Mr Nicholas Wells

Mr Nicholas Wells

E-mail:

22ndMarch 2013

Our reference: FOI 13/086

DearMr Wells

FOI 13/086 – Freedom of Information request - Aluminium in Vaccines

Thank you for your recent Freedom of Information request (FOI)of the 22nd February 2013, regarding aluminium in vaccines for which you have submitted a number of questions detailed below.

What is the total amount of aluminium that would enter into their body from these injections?

What amount of the aluminium provided in response to question 1above would enter into their bloodstream?

What amount of the aluminium provided in response to question above would cross the blood-brain barrier and enter into theirbrain?

What are the long term effects of aluminium entering the body asa result of these immunisations?

What are the long term effects of aluminium entering the brainas a result of these immunisations?

What is the elimination rate of aluminium from a child’sbody?

What is the elimination rate of aluminium from a child’sbrain?

What is the recommended safe level of aluminium to enter achild’s body via injection and how was this determined?

What is the recommended safe level of aluminium to enter achild’s brain and how was this determined?

Other than any studies mentioned in response to the above 9 questions, what other studies have been carried out to determinethe safety of children receiving aluminium-containing vaccines?

Many vaccines contain very small amounts of aluminium salts which are included as an ‘adjuvant’ to enhance the effectiveness of the vaccine. Aluminium is the most common adjuvant used in vaccines and has been used for more than 60 years. Aluminium is ubiquitous in the environment and is inherently present in some foods.

In answer to your first question, themaximum total aluminium content that a child, assuming he is a boy, would receive through vaccination as part of the current UK routine childhood immunisation programme is 3.215 milligrams. This amount is over a period of greater than 10 years and is far less than aluminium exposure from other environmental sources, including foods with people having an average daily weekly exposure of about 0.2-1.5 mg/kg body weight[1].

In answer to your question of ‘what are the long term effects of aluminium entering the body asa result of these immunisations’, there is no evidence to suggest that exposure to the levels of aluminium found in some vaccines poses any serious risks to health, including any risk of neurological damage.

In relation to your questions on the pharmacokinetics of aluminium salts from childhood vaccines, you may find a recently-published analysis from the United States Food and Drug Administration (FDA) helpful[2]. This can be summarised as follows. Aluminium in injections is in an insoluble form as a phosphate or hydroxide of aluminium. Over time the insoluble aluminium hydroxide or aluminium phosphate are solubilised within the muscle. Using data from both clinical intravenous aluminium injection studies[3][4] and animal studies[5], Mitkus et al2made assumptions that 51% of aluminium phosphate or 17% of aluminium hydroxide of injected aluminium would be absorbed into the blood following a single intramuscular vaccine injection over the first 28 days after exposure, and that absorption of the remaining adjuvant at the site of injection would take place at a constant rate over the next 28 days for aluminium phosphate and 137 days for aluminium hydroxide rather than instantaneously. They add that these rates are considered to be highly conservative, since blood concentrations of aluminium hydroxide approached zero by the end of the experiment, thereby implying a very low rate of uptake into blood.

Using these assumptions Mitkus at al modelled the slower release ofaluminium adjuvantfrom the site of injection and at no time found that the estimated level of aluminium in infantsexceeds the minimum risk levels (MRL) body burden and the margin ofexposure between aluminium body burden from vaccine and the MRL was found to increase with age. They add that the bodyburden of aluminium from vaccines is not more than 2-fold higherthan that received in the diet.

Assuming these calculations then similar absorption into the blood would hold true for the childhood immunisations namely 17-51% of aluminium absorbed into the blood within the first 28 days of exposure followed by a slower rate. Importantly Priest highlights that most aluminium that enters the blood is excreted in urine within a few days or weeks3. Within the model Mitkus et al used infants as the renal elimination pathway is not fully developed in newborns and therefore they postulate that aluminium is not as quickly cleared from the blood as for adults. The FDA study found that the maximum amount of aluminium an infant could be exposed to over the first year of life would be 4.225 milligrams (mg), based on the recommended USschedule of vaccines[6]. The FDA review concluded that episodic exposures to vaccines that contain aluminium adjuvant continue to be extremely low risk to infants and that the benefits of using vaccines containing aluminum adjuvant outweigh any theoretical concerns.

The World Health Organization’s Global Advisory Committee on Vaccine Safety (GACVS)[7] also reviewed the study by Mikras et al. and concluded that this further supports the clinical trial and epidemiological evidence of the safety of aluminium in vaccines.

I hope this information is of use to you. If you are unhappy with our response, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, Area 4-T, Medicines and Healthcare products Regulatory Agency, at the above address quoting reference FOI 13/033. After that, if you remain dissatisfied, you may ask the Information Commissioner to make a decision on whether or not we have interpreted the FOIA correctly in withholding some information from you.

Yours sincerely,

FOI Team

The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder. For full details on our copyright policy please visit:

[1] European Food Safety Authority

[2] Mitkus RJ et al. Updated aluminum pharmacokinetics following infant exposures through diet and vaccination. Vaccine 29 (2011) 9538– 9543.

[3]PriestND. The biological behaviour and bioavailability of aluminium in man, with special reference to studies employing aluminium-26 as a tracer: review and study update. J Environ Monit 2004;6(5):375–403.

[4]PriestND, Newton D, Day JP, Talbot RJ, Warner AJ. Human metabolism of aluminium-26 and gallium-67 injected as citrates. Hum Exp Toxicol 1995;14(3):287–93.

[5] Flarend RE, Hem SL, White JL, Elmore D, Suckow MA, Rudy AC, et al. In vivo absorption of aluminium-containing vaccine adjuvants using 26Al. Vaccine 1997;15(12–13):1314–8.

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