Dear Medicines and Healthcare products Regulatory Agency

The Department of Health did not have the requested information contained in the following 10 questions, and they recommended I approach you for this information. As such this is a request under the Freedom of Information Act 2000:

I recently received promotional material from the Department of Health regarding the immunisation of children (up to 18 years of age).

If one of my offspring were to receive the full immunisation
schedule promoted in their leaflet, and assuming the offspring in question is male, please confirm the following (for the avoidance of doubt, the same immunisation schedule can be found at http://www.nhs.uk/Conditions/vaccination...

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

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

3) What amount of the aluminium provided in response to question 2 above would cross the blood-brain barrier and enter into their brain?

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?

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?

10) 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?

For each response please quote the source of your information. If no data from studies published in recognised peer-reviewed journals exists please state this for any applicable response.

If answering all 10 questions would result in your response falling outside of the scope of a request made under the Freedom of Information Act 2000, then please treat each question as if it were an individual request.

Faithfully

Nicholas Wells

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:
 
[1]http://www.mhra.gov.uk/Contactus/Custome...
 
The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:
 
Clinical Trials of medicines:
 
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:
 
[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Manufacturer’s and wholesale dealer’s licences:

[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Reporting a side effect to a medicine:

[6]http://www.mhra.gov.uk/Safetyinformation...
 
Reporting an adverse incident involving a medical device:
 
[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
Reporting a counterfeit medical product:
 
[9]http://www.mhra.gov.uk/Safetyinformation...
 
Buying medicines over the internet:
 
[10]http://www.mhra.gov.uk/Safetyinformation...
 
If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
Customer Services
External Relations
Medicines and Healthcare products Regulatory Agency
 
Please note this is an automated reply; please do not respond to this
message.
 
 
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Custome...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 13/086

Dear Mr Wells,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 22nd February 2013.

I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Yours Sincerely


Customer Services
External Relations
MHRA
Tel: 020 3080 6000

show quoted sections

FOILicensing, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Mr Wells
Please find the response to your FOI attached.
Kind regards
FOI Team
 
 
 
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

Caron Ryalls left an annotation ()

I'd like to direct you to an article about newly published research by Keele Conference scientists which shows that aluminum adjuvant in vaccines transfers to the brain. The research documents the path from injection site to the brain, and shows that once in the brain, it persists. Newborns, the elderly, and people with a certain genetic variation are particularly at risk. (A link to the published research is found at the end of the article)

http://gaia-health.com/gaia-blog/2013-04...

Dear Medicines and Healthcare products Regulatory Agency (MHRA),

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Aluminium in Vaccines'.

In your responses to my 10 questions included in my original request you have provided incomplete/inadequate responses. Details of which are provided below:

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

In response you state that the maximum amount of aluminium a boy would receive is 3.215 milligrams. Please confirm how this was calculated. You also state that people (adults) have a daily/weekly dietary exposure of 0.2 - 1.5 mg/kg bodyweight (0.7 - 2.3 mg/kg bodyweight in children and young people). However what you fail to mention is that the majority of aluminium consumed in your diet does not enter your bloodstream as it is not absorbed via the gut. Why did you not mention this or give an accurate amount of aluminium that would actually enter the blood following digestion? There is also a major discrepancy between the amount of aluminium an infant in the United States of America would receive in their first year as an infant if following the recommended US schedule (4.225 mg) versus the 3.215 mg when following the UK schedule over 10 years, as quoted by you. Do you need to revisit your figures for accuracy, and if not why such a discrepancy?

Question 2: What amount of the aluminium provided in response to question 1 above would enter into their bloodstream?

In your response you refer to the FDA published analysis by Mitkus et al. I cannot obtain this paper without paying therefore cannot review it. From the limited references you make to it, I remain far from convinced of your arguments. I would also like to remind you that I am referring to the UK and the immunisation schedule promoted by the Department of Health/NHS, therefore US data is not wholly appropriate/applicable. You also refer to 3 further studies, again all of which I am required to pay for to review.

You suggest in your summary of this study that, depending upon the type of aluminium salt contained in the vaccine, aluminium (a demonstrated neurotoxin) is absorbed into the blood at varying rates, which you admit are assumptions made by the authors. I assume that eventually all of the aluminium will enter the blood, or does some remain around the injection site?

You then state that "... blood concentrations of aluminium hydroxide approached zero by the end of the experiment, thereby implying a very low rate of uptake into blood"; please confirm whether measurements for any other aluminium salts were taken, how frequently they were taken, and whether this, or the implied low rate of uptake of aluminium hydroxide into the blood, or both, are mere speculation or fact?

I fear that your next paragraph is an even more inadequate response, which states as follows:

"[u]sing these assumptions Mitkus at [sic] 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."

You refer to modelling of assumptions and then apply them to estimates. Is this good science? You do however refer to the body burden of aluminium from vaccines being not more than twice that received in diet (no reference provided). You fail, again, to mention that aluminium received in the diet is in the main not absorbed via the gut.

Question 3: What amount of the aluminium provided in response to question [2] above would cross the blood-brain barrier and enter into their brain?

I presume that as you fail to provide a written response to this question then you are not aware of the actual amount that would enter into the brain. Alternatively, if you are withholding this information please provide a justification for doing so.

Question 4: What are the long term effects of aluminium entering the body as a result of these immunisations?

You state that 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. Please be more precise in this response as I have found countless examples of evidence that suggest the contrary. Where did you search and what do you define evidence as? If no evidence exists please confirm whether or not the MHRA have requested for any of the Marketing Authorisation (MA) Holders of the vaccines in the immunisation schedule to prove the long term safety of their vaccine(s) including but not limited to the potential for damaging effects from a demonstrated neurotoxin such as aluminium, and if not, why not?

Question 5: What are the long term effects of aluminium entering the brain as a result of these immunisations?

See response above to Question 4.

Question 6: What is the elimination rate of aluminium from a child’s body?

I presume that as you fail to provide a written response to this question then you are not aware of the actual elimination rate of aluminium from a child's body. Alternatively, if you are withholding this information please provide a justification for doing so.

Question 7: What is the elimination rate of aluminium from a child’s brain?

I presume that as you fail to provide a written response to this question then you are not aware of the actual elimination rate of aluminium from a child's brain. Alternatively, if you are withholding this information please provide a justification for doing so.

Question 8: What is the recommended safe level of aluminium to enter a child’s body via injection and how was this determined?

I presume that as you fail to provide a written response to this question then you are not aware of the recommended safe level of aluminium to enter a child's body via injection. Alternatively, if you are withholding this information please provide a justification for doing so.

Question 9: What is the recommended safe level of aluminium to enter a child’s brain and how was this determined?

I presume that as you fail to provide a written response to this question then you are not aware of the recommended safe level of aluminium to enter a child's brain. Alternatively, if you are withholding this information please provide a justification for doing so.

Question 10: 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?

I presume that as you fail to provide a written response to this question then you are not aware of any other studies carried out to determine the safety of children receiving aluminium-containing vaccines. Alternatively, if you are withholding this information please provide a justification for doing so.

In light of all of the above I strongly recommend that until the safety of aluminium in vaccines, and its potential for long term damage to its recipients, is/are determined you immediately instruct the Department of Health (DoH) and NHS to cease any further promotion of the currently advertised immunisation schedule, and that you suspend the Marketing Authorisations of all aluminium-containing vaccines contained in the immunisation schedule promoted by the DoH and NHS until their safety is proven.

A full history of my FOI request and all correspondence is available on the Internet at this address:
http://www.whatdotheyknow.com/request/al...

Yours faithfully,

Nicholas Wells

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare Products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 18 working days. Further information on how we handle different
requests can be found on our website at the link below:
 
[1]http://www.mhra.gov.uk/Contactus/Custome...
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical Trials of medicines:
 
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:
 
[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Manufacturer’s and wholesale dealer’s licences:

[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Reporting a side effect to a medicine:

[6]http://www.mhra.gov.uk/Safetyinformation...
 
Reporting an adverse incident involving a medical device:
 
[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
Reporting a counterfeit medical product:
 
[9]http://www.mhra.gov.uk/Safetyinformation...
 
Buying medicines over the internet:
 
[10]http://www.mhra.gov.uk/Safetyinformation...
 
If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.
 
 
Kind regards
 
Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency
 
For a short period during April and May we are conducting a survey of the
service offered by our Customer Services team. We endeavour to provide a
friendly and informative customer focused service in line with the
standards outlined below. The purpose of the survey is to establish how
our customers feel about the service, and where they’d like to see
developments made. A link to the survey is included below; alternatively
you can take the survey over the telephone by contacting us on 020 3080
6000. Your feedback is critical in enabling us to identify where and in
what ways our customers would like to see the service develop. Summary
results from the survey will be posted on this page in late 2013.
 
[11]https://www.surveymonkey.com/s/CustomerS...
 
Please note this is an automated reply; please do not respond to this
message.
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Custome...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...
11. https://www.surveymonkey.com/s/CustomerS...

Steve Mackerman left an annotation ()

That study explains why thousands of Gulf war Veterans are suffering with neurological problems.
They received multiple vaccinations containing aluminium adjuvants.
Veterans have been trying to get the truth from the MOD for years, with no joy.

https://www.whatdotheyknow.com/request/w...

Is one of many requests.

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Mr Wells,

Thank you for your follow up email below.

Please note that an internal review will be carried out as requested by our Policy Team and we will be in touch with you shortly.

Yours Sincerely


Customer Services
External Relations
MHRA
Tel: 020 3080 6000

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Mr Wells,

Thank you for your recent request for internal review to the Medicines and Healthcare Products Regulatory Agency.

The attached document details the findings of the internal review that you requested and we plan to send a revised reply within 10 working days (please note that 27 and 28 May 2013 will not be working days).


Kind Regards,

Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency

Tel: 020 3080 6000
This email and any files transmitted with it are confidential. If you are not the intended recipient, any reading, printing, storage, disclosure, copying or any other action taken in respect of this email is prohibited and may be unlawful.

If you are not the intended recipient, please notify the sender immediately by using the reply function and then permanently delete what you have received.Incoming and outgoing email messages are routinely monitored for compliance with the Department of Healths policy on the use of electronic communications.

For more information on the Department of Healths email policy, click
http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Mr Wells,

This document details the findings of the internal review that you requested and that we plan to send a revised reply within 10 working days (please note next Monday and next Tuesday will not be working days).

Kind Regards,

Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency
Tel: 020 3080 6000

show quoted sections

Pharmacovigilanceservice, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Mr Wells,
 
Please see the attacghed Response for FOI 13-186.
Kind Regards,
 
Pharmacovigilance Service Team
 
Pharmacovigilance Service Team
 
MHRA
3-O
151 Buckingham Palace Road
London
SW1W 9SZ
 
T   020 3080 6000
F   020 8754 3967
 
[email address]
 
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

Steve Mackerman left an annotation ()

In regards to question 3, there is evidence that aluminium in vaccines transfers to the brain.
here's one link:
http://gaia-health.com/gaia-blog/2013-04...

Looking for an EU Authority?

You can request documents directly from EU Institutions at our sister site AskTheEU.org . Find out more .

AskTheEU.org