UK Covid-19 "Vaccine" Categorisation Issues - MP/Lords/MHRA/DHSC Letter
This template can be used in whole or part to alert your MPs, Lords, the MHRA and Minister for Health to fundamental categorisation issues relating to all of the Covid-19 "vaccines" in use 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 [NAME],
As your constituent, I write to you to ask a specific question about Covid-19 “vaccines” in the context of and in relation to the specific information that I provide to you below.
I highlight to you 6 issues and I ask one question.
1. Statement by Moderna that its products are considered gene therapies by the FDA
In June 2020 – 9 months before the MHRA issued its CMA for Spikevax – Moderna itself publicly declared the following:
Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict.
2. Definition of “vaccine”
Vaccine is a word whose meaning is variously defined and variously understood. This definition has recently been changed in many places including the US CDC and various dictionaries, after Covid-19 vaccines began to be deployed globally.
As Dr. Peter Doshi PhD, editor of the British Medical Journal, recently pointed out at Senator Ron Johnson's Expert Panel On Federal Vaccine Mandates and Vaccine Injuries, mRNA/DNA “vaccines” do not meet the previous definition of vaccine, which has been changed in many (see Merriam Webster 11-07-21 vs 03-31-2019) but not all dictionaries (see Collins). The Wayback Machine proves this. Doshi stated:
“Another definition worth checking is “vaccine”... I am one of the academics that argues that these mRNA products that everybody calls “vaccines” are qualitatively different than standard vaccines, and so I found it fascinating to learn the Merriam Webster changed its definition of “vaccine” early this year. mRNA products did not meet the definition of “vaccine” that has been in place for fifteen years at Merriam Webster but the definition was expanded such that now, mRNA products are now “vaccines”. I highlight this to ask a question:
“How would you feel about mandating Covid-19 vaccines if we didn't call them “vaccines”? What if these injections were called drugs instead?”.
So here's the scenario: we have this drug, and we have evidence that it doesn't prevent infection nor does it stop viral transmission. But the drug is understood to reduce your risk of becoming very sick and dying from Covid. Would you take a dose of this drug every six months or so and possibly the rest of your life, if that's what it took for the drug to stay effective?
...The point is, just because we call it a “vaccine” doesn't mean we should assume these new products are just like all other childhood vaccines which get mandated. Each product is a different product and if people are OK with mandating something simply because “it's a vaccine and we mandate other vaccines, so why shouldn't we mandate this?”, I think it's time to inject some critical thinking into that conversation.”.
Source: https://youtu.be/KL8SJRBNh_w?t=229
3. Approval of Covid-19 Vaccines re “Comirnaty”
The FDA full but conditional approval of “Comirnaty” relates to a product that is compositionally the same as the original Pfizer BNT162b2 vaccine but asserted to be legally different and is not available within the United States. The UK's reference to “Comirnaty” within MHRA regulatory documentation would appear to be a synonymous reference to the Pfizer BNT162b2 product and should that be the case then neither Comirnaty nor BNT162b2 have been granted full approval outside of the USA and by the UK MHRA.
4. Approval of Other Covid-19 Vaccines
All Covid-19 “vaccines” in use in the UK are under Conditional Marketing Authorities and are not fully approved. They all remain in Phase 3 trial until mid 2023 at the earliest. Under their CMAs, these products are indicated for “the prevention of Covid-19”. None of them prevent Covid-19 disease from the SARS-CoV-2 virus, as is repeatedly confirmed by the UKHSA weekly bulletins and datasets.
5. Covid-19 “Vaccines'” Mechanism of Action
The mechanism of action of these products is different to the previous definition of and to all previous vaccines in widely approved use. No mRNA/DNA Covid-19 product in use has been approved at time of writing. The primary objective of these products is not that of previous vaccines:
Their primary objective is to make host cell machinery express a toxic, biologically active and foreign Spike protein;
Their dependent secondary objective is that, in response to the host cell expression of the toxic Spike protein antigen, the host immune system then mounts a defence against that foreign, toxic Spike antigen before the host sustains significant damage caused by the expressed Spike protein itself;
Their dependent tertiary objective is that some form of immune response (preferably persistent but now proven to be short-lived and possibly deleterious to the overall host immune system) to the toxic Spike protein that may remain in the host.
N.B: Spike protein has been and continues to be described by some, including US CDC as “harmless”:
“The mRNA vaccines do not contain any live virus. Instead, they work by teaching our cells to make a harmless piece of a “spike protein,” which is found on the surface of the virus that causes COVID-19.”.
Source: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html
This claim that Spike protein is “harmless” is patently false as shown by increasing amounts of scientific and medical research.
Additionally, in silico genetic analysis of the mRNA used to induce Spike proteins by the various Covid-19 “vaccines” has been shown to actually differ from “naturally occurring” RNA found within the virus variants. There are several reasons given for this in the research, including the optimisation of the “vaccines'” mRNA payload, which incorporates codon optimisation and pseudouridisation in order to achieve this.
In fulfilling just the above primary and secondary objectives, these products could and do induce autoimmune damage within the host. This outcome is inherent in these products' mechanism of action. This is unlike any prior vaccine in use in the human race prior to Covid-19 “vaccine” deployment. That this is mechanistically possible is stated even by the UK Government and MHRA in regulatory documentation, when it describes their 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.".
It appears that the scale, location and speed of this autoimmune damage is indeterminate and uncontrollable by the host or a third party. The scientific and medical research about why, how, and to whom this autoimmune damage occurs is incomplete. This means that predicting who would be vulnerable to such damage at this stage in a global, top-down deployment of novel and still experimental medical treatments, is impossible.
These product's mechanistic objectives, the difference between them and previous traditional (inactivated, or live-attenuated) fully approved vaccines for other diseases, and the serious potential (and now seen actual) autoimmune damage are not fully known about and understood by the general population, and yet the population uses or is being made to use these products. Informed consent issues directly flow from this.
None of the above is explained in accessible, unifying lay terms in any UK Patient Information Leaflet provided via the MHRA to UK patients despite constantly increasing published research. This makes patient informed consent either difficult or impossible. The vast majority of information which underpins the above is published in peer-reviewed journals but is absent from the guidance given to patients by the UK Government and its agents.
6. Moderna's “Spikevax” Conditional Marketing Authorisation (CMA)
The MHRA's CMA for Moderna Spikevax states the following:
What is COVID-19 Vaccine Moderna and what is it used for?
COVID-19 Vaccine Moderna is a vaccine indicated for active immunisation to prevent coronavirus disease 19 (COVID-19) caused by the SARS-CoV-2 virus in individuals 18 years of age and older.
This product has been authorised by MHRA in Great Britain (consisting of England, Scotland and Wales). This procedure follows a European Commission (EC) decision on 6 January 2021 (EMEA/H/C/005791), in accordance with the advice from the Committee for Medicinal Products for Human Use (CHMP). This is known as the EC Decision Reliance Procedure
Other information about COVID-19 Vaccine Moderna
A conditional marketing authorisation was granted in Great Britain (consisting of England, Scotland and Wales) on 31 March 2021.
The public assessment report for COVID 19 Vaccine Moderna follows this summary.
This summary was last updated 7 April 2021.
N.B.: Moderna's Spikevax Covid-19 vaccine does not prevent infection or transmission of Covid-19, which would appear to be in contradiction of the specified indication in the MHRA's Spikevax CMA.
Question: Given all of the above information, please can you explain why you feel, believe or know that the Moderna Spikevax Covid-19 “vaccine” and any other mRNA/DNA “vaccines” have been correctly categorised by the MHRA as vaccines and therefore been subjected to the appropriate regulatory and approval pathway and oversight?
Yours sincerely,
[NAME]