Bartholomeus Lakeman

Dear Department of Health and Social Care,
Under FOIA 2002 and the Nuremberg Code (Art 7 of the United Nations International Covenant on Civil and Political Rights (1966) you are asked to provide the data of the following issues:
1. ‘REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS’. As it contains neither a logo of DHSC, MHRA nor an author: Who is its author, and when was it dated;

2. The data in support of above document REG 174: To what degree have these been reviewed by (a group of) independent scientists;

3. Pfizer’s 90% effectiveness rating: Does that refer to: Active immunisation against SARS-CoV-2 virus or to the rate of suppressing Covid-19 symptoms;

4. The data proving that Pfizer’s BNT162b2 Actively immunised against SARS-CoV-2 virus;

5. BNT162b2' Number Needed to Vaccinate (NNTV), and why is that small enough? Considering its ‘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) then NNTV = 1/0.0039 = 256;

6. What is the number of those who completed the BNT162b2 Trail? If it’s ±10,000: why would that ensure that it will be safe to be implemented on the whole UK population;

7. How many of those enrolled in BNT162b2 trail were known with an allergy, and how many died?

8. Reasons for not to screen for and monitor the levels of anti-PEG antibodies in blood before and during treatment with BNT162b2? In consideration of the following facts:
a) BNT162b2 uses technologies of mRNA, polyethylene glycol (PEG) & Lipid-Nanoparticles (LNP);
b) ±70% of people develop antibodies against PEG. If high-titer anti-PEG Abs are present in blood, even people without known allergies may have severe hypersensitivity reactions when receiving PEG-containing therapeutics for the first time: https://www. ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=24932437
c) PEG & LNP have the potential to produce systemic side effects, contributing to immune reactions, infusion reactions, complement reactions, opsonization reactions, as by ARDs within liver pathways or degradation of the mRNA or the LNP;
d) Approximately 8% (6 million) of UK population has highly elevated levels of anti-PEG antibodies;
e) Re-exposure to PEG-containing drugs (e.g., vaccine) may greatly increase adverse effects due to B cell memory of anti-PEG Abs.

9. Reasons for not to rule out that the vaccine triggers an immune reaction against syncytin-1? Considering BNT162b2 is expected to produce antibodies against SARS-CoV-2’ spike proteins which contain syncytin-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 rendering a woman to be permanently infertile.

Yours faithfully,
Bartholomeus Lakeman

Bartholomeus Lakeman

Dear Department of Health and Social Care,
My apologies for a possible mistake in question 6: The number of those who completed the BNT162b2 Trail. According to Pfizer's own data, of the vaccinated group 18555 completed the trail.
Yet, to note is that Pfizer has been taken to court or fined several times for data falsification.
Hopefully the DHSC will seek for the independent review of their data.

Yours faithfully,
Bartholomeus Lakeman

FreedomofInformation, Department of Health and Social Care

Dear Dr Lakeman,

Thank you for your email.

The Freedom of Information Act only applies to recorded information such as paper or electronic archive material. As your correspondence asked for "reasons" rather than requesting recorded information or documentation, it did not fall under the provisions of the Act. It will be answered as general correspondence in due course. Please note that asking for "data" does not make a question a valid FOI request.

You may find it helpful to refer to the Information Commissioner’s ‘How to access information from a public body’ webpage. It includes advice for requesters on how to word requests to get the best result. Future requests are less likely to be refused if framed in accordance with these guidelines.

https://ico.org.uk/your-data-matters/off...

Yours sincerely,

FOI Team
Department of Health and Social Care

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Bartholomeus Lakeman

Dear FreedomofInformation,
This FOI #712098, as that of 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 FOI 20/504 by MHRA review on Pfizer’s submitted data on BNT162b2. This reply and that of DHSC to FOI #712098 are however, 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 criteria of Good Laboratorial and of the WHO; which are based on pre-existing 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: These 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 toxicokinetic reaction, and/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 approved 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 have to be answered in its details. Otherwise 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 for that DHSC has to put the issuing of said vaccine on halt.

Yours sincerely,
Bartholomeus Lakeman

FreedomofInformation, Department of Health and Social Care

Dear Dr Lakeman,

Thank you for your email.

As you are aware, your correspondence asked for general information and an opinion rather than requesting recorded information or documentation. It therefore did not fall under the provisions of the Act. It has therefore been answered as general correspondence.

Your email below is not a valid FOI request either and will be answered as general correspondence in due course. Any further correspondence on this topic from you that is not a specific FOI request will be logged, but may not receive a reply.

Yours sincerely,

FOI Team
Department of Health and Social Care

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Bartholomeus Lakeman

Dear FreedomofInformation,

For the Govt. /DHSC to award a contract; it has to do so under the rules, terms and principles of various regulations, e.g., Public Contract Regulations 2015 (PCR), Public Law, Equal Duty and Transparency, HM Treasury Green Book, Art 107 Treaty of Functioning of the European Union (TFEU). Due to said obligation; the Govt. /DHSC has to have a record of the conditions, the reasons, and the weighing up of its criteria for deciding to award a contract.

Said legal obligations are there to prevent that the Govt awards contracts whilst treating the Public need as a political- or commercial- commodity. The degree by which the public health has been affected by the Covid-19 crisis; defines the state of a nation’ public health service: which goes parallel with in how far the Govt. has awarded the (health service) contract in good candour.

It appears that under the Corona Act 2020, the Govt. /DHSC awarded contracts to various private companies with whom personal members it has such a pre-existing relationship that the Govt. /DHSC decided to award said contracts whilst discharging themselves (without public consent) from their obligations to the rules, terms and principles of said regulations. Contracts which involve about 11 billion pound which have been credited by -and to the detriment of- the taxpayers.

Examples of such private companies are Abingdon Health, UK Rapid Test Consortium (UK-RTC), BBI Solutions, Oxford University, CIGA Healthcare, Ayanda Capital, AstraZeneca, GKS(B), and Pfizer. It appears that many of these contracts, made under the exemption of said obligation, resulted (or are likely to result) in the purchase of products which are unfit for purpose e.g., PPE, PCR tests, Antibody tests, and the novelty vaccines. Of said purchased products there was no independent assessment or a verification. Mistakes which are to be anticipated when said legal obligations are skipped: which the Govt /DHSC is seeking to obscure by not answering certain critical FOI requests e.g., FOI #712098 and in FOI 20/504.

It has to be assed whether Pfizer’s vaccine is also purchased by said illegal manner and its related mistake. The CDC published, within the first week of the vaccination campaign that said Vaccine’s ADR (unable to work and in need of health care, e.g., hospital treatment) is between 0.25 - 1% of the working population. Compare this with the WHO calculated 0.1% mortality rate of coivd-19 which include mainly those over 75 yrs. of age. It rises the suspect that the DHSC has awarded Pfizer a contract without it having on record the details of an independent assessment or a verification of BNT162b2’ effectiveness and safety profile.

In case the DHSC refuses or fails to answer the detailed queries in this FOI about the quality and the risks of this novelty vaccine: said failure is DHSC confirmation of the above-mentioned illegal practice.

Yours sincerely,
Bartholomeus Lakeman

Bartholomeus Lakeman

Dear FreedomofInformation,
For the Govt. /DHSC to award a contract; it has to do so under the rules, terms and principles of various regulations, e.g., Public Contract Regulations 2015 (PCR), Public Law, Equal Duty and Transparency, HM Treasury Green Book, Art 107 Treaty of Functioning of the European Union (TFEU). Due to said obligation; the Govt. /DHSC has to have a record of the conditions, the reasons, and the weighing up of its criteria for deciding to award a contract.

Said legal obligations are there to prevent that the Govt awards contracts whilst treating the Public need as a political- or commercial- commodity. The degree by which the public health has been affected by the Covid-19 crisis; defines the state of a nation’ public health service: which goes parallel with in how far the Govt. has awarded health service contract in good candour.

However, it appears that under the Corona Act 2020, the Govt. /DHSC awarded contracts to various private companies with whom personal members it has such a pre-existing relationship that the Govt. /DHSC decided to award said contracts whilst discharging themselves (without public consent) from their obligations to the rules, terms and principles of said regulations. Contracts which involve about 11 billion pound which have been credited by the taxpayers who have to suffer grave injuries, due to the Corona Act and its private contracts.

Examples of such private companies are Abingdon Health, UK Rapid Test Consortium (UK-RTC), BBI Solutions, Oxford University, CIGA Healthcare, Ayanda Capital, AstraZeneca, GKS(B), and Pfizer. It appears that many of these contracts, made under the exemption of said obligation, resulted (or are likely to result) in the purchase of products which are unfit for purpose e.g., PPE, PCR tests, Antibody tests, and novelty vaccines. Of said purchased products there was no independent assessment or a verification. Mistakes which are to be anticipated when said legal obligations are skipped: Mistakes made under illegal circumstances which the Govt /DHSC is seeking to obscure by not answering certain critical FOI requests e.g., FOI #712098 and in FOI 20/504.

It has to be assed whether Pfizer’s vaccine is also purchased by said illegal manner and as a mistake. The CDC, within the first week of the vaccination campaign, published that said Vaccine’s ADR (unable to work and in need of health care, e.g., hospital treatment) is between 0.25 - 1% of the working population. Compare this with the WHO calculated 0.1% mortality rate of coivd-19 which include mainly those over 75 yrs. of age. It rises the suspect that the DHSC has awarded Pfizer a contract without it having on record the details of an independent assessment or a verification of BNT162b2’ effectiveness and safety profile.
In case the DHSC refuses or fails to answer the detailed queries in this FOI about the quality and the risks of this novelty vaccine: said failure is DHSC confession of having practiced above-mentioned illegal contract award with its related harm to the public.

Yours sincerely,
Bartholomeus Lakeman

Department of Health and Social Care

Our ref: DE-1281534
 
Dear Mr Lakeman,
 
Thank you for your correspondence of 10 and 21 December about the Pfizer
COVID-19 vaccination. I have been asked to reply.

The Freedom of Information Act only applies to recorded information such
as paper or electronic archive material.  As your correspondence asked for
general information, rather than requesting recorded information or
documentation, it did not fall under the provisions of the Act. There is
no obligation under the FOI Act for public authorities to create new
information.
Yours sincerely,
 
Aymee Smith
Ministerial Correspondence and Public Enquiries
Department of Health and Social Care
 

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Bartholomeus Lakeman

Dear Department of Health and Social Care,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Department of Health and Social Care's handling of my FOI request 'Pfizer’s vaccine BNT162b2’ data verification'.

On 10 Dec-, when I raised questions about Reg 174 and MHRA review of Pfizer’s COVID-19 vaccine, all that was in the public domain were its study protocols and a few press releases. Now, two journal publications and around 400 pages of summary data are available in the form of multiple reports presented by and to the FDA prior to the agency’s emergency authorization of said mRNA vaccine. In the BMJ 4 Jan. 2021 Peter Doshi outlines new concerns about the trustworthiness and meaningfulness of the reported efficacy results.

1) Efficacy:
All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR confirmed COVID-19 cases, split 8 to 162 between vaccine and placebo groups. But these numbers were dwarfed by a category of disease called “suspected COVID-19”—those with symptomatic COVID-19 that were not PCR confirmed. According to FDA/MHRA review on Pfizer’s vaccine, there were “3410 total cases of suspected, but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”
With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed, this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing COVID-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (19% = 1 –(8+1594)/(162+1816) far below the 50% effectiveness threshold for authorization set by regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (29% = 1 – (8 + 1594 – 409)/(162 + 1816 – 287).

2) Aetiology:
If many or most of these suspected cases were in people who had a false negative PCR test result, this would dramatically decrease vaccine efficacy. But considering that influenza-like illnesses have always had myriad causes—rhinoviruses, influenza viruses, other coronaviruses, adenoviruses, respiratory syncytial virus, etc.—some or many of the suspected COVID-19 cases may be due to a different causative agent.
But why should aetiology matter? If those experiencing “suspected COVID-19” had essentially the same clinical course as confirmed COVID-19, then “suspected plus confirmed COVID-19” may be a more clinically meaningful endpoint than just confirmed covid-19.
However, if confirmed COVID-19 is on average more severe than suspected COVID-19, we must still keep in mind that at the end of the day, it is not average clinical severity that matters, it’s the incidence of severe disease that affects hospital admissions. With 20 times more suspected covid-19 than confirmed covid-19, and trials not designed to assess whether the vaccines can interrupt viral transmission, an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants—seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic.
There is a clear need for data to answer these questions, but Pfizer’s 92-page report didn’t mention the 3410 “suspected COVID-19” cases. Nor did its publication in the New England Journal of Medicine.

3) The 371 individuals excluded from Pfizer vaccine efficacy analysis:
Another reason we need more data is to analyse an unexplained detail found in a table of FDA /MHRA review of Pfizer’s vaccine: 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance between randomized groups in the number of these excluded individuals: 311 from the vaccine group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.)
What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group? The FDA/ MHRA review doesn’t say, and these exclusions are difficult to even spot in Pfizer’s report and journal publication.

4) Fever and pain medications, unblinding, and primary event adjudication committees:
Concern have been raised about the potential confounding role of pain and fever medications to treat symptoms. Such drugs could mask symptoms, leading to under detection of COVID-19 cases, possibly in greater numbers in people who received the vaccine in an effort to prevent or treat adverse events. However, it seems their potential to confound results was fairly limited: although the results indicate that these medicines were taken around 3–4 times more often in vaccine versus placebo recipients their use was presumably concentrated in the first week after vaccine use, taken to relieve post-injection local and systemic adverse events. But the cumulative incidence curves suggest a fairly constant rate of confirmed COVID-19 cases over time, with symptom onset dates extending well beyond a week after dosing.
That said, the higher rate of medication use in the vaccine arm provides further reason to worry about unofficial unblinding. Given the vaccines’ reactogenicity, it’s hard to imagine participants and investigators could not make educated guesses about which group they were in. The primary endpoint in the trials is relatively subjective making unblinding an important concern. Yet neither FDA/MHRA nor the companies seem to have formally probed the reliability of the blinding procedure, and its effects on the reported outcomes.

5) Nor do we know enough about the processes of the primary event adjudication committees that counted COVID-19 cases. Were they blinded to antibody data and information on patients’ symptoms in the first week after vaccination? What criteria did they employ, and why, with a primary event consisting of a patient-reported outcome (COVID-19 symptoms) and PCR test result, was such a committee even necessary? It’s also important to understand who was on these committees. While Moderna has named its four-member adjudication committee—all university-affiliated physicians—Pfizer’s protocol says three Pfizer employees did the work. Yes, Pfizer staff members.

6) Individuals with a known history of SARS-CoV-2 infection or previous diagnosis of COVID-19 were excluded from Moderna’s and Pfizer’s trials. But still 1125 (3.0%) and 675 (2.2%) of participants in Pfizer’s and Moderna’s trials, respectively, were deemed to be positive for SARS-CoV-2 at baseline.
Vaccine safety and efficacy in these recipients has not received much attention, but as increasingly large portions of many countries’ populations may be “post-COVID,” these data seem important—and all the more so as the Govt, DHSC, MHRA recommends offering vaccine “regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection.” This follows on from the agency’s conclusions, regarding Pfizer’s vaccine, that it had ≥92% efficacy and “no specific safety concerns” in people with previous SARS-CoV-2 infection.
However, Pfizer apparently reported 8 cases of confirmed, symptomatic COVID-19 in people positive for SARS-CoV-2 at baseline (1 in the vaccine group, 7 in the placebo group, using the differences between Tables 9 and 10).
But with only around four to 31 reinfections documented globally, how, in trials of tens of thousands, with median follow-up of two months, could there be nine confirmed COVID-19 cases among those with SARS-CoV-2 infection at baseline? Is this representative of meaningful vaccine efficacy, as MHRA seems to have endorsed? Or could it be something else, like prevention of COVID-19 symptoms, possibly by the vaccine or by the use of medicines which suppress symptoms, and nothing to do with reinfection?

7) We need the raw data:
Addressing the many open questions about these trials requires access to the raw trial data. But no company seems to have shared data with any third party at this point.
Pfizer says it is making data available “upon request, and subject to review.” This stops far short of making data publicly available, but at least leaves the door open. How open is unclear, since the study protocol says Pfizer will only start making data available 24 months after study completion.
Things may be no different for the Oxford/AstraZeneca vaccine which has pledged patient-level data “when the trial is complete.”.
The European Medicines Agency and Health Canada, however, may share data for any authorized vaccines much earlier. EMA has already pledged to publish the data submitted by Pfizer on its website “in due course,” as has Health Canada.

8) Yet in the meanwhile a relative high percentage of those who have been inoculated with said mRNA vaccine have been exposed or will suffer or die from said vaccine ADRs without being protected from the covid19 virus.

Due to abovementioned 8 issues it is in the public interest that DHSC and MHRA do answer this FOI.

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

Yours faithfully,
Bartholomeus Lakeman

FreedomofInformation, Department of Health and Social Care

Dear Dr Lakeman,

As you have been advised numerous times, your correspondence has not been handled as a freedom of information request and is therefore not subject to an internal review. Should you wish to complain about the response you received, you may do so at the following link: https://contactus.dhsc.gov.uk.

Should you wish to submit an FOI request, you may find it useful to refer to the Information Commissioner’s guidance on communicating effectively with public authorities at: https://ico.org.uk/your-data-matters/off....

Yours sincerely,

FOI Team
Department of Health and Social Care

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