Covid-19 vaccine’ risks have these been disclosed?

Bartholomeus Lakeman made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

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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,

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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency


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Our Ref: FOI 20/504

Dear Bartholomeus Lakeman,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 2 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

1 Attachment

  • Attachment

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

    6K Download View as HTML

 
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]
 
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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 '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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Bartholomeus Lakeman,

Thank you for your email.

We confirm that an internal review is being carried out on FOI 20/504.

Please note the deadline for reply for Internal Reviews is 20 working days and for this Internal Review the deadline will be 21 January 2021.

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

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