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Aluminum and Vaccines – The Evidence for Continuing Safety

SUMMARY:

Aluminum has been present in vaccines as an adjuvant for over 70 years. By boosting immune response, aluminum reduces the amount of vaccine required to provide immunity. In the US, the two aluminum salts that are used are monophosphoryl A (a detoxified bacterial component), and squalene (a compound of the body’s normal cholesterol synthesis pathway).  Aluminum in vaccines has an excellent safety record and according to the FDA,

The risk to infants posed by the total aluminum exposure received from the entire recommended series of childhood vaccines over the first year of life is extremely low, according to a study by the U.S. Food and Drug Administration (FDA).

Supporting Data

  • The FDA (Vaccine, 2011) specifically addressed the issue of aluminum and vaccines due to public concern
  • Using the most current infant exposures and research on the pharmacokinetics of aluminum, they calculated that an infant would be exposed over the first year of life to a maximum of 4.225 mg
    • Based on minimal risk levels established by the ATSDR, the aluminum exposure to vaccines in the first year of life is well below this threshold
    • Multiple other studies have similarly validated the safety profile of aluminum in vaccines (See CHOP reference summary in ‘Learn More – Primary Sources’ below)

Aluminum in Context

  • Third most abundant element after oxygen and silicon
  • Most abundant metal, making up almost 9 percent of the earth’s crust
  • Found in multiple foods and vegetables, aside from storage containers
  • Typical adult exposure is 7 to 9 mg/day

Aluminum Levels in Vaccines

  • The aluminum in vaccines is similar to a liter of infant formula
  • Infants receive approximately 4.4 milligrams of aluminum in the first six months of life from vaccines, which is less than they receive through diet
    • Breast-fed infants ingest about 7 milligrams
    • Formula-fed infants ingest about 38 milligrams
    • Soy formula-fed infants ingest almost 117 milligrams of aluminum during the first six months of life

Recent Publication Linking Aluminum in Vaccines to Autism

  • A recent publication by Li et al. (Journal of Inorganic Biochemistry 2017) exposed mice to aluminum vaccine adjuvants
  • When compared to control mice, certain genes were over and under expressed in the mice that received aluminum injections
  • In one example, the downregulation of NF-κB inhibitor resulted in the activation of the inflammatory pathways and released cytokines
  • The authors claim these findings are ‘consistent with those in autism’ and that aluminum adjuvant promotes brain inflammation

Study Retraction

  • Based on concerns that images in the Li et al. study may have been altered, John Dawson, the editor of the Journal of Inorganic Biochemistry, told ‘Retraction Watch’ that

The paper by Shaw and co-workers is being retracted jointly by the authors and the editor

Read more on the pending retraction at ‘Retraction Watch’ (see ‘Learn More’ below)

Other Study Limitations Beyond Altered Images

  • Assumption that immune changes in mice brain adequately represent the underlying mechanism of autism in humans is unproven
  • Mice used for these studies were not strains associated with autism
  • Mice received 6 vaccine doses earlier in development then humans and over a few days compared to human vaccine which is scheduled over months
  • For ease of experiment, injections were subcutaneous not intramuscular
    • In the FDA study (Vaccine, 2015), the authors point out that intramuscular injection results in a depot effect with different kinetics than other routes of aluminum administration
  • Genetic experiments  are very dated
    • Current methodology for gene expression is gene profiling, which is quantitative and looks at thousands of genes at the same time to understand gene/gene interactions due to complexity of pathways
    • In this study, very few genes selected (based on old literature) and technology is no longer in use for expression in most laboratories as the older method is not truly quantitative
      • Lack of precise quantification make study images difficult to accurately interpret

Read more on the limited quality of the Li et al. paper at ‘Science Blogs’  (see ‘Learn More’ below)

KEY POINTS:

  • There is no clear evidence that inflammation causes autism
  • Vaccines prevent inflammation by preventing significant infectious diseases
  • Not all vaccines contain adjuvants
  • According to the CDC, Aluminum is present in U.S. childhood vaccines that prevent hepatitis A | Hepatitis B | Diphtheria-tetanus-pertussis (DTaP, Tdap) | Haemophilus influenzae type b (Hib) | Human papillomavirus (HPV) and pneumococcus infection.
  • Monophosphoryl lipid A is included in one human papillomavirus (HPV) vaccine, Cervarix. One licensed pandemic influenza vaccine contains an adjuvant called AS03. It is included in the US pandemic influenza vaccine stockpile, but it is not available to the general public.
  • Fluad is a newly-licensed flu vaccine that contains MF59 as an adjuvant. MF59 is an oil-in-water emulsion that boosts the body’s immune response to this vaccine. In some vaccines, the weakened or inactivated virus stimulates a strong immune response so no additional adjuvant is needed for it to be effective to protect against infections.  
  • In the United States, vaccines against measles | Mumps | Rubella | Chickenpox | Rotavirus | Polio | And seasonal influenza vaccines do not contain added adjuvants.

Learn More – Primary Sources:

Updated aluminum pharmacokinetics following infant exposures through diet and vaccination 

FDA Study Reports Aluminum in Vaccines Poses Extremely Low Risk to Infants

CDC: ATSDR Minimal Risk Levels (MRLs) 

Updated aluminum pharmacokinetics following infant exposures through diet and vaccination 

Subcutaneous injections of aluminum at vaccine adjuvant levels activate innate immune genes in mouse brain that are homologous with biomarkers of autism

ScienceBlogs: Torturing more mice in the name of antivaccine pseudoscience, 2017 aluminum edition 

Retraction Watch: Journal to retract paper called “anti-vaccine pseudoscience”

Children’s Hospital of Philadelphia: Vaccine Ingredients – Aluminum