UK Covid-19 "Vaccine" Regulatory Issues - MP/Lords Template Letter
This template can be used in whole or part to alert your MP or a Lord to fundamental regulatory issues relating to the deployment and ongoing use of Covid-19 "vaccines" in the UK.
You can find your MP's email address here: https://members.parliament.uk/members/Commons
You can find Lords' email adresses here: https://members.parliament.uk/members/Lords
You can contact Dr. June Raine, Interim CEO of the MHRA here (use all email addresses): info@mhra.gov.uk specialpopulationsunit@mhra.gov.uk dmrc@mhra.gov.uk
You can contact Minister for Health, Sajid Javid MP here: sajid.javid.mp@parliament.uk
From:
[YOUR NAME]
[YOUR ADDRESS]
Dear [MP NAME],
Re Coronavirus MHRA Conditional Marketing Authorities Issues and Enquiries for Your Attention and Response
As your constituent, I write to make you aware of the numerous following issues and seek your direct analysis and explanation of them, as my elected representative.
I also ask you to explain the issues that follow in the context of your personal voting record on bills etc. that have passed since January 2020, including the Coronavirus Act 2020 and its extension.
I present these 7 issues and I ask 23 questions of you.
1. MHRA UK Conditional Marketing Authorities for Covid-19 Vaccines May Have Been Contradicted, Violated or Invalidated
The following phrases can be found in the documents on the MHRA's page of regulatory information (link above):
4.1 Therapeutic indications
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.
4.1 Therapeutic indications
Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.
What is BNT162b2 and what is it used for?
BNT162b2 is a vaccine indicated for active immunisation to prevent COVID-19 caused by the SARS-CoV-2 virus, in individuals 12 years of age and older.
Following an extensive review of the quality, safety and efficacy data, COVID-19 mRNA Vaccine BNT162b2 has been authorised for temporary supply in the UK for the following indication: active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
Question 1: Based on the above, please can you explain how the UK Conditional Marketing Authorisation issued by the MHRA for the Pfizer Covid-19 "vaccine" (and actually any other Covid-19 "vaccine") remains legal and valid, if:
the UK Government's own data shows that the Covid-19 "vaccines" do not prevent Covid-19 infection or transmission;
The Prime Minister and other Goverment Ministers, agents and advisors have stated in various media, including via the BBC and on video, that Covid-19 is NOT prevented by the "vaccines";
The NHS states that Covid-19 is not prevented by the "vaccines";
UK HSA Data, NHS data including ICNARC hospital admissions data show that vaccinated persons are still transmitting and becoming infected with Covid-19 and being hospitalised as a result, in volumes that are exceeding those of the unvaccinated;
Albert Bourla, Pfizer CEO, is on video expressly stating that "we know two doses of the vaccine provides very limited protection, if any. The three doses with the booster, they offer reasonable protection against hospitalisation and deaths... and less protection against infection.".
Question 2: If Covid-19 "vaccines" are known and admitted to not prevent Covid-19 and the CMAs are contradicted by that knowledge, why are Covid-19 "vaccines" still in use in the UK under the present CMAs?
Question 3: If Covid-19 "vaccines" do not prevent Covid-19 infection, why does the UK Government instruct UK citizens and persons within its territory to take them?
Question 4: If Omicron, the now dominant but less virulent variant, can escape or evade the current Covid-19 "vaccines" and is more transmissible than prior variants, why is the UK Government telling citizens to take further doses of the "vaccines" which even Albert Bourla has stated are ineffective against Omicron, other variants and the resultant development of Covid-19 disease?
Question 5: If Omicron is and has been infecting people globally since late Q3 2021 or earlier, why would it make sense to "boost" against that widespread variant with ineffective "vaccines" based on the original Wuhan strain, and why would it make sense to do that in the interim period until Pfizer has a "vaccine" version that it claims will be effective against Omicron, subject to further scientific and medical testing and evidence?
Question 6: What is your understanding of the regulatory process that will be applied to any and all new versions of Covid-19 “vaccines”, including but not limited to whether they will be subject to any new and independent Phase 1-3 trials specifically for that version or iteration of that "vaccine"?
Question 7: Why do some of the MHRA documents in relation to the Pfizer Covid-19 "vaccine" refer to "Comirnaty" and some refer instead to "BNT162b2"? Which of these products are in use in the UK and what is the difference between them that results in two different names? N.B.: this distinction in name did not exist when the "BNT162b2" was initially deployed under its original CMA.
2. UK Government admits that the "vaccine" mechanism of action is not proven
From the UK HSA:
Researchers across the globe are working to better understand what antibody levels mean in terms of protection against COVID-19. Current thinking is that there is no threshold antibody level that offers complete protection against infection, but instead that higher antibody levels are likely to be associated with lower probability of infection.
https://www.gov.uk/government/publications/covid-19-vaccine-weekly-surveillance-reports
To paraphrase, this means that:
Currently, no level of vaccine-induced antibodies can offer complete protection from Covid-19 infection (supporting point 1, above) i.e. Covid-19 "vaccines" cannot prevent Covid-19 infection.
Antibody levels are only assumed to correlate to a lower probability of infection i.e. the stated mechanism of action of Covid-19 "vaccinations" is not proven with certainty.
As stated previously, the UK Government itself has stated that Covid-19 "vaccines" do not prevent Covid-19.
This is again a contradiction of the Therapeutic Indications of the MHRA Conditional Marketing Authority issued for Pfizer's Covid-19 "vaccine" (see point 1, above).
Compare this with MHRA statements about mechanism of action:
"The viral spike (S) protein antigen induces an adaptive immune response through neutralising antibodies. Furthermore, as the expressed spike (S) protein is being degraded intracellularly, the resulting peptides can be presented at the cell surface, triggering a specific T cell-mediated immune response with activity against the virus and infected cells.".
This ambiguity is supported by the fact that Pfizer phase 1-3 trials do not explicitly prove the mechanism of action. Further, Pfizer's own Phase 3 trials show an Absolute Risk Reduction of sub 2% from their own trial data i.e. it was ineffective at the Phase 3 Trial initial preliminary study end-point, from which the government and the UK media told the UK public that the Pfizer Covid-19 "vaccine" demonstrated "~95% efficacy". This was a reference to a Relative Risk Reduction measure based on only 170 subjects in a study of over 44,000 subjects. This is not a meaningful, valid or accurate measure of true efficacy of that product within the total cohort of the (then) double-blind Randomised Controlled Trial, especially when the trial design is evaluated closely and relevant subject data that was withheld by Pfizer is also considered (as the EMA did).
Question 8: What evidence is available to directly prove the effective mechanism of action of Covid-19 "vaccines" - stated by the MHRA to be the "induction of adaptive immune response through neutralising antibodies" - that ensures that the Covid-19 "vaccines" meet the authorised Conditional Marketing Authority indication of "prevention of Covid-19"?
Question 9: If you believe or feel or know that the initial claim of "~95% efficacy" that the government and media stated was true, accurate, correct and meaningful, why do you believe or feel that? If you know, how do you know?
Question 10: Do you feel or believe or know that Relative Risk Reduction is the measure of efficacy of any medical intervention (in any form) that takes precedence and means more than Absolute Risk Reduction? If so, why?
3. Autoimmune disease/damage may be inherent in the design and primary/secondary/tertiary mechanism of action of Covid-19 "vaccines"
"The viral spike (S) protein antigen induces an adaptive immune response through neutralising antibodies. Furthermore, as the expressed spike (S) protein is being degraded intracellularly, the resulting peptides can be presented at the cell surface, triggering a specific T cell-mediated immune response with activity against the virus and infected cells.".
If one looks at that the entire Covid-19 "vaccine" mechanism, the following is an obvious possible mechanistic outcome of the Covid-19 "vaccine" design that experts including Dr. Peter McCullough and the inventor of mRNA technology, Dr. Robert Malone, have stated is possible and has now been seen in pre-clinical studies:
The vaccines trigger the expression of Spike antigen in a host cell, which can make it look, to the host immune system, like infected native or foreign tissue.
In mounting an adaptive immune response which can employ T-Cells, the body may actively kill the host cells engaged in Spike antigen production.
If this happens in sufficient quantity and/or concentration in a tissue, organ or system, it is possible that the patient may experience damage that could be temporary or permanent, to an unknown degree. Dr. McCullough has stated that this vaccine-induced autoimmune damage is occurring in the cardiovascular systems of the vaccinated.
To be clear with regard to the immune responses that the "vaccines" induce - as confirmed and stated within the above MHRA document references - the NIH describes the following:
"Innate immune responses are activated directly by pathogens and defend all multicellular organisms against infection. In vertebrates, pathogens, together with the innate immune responses they activate, stimulate adaptive immune responses, which then help fight the infection.
The function of adaptive immune responses is to destroy invading pathogens and any toxic molecules they produce. Because these responses are destructive, it is crucial that they be made only in response to molecules that are foreign to the host and not to the molecules of the host itself. The ability to distinguish what is foreign from what is self in this way is a fundamental feature of the adaptive immune system. Occasionally, the system fails to make this distinction and reacts destructively against the host's own molecules. Such autoimmune diseases can be fatal.
In cell-mediated immune responses, the second class of adaptive immune response, activated T cells react directly against a foreign antigen that is presented to them on the surface of a host cell. The T cell, for example, might kill a virus-infected host cell that has viral antigens on its surface, thereby eliminating the infected cell before the virus has had a chance to replicate (see Figure 24-2). In other cases, the T cell produces signal molecules that activate macrophages to destroy the invading microbes that they have phagocytosed.".
Source: https://www.ncbi.nlm.nih.gov/books/NBK21070/
Question 11: What do you feel, believe or know about the above issue of vaccine-induced autoimmune disease within the UK population, in the context of the UK Government's past, present and future vaccination strategy and the methods, means and expense employed in achieving it?
Question 12: What would your feelings or belief be should it be shown that Covid-19 "vaccines" have caused any form of harm, injury or death to any UK citizen via any mechanism, including but not limited to vaccine-induced autoimmune damage (described above) that may have been: known about prior to the "vaccines'" deployment; learned about or signalled during their development or testing; learned about or signalled at any point since their deployment?
Question 13: What methods, means, skills and resources would you personally or via third party employ to evaluate for yourself your own risk/benefit analysis, past, present or future of the Covid-19 "vaccines" and what have you done in this regard to date?
Question 14: Do you personally and professionally have any measure, boundary or limit established at or beyond which you feel, believe or know that the risk benefit of Covid-19 "vaccines" deployed in the UK becomes unfavourable, to the point that you personally would: declare publicly or privately to the UK Government that it should cease their use for some or all UK citizens; refuse any or further personal doses of Covid-19 "vaccines" for you and/or your family?
4. Ingredients
"In addition to those excipients, the vaccine contains four lipids, of which two are used in approved medicinal products (cholesterol and 1,2-distearoyl-sn-glycero-3-phosphocholine, hereafter termed DSPC) and two are considered novel in that they have not been used in an authorised medicinal product in the UK.".
Question 15: Where is the scientific and medical evidence that these two novel lipids, never used before in a human medicine in the UK, are fully tested and understood in vivo separately and in combination with the "vaccine's" other ingredients, prior to CMA and deployment?
5. Post Authorisation Measures for the CMA
Question 16: Where are the data and reports that are on this schedule (link above), for which the deadlines have passed?
6. Past and ongoing scope and validity of Phase 3 trials
"Phase 3 clinical trials showed the safety and efficacy of the mRNA vaccines, and early data from observational studies have supported the clinical trial results. Real-world data on vaccine effectiveness are useful for building on evidence from clinical trials and continuing to inform Covid-19 vaccine policy. The randomized, controlled trials were not powered to evaluate efficacy among persons with chronic illness or among those in racial and ethnic minority groups that have been disproportionately affected by Covid-19.".
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2106599
Question 17: If Pfizer's own Phase 1 - 3 trials excluded subjects with chronic illness and racial and ethnic minority groups, on what evidential basis did the UK Government deploy the "vaccine" to those groups of UK citizens?
Question 18: Do you feel, believe or know that any of the Covid-19 "vaccines" have been tested and proven safe in terms of human (male or female) fertility? What is the basis for your feelings, belief or knowledge in this regard?
Question 19: What is your interpretation of Judge Swift's High Court ruling to block the release of data relating to child injuries and deaths related to the Covid-19 "vaccines"?
7. Impact and meaning of the deliberate unblinding and crossover of the Pfizer (and other manufacturer) Phase 3 double-blind Randomised Controlled Trials
Each Covid-19 "vaccine" Phase 3 trial was technically set up to last approximately three years as double-blind RCTs. RCT is the "gold standard" of medical evidence. That evidence drives ongoing safety and efficacy evaluation over the trial period. CMA is contingent upon those data derived from that original trial design.
Covid-19 "vaccine" manufacturers have now unblinded and crossed over the trials. This essentially means that the benefits of double-blind trial design and the trials' control groups no longer exist. Therefore, there is no RCT trial actually running for the "vaccines" where unblinding and crossover has occurred. Therefore, no further safety and efficacy evaluation can be made in the way that was required by the MHRA at trial inception, on which CMA was conditional and dependent.
Question 20: What does the unblinding and crossover of any Covid-19 "vaccine" Phase 3 trial mean, in any and all senses, to you in terms of safety and efficacy of any of these products?
Question 21: What does the unblinding and crossover of any Covid-19 "vaccine" Phase 3 trial mean, in any and all senses, to you in terms of the conditions laid out in the MHRA's CMA for these products?
Question 22: Which manufacturers of Covid-19 "vaccines" available and in use past or present within British territories under the control and legal remit of the UK Government have either unblinded and/or crossed over their Phase 3 double-blind RCTs of their Covid-19 "vaccine(s)"?
Question 23: If some or all of the Phase 3 trials have not been unblinded or crossed over, where is the evidence that they remain in the original trial form and follow the original test design on which MHRA CMA was conditional?
Source: https://www.bmj.com/content/371/bmj.m4956
Yours sincerely,
[NAME]