful in numerous industries recognized as safe (GRAS) since 1975.9 However, before
and products, including machinery, construction, storage, 1990, the technology did not exist to accurately detect
cookware, eating utensils, textiles, dyes, and cosmetics. small quantities of aluminum administered to subjects in
Aluminum is also the most abundant metal in the Earth’s scientific studies.10 Consequently, the amount of aluminum
crust, and virtually all aluminum in the environment is in that could be absorbed before the onset of negative effects
soil. However, aluminum is not naturally found in significant was not known.
amounts in living organisms (such as plants and animals),
and aluminum has no known biological function. During the Since 1990, due to advancements in technology, small
past century, aluminum usage in certain products has led amounts of aluminum that remain in the human body have
to higher human exposure. The greatest sources of such been observed to interfere with a variety of cellular and
metabolic processes in the nervous system and in tissues
exposure are aluminum-containing foods (e.g., baking powder,
of other parts of the body.1,10,11 The greatest negative effects
processed foods, infant formulas, etc.), medical products (e.g.,
of aluminum have been observed in the nervous system
antiperspirants, antacids, etc.), allergy shots, and vaccines.1-3
and range from motor skill impairment to encephalopathy
(altered mental state, personality changes, difficulty
2. WHY IS ALUMINUM IN VACCINES? thinking, loss of memory, seizures, coma, and more).2,12
Certain vaccines use aluminum compounds (i.e., aluminum The U.S. Department of Health and Human Services (HHS)
hydroxide and aluminum phosphate) as adjuvants, recognizes aluminum as a known neurotoxin.2 In addition,
ingredients that enhance the immune response to an antigen the FDA has warned about the risks of aluminum toxicity in
(foreign substance).4,5 The U.S. Food and Drug Administration infants and children.13
(FDA) states that if some vaccines did not include aluminum,
the immune response they trigger may be diminished.6

3. WHICH VACCINES CONTAIN ALUMINUM?


“Term infants with normal renal function may also be at
The following vaccines contain aluminum and are administ- risk because of their rapidly growing and immature brain
ered to infants, children and adolescents (Fig. 1): and skeleton, and an immature blood-brain barrier. Until
they are 1 to 2 years old, infants have lower glomerular
• Hepatitis B (HepB)
filtration rates than adults, which affects their kidney
• Diphtheria, tetanus, and pertussis (whooping cough) function. The agency is concerned that young children
(DTaP and Tdap) and children with immature renal function are at a
• Haemophilus influenzae type b (PedvaxHIB) higher risk resulting from any exposure to aluminum.”
• Pneumococcal (PCV) — U.S. Food and Drug Administration (FDA), June 200313
• Hepatitis A (HepA)
• Human papillomavirus (HPV)
• Meningococcal B (MenB)
5. 
HOW MUCH ORAL ALUMINUM IS
UNSAFE?
Figure 1: Up to 22 Doses of Aluminum-Containing Vaccines In 2008, the Agency for Toxic Substances and Disease
Are Administered from Birth to 18 Years of Age7,8
Registry (ATSDR), a division of HHS, used studies of the
neurotoxic effects of aluminum to determine that no more
12 months than 1 milligram (mg) (1,000 micrograms [mcg]) of aluminum
— 6 years per kilogram (kg) of body weight should be taken orally per
Birth — day to avoid aluminum’s negative effects.2
6 months 11— 12 years
The U.S. Department of Health and Human
Services (HHS) states that aluminum is a neu-
rotoxin and exposure can lead to significant
16 — 18 years “alterations in motor function, sensory
function, and cognitive function.”2
ALUMINUM – VACCINE RISK STATEMENT (VRS)

6. HOW MUCH INJECTED ALUMINUM IS 8. HAVE ANY STUDIES COMPARED THE


UNSAFE? AMOUNT OF ALUMINUM IN VACCINES
To determine the amount of aluminum that can be safely TO THE ATSDR-DERIVED LIMIT?
injected requires a conversion of the ATSDR oral aluminum
A recent study that intended to compare the amount
limit. The ATSDR oral aluminum limit is based on 0.1% of
of aluminum in vaccines to the ATSDR-derived bloodstream
oral aluminum being absorbed into the bloodstream, as the
limit was published in 2011.20 However, this study incorrectly
digestive tract blocks nearly all oral aluminum (Fig. 2a).2 In
based its calculations on 0.78% of oral aluminum being
contrast, aluminum injected intramuscularly bypasses the
absorbed into the bloodstream rather than the value of 0.1%
digestive tract, and 100% of aluminum may be absorbed into
used by the ATSDR in its computations.21,22 As a result, the
the bloodstream over time (i.e., the proportion of absorbed
2011 study assumed that nearly 8 (0.78%/0.1%) times more
aluminum is 1,000 times greater). To account for these
aluminum can safely enter the bloodstream, and this led to
different absorption amounts, the ATSDR oral aluminum limit
an incorrect conclusion.
must be divided by 1,000. This conversion results in an ATSDR-
derived bloodstream aluminum limit of 1 mcg of aluminum
(0.1% of 1,000 mcg) per kg of body weight per day (Fig. 2b). 9. IS EXPOSURE TO ALUMINUM FROM
Consequently, to avoid the neurotoxic effects of aluminum, no VACCINES SAFE?
more than 1 mcg of aluminum per kg of body weight should
Vaccines are injected intramuscularly, and the rate at which
enter the bloodstream on a daily basis. Figure 3 shows the
aluminum from vaccines migrates from human muscle to the
ATSDR-derived bloodstream aluminum limit for infants of
bloodstream is not known. Studies in animals suggest that
various ages based on their weight.
it can take from a couple of months to more than a year for
Oral Aluminum ≠ Injected Aluminum2 aluminum from vaccines to enter into the bloodstream, due
• Oral aluminum limit = 1,000 mcg/kg/day • Bloodstream aluminum limit = 1 mcg/kg/day to multiple variables.23-25 Because the cumulative aluminum
• Digestive tract blocks the absorption of all • Bloodstream may absorb 100% of intramuscu-
larly injected aluminum over time
exposure from vaccines in children less than 1 year old exceeds
but about 0.1% of oral aluminum
the ATSDR-derived daily limit by several hundreds (Figs. 3 and
4), the limit would still be exceeded if aluminum from vaccines
entered the bloodstream over the course of about a year.
Moreover, studies have shown that aluminum from vaccines
is absorbed by immune cells that travel to distant parts of the
body, including the brain.26
2a 2b

Figures 2a, 2b: When taken orally, only about 0.1% of aluminum is able to Studies have also shown that adverse effects of aluminum
enter the bloodstream through the digestive tract (2a). In contrast, when in vaccines may not be restricted to neurological conditions.
intramuscularly injected, the proportion of aluminum that enters the blood-
stream over time is 1,000 times greater (100%) because the digestive tract A study published in Academic Pediatrics found that asthma
is bypassed (2b). occurred in 1 in 183 vaccinated children for every 1 mg
(1,000 mcg) increase in aluminum exposure.27
7. HOW MUCH ALUMINUM IS IN VACCINES?
The extent of the negative effects of aluminum in vaccines
The amount of aluminum in vaccines varies.16 In 1968, the is not known, as safety studies comparing a population
federal government set the limit for the amount of aluminum vaccinated with aluminum-containing vaccines to a population
in vaccines to 850 mcg per dose based on the amount of not vaccinated with such vaccines have not been conducted.
aluminum needed to make certain vaccines effective.6,17
Consequently, the amount of aluminum in aluminum- Amount of Aluminum in Vaccines7,18,19
containing childhood vaccines ranges from 125 to 850 mcg 900

per dose. Figure 4 shows the aluminum content of one dose 800

of various vaccines administered to children.7,18,19


700

600

ATSDR-Derived Bloodstream Aluminum Limit2,14,15 500

400

300

200

100

Figure 4: This graph shows the aluminum content of one dose of various vaccines
Figure 3: This chart shows the aluminum limit for infants of various ages, as administered to children. The administration of one dose each of Prevnar 13,
derived from the Agency for Toxic Substances and Disease Registry, a division PedvaxHIB, Engerix-B, and Infanrix at one visit delivers 1,225 mcg of aluminum.
of the U.S. Department of Health and Human Services. The limit indicates that no PCV, Hib, HepB, and DTaP vaccines are administered multiple times by 6 months
more than 1 mcg of aluminum per kg of body weight should enter the bloodstream of age. The rate at which aluminum from vaccines migrates from human muscle
on a daily basis to avoid the neurotoxic effects of aluminum. to the bloodstream is not known.

All references are available at physiciansforinformedconsent.org/aluminum.


These statements are intended for informational purposes only and should not be construed as personal medical advice.
© 2023 Physicians for Informed Consent, an independent 501(c)(3) nonprofit educational organization.
All rights reserved. For more information, visit physiciansforinformedconsent.org. 2020 Aug; updated 2023 Apr.
ALUMINUM – VACCINE RISK STATEMENT (VRS)

REFERENCES
1. American Academy of Pediatrics, Committee on Nutrition. Aluminum 17. Office of the Federal Register, National Archives and Records Service,
toxicity in infants and children. Pediatrics. 1996 Mar;97(3):413. General Services Administration. Rules and regulations. Fed Regist.
https://pubmed.ncbi.nlm.nih.gov/8604282/. 1968 Jan; 33(6):369. https://tile.loc.gov/storage-services/service/ll/
2. Agency for Toxic Substances and Disease Registry (ATSDR). fedreg/fr033/fr033006/fr033006.pdf.
Toxicological profile for aluminum. Washington, D.C.: U.S. Department 18. GlaxoSmithKline Biologics. Rixensart, Belgium: GlaxoSmithKline.
of Health and Human Services; 2008.3, 13-24, 145, 171-7, 208. https:// Kinrix (diphtheria and tetanus toxoids and acellular pertussis
www.atsdr.cdc.gov/toxprofiles/tp22.pdf. adsorbed and inactivated poliovirus vaccine); [cited 2023 Apr 9].
3. Yokel RA. Aluminum in food—the nature and contribution of food http://wayback.archive-it.org/7993/20170723032435/https://
additives. In: El-Samragy Y, editor. Food additive. Rijeka (Croatia): www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/
InTech; 2012. 203-28. https://www.intechopen.com/chapters/28917. ApprovedProducts/UCM241453.pdf; as of November 2022, the FDA
posted an updated package insert, with decreased aluminum content,
4. Marrack P, McKee AS, Munks MW. Towards an understanding of the to its Kinrix product information webpage. No documentation is
adjuvant action of aluminium. Nat Rev Immunol. 2009 Apr;9(4):287. available explaining the change in the aluminum content. PIC has
https://pubmed.ncbi.nlm.nih.gov/19247370/. filed a FOIA request to examine the discrepancy.
5. Volk VK, Bunney WE. Diphtheria immunization with fluid toxoid 19. GlaxoSmithKline Biologics. Rixensart, Belgium: GlaxoSmithKline.
and alum-precipitated toxoid. Am J Public Health Nations Health. Infanrix (diphtheria and tetanus toxoids and acellular pertussis
1942 Jul;32(7):690-9. https://www.ncbi.nlm.nih.gov/pmc/articles/ vaccine adsorbed); [cited 2023 Feb 23]. http://wayback.archive-
PMC1527016/. it.org/7993/20170723024611/https://www.fda.gov/downloads/
6. Baylor NW, Egan W, Richman P. Aluminum salts in vaccines—U.S. BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM124514.
perspective. Vaccine. 2002 May 31;20 Suppl 3:S18-22. https:// pdf; as of November 2022, the FDA posted an updated package insert,
pubmed.ncbi.nlm.nih.gov/12184360/. with decreased aluminum content, to its Infanrix product information
7. U.S. Food and Drug Administration. Silver Spring (MD): U.S. Food and webpage. No documentation is available explaining the change in
Drug Administration. Vaccines licensed for use in the United States; the aluminum content. PIC has filed a FOIA request to examine the
[updated 2018 Feb 14; cited 2018 Feb 27]. https://www.fda.gov/ discrepancy.
BiologicsBloodVaccines/Vaccines/ApprovedProducts/Ucm093833.htm. 20. Mitkus RJ, King DB, Hess MA, Forshee RA, Walderhaug MO. Updated
8. Centers for Disease Control and Prevention. Washington, D.C.: U.S. aluminum pharmacokinetics following infant exposures through
Department of Health and Human Services. Recommended child diet and vaccination. Vaccine. 2011 Nov 28;29(51):9538-43. https://
and adolescent immunization schedule for ages 18 years or younger, pubmed.ncbi.nlm.nih.gov/22001122/.
United States, 2022; 2022 Feb 17 [cited 2022 Dec 4]. https://www. 21. Miller S, Physicians for Informed Consent. Erratum in ‘Updated
cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child- aluminum pharmacokinetics following infant exposures through diet
combined-schedule.pdf. and vaccination.’ In: ResearchGate. Berlin (Germany): ResearchGate
9. U.S. Food and Drug Administration. Silver Spring (MD): U.S. Food GmbH; 2020 Mar 6 [cited 2020 Mar 6]. https://www.researchgate.
and Drug Administration. SCOGS (Select Committee on GRAS net/publication/51718934_Updated_Aluminum_pharmacokinetics_
Substances); [cited 2018 Aug 16]. https://www.accessdata.fda.gov/ following_infant_exposures_through_diet_and_vaccines/comments.
scripts/fdcc/?set=SCOGS. 22. Physicians for Informed Consent. Newport Beach (CA): Physicians for
10. Priest ND. The biological behaviour and bioavailability of aluminium Informed Consent. Erratum in ‘Updated aluminum pharmacokinetics
in man, with special reference to studies employing aluminium-26 as following infant exposures through diet and vaccination’; [cited 2020 Mar
a tracer: review and study update. J Environ Monit. 2004;6:376,392. 6]. https://physiciansforinformedconsent.org/mitkus-2011-erratum/.
https://www.ncbi.nlm.nih.gov/pubmed/15152306. 23. Flarend RE, Hem SL, White JL, Elmore D, Suckow MA, Rudy AC,
11. Poole RL, Pieroni KP, Gaskari S, Dixon TK, Park KT, Kerner JA. Dandashli EA. In vivo absorption of aluminium-containing vaccine
Aluminum in pediatric parenteral nutrition products: measured adjuvants using 26Al. Vaccine. 1997 Aug-Sept;15(12-13):1314-8.
versus labeled content. J Pediatr Pharmacol Ther. 2011;16(2):92-7. https://pubmed.ncbi.nlm.nih.gov/9302736/.
https://www.ncbi.nlm.nih.gov/pubmed/22477831. 24. Verdier F, Burnett R, Michelet-Habchi C, Moretto P, Fievet-Groyne F,
12. Sedman A. Aluminum toxicity in childhood. Pediatr Nephrol. 1992 Sauzeat E. Aluminium assay and evaluation of the local reaction at
Jul;6(4):383-93. https://www.ncbi.nlm.nih.gov/pubmed/1498007. several time points after intramuscular administration of aluminium
containing vaccines in the Cynomolgus monkey. Vaccine. 2005 Feb
13. U.S. Food and Drug Administration, Department of Health and
3;23(11):1359-67. https://pubmed.ncbi.nlm.nih.gov/15661384/.
Human Services. Rules and regulations. Fed Regist. 2003 Jun
9;68(110):34286. https://www.govinfo.gov/content/pkg/FR-2003- 25. Weisser K, Göen T, Oduro JD, Wangorsch G, Hanschmann KO, Keller-
06-09/pdf/03-14140.pdf. Stanislawski B. Aluminium in plasma and tissues after intramuscular
injection of adjuvanted human vaccines in rats. Arch Toxicol. 2019
14. Centers for Disease Control and Prevention. Washington, D.C.: U.S.
Oct;93(10):2787-96. https://pubmed.ncbi.nlm.nih.gov/31522239/.
Department of Health and Human Services. National Center for
Health Statistics: Data table for boys length-for-age and weight-for- 26. Masson JD, Crépeaux G, Authier FJ, Exley C, Gherardi RK. Critical
age charts; [cited 2019 April 2]. https://www.cdc.gov/growthcharts/ analysis of reference studies on the toxicokinetics of aluminum-
who/boys_length_weight.htm. based adjuvants. J Inorg Biochem. 2018 Apr;181:87-95. https://
pubmed.ncbi.nlm.nih.gov/29307441/.
15. Centers for Disease Control and Prevention. Washington, D.C.: U.S.
Department of Health and Human Services. National Center for 27. Daley MF, Reifler LM, Glanz JM, Hambidge SJ, Getahun D, Irving SA,
Health Statistics: Data table for girls length-for-age and weight-for- Nordin JD, McClure DL, Klein NP, Jackson ML, Kamidani S, Duffy J,
age charts; [cited 2019 April 2]. https://www.cdc.gov/growthcharts/ DeStefano F. Association between aluminum exposure from vaccines
who/girls_length_weight.htm. before age 24 months and persistent asthma at age 24 to 59 months.
Acad Pediatr. 2022 Sep 27:S1876-2859(22)00417-X. Epub ahead of
16. U.S Food and Drug Administration, Department of Health
print. https://pubmed.ncbi.nlm.nih.gov/36180331/; the study found
and Human Services. Revision of the requirements for constituent
a 26% increased risk of asthma for every 1 mg increase in aluminum
materials. Final rule. Fed Regist. 2011 Apr 13;76(71):20513-8. https://
exposure. Because the overall risk of asthma in children without
www.federalregister.gov/documents/2011/04/13/2011-8885/
eczema was 2.1%, an increased risk of 26% results in an absolute risk
revision-of-the-requirements-for-constituent-materials.
of 0.546% (2.1% times 26%, or 1 in 183).

© 2023 Physicians for Informed Consent, an independent 501(c)(3) nonprofit educational organization.
All rights reserved. For more information, visit physiciansforinformedconsent.org. 2020 Aug; updated 2023 Apr.

You might also like