Verified health benefit data of the covid-19 vaccine

Response to this request is long overdue. By law, under all circumstances, Medicines and Healthcare products Regulatory Agency should have responded by now (details). You can complain by requesting an internal review.

Bartholomeus Lakeman

Dear Medicines and Healthcare products Regulatory Agency,

In Oct. the European Ted published that the UK- MHRA seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) to ensure that no details from the ADRs’ reaction text are missed.

All (except one) SARS-CoV-2 immunogenic epitopes have similarity to human proteins which might cause autoimmunological pathogenic priming. Said risk include neurological disorders (e.g. Guillain-Barré, Transverse myelitis (inflammation of the spinal cord), Narcolepsy), Idiopathic inflammatory myopathies (autoimmune musculoskeletal diseases including respiratory and cardiovascular systems): In case of Moderna’ and Pfizer’s mRNA covid-19 vaccine this risk is about 20%.

A Review of the Covid-19 vaccines protocols show that none of their manufactures assume that the vaccine will prevent a covid19 infection. Instead of measuring the difference between infection and non-infection: their criteria for approval is the difference in 'symptoms' between an infected control group and an infected vaccine group. In addition to that, some Covid-19 vaccine trials are using, instead of a truly biologically inert substances, e.g. saline, other vaccines as “placebo”. E.g.
a) AstraZeneca (AZ) vaccine AZD1222 (study start date: 17 Aug. 2020 estimated study completion date 5 Oct. 2022) its interim analysis includes 50 vaccine recipients; healthy individual between 18 and 30 yrs. The vaccine will be a success if 38 (±82%) or more do not develop symptoms after exposure to SARS-CoV-2, compared to 6 (±20%) in the 25-person control group. The minimum qualification for a “case of Covid-19” amounts to just one positive PCR test and one or two mild symptoms, e.g. headache, fever, cough or mild nausea (as that of the common cold);
b) AZ vaccine will be administered along with Paracetamol which subjects receive every six hours for the first 24 hours after inoculation;
c) AZ’ third way to mask ADRs is by injecting as a “placebo” a meningococcal vaccine;
d) AZD1222 trial has documented at least two cases of transverse myelitis due to which AZ halted its trial. Yet MHRA allowed AZ to resume its trial: which resulted into 1 death.

Whereas the Govt. has planned to coerce the public into accepting the novelty of an mRNA covid-19 vaccine without a recourse: The Declaration of Helsinki and the Nuremberg convention oblige you to provide the evidence of that your verification of the data from Pfizer, Moderna, AstraZeneca, Novalis; do confirm that their covid-19 vaccine:
1) is causing an anamnestic response;
2) is a prophylactic treatment against Covid-19;
3) will protect against a SARS-CoV-2 infection;
4) will prevent serious Covid-19 and/or influenza complications;
5) will reduce, for those over the age 60 their covid19 CFR to less than 0.1% (Influenza A);
6) will reduce, for those under the age 60. their covid19 CFR to less than 0.01% (ses-flu);
7) does fulfil the criteria for to be a genuine vaccine;
8) its safety profile (its health benefits -vs- ADRs risks) has been calculated according to the standards for general medications and does fulfil clinical and regulatory milestones;
9) its safety profile rate is such that with a scientific calculated probability said vaccine can be safely enforced as a mass inoculation and does justify its Harmless clausula.

Yours faithfully,
Bartholomeus Lakeman

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency


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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 20/509

Dear Bartholomeus Lakeman,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 3 December 2020.

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

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    FOI 20 509 RE Freedom of Information request Verified health benefit data of the covid 19 vaccine.txt

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Dear Mr Lakeman,
 
Re FOI 20/504 & FOI 20/509
 
Thank you for sending the above and below two requests, received by MHRA
on 02 & 03 December 2020, respectively.
 
The approval for use of the Pfizer/BioNTech COVID-19 vaccine 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.
 
Information on the studies conducted using the Pfizer/BioNTech COVID-19
vaccine and their results are available in a peer-reviewed journal, the
New England Journal of Medicine. A link to this is provided below:
[1]https://www.nejm.org/doi/full/10.1056/NE...
 
Furthermore, MHRA has published a Public Assessment Report (PAR), which
consists of the non-confidential aspects of MHRA’s assessment of this
vaccine. A link to the MHRA PAR is provided below:
[2]https://assets.publishing.service.gov.uk...
 
Regarding your request for the adverse event data and post marketing
surveillance, MHRA will be publishing Yellow Card data associated with
COVID-19 vaccinations. Yellow Card data for drugs is routinely published
to the Yellow Card website, with vaccine data available on request.
However, for COVID-19 vaccinations, we will be proactively publishing
details of Adverse Drug Reactions (ADRs) received, including MHRA
assessment of the data to provide context
 
The documents Information for Healthcare Professionals and Information for
UK Recipients on the Pfizer/BioNTech COVID-19 vaccine provide more details
on the vaccine, including the qualitative composition and undesirable
effects that may be experienced on administration. Links to these
documents are provided below:
[3]https://assets.publishing.service.gov.uk...
[4]https://assets.publishing.service.gov.uk...
 
Regarding points 7 to 10 raised in FOI 20/504, MHRA holds no data on these
issues. We suggest that you contact the Department of Health and Social
Care (DHSC) for further information on matters concerning government
indemnity, vaccine injury payouts/compensation, and matters concerning
vaccine rollout. Their contact details are provided below:
[5]Web contact form - https://contactus.dh.gov.uk/?openform 
  
Telephone: 020 7210 4850
 
If you have a query about the information provided, please reply to this
email.
 
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]
 
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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Bartholomeus Lakeman

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 'Verified health benefit data of the covid-19 vaccine'.

This FOI is about Pfizer’s vaccine BNT162b2’ effectiveness and safety profile in different subgroups and whether it is a true vaccine. MHRA replied by its review on Pfizer’s submitted data on BNT162b2: it is a selective rewrite of Pfizer’s script (published in the New England Journal of Medicine [nejm]); said review is written in support of Reg 174 (author?). Which is however, unacceptable due to the following:

1. Nejm editors commented that Pfizer’s study was not powered to definitively assess efficacy by subgroup. For all analysed subgroups in which more than 10 cases of Covid-19 occurred, the lower limit for efficacy was ±30%; which only applies to a 2-month period. Unknown whether this efficacy implies the prevention of infection transmission.

2. The participants number drop from 43,448 to 37,706 in Pfizer’s figure 1; and at the time of the analyses, it drops to 19,067 (9,531 Pfizer-BioNTech COVID-19 Vaccine and 9,536 placebo) (see ‘product monograph from Health Canada’). MHRA did neither address nor mention these figure drops.

3. Unknown is whether all participants were actually exposed to the covid-19 virus with the potential to cause infection: Did they just measure the development of in vivo antibodies formed after vaccine administration and decided that this translates to not being able to contract the virus clinically? Did they just follow participants living their normal lives and count how many contracted Covid-19 at the end of the study? Did they expose participant’s cells to SARS-CoV-2 in vitro?

4. Unknown is whether it is about SARS-CoV2 infection. The study endpoint is Covid19 symptoms with a confirmative +PCR and antibody. So, only swabbed people with symptoms, and they did not do surveillance swabs; whilst, the rate of +PCR which includes both asymptomatic and minimally symptomatic is likely much higher. Then all +PCR data where not checked/ confirmed with an antibody and/or CD4+ and CD8+ T-cell titters surveillance.

5. According to a scientific principle; MHRA has to proof that H1 > H0: MHRA claim of 90.7% effectiveness of BNT162b2 (H1) has to be rated versus Covid-19 natural survival rate (H0). Recently the CDC published Covid19 Survival Rates by age Groups: (a) 0 – 19: 99.99%. (b) 20 – 49: 99.98%. (c) 50 – 69: 99.5%. (d) 70+ 94.6%. In Oct, the WHO published that covid-19’ mortality rate is ±0.1%. As H0 (99.7%) > H1 (90.7%) the question arises what is BNT162b2 Number Needed to Vaccinate (NNTV) (the ‘N’ to make 1 person immune). Considering its claimed effectiveness of 90.7% [100(1-0.093)] = Covid-19 attack rate of 0.0004 (RR = 0.093) in the vaccine group and 0.0043 in the placebo group: the absolute risk reduction (ARR) for an individual is ±0.4% (0.0043-0.0004=0.0039): NNTV = (1/0.0039) = 256 (255 people will not get immune) and as the ARR = 0.4%; these result in a 0,06% reduction of the infection risk (efficiency). Consequently, BNT162b2 fails the criteria to be a vaccine.

6. MHRA or Pfizer claims of BNT162b2 effectiveness is based on the rates of: (a) Positive PCR test results, (b) Covid-19 symptoms, (c) Antibody responses, (d) Blood titters of induced CD4+ and CD8+ T-cells, and (e) Extrapolating these rates as being durable in the different subgroups. Yet, said used parameters have the following biases and flaws:
a) PCR tests do neither discriminate the source of the detected RNA nor whether the virus is alive or dead, nor the viral load whereas the used Ct is left unreported. Several Studies, a Cochrane review “Antibody tests for identification of current and past infection with SARS-CoV-2” and a Cambridge study on PCR test show that the PCR test’s false positive rate is 98- 100%.
b) Only 1 symptom is used to count a Covid-19 infection; which cannot be a discerning parameter by itself as there is no specific covid-19 symptom. The criteria for a severe case in the vaccine group is when a resting pulse oxygenation is less than 93 but who does not need advanced therapies or hospitalization. Such criteria is not the same as what is usually classified as a severe covid-19 case.
c) Specific neutralising antibodies against Covid-19 are unknown: there is no peer reviewed proof of a fully isolated SARS-CoV-2 genome. Instead Pfizer used a synthetic version provided by the Wuhan BLS4 Laboratory; yet from which corona virus and which strain? And an antibody response does not represent the immune system main protection: it being the Lymphocytes in the body.
d) Induced CD4+ and CD8+ T-cell were measured in the blood for only 2 months. Unknown is to what rate these blood titters account for the total amount of CD4+ and CD8+ T-cell or Lymphocytes in the body (e.g. spleen and guts). In average it is about 10%; depending on the stage of an infection;
e) T cell-mediated immunity duration* is unknown. Studies show that that this duration is shorter in the population over 55 yrs. of age: as *immunosenescence rate drops with age or frailty.

7. Unknown is why the adverse reactions (ARDs)/systemic events in the reactogenicity (solicited) subset is so much more than the trial in general? In the product monograph from Health Canada, it appears that the 2nd dose is one hell of a time for 18-55 yrs. old. Comparing ARDs/systemic event in the 7 days after the 1st and 2nd dose (D1 & D2); in the vaccine group their ARDs after D2 was 2-3 x higher than after D1 (particular muscles and joints pain) whilst, in the control group their ADR after D2 remained roughly the same as after D1. As the D2 ADR was much higher; it predicts that at a next viral or toxigenic exposer ADR will be higher. 30 days after D2 there were in vaccine group 4 x more lymphadenopathy and 4 bell’s palsy in the vaccine group -vs- control group; and the numbers of other neurologic or neuro-inflammatory, and thrombotic events; were left unknown.
Out of 9,531 vaccine participants 8,183 (85%) had an ARD. It has not clearly reported how many of these disappeared after 7 days, and whether these are a potential for a high risk of long-term ADR. E.g., transverse myelitis or GBS or some other debilitating neuropathy: With the swine flu vaccine, the rate of GBS was 1 in 100,000. So, as the BNT162b2 vaccine trial included 10,000 people, then we cannot exclude this risk and we do not know whether its risk rate is acceptable or not: MHRA cannot claim it is safe.

8. Pfizer did not test whether its vaccine might cause antibodies against PEG or toxicokinetic reaction, and/or binding antibodies which might cause autoimmune reactions or neurological symptoms, or affect fertility and reproduction. Which should have be done due to the following:
a) Polyethylene glycol (PEG) is the compound suspected of triggering allergic/ anaphylactic reactions in the 2 UK healthcare workers. Anti-PEG antibodies have been detected not only in patients treated with PEG gylated therapeutics, but also in those who have no knowledge of PEG previous exposures. Approximately 8% of the UK population has highly elevated levels of anti-PEG antibodies. Pathogenic priming is a condition that occurs in some people when a vaccine triggers autoimmunity, causing severe illness and or death, especially in older adults.
b) As Pfizer’s study on reactogenicity events stops at 2 months: unknown are the risks from the vaccine binding antibodies response. In general, it takes 3 – 12 months for binding antibodies to cause autoimmune reactions or neurological symptoms e.g., meningitis myelitis, Guillain Barre, birth defect, autoimmune diseases and death.
c) The vaccine is to trigger an immune response ability by its mRNA attacking the covid-19 spike s-protein which contain syncytin-1 homologous proteins: essential for the formation of the placenta. Yet HMRA fails to advise the NHS to check whether a young woman’s syncytin-1 could be targeted by said vaccine. Novelty vaccines can also cause Abs against the HCG antigen or contain ‘beta human chorionic gonadotropin’ (b-HCG) sub unit: Both render a woman to be permanently infertile. Further, which gene is that said mRNA is going to modify? There are (double strained) mRNA vaccines which accidently or aim to cause infertility in animals: e.g., mosquitoes, wild horses and monkeys (as it occurred in Astra Zeneca covid-19 vaccine trial on the monkeys).

9. For vaccine producers to insist on blanket indemnification from injuries and deaths; there must be a reason. No existing vaccines have been shown to be effective against infection with any beta-coronavirus, the family that includes SARS-CoV-2 (causing Covid-19) and a mRNA vaccine is a novelty, and as Pfizer’ vaccine is only tested for 3 months. Compare to other medications, with Pfizer’s data, MHRA cannot approved said mRNA vaccine to be licenced; without having rigorous tested and reviewed said vaccine. Yet MHRA did only review whether Pfizer’s data conform Good Laboratorial criteria and that of the WHO; which are based on pre-existing classic vaccines.

10. Pfizer’s data fail to prove that its vaccine prevents an asymptomatic infection or offers an active immunization. See BMJ 2020:317:m4037 https://doi.org/10.1136/bmj. m4037 “Will covid-19 vaccines save lives? Current trials aren’t designed to tell us.” BNT162b2, as most covid-19 vaccines protocols show; it is only to supress flu symptoms. Yet, the MHRA fails to prove that this vaccine reduces covid-19 symptoms more effectively than what is achieved by hydro-chloroquine and Nevirapine; which are known to be safe and cost effective.

11. Unanswered questions are: Will unexpected safety issues arise when the number grows to millions and possibly billions of people (as only about 10,000 people completed the vaccine trial)? Will side effects emerge with longer follow-up? As implementing a vaccine that requires two doses is challenging: What happens to the inevitable large number of recipients who miss their second dose? How long will the vaccine remain effective? Does the vaccine prevent asymptomatic disease and limit transmission?

The abovementioned 11 points, including Pfizer’s and MHRA biases and flaws, conclude that the basic questions in this FOI about BNT162b2 have to be answered in its details. Otherwise said 11 points, including said biases and flaws do provide sufficient arguments for to retract MHRA review on BNT162b2, and to have Pfizer’s data to be reviewed by an independent scientific scientist or scientific body e.g., the independent SAGE: And that in the meantime, out of the precaution principle; DHSC should put the issuing of said vaccine on halt.

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

Yours faithfully,
Bartholomeus Lakeman

Bartholomeus Lakeman

Dear MHRA Customer Services,
To my FOI 20/504 & 20/509 of 3 Dec, you on 16 Dec- responded “The approval for use of the Pfizer/ BioNTech COVID-19 vaccine in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by … the MHRA.” And yet you could not answer the question in my FOI. So, in turn you received my arguments for an internal review.
On 27 Dec. you promised to do an internal review which after 18 weeks has not been fulfilled. In turn, I herewith provided you the following arguments of which D & E are points in law.

A) Your yellow card report of 5 April shows that per 1,000,000 covid19 vaccine doses; about 50,000 people had an adverse reaction; 6000 peoples got serious injured (10% might die later), 15 permanent disabled and 35 died. Which sums a fatality risk between 0.004 and 0.04%.
After an ‘vaccination’ period of 4 months, the MHRA also reported that 4 million (7% of UK population) tested positive; of whom 120,000 (3%) died within 28 days. Yet, 89% of the deceased were age 70+ and 95% of the deceased had, similar as vaccine fatal ADRs. pre-existing conditions: cardio- & cerebrovascular & hypertension 45%; Nervous system (Dementia) 29%; Diabetes & obesity (metabolic) 25%; Infections and Blood disorders.
As less than 40% of whom tested positive have symptoms and as 5% of the people dying of or with Covid-19 had no comorbidity; it results in 6000; covid-19 IFR =0.08%. Yet for those under age 65 yrs. covid-19 IFR = 0.01%. Later in the year (Aug) the vaccine fatality rate will be higher as Covid-19’ IFR 0.08%.

B) Comparing your ADR reporting with that of Europe, Netherlands, and the VAERS shows MHRA report discrepancies in regards fatal ADRs; e.g., disorders -General, -Immune, -Muscle/tissue, -Nervous, - Reproduction, Vascular and Infections. Excluded from the report Death after vaccination is when there is a pre-existing comorbidity e.g., Cancer, Kidney, Heart and vascular disease. These, when testing PCR positive are registered as Covid19 death ( biasing the 'vaccine's benefits).
Another explanation for the differences between the national numbers of an ADR per 1000 vaccine doses, is that Health staff having reluctantly accepted the inoculation; cannot face its risks: as reporting and so worrying about the vaccine’s ADR would cause sleepless nights and/or their duty to warn others. It is estimated that NHS staff do not report for about 10%. Idem for European countries and regarding the VAERS this under-reporting estimation is 90%.

C) Pfizer’s trial data (fig. 6) show that out of its 36,523 participants there were only 118 (in the vaccine group) and 123 (control group) who had prior the trial a negative PCR test. Meaning that 99.7% of the participants might have had Antibodies against Covid-19 prior the trial which has biased the vaccine effectiveness rate (the difference of antibodies of the vaccine group -vs- control group) So, no 95% effectiveness, and as Pfizer noted: “Limitation and remaining questions: further study is required to understand the following:
1) Safety and efficacy beyond 2 months and in groups not included in this trial (e.g., children, pregnant women and immunocompromised persons).
2) Whether the vaccine protects against asymptomatic infection and transmission to unvaccinated persons.
3) Whether the vaccine protects against asymptomatic infection and transmission”
4) How to deal with those who missed the second dose.
The MHRA report and its REG 174 fails to mention said bias, concerns, queries and that all covid19 vaccines are until Oct- 2022/ Jan 2023 in their trial phase III, that the manufactures have refused to publish their raw data (it is still in an experimental phase) and that accepting the vaccine is at one’s own risk (the manufactures are indemnified for any potential harm caused to the public).

D) Under Article 32 of the 1949 Geneva Convention IV, “mutilation and medical or scientific experiments not necessitated by the medical treatment of a protected person” are prohibited. According to Article 147, conducting biological experiments on protected persons is a grave breach of the Convention.
Yet the “vaccine” fails to meet the following 5 “requirements” to be considered a vaccine and is by definition a medical “experiment” and trial:
1. “Provides immunity to the virus”. Yet this is a “leaky” gene-therapy that does not provide immunity to Covid and claims to reduce symptoms yet double-vaccinated are now 60% of the patients requiring AE (ER) or ICU with covid infections.
2. “Protects recipients from getting the virus”. Yet this gene-therapy does not provide immunity and double-vaccinated can still catch and spread the virus.
3. “Reduces deaths from the virus infection”. Yet this gene-therapy does not reduce deaths from the infection. Double-Vaccinated infected with Covid have also died.
4. “Reduces circulation of the virus”. Yet this gene-therapy still permits the spread of the virus as it offers zero immunity to the virus.
5. “Reduces transmission of the virus”. Yet this gene-therapy still permits the transmission of the virus as it offers zero immunity to the virus.

E) The “experimental” coivd19 vaccine is also in violation of all 10 of the Nuremburg Codes which carry the death penalty for those who seek to violate these International Laws.
Nuremburg Code #1: Voluntary consent is essential: No person should be coerced to take a medical experiment without informed consent. Yet Many media, political and non-medical persons are telling people to take the shot, it’s safe and offer no information as to the adverse effects or dangers of this gene-therapy. Countries are using lockdowns, duress and threats to force people to take this vaccine or be prohibited to participate in free society under the mandate of a Vaccine Passport or Green Pass. During the Nuremberg trail, even the media was prosecuted and members were put to death for lying to the public amongst many of the doctors and Nazis found guilty of Crimes Against Humanity.
Nuremburg Code #2: Yield fruitful results unprocurable by other means: As listed above, the gene-therapy does not meet the criteria of a vaccine and does not offer immunity to the virus. There are other medical treatments that yield fruitful results against Covid such as Ivermectin, hydroxy-chloroquine, Vitamin D, Vitamin C, Zinc and boosted immune systems for flu and colds.
Nuremburg Code #3: Base experiments on results of animal experimentation and natural history of disease: This gene-therapy skipped Animal testing and went straight to human trials. In mRNA research that Pfizer used a candidate study on mRNA with rhesus macaques monkeys using BNT162b2 mRNA and in that study all the monkeys developed pulmonary inflammation but the researchers considered the risk low as these were young healthy monkeys from the age of 2-4. Israel has used Pfizer and the International Court of Law has accepted a claim for 80% of the recipients having pulmonary inflammation from being injected with this gene-therapy. Despite this alarming development Pfizer proceeded to develop their mRNA for Covid without animal testing.
Nuremburg Code #4: Avoid all unnecessary suffering and injury: Since the rollout of the experiment and listed under the CDC VAERS reporting system over 4,000 deaths and 50,000 vaccine injuries have been reported in America. In the EU over 7,000 deaths and 365,000 vaccine injuries have been reported. This is a grievous violation of this code.
Nuremburg Code #5: No experiment to be conducted if there’s reason to think injury or death will occur: See #4, based on fact-based medical data this gene-therapy is causing death and injury. Past research on mRNA also shows several risks that have been ignored for this current trial gene-experiment. A 2002 study on Sars-Cov spike proteins showed they cause inflammation, immunopathology, blood clots and impede Angiotensin 2 expression. This experiment forces the body to produce this spike-protein inheriting all these risks.
N-Code #6: Risk should never exceed the benefit: Covid-19 has a 98-99% recover rate. The vaccine injuries, deaths and adverse side-effects of mRNA gene-therapy far exceed this risk. The use of “leaky” vaccines was banned for agriculture use by the US and EU due to the Marek Chicken study that shows ‘hot-viruses’ and variants emerge making the disease even more deadly. Yet, this has been ignored for human use by the MHRA knowing fully the risk of new deadlier variants emerge from leaky vaccinations.
N- Code #7: Preparation must be made against even remote possibility of injury, disability or death: There were no preparations made. This gene-therapy was approved under an Emergency Use only act, skipped animal and human trials and forced on a misinformed public.
N- Code #8: Experiment must be conducted by scientifically qualified persons: Politicians, media and actors claiming that this is a safe and effective vaccine are not qualified. Propaganda is not medical science. Many retail outlets as vaccine centres are not qualified to administer experimental medical gene-therapies to the uninformed public.
N- Code #9: Anyone must have the freedom to bring the experiment to an end at any time: Despite the outcry of over 85,000 doctors, nurses, virologists, epidemiologist the experiment is not being ended. In fact, more attempts to change laws to force vaccine compliance, mandatory and forced vaccinations are being pushed through, and experimental ‘update’ shots are planned for every 6 months without any recourse to the surmountable number of deaths and injuries already caused by this experiment.
N- Code #10: The Scientist must bring the experiment to an end at any time if there’s Probable Cause of it resulting in injury or death: It is clear in the statistical reporting data that this experiment is resulting in death and injury yet all the politicians, drug companies and so-called experts are not making any attempt to stop this gene-therapy experiment from inflicting harm on a misinformed public.

Due to abovementioned arguments and point in law is the MHRA obliged to complete within 10 days their internal review and response or else you have agreed with the investigation by the ICO.

Yours sincerely,
Bartholomeus Lakeman

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
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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,
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The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

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Bartholomeus Lakeman

Dear Medicines and Healthcare products Regulatory Agency,

On 16 Dec- you responded to my FOI 20/504 & 20/509 of 3 Dec- with “The approval for use of the Pfizer/ BioNTech COVID-19 vaccine in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by … the MHRA.” And yet you could not answer the question in my FOI; leaving the suspect of that ‘covid-19 vaccines’ contain dangerous, even deadly substances by which you are knowingly causing harm to people.
In turn you received my arguments for an internal review; which you promised to do on 27 Dec.
For you to fulfil your promise: to submit said internal review within 10 days, on 7 May, I provided you the arguments in law to do so; or else you agree to that the ICO conduct an investigation on this case.
Yet, in case your failure to submit said review timely was an oversight: I grant you 3 more days.

Yours faithfully,
Bartholomeus Lakeman

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

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Bartholomeus Lakeman

Dear Medicines and Healthcare products Regulatory Agency,
To FOI 20/504 & 20/509 of 3 Dec, the MHRA responded on 16 Dec with that they had proved Covid-19 vaccines to be safe - yet they could not answer the question in my FOI. In turn they received the arguments for an internal review. On 27 Dec. the MHRA promised to do this internal review. On the 7th May they received another set of reasons for to conduct their internal review with the Notice that if they failed to do: they have agreed to this FOI case being investigation by the ICO.

The given emails provided the reasons for said internal review and investigation; to which I hereby add the following.

On April 20, The Lancet published an analysis on the efficacy of the Covid injections. This analysis shows that Pfizer’s vaccine Absolute Risk Reduction (ARR) is 0.84% and Numbers Needed to Vaccinate (NNV) is 119; Moderna ARR is 1.2% and NNV = 81; Johnson & Jonson ARR is 1.2% and NNV = 84; AstraZeneca ARR is 1.3% and NNV = 78.
Meaning that between 119 and 78 people must be injected for it to reduce a “Covid” case in one person. An average benefit chance of 0.84% Whilst between 118 and 77 (99.1%) of those vaccinated people incurred its ADR risk with no benefit whatsoever.
The Lancet, data from the Pfizer rollout in Israel suggests an NNV of 217 and some NNV estimates are even higher, namely 256! The actual efficacy is less than 1% as some of the injected groups who became ill with “Covid like symptoms” were fallaciously labelled as side effects, rather than potential breakthrough infections.
Also unaccounted for, in the lucky 0.84% of people who hypothetically benefited from the “vaccine”, are the side effects. Efficacy metrics do not include adverse events from the injections. In other words, safety and efficacy are entirely different considerations. For example, even an efficacious intervention may not be safe if the risk of harm is high.

According to MHRA yellow card report is Covid-19 vaccines’ ADR risks 1.5%: AstraZeneca (AZ) 2.1%.
Comparing Pfizer vaccine benefit chance of 0.84% -vs- its ADR risks of 0.8% = 1 -vs- 1
Comparing AZ vaccine benefit chance of 1.3% -vs- its ADR risks of 2.1% = 1 -vs- 2
Comparing Moderna vaccine benefit chance of 1.2% -vs- its ADR risks of 0.7% = 2 -vs- 3
Comparing Covid-19 vaccine benefit chance of 0.84% -vs- its ADR risks of 1.5% = 1 -vs- 2
Comparing Covid-19 vaccine death risk of 0.07% -vs- a Covid19 virus death risk of 0.005% = 14 -vs- 1
According to Eurovigilinance Covid19 vaccine Adverse Drug Reaction (ADR) report of 8th May is covid-19 vaccine death risk 0.07% (MHRA 0.03%).

To properly exercise ethical and legal informed consent, every trial participant must understand the potential benefits and risks from the injections, the potential risks from Covid (based on age and health status) as well as the efficacious treatment alternatives for those who may need them.
Would you feel comfortable suited up with a parachute that worked about 1% of the time? Would you then say that it is 95% effective because that particular parachute worked 95% better than the competition?
A product with very questionable, minuscule efficacy and many concerns regarding potential severe short and long-term side effects (including deaths), might be more accurately classified as a poison.
A poison can be described as ‘any substance which when introduced into or absorbed by a living organism, destroys life or injures health’. The adverse effects may take many forms from immediate death to subtle changes not realised until months or years later.” Definition of “poison”, according the Royal Society of Chemistry.

Since the 5 - 4 months ‘vaccine’ experiment is daily violating Article 32 of the 1949 Geneva Convention IV, The Nuremberg Code and principles of Informed Consent.
Above mentioned analytic results and the legal duties to said Article 32 and the Codes do reasons that: MHRA has a case to answer to the public and the ICO

Yours faithfully,
Bartholomeus Lakeman

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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