Origination of Biotechnology, Biotechnology Companies and Vaccines,

Dominique Anderson 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.

Medicines and Healthcare Products Regulatory Agency did not have the information requested.

Dominique Anderson

Dear Medicines and Healthcare products Regulatory Agency,

Is Biotechnology being experimented on humans because Biotechnology is inexpensive compared to other traditional vaccines? https://www.nhs.uk/conditions/vaccinatio... Please provide documents.

Is Biotechnology going to replace traditional Flu, MMR, vaccines? https://www.nhs.uk/conditions/vaccinatio... Please provide documents.

I am requesting details of all Biotechnology pharmaceutical companies the Uk, England, Wales and Northern Ireland are doing business with? Please provide documents.

How does Biotechnology begin at a University before moving across to a Pharmaceutical company promoting the product? Please provide documents of the process.

I am requesting a date and year the contract was made with the Biotechnology universities to produce mRNA's?

Is Biotechnology made in a lab? Please provide documents of where and how Biotechnology is made?

Yours faithfully,

Dominique Anderson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
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Medicines and Healthcare products Regulatory Agency
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London 
E14 4PU
gov.uk/mhra
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References

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Dominique Anderson

Dear Medicines and Healthcare products Regulatory Agency,

I look forward to you fulfilling my FOI request.

Yours faithfully,

Dominique Anderson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/035

Dear Dominique Anderson,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 13 January 2021.

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.

Kind Regards,


MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

13 Attachments

  • Attachment

    FOI 21 044 Freedom of Information request Isolation of Coronavirus New Variant SARS CoV 2 virus and the South African Variant Mutation E484K.txt

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    FOI 21 042 Freedom of Information request Biotechnology Pfizer mRNA and Moderna mRNA Risk Assessment vs a Healthy Immune system.txt

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    FOI 21 045 Freedom of Information request Isolation of Brazilian Coronavirus Variant.txt

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  • Attachment

    Freedom of Information request Coronavirus Experiments Risk Assessments Herd Immunity vs Healthy Immune System.txt

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  • Attachment

    Freedom of Information request Interferon Beta Coronavirus Treatment Part 2.txt

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    Freedom of Information request Interferon Beta Coronavirus Treatment Part 1.txt

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    Freedom of Information request Interferon Beta Coronavirus Treatment Part 3.txt

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    Freedom of Information request Interferon Beta Coronavirus Treatment Part 4.txt

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    Freedom of Information request Interferon Beta Coronavirus Treatment Part 6.txt

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    Freedom of Information request Interferon Beta Coronavirus Treatment Part 5.txt

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    Freedom of Information request Interferon Beta Coronavirus Treatment Part 7.txt

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    Freedom of Information request Interferon Beta Coronavirus Treatment Part 8.txt

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    Freedom of Information request Interferon Beta Coronavirus Treatment Final.txt

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Dear Dominique Anderson,

Thank you for your emails below and attached.

The authorisation of the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines was done through an expedited rolling review. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The temporary authorisation under Regulation 174 permits the supply of identified vaccine batches, based on the safety, quality and efficacy data submitted to MHRA. These authorisations do not constitute a marketing authorisation.

All vaccines are tested through three phases of clinical trials to ensure they meet the gold standard. Phase 1 trials are with a small group of people to make sure there are no safety concerns and determines the appropriate dosage for the best immune response. Phase 2 trials are conducted on a larger group of people to check the vaccine works consistently and that the immune response is sufficient. Phase 3 trials test the vaccines on thousands of people for scientists to assess if the vaccine is producing immunity that will prevent disease. Usually, these phases are run in sequence, but in an effort to find a safe and effective Covid-19 vaccine as quickly as possible, once safety has been ascertained through Phase 1, Phases 2 and 3 are being run in parallel. Extensive checks and balances are required at every stage of the development of a vaccine, and this is no different for a Covid-19 vaccine. No stages in the vaccine development processes were bypassed.

Information on the study conducted using the Pfizer/BioNTech vaccine and its results are available in a peer-reviewed journal, the New England Journal of Medicine. A link to this is provided below:
https://www.nejm.org/doi/full/10.1056/NE...

The approval for use of the Pfizer/BioNTech and Oxford/AstraZeneca COVID-19 vaccines in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine, and also considered the conditions for its safe supply and distribution. The decision was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. Regarding the MHRA approval of the Pfizer/BioNTech and the Oxford/AstraZeneca COVID-19 vaccines, further information (including information for physicians and recipients of the vaccine, and Public Assessment Reports [PARs] for each vaccine) are available on the MHRA website. The PARs contain useful information on the mechanism of action of the Pfizer/BioNTech and Oxford/AstraZeneca vaccines. Links to these are provided below:
https://www.gov.uk/government/publicatio...


https://www.gov.uk/government/publicatio...

Further to the above, the Moderna vaccine has also recently been authorised for use. Further information on this is provided below:
https://www.gov.uk/government/publicatio...

The following Department of Health and Social Care (DHSC) webpage for the independent report ‘Optimising the COVID-19 vaccination programme for maximum short-term impact’ from the Joint Committee on Vaccination and Immunisation (JCVI) provides the rationale for the government’s implemented dosing strategy:
https://www.gov.uk/government/publicatio...

Further, the scientific basis from the JCVI concerning the current evidence on efficacy after single doses of the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines is provided below:
https://www.cas.mhra.gov.uk/ViewandAckno...

MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes, including the Yellow Card scheme. The MHRA, together with independent expert advice from the Commission on Human Medicines (CHM), is responsible for ensuring that the overall balance of benefits in terms of effectiveness, and risks of medicines and vaccines is positive at the time of licensing and remains so thereafter. Any emerging evidence relating to possible risks associated with medicines and vaccines, would be carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

Regarding your questions concerning the isolation of the Covid-19 virus and its variants, further information on the current pandemic and the evidence supporting the measures being taken by the UK government (including the isolation of the Covid-19 virus and any available data on variants) are available via the Scientific Advisory Group for Emergencies (SAGE) website:
https://www.gov.uk/government/organisati...

Regarding the use of interferon beta, information on current clinical trials involving the use of interferon beta are available through the EU Clinical Trials Register:
https://www.clinicaltrialsregister.eu/

For more information on the interferon beta please review the company website https://www.synairgen.com/ that has a wealth of information including a link to the Lancet publication for results.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [MHRA request email]

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely


MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000

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Dominique Anderson

Dear Medicines and Healthcare products Regulatory Agency,

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 'Origination of Biotechnology, Biotechnology Companies and Vaccines,'.

I studied the links provided and the information does not match my FOI request.

I am requesting an entirely accurate and complete list of records held by the Medicines and Healthcare products Regulatory Agency. Describing the isolation of Coronavirus including describing the isolation of the New Variant SARS-CoV-2 virus and the South African Variant Mutation E484K. Taken directly from an asymptomatic patient with Coronavirus, New Variant SARS-CoV-2 and the South African Variant Mutation E484K. Where the sample was not combined or mixed with any other source of genetic material. For example, monkey cells, kidney cells, and cancer cells eliminate contamination as a possible alternative source of sampling.

I did not receive information highlighting Pfizer mRNA, and Moderna mRNA is a healthy pathogen. I did not receive information highlighting a suitable and sufficient health and safety risk assessment before testing the Pfizer mRNA and Moderna mRNA on humans in trials and before the present mass rollout of Pfizer mRNA and Moderna mRNA. I did not receive information highlighting risk assessments carried out before any new Coronavirus experimental treatment is offered. I did not receive information highlighting the ingredients of special formulation interferon-beta. Including how special formulation interferon beta was made at Southampton University Hospital from the beginning to the finished product detailing the making formula process. I did not receive information highlighting the costs involved in making special formulation interferon-beta.

I did not receive information highlighting the time scale taken with the same trial participants to improve health after inhaling the interferon-beta special formulation deep into their lungs. I did not receive information highlighting why interferon-beta special formulation needs to be inhaled deep into the lungs. I did not receive information highlighting the health effects of inhaling with a short breath of interferon-beta special formulation compared to a long deep breath of interferon-beta special formulation. I did not receive information highlighting how Coronavirus seem to suppress the immune system.

I did not receive information highlighting names responsible approving interferon-beta special formulation to be used on the UK public in trials. I did not receive information highlighting how interferon-beta special formulation artificially stimulates the immune system. I did not receive information highlighting how interferon-beta special formulation activates a strong immune response. Compared with a healthy immune system with a strong immune response. I did not receive information highlighting if all volunteers in interferon-beta special formulation trial had an immune deficiency before inhaling interferon-beta special formulation into their lungs. I did not receive information highlighting the same trial volunteers who benefited listing all health benefits after inhaling interferon-beta special formulation. I did not receive information highlighting how interferon-beta special formulation is delivered directly into the airways via a nebuliser, making protein into an aerosol. Providing information about the aerosol.

I did not receive information highlighting Names of team members running phase three interferon-beta special formulation trials on 600+ volunteers in twenty countries. I did not receive information highlighting listing twenty countries participating in phase three interferon-beta special formulation trial. I did not receive information highlighting Names who developed interferon-beta special formulation. I did not receive information highlighting the approved/licenced test used for detecting the status of a healthy, strong, or weak immune system. I did not receive information highlighting names responsible who gave authorisation for an interferon-beta special formulation used on the public in the UK trials.

I did not receive information highlighting a health and safety risk assessment in connection with hydroxychloroquine used in the Coronavirus trial. I did not receive information highlighting if mRNAs are licenced like the flu vaccine is licenced. I did not receive information highlighting how the decision is made when deciding which new treatments are used on volunteers in Coronavirus trials. I did not receive information highlighting if newer versions/forms of coronavirus treatment mRNAs throughout 2021, 2022, 2023, 2024 and 2025 predicted to be an experiment on the public. I did not receive information highlighting a date and year contracts were made with Biotechnology Universities producing mRNAs.

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

Yours faithfully,

Dominique Anderson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

 

Please note that we may not respond if your query: 

 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

 

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 

 

The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Dominique Anderson,

Thank you for your email.

We confirm that an internal review is being carried out on FOI 21/035.

Please note the deadline for reply for Internal Reviews is 20 working days from our date of receipt and the date for this request is 8th March.

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Dominique Anderson,

MHRA would like to understand what exactly it is that you disagree with in our response.

From our perspective we have provided information we hold in our reply. Where we do not hold the information we provided links to other organisations where information may be held.

Before we can do an internal review we need to know what exactly your objections are in our response to you.

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000

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Dominique Anderson

Dear MHRA Customer Services,

Thank you for explaining to me that you do not hold the information.

Yours sincerely,

Dominique Anderson