Dear Medicines and Healthcare products Regulatory Agency,

Members of the public have long argued for full transparency of trial data to allow clinical trials by vaccine makers to be independently analysed. An important priority for many will be to weigh up the known risk/benefit profile of the vaccine against need. This requires understanding the danger posed by the virus, the virulence of which is likely weakening, as well as knowing the extent of naturally-acquired immunity. It should also take into account other potential interactions, such as the observed correlation between flu vaccination and COVID-related deaths.

Several studies have proved that herd immunity thresholds that interrupt the progress of transmission might be as low as 10% from naturally acquired immunity, as compared with over 60% if immunity is to be gained by randomised vaccination. The reality is that it will take many more months to compare the complex pattern of sustained immunity from memory B and T cells, and it may well be that exposure to the real virus elicits a more robust and persistent response than exposure to, for example, endogenously produced spike protein following injection of synthetic messenger RNA sequences.

Before an EUA or unrestricted license is issued for a covid-19 vaccine for which PCR results are the primary evidence of infection, all “endpoints” or COVID-19 cases used to determine vaccine efficacy in the Phase 3 or 2/3 trials should have their infection status confirmed by Sanger sequencing, given the high cycle thresholds used in some trials. High cycle thresholds, or Ct values, in RT-qPCR test results have been widely acknowledged to lead to a too high false positive (93%).
If the assignment of cases and non-cases during the course of the trial is not accurate, the vaccine will not have been properly tested. If the vaccine is not properly tested, important public policy decisions regarding its use will be based on misleading evidence. Its medical and economic consequences to the nation could hardly be higher.

The lack of established treatment protocols for immune backfiring known as Antibody Dependent Enhancement, when antibodies enhance uptake of the virus instead of neutralizing, should set off alarms for this entire mRNA vaccine program. According to virologists, e.g. Dr James Lloyds “All SARS-CoV-2 immunogenic epitopes have similarity to human proteins except one, which implies that:
• Roughly one-third of the potentially targeted human proteins (putative autoantigens) are key players in the adaptive immune system.
• The list of viral/human protein matches provides clues on which epitopes or parts of epitopes might be involved in the immunopathogenesis of COVID-19 disease from SARS-CoV-2 infection.
• It also indicates which epitopes might be responsible for autoimmunological pathogenic priming due to prior infection or following exposure to SARS-CoV-2 or relatives following vaccination.
• These epitopes should be excluded from vaccines under development to minimize autoimmunity due to risk of pathogenic priming. In case of Moderna’ and Pfizer’s vaccine the risk is about 20%”
Said risk include Guillain-Barré syndrome, Transverse myelitis (inflaming the spinal cord), Narcolepsy and other neurological disorders, Idiopathic inflammatory myopathies (autoimmune musculoskeletal diseases including respiratory and cardiovascular systems).

Under the maxim ‘Primum non nocere’ (first, do no harm) and the Govt' duty to practice Transparency and Accountability towards its actions, as for the public to come to an informed consent; you have to provide all necessary data regarding the risks of covid-19 vaccine: including the evidence of that its manufactures provided, and you can provide:
1. Full disclosure of raw data from studies and trails to allow independent analysis;
2. Full transparency in relation to safety and efficacy trials;
3. Full transparency over the vaccine platform(s) and technology used for commercial vaccines;
4. Conduct of comprehensive studies evaluating the independent risk form adjutants (additives);
5. Full disclosure of vaccine composition in commercial formulations;
6. Full transparency of all adverse event data in all studies and post-marketing surveillance;
7. Clarification of eligibility and criteria for no-fault vaccine injury payments or compensation;
8. Clarification of nature and extent of government indemnity if manufactures in the event in jury;
9. Public dissemination of extent of naturally acquired (herd) immunity prior to vaccine roll-out;
10. Engagement of due democratic process if a vaccination is imposed.

In case you fail to provide the details of abovementioned issues, it implies that the Govt. treats the public health as a political- and corporative financial- commodity and that the Govt, by issuing or imposing said covid-19 vaccine is breaching the Declaration of Helsinki and the Nuremberg Convention.

Yours faithfully,
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 'Covid-19 vaccine’ risks have these been disclosed?'.

FOI 20/504 is about Pfizer’s vaccine BNT162b2’ effectiveness and safety profile in different subgroups and whether it is a true vaccine. DHSC replied to this FOI by MHRA review on Pfizer’s submitted data on BNT162b2. This reply however is unacceptable and misleading for the following reasons:

1. MHRA review was written in support of Reg 174 (author Pfizer?) and it appears to be a selective rewrite of Pfizer’s script (published in the New England Journal of Medicine [nejm]). Which editors commented that Pfizer’s study was not powered to definitively assess efficacy by subgroup: the point estimates of efficacy for subgroups based on age, sex, race, ethnicity, body-mass index, or the presence of an underlying condition associated with a high risk of Covid-19 complications were inaccurately defined. 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. Pfizer’s claimed 90% effectiveness only applies to the healthy population, whilst to the vulnerable population it is a 30% effectiveness, which applies not to achieved immunity but to reduction of covid19 symptoms. Remaining questions are: Will unexpected safety issues arise when the number grows to millions and possibly billions of people (as only about 20,000 people were in 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? Said nejm editors’ comments and questions have been in the MHRA review; omitted.

2. No existing vaccines have been shown to be effective against infection with any betacoronavirus, the family that includes SARS-CoV-2, which causes Covid-19. As mRNA vaccines are a novelty: the covid-19 vaccine should be rigorous tested and reviewed. Yet MHRA has only reviewed whether Pfizer’s data do confirm Good Laboratorial criteria and that of the WHO which are based on preexisting classic vaccines.

3. According to a scientific principle; MHRA has to proof that H1 >> H0: MHRA claimed 90% 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: 99.997%. (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 >> H1 the question is; 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 (meaning that 255 people will not be immune). Consequently, BNT162b2 fails the criteria to be a vaccine.

4. BNT162b2, as most covid-19 vaccines protocols show; it is only to supress flu symptoms. Yet, the MHRA failed 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.

5. MHRA or Pfizer claims of BNT162b2 effectiveness is based on the rates of: (a) Positive PCR test results, (b) Covid-19 symptoms, (c) Antibody response, (d) Blood titters of induced CD4+ and CD8+ T-cells, and (e) Extrapolating these rates as being durable in the different subgroups. Yet, said parameters have profound biases and flaws. Which are the following:
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. Studies show that the PCR test’s false positive rate is 98%; and a Cambridge study on PCR test showed a 100% false positive rate.
b) Only 1 symptom was used to count a Covid-19 infection; which cannot be a discerning parameter by itself as there is no specific covid-19 symptom.
c) Specific neutralising antibodies against Covid-19 are unknown, as there is no peer reviewed proof that SARS-CoV-2 genome has been fully isolated. For this (as for the PCR test) has been used a synthetic version based on that of other corona viruses; provided by the Wuhan BLS4 Laboratory. And an antibody response does not represent the main protection strength of the immune system: it being the Lymphocytes in the body.
d) Induced CD4+ and CD8+ T-cell were measured for only 2 months. Unknown is to what rate blood titters of these account for the total available CD4+ and CD8+ T-cell or Lymphocytes in the body (e.g. spleen and guts). In average this is about 10% yet this depends 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: *immunosenescence rate drops with age or frailty.
According to said biases, 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.” So, for the MHRA to accept Pfizer’s study results and effectiveness claims unverified; is at least misleading.

6. Pfizer did not test whether its vaccine might cause antibodies against PEG (ALC 0313 & 0159) or a toxicokinetic reaction, or binding antibodies which might cause autoimmune reactions or neurological symptoms, or affect fertility and reproduction. MHRA conclusion regarding the safety profile of BNT162b2 is misleading due to the following:
a) For vaccine producers to insist on blanket indemnification from injuries and deaths; there must be a reason. Compare to other medications; with Pfizer’s data; its vaccine tested for 3 months; MHRA cannot approve said mRNA vaccine to be licenced;
b) Pfizer failed to pre-screen patients for having antibodies against polyethylene glycol (PEG: the compound suspected of triggering allergic reactions). An initial investigation into the allergic reactions experienced by the two UK healthcare workers identified PEG as the likely trigger for those anaphylactic reactions. Anti-PEG antibodies have been detected not only in patients treated with PEG gylated therapeutics, but also in individuals 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.
c) 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.
d) The vaccine mRNA is to trigger an immune response against the covid-19 spike protein which contain syncytin-1 homologous proteins: essential for the formation of the placenta. 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. Yet HMRA fails to advise the NHS to check whether a young woman’s syncytin-1 could be targeted by said vaccine. Further it has to be answered: 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).

The abovementioned 6 points, including Pfizer’s and MHRA biases and flaws, conclude that the basic questions in this FOI about BNT162b2 are not answered. And said 5 points, including said biases and flaws, provide sufficient arguments for the DHSC to retract or dismiss 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 in the meantime; 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/c...

Yours faithfully,
Bartholomeus Lakeman

Dear MHRA Customer Services,
In its internal review the MHRA states that under Section 41 & 42 it is exempt from answering FOI 20/509 regarding AstraZeneca ChAdOx1 nCoV (AZ), whereas it had authorised AZ after this FOI of 3 Dec- 2020. However, MHRA did approve of its study/trial under ISRCTN 15281137 including participants to be inoculated with AZ which started in March 2020 and had its first review on 17 Nov- 2020 supervised by Dr Andrew Pollard (MHRA). And as the UK Govt is a main stakeholder of AZ, it was for sure that MHRA would authorise the administration of AZ. Which it continued to do despite that due to its exceptionally high incidents of harm; a substantial number of countries amended, suspended or withdrew its authorisation for AZ. Further, ISRCTN registry shows in total 33 studies on Covid19 vaccines; all which are still under an assessment stage as these have until now no definite result. Therefore, it is in the public interest that MHRA answers this FOI regarding AZ vaccine.

MHRA states to hold the raw data of the covid vaccines yet applies section 12 to be exempted from releasing said data. However, my FOI was very soon after MHRA had authorised BNT162b2 and so it is most likely that it had the raw data still on its desk or in its PC as one of its most recent documents. As MHRA is under the obligation to facilitate an informed consent, it has to release the full or at least the most essential data concerning the BNT162b2’ content, effectiveness and safety. Yet, in previous emails I pointed out that REG 175 and PAR and the article in NEJM are a selective copy and paste exercise from what Pfizer had provided as what will incite the public to accept the vaccine. As Pfizer expects that its covid vaccine profits will be a manyfold of what it could be fined for fraudulent data, and as its vaccine has a ‘no liability clausal’; Pfizer has no incentive to provide truthful data.

Many scientists have warned that Pfizer’s data is misleading, incomplete and that its raw data is in need of being revised, and scientists have shown that BNT162b2 Absolute Risk Reduction (its effectiveness) is less than 1%. 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 (no previous Covid19 infection). Meaning that 99.7% of the participants might had Antibodies against Covid-19 prior the trial which biased the vaccine effectiveness rate. Studies show BNT162b2’ NNV to be 217 or much higher; meaning that its actual efficacy is less than 1%. And many of the injected became ill with “Covid like symptoms” which were fallaciously labelled as side effects, rather than potential breakthrough infections. Further, Pfizer’s study failed to exclude the ADE harm. Many scientists have warned about -and several studies have proven that all UK approved covid vaccines do circulate in the blood and the capillary system, disrupting the immune system, causing antibody-dependent enhancement (ADE), microthrombus and infertility. Most alarming is that a Spanish research and that of others have shown that the vaccines contain Graphene Oxide (GO) nanoparticles which are electromagnetic, scannable, toxic and can cause blood clotting and death.

All covid vaccines and BNT162b2 RNA are derived from GenBank MN908947.3 which is an in-silico /computerised model estimating for <78% the genome of the real coronavirus spike S glycoprotein. Which is equal to comparing the genome of a human with that of a giraffe. For that reason, said vaccines cannot provide immunity against Covid-19: its efficacy (of 95%) applies only to the reduction of its symptoms. Pfizer’s data on BNT162b2 do not disclose all its excipients, it fails to include pharmacokinetics, biodistribution, genotoxicity and Carcinogenicity and general toxicity con-ducted on humans. Overall, as the EMA remarked: Pfizer’s study fails to meet the Good Laboratory Standard (GLS).

In case MHRA had investigated the ‘covid vaccines’ safety then it would have to disclose the vaccine its biodistribution, to warn that its LNP and mRNA penetrates every organ and to warn against the GO nanoparticles. According to said biodistribution and toxins the MHRA would interpret its yellow card reports and made a tresshold criteria for the vaccine harm. And the MHRA would answer each point of my FOI questions. Either the MHRA did not rigorously investigate said vaccine or it is willingly enforcing the said vaccines’ risks on the public: such as the funder of the covid vaccines stated; it being a method to reduce the world’ population.

Regarding FOI point 7 – 10. In case the covid vaccines are safe, then for its manufactures there would be no need for ‘no liability clausal’. Whereas the MHRA has been accomplished to the ‘no liability clausal’ the MHRA has a candour duty to disclose who is liable to -has to compensate- the ‘vaccines’ harms.

To approve the administration the Covid-19 vaccines -and as every doctor, scientist and civil servant who authorises and constructively imposes such an experimental medical product has to comply to Article 32 of the 1949 Geneva Convention IV and the Nuremberg Code: Whereas: a) All Covid-19 vaccines are ‘de novo’ and in trial phase III and so those being injected with it are in an experiment until end 2022 or beginning 2023; b) MHRA yellow card reports, Euro-vigilance and that of VAERS show that Covid-19 vaccines’ have more reported injuries and deaths and case breakthroughs than all previous vaccines together; c) said vaccine injection and risks are constructively mandatory, in order to regain one’s rights under ECHR (due to a vaccine certificate for employment, travel and social life); d) MHRA failed to rigorously investigate the vaccines’ safety and harm profile, and it has no cut-off criteria concerning the vaccine’s harm.
The abovementioned facts prove there is for the MHRA a case to answer this FOI fully.

Yours sincerely,
Bartholomeus Lakeman