Genotoxicity of mRNA products

Dan Couzens made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

The request was successful.

Dear Medicines and Healthcare Products Regulatory Agency,

Given the information supplied to me in previous FOIA requests regarding genotoxicity of the mRNA products, it is increasing apparent that the Pfizer (EUA and non-EUA) issued mRNA 'vaccines' (they are anything but), ARE in fact genotoxic and carcinogenic.

Recent studies by scientists and doctors have highlighted the presence of the the cancer promoting genetic sequence SV40 in the Pfizer products.

Under FOIA I would like to see all official MHRA letters, emails and correspondence regarding the SV40 genetic sequence in the mRNA products, what testing was conducted by MHRA or outsourced to the EMA, regarding the safety of these products and why informed consent was obstructed.

Further, given that under prior FOIA requests you hid information under 'trade secret' and 'commercial confidence' clauses concerning the exact make -up and ingredients of the product, quality and safety testing reports, will you now make that information available to the public writ-large.

Studies have also shown the presence of bacterial DNA in the products. Can you supply information regarding the quality testing and any reports of your knowledge of said DNA contamination and any high-level discussions on continued authorization in the UK.

Yours faithfully,

Dan Couzens

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 23/743

Dear Dan Couzens,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 5 October.

I confirm that your request is now 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.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...

Kind Regards,

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf,
London E14 4PU
Telephone 020 3080 6000

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FOILicensing, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Dan Couzens,

Please find attached the final response to the above-referenced FOI request.

Kind regards

The FOI Team,
Healthcare Quality and Access

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Dear FOILicensing,

Thank you for your reply dated 03 Nov 23, to my FOIA requests FOI 23/070 and FOI 22/1223.

It is not surprising that a search if the Pfizer documentation supplied to MHRA didn't hold the SV40 information because it would appear Pfizer deliberately withheld this information to worldwide regulators.

When you mention the 'independent testing' conducted by The National Institute for Biological Standards and Control (NIBSC) a quick glance of their website proves they are ANYTHING but independent when declaring a partnership with the WHO. One of the WHO's major donors happen to be the Bill and Melinda Gates Foundation. Dr Niel Almond, Head of the Blood and Tissue Pathogens, Adventitious Agents and Diagnostics group, Division of Virology, is hardly independent either as he has received funding from 2005 through 2013 from Bill and Melinda Gates Foundation too.

Dr Paul Bower, Principal Scientist, Division of Bacteriology, is an ex Pfizer employee. Dr Nicola Rose has deep ties with Imperial College which in turn has deep ties with Bill Gates- his last visit to Imperial being earlier this year with the Prime Minister. Need I go on?

So, I would like to know, what TRULY independent testing of production vaccines with certifiable custody chain has MHRA or the EMA done on these 'mRNA EUA vaccines'? So, I ask again, can you categorically confirm that the Pfizer mRNA Covid-19 vaccine in use/past use in the UK does NOT contain the SV40 large T antigen?

Yours sincerely,

Dan Couzens

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 23/851

Dear Dan Couzens,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 5 November.

I confirm that your request is now 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.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...

Kind Regards,

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf,
London E14 4PU
Telephone 020 3080 6000

show quoted sections

FOILicensing, Medicines and Healthcare Products Regulatory Agency

Dear Dan Couzens,

 

Many thanks for your request for information, dated 05 November 2023,
where you asked:

I would like to know, what TRULY independent testing of production
vaccines with certifiable custody chain has MHRA or the EMA done on these
'mRNA EUA vaccines'? So, I ask again, can you categorically confirm that
the Pfizer mRNA Covid-19 vaccine in use/past use in the UK does NOT
contain the SV40 large T antigen?

 

Our response:

Simian vacuolating virus 40 (SV40) is a virus present in monkey kidney
cells.  We are not aware of any Covid-19 vaccine containing SV40 virus or
SV40 antigens. A short sequence of the nucleic acid from the SV40 virus is
present in the Pfizer/BioNTech Covid-19 vaccine, but this is not the
sequence coding for the SV40 large T antigen (see Figure 1 of ‘BNT162b
vaccines protect rhesus macaques from SARS-CoV-2’ :
 [1]https://www.nature.com/articles/s41586-0...) and therefore the
vaccine cannot direct the synthesis of that antigen. 

 

Biological medicines (such as vaccines, monoclonal antibodies used to
treat cancers and immunological diseases, certain clotting factors used to
treat haemophilia, etc) utilise living cells in their manufacturing
process and all cells contain DNA.  Since no purification process is 100%
effective, and since modern analytical methods are extremely sensitive, it
is known that there will be low levels of DNA impurities in these
medicines.  There are international guidelines on the acceptable levels of
DNA in such products.  Covid-19 vaccines have purity specifications and
all batches must pass these specifications before they can be released. 
All released batches of the Pfizer/BioNTech Covid-19 vaccines have passed
their specifications.

 

As previously described in our response to FOI 23/743, Independent
laboratory testing of vaccines is carried out by the National Institute
for Biological Standards and Control (NIBSC). Batches of vaccine that meet
the specifications in the approval are certificated, allowing the
manufacturer to market them in the UK for use before the batch expiry
date.

 

All vaccine manufacturers must operate to Good Manufacturing Practices and
their facilities are licensed, and are inspected periodically.

 

We now consider this request to be closed. If you are unhappy with our
decision, 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 email:
[2][MHRA request email]

 

After that, if you remain dissatisfied, you may write to the Information
Commissioner at;

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow                                                                                                                                                                             

Cheshire

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5AF                                                                                                                                                                             

 

They will make a decision on whether or not we have interpreted the FOIA
correctly in handling your request.

 

Yours sincerely

 

FOI Team

 

 

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References

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1. https://www.nature.com/articles/s41586-0...
2. mailto:[MHRA request email]
3. https://www.gov.uk/help/terms-conditions