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

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1 Mr Nicholas Wells Dear Mr Wells 7th June 213 Our reference: FOI 13/86 FOI 13/86 Freedom of Information request - in Vaccines Please find below a revised response following your correspondence of 16th April 213 requesting an internal review of the FOI response 13/86 to your queries concerning aluminium in vaccines. 1. What is the total amount of aluminium that would enter into their body from these injections? In answer to your first question, the maximum 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 milligrams. Please find below details of how this amount was calculated based on the childhood immunisation schedule that was current at the time of the response. Highest (mg) possible Lowest (mg) possible Age Vaccines offered (mg) 2 mth Pediacel mth Pediacel Menjugate.4.4 or Neisvac mth Pediacel Menjugate.4.4 or Neisvac mth Menitorix Priorix or MMR VaxPRO

2 3 yr 4 mth Repevax or Infanrix-IPV.5.5 Priorix or MMR VaxPRO yrs Gardasil yrs Revaxis Total Total boy As the data requested referred to a boy and Gardasil is not routinely offered to boys, the total a boy would receive through vaccination as part of the current UK routine childhood immunisation programme is milligrams. The US immunisation schedule differs from the UK immunisation schedule both in terms of vaccines used within the programme and the timing and number of vaccinations. This amount is over a period of greater than 1 years and is far less than aluminium exposure from other environmental sources, including foods with people having an average daily weekly exposure of about mg/kg body weight 1. However exposure through the digestive system differs from exposure via vaccination as these are generally administered intramuscularly or subcutaneously. Mitkus et al. 2 state that the body burden of aluminium from vaccines is not more than 2-fold higher than that received in the diet. 2. What amount of the aluminium provided in response to question 1 above would enter into their bloodstream? The MHRA does not hold these data. However please see the response to questions 6, 7 and 8 below. 1 European Food Safety Authority 2 Mitkus RJ et al. Updated aluminum pharmacokinetics following infant exposures through diet and vaccination. Vaccine 29 (211)

3 References to US studies are applicable to the UK situation as a child administered a vaccine in the UK would be expected to have the same experience if they were administered the vaccine in the US. 3. What amount of the aluminium provided in response to question above would cross the bloodbrain barrier and enter into their brain? The MHRA does not hold these data. However there is some evidence that some aluminium is retained in the body and some deposits have been found in the brain 3. However the MHRA is unaware of any evidence that demonstrates that aluminium from vaccines crosses the blood-brain barrier and there is no evidence to suggest that the aluminium in vaccines poses any serious health risks. 4. What are the long term effects of aluminium entering the body as a result of these immunisations? 5. What are the long term effects of aluminium entering the brain as a result of these immunisations? In answer to your question of what are the long term effects of aluminium entering the body as a result of these immunisations, we are unaware of any 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. 6. What is the elimination rate of aluminium from a child s body? 7. What is the elimination rate of aluminium from a child s brain? 8. What is the recommended safe level of aluminium to enter a child s body via injection and how was this determined? 9. What is the recommended safe level of aluminium to enter a child s brain and how was this determined? 3 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. J Environ Monit 24;6(5):

4 We do not hold the data to the specific questions you posed, however, you may find the following summary helpful from published studies. 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 4. This can be summarised as follows. 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 5 6 and animal studies 7, Mitkus et al 2 made 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 of aluminium adjuvant from the site of injection and at no time found that the estimated level of aluminium in infants exceeds the minimum risk levels (MRL) body burden and the margin of exposure between aluminium body burden from vaccine and the MRL was found to increase with age. They add that the body burden of aluminium from vaccines is not more than 2-fold higher than 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 weeks 3. 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 4 Mitkus RJ et al. Updated aluminum pharmacokinetics following infant exposures through diet and vaccination. Vaccine 29 (211) 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. J Environ Monit 24;6(5): Priest ND, 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): 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):

5 life would be milligrams (mg), based on the recommended US schedule of vaccines 8. 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 aluminium adjuvant outweigh any theoretical concerns. 1. Other than any studies mentioned in response to the above 9 questions, what other studies have been carried out to determine the safety of children receiving aluminium-containing vaccines? The World Health Organization s Global Advisory Committee on Vaccine Safety (GACVS) 9 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 13/33. 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: