3 simple, easy to answer questions I asked the MHRA - and they couldn't
From January 2021 and still no coherent information from them (nor any other regulator worldwide)
In January 2021 I asked the UK’s medicines regulatory the MHRA these questions in a FOI:
“I received a document titled "COVID-19 mRNA Vaccine BioNTech BNT162b2, 5’capped mRNA encoding full length SARS-CoV-2 Spike protein” by the European Medicines Agency.
In it it states:
"ALC-0315 and ALC-0159 are novel excipients, not previously used in an approved drug product within EU."
Question 1 - has there been any studies done on the vaccine ingredient ALC-0315 and it’s effects on the human body? If so please supply the study.
Question 2 - has there been any studies done on the vaccine ingredient ALC-0159 and it’s effects on the human body? If so please supply the study.
Question 3 - Are ALC-0315 and ALC 0159 licensed for use in the UK? If so please supply the relevant documentation and the safety studies that support it’s use.”
There first answer was this:
Thank you for your email which is no longer being dealt with under FOI.
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/NEJMoa2034577?query=featured_home
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 healthcare practitioners and recipients of the vaccine, and Public Assessment Reports for each vaccine) are available on the MHRA website. Links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
The PAR for the Pfizer/BioNtech vaccine contains analyses of the non-clinical data submitted for the excipients ALC-0315 and ALC-0159.
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/publications/regulatory-approval-of-covid-19-vaccine-moderna
Throughout this global pandemic, we have always been guided by the latest scientific advice. Having studied evidence on both the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, the Joint Committee on Vaccination and Immunisation (JCVI) has advised that we should prioritise giving as many people in at-risk groups their first dose, rather than providing two doses in as short a time as possible.
The four UK Chief Medical Officers agree with JCVI that at this stage of the pandemic prioritising the first doses of vaccine for as many people as possible on the priority list will protect the greatest number of at risk people overall in the shortest possible time and will have the greatest impact on reducing mortality, severe disease and hospitalisations and in protecting the NHS and equivalent health services.
This is because the evidence shows that one dose of either vaccine provides a high level of protection from Covid-19.
For both vaccines, data provided to MHRA demonstrate that whilst efficacy is optimised when a second dose is administered both offer considerable protection after a single dose, at least in the short term. For both vaccines the second dose completes the course and is likely to be important for longer term protection.
The NHS across the UK will prioritise giving the first dose of the vaccine to those in the most high-risk groups. Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer-term protection.
The JCVI’s independent advice is that this approach will maximise the benefits of both vaccines allowing the NHS to help the greatest number of people in the shortest possible time. It will ensure that more at-risk people are able to get meaningful protection from a vaccine in the coming weeks and months, reducing deaths and starting to ease pressure on our NHS.
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:
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 available in the public domain and is provided below:
https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?Attachment_id=103741
Kind Regards
Which does not answer the 3 questions nor would they say why it was not under FOI regulations.
They then attempted to recall the message but I had already read it so tough luck on them.
This is their replacement answer which is just as nonsensical when compared against the original questions:
Thank you for your email which is no longer being dealt with under FOI.
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/NEJMoa2034577?query=featured_home
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 healthcare practitioners and recipients of the vaccine, and Public Assessment Reports for each vaccine) are available on the MHRA website. Links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
The PAR for the Pfizer/BioNtech vaccine contains analyses of the non-clinical data submitted for the excipients ALC-0315 and ALC-0159.
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/publications/regulatory-approval-of-covid-19-vaccine-moderna
Throughout this global pandemic, we have always been guided by the latest scientific advice. Having studied evidence on both the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, the Joint Committee on Vaccination and Immunisation (JCVI) has advised that we should prioritise giving as many people in at-risk groups their first dose, rather than providing two doses in as short a time as possible.
The four UK Chief Medical Officers agree with JCVI that at this stage of the pandemic prioritising the first doses of vaccine for as many people as possible on the priority list will protect the greatest number of at risk people overall in the shortest possible time and will have the greatest impact on reducing mortality, severe disease and hospitalisations and in protecting the NHS and equivalent health services.
This is because the evidence shows that one dose of either vaccine provides a high level of protection from Covid-19.
For both vaccines, data provided to MHRA demonstrate that whilst efficacy is optimised when a second dose is administered both offer considerable protection after a single dose, at least in the short term. For both vaccines the second dose completes the course and is likely to be important for longer term protection.
The NHS across the UK will prioritise giving the first dose of the vaccine to those in the most high-risk groups. Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer-term protection.
The JCVI’s independent advice is that this approach will maximise the benefits of both vaccines allowing the NHS to help the greatest number of people in the shortest possible time. It will ensure that more at-risk people are able to get meaningful protection from a vaccine in the coming weeks and months, reducing deaths and starting to ease pressure on our NHS.
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:
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 available in the public domain and is provided below:
https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?Attachment_id=103741
Kind Regards
I then challenged the answers supplied with:
“Why was my request not done under FOI?
It was a request for information that should be held and publicly available on request.
Instead you sent me a few links that do not supply any of the information asked for, a link to a statistical analysis (similar to many others) that can be interpreted any way you want and certainly does not “prove” the “vaccine” works as claimed and has been analysed by independent researchers and found to be flawed in it’s conclusion and some information on the prioritising of who to give the “vaccines” to (and who were not included in the manufacturer’s pitiful small and quick safety study)
Phase 1 trials were pitiful to say the least. Pfizer refuse to release any information until 2023 from what I understand so the MHRA have no “safety” information from them prior to the vaccination programme being started.
Or do you? If so please supply a copy of the information Pfizer supplied the MHRA prior to the emergency use approval being given.
Phase 2 trials are currently on-going on the general population and is showing an adverse effect on the health and wellbeing of many of those included in this trial not just in this country but wherever a mass vaccination programme has been rolled out - Gibraltar, Israel, California and the UAE for example - and Government’s refusal to acknowledge or investigate if there are any links between, for example, vulnerable care home residents receiving a vaccine dose and the subsequent rise in positive tests for coronavirus and increased deaths within the same group.
Phase 3 trial will not finish for many years - maybe 10 or 20 years more.
Other than that you seem to quote direct from the manufacturer’s statements about how great their vaccines will make everything.
And as for the JCVI or GAVI etc and out CMOs taking their advice as our CMO and CSO and many others in the decision making are known to be in the pay of vaccine manufacturers and pharmaceutical companies and they have large personal investments in these companies their decision making cannot be construed in anyway as independent nor unbiased.”
and received this:
Thank you for your email.
The information we are permitted to give out is in the already referenced PAR. The studies and other data have been reviewed by UK (and European) experts in the relevant field.
Regarding your request for information on any studies done for vaccine ingredient ALC-0159, this information is exempt from release under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act.
Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.
Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in releasing information that can be used by competitors in the product development of their own rival products. Examples of public interest arguments would be a major public health risk, or a major procedural failure or irregularity.
And this:
MHRA’s assessment of the safety information that was submitted prior to the authorisation of each vaccine is available in the Public Assessment Report for each vaccine. Links to these were provided to you in our previous response.
As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring and that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. This is a process known as safety monitoring (pharmacovigilance). This ensures that any potential medium and long term safety issues are promptly and adequately evaluated. As part of our signal detection processes, all adverse reaction reports received are individually assessed and cumulative information reviewed at regular intervals. Be reassured that the MHRA is working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary.
That answer we now know is a total fantasy.
I had already told them that I had read the relevant documentation they reference (the EMA’s Public Assessment report {PAR} and it did not contain the information I was requiring.
To me the sentences “The information we are permitted to give out is in the already referenced PAR.” and “We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in releasing information” means there is more and they are hiding behind Section 41 and Section 43 to avoid making public the fact that the novel excipients I requested information on have never been safety tested for use in human medicines.
So protecting Pfizer is more important than the public interest - in their own words.
I again challenged their answer with:
“I have read the links that you previously supplied more than once and prior to submitting the original FOI request.
I have read all the publicly available information on the Government website about all 3 of the mRNA gene replacement therapy injections and in the Pfizer assessment it states:
Pharmacokinetics
Study PF-07302048: Single dose pharmacokinetics study of ALC-0315 and ALC-0159 following intravenous bolus injection of a nanoparticle formulation in rats
Please supply all documentation and all communications in whatever form between MHRA and Pfizer/BioNTech held in relation to study PF-07302048 complete and in full.
This is the information I previously asked for and you have not so far supplied.
My original questions were:
Question 1 - has there been any studies done on the vaccine ingredient ALC-0315 and it’s effects on the human body? If so please supply the study.
Question 2 - has there been any studies done on the vaccine ingredient ALC-0159 and it’s effects on the human body? If so please supply the study.
The correct answer to my original FOI request should have been YES there has been a study and here it is.
Instead you have sent me nothing but links to meaningless documents and what can only quotes and comments that could easily have been supplied straight from the manufacturer’s PR and sales brochures and quote “safety” studies that do not finish until mid-2023 at the earliest and the MHRA Yellow Card adverse reporting system that when analysed has too many “coincidences” in timing that do not support your statements that the vaccine is proven “safe”.
I will also now ask 1 more additional question:
Why has the MHRA been trying to avoid supplying the relevant information asked for when it’s existence is admitted to in a document that the MHRA sent me?”
They then answered:
We are sorry you have not yet received a response to your internal review request.
We have followed this up with our Licensing colleagues and hope to respond to you as soon as we can.
We apologise for any inconvenience caused.
I then asked them this:
“Can you please supply the following information:
In February 2021 the US Federal Drug Administration received a Pfizer document with the following title and references:
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT
REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
Report Prepared by:
Worldwide Safety
Pfizer
With reference to the above document:
1 - was the MHRA made aware of this document or receive a copy of this document from Pfizer or officially or unofficially via another Government regulator or agency?
2 - if the answer to Q1 is yes then what date did the MHRA receive this document?
3 - if the answer to Q1 is yes then what investigation did the MHRA do to verify the conclusion stated in "Section 5 Summary and Conclusion” based on the numbers of adverse events and the range of medical issues reported reported in the body of the document and in APPENDIX 1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST?
4 - if the answer to Q1 is no then now that the mHRA is aware the document exists will they be requesting a copy (I have one available upon request) and perform an investigation into the safety of the Pfizer covid vaccine in question as part of the rolling review mention in an e-mail answer to a FOI with the reference CSC 28806?
5 - if the answer to Q1 is yes was the document one of the documents that were refused to be released in an e-mail answer to a FOI with the reference CSC 28806?”
They replied with:
The document you refer to has not been submitted to the MHRA. However, we regularly review safety information from the COVID-19 vaccine manufacturers and are in regular contact with other regulators across the world to exchange safety data on the COVID-19 vaccines. This information is considered in our assessments alongside the UK data, to ensure that the balance of benefits and risks of the COVID-19 vaccines remains favourable.
So they say that Pfizer did not submit this document to them? The FDA had a copy so why does the MHRA not have a copy?
I think it is because Pfizer never supplied it to them as they are an irrelevance - but it could be they lied in a FOI answer.
Then I asked:
“Now you know the document exists will you be requesting it from Pfizer?
Also try asking for this one:
https://www.docdroid.net/xq0Z8B0/pfizer-report-japanese-government-pdf”
I also sent them pdfs of the documents in questions and the actual internet links and again was told that the MHRA had not received these documents.
Note how they avoid answering the question about obtaining a copy of this document from Pfizer.
During all this I have been answered by the main FOI team, the Licensing team and the Vigilance Risk Management of Medicines team.
Not one inspires any confidence that they have the public interest in mind in any way, shape or form.
Nor do they inspire confidence that they actually know anything about the “covid vaccines” other than media sound bites and pharmaceutical company and the WHO PR blurb.
I have also had the same non-answers about the AstraZeneca jab.
I asked:
“Under FOI legislation please supply the following information:
1 - the studies that show that the bovine growth hormone used in the AstraZeneca covid-19 vaccine polyA tail is safe for use in humans
2 - the product licence for the bovine growth hormone used in the AstraZeneca covid-19 vaccine polyA tail that shows it is approved for use in humans in any form or method of use”
As you can surmise the answers.
A list of the excipients in the AstraZeneca can be found at the following link:
Summary of Product Characteristics for Vaxzevria - GOV.UK (www.gov.uk)
Please note that the bovine growth hormone polyA tail is a nucleotide sequence from a bovine growth hormone gene. There is no bovine growth hormone in the AZ COVID-19 vaccine.
The structure of the gene construct encoded in the AZD1222 genome is shown in Figure 1 of the European Public Assessment Report (Page 16) available at this link:
Many thanks,
Again, no supply of the information required nor any reference to safety studies.
So when is a bovine growth hormone (or part thereof) is not a bovine growth hormone?
When it’s in the AstraZeneca jab.
This then morphed into enquiries into about the licensing process
Under FOI legislation please supply the following documentation:
- the MHRA’s own internal assessment (not the EMA documentation) of the Pfizer "covid-19 vaccine" prior to the issue of the emergency use authorisation
- the MHRA’s own internal assessment (not the EMA documentation) of the Moderna "covid-19 vaccine" prior to the issue of the emergency use authorisation
- the MHRA’s own internal assessment (not the EMA documentation) of the AstraZeneca "covid-19 vaccine" prior to the issue of the emergency use authorisation
- the list of documentation used to assess the Pfizer "covid-19 vaccine" prior to the issue of the emergency use authorisation
- the list of documentation used to assess the Moderna "covid-19 vaccine" prior to the issue of the emergency use authorisation
- the list of documentation used to assess the AstraZeneca "covid-19 vaccine" prior to the issue of the emergency use authorisation
Their answers are described here:
So I am now preparing a new FOI challenge for them as Section 43 can be challenged with this: “Examples of public interest arguments would be a major public health risk, or a major procedural failure or irregularity.”
As has now been show to be happening, there are major public health risks involved with the Covid gene editing/replacement therapies.