REG 174 for Pfizer COVID-19 mRNA Vaccine BNT162b2 to be corrected

Currently waiting for a response from Medicines and Healthcare products Regulatory Agency, they should respond promptly and normally no later than (details).

Bartholomeus Lakeman

Dear Medicines and Healthcare products Regulatory Agency,

In REG 174 for Pfizer COVID-19 mRNA Vaccine BNT162b2; under 5.2 Pharmacokinetic properties it states "Not Applicable"
Herewith does MHRA suggest that the novel mRNA COVID vaccines behave like “traditional” vaccines and the vaccine spike protein — responsible for infection and its most severe symptoms — would remain mostly in the vaccination site at the shoulder muscle.

However, there is a Pharmacokinetic property study done “2.6.5B Pharmacokinetics: Organ distribution. Test Article Labelled LNP mRNA formulation containing ALC-0315 and ALC 0159. Report number 185350” see https://www.docdroid.net/xq0Z8B0/pfizer-...
This Japanese data shows that the spike protein of the Pfizer ‘vaccine’ gets into the blood where it circulates for several days post-vaccination and then accumulated in organs and tissues including the spleen, bone marrow, the liver, adrenal glands, and in the ovaries.
Once in circulation, the spike protein can attach to specific ACE2 receptors that are on blood platelets and the cells that line blood vessels. This can either cause platelets to clump, and that can lead to clotting. It can also lead to bleeding.

This study looked at the vaccine distribution (as of ALC 0315/0159 plasma level) in about 45 organs were measured over time intervals of 15 min, 1hr, 2hr, 4hr, 8hr, 24hr and 48 hr. Pharmacokinetic studies have also been done over the days up to a 9 days period.

The study shows that in many organs the vaccine plasma level keeps rising after 2 days (concentration (ug lipid equivalent/g [or mL]: males and females combined) (ranking) Liver (24.3); Spleen (23.4); Adrenaline glands (18.2); Ovarium (12.3); Bone marrow (3,77); Pancreas (0.6); Uterus (0.5); Testes (0.3); Eyes (0.1)
To note is that the Adrenaline glands being affected by high plasma levels will cause an overall organ stress; which in turn affects particular the immune and the nervous system.

Compare that to Pfizer vaccine's Adverse Drug Reaction (see yellow cards of 21 May) in related organs (ranking in % of vaccine doses): Nervous system disorders 0.14%; Muscle & tissue disorders 0.1%; Gastrointestinal disorders 0.08%; Skin disorders 0.06%; Respiratory disorders 0.035%; Eye disorders 0.012%; Blood disorders 0.026%; Infections 0.02%; Cardiac disorder 0.01%; Reproductive & breast disorder 0.0116%

Further it is shown that the COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk: babies got Thrombotic Thrombocytopenic Purpura and died.

Moreover, there is a coloration between the Pharmacokinetics and the vaccine injuries.
Therefor significant changes have to be made in Reg 174 or better due to the seriousness of the found injuries; it should be withdrawn.

Question: In case MHRA does (according to the above findings) not amend or withdrawn its current version: please state why and which study supports such reasoning

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

Visible links
1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

 

 

Our Ref: FOI 21/611

       

Dear Bartholomeus Lakeman,

       

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

Thank you for your enquiry which we received on 2 June 2021.

  

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.

 

Please be aware that we publish FOIs replies and these are redacted and
are located on our website at the following link below.

[1]https://www.gov.uk/government/collection...

        

Kind Regards,

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

 

 

 

show quoted sections

Bartholomeus Lakeman

Dear MHRA Customer Services,
Please do integrate in our Ref: FOI 21/611 the following information:

European Medicines Agency (EMA) reviewers revealed Pfizer didn’t thoroughly examine biodistribution and pharmacokinetics issues relating to its vaccine before submitting the vaccine to the EMA. Its reviewers shared with the HMRA this explicit admission: “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.”
In fact, in key studies — called biodistribution studies, which are designed to test where an injected compound moves throughout the body — the time course of its absorption, bioavailability, distribution, metabolism and excretion travels in the body, and which tissues or organs it accumulates in — Pfizer did not use the commercial vaccine (BNT162b2) but instead relied on a “surrogate” mRNA that produced the luciferase protein.
Regulatory documents also show Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies of its vaccine, as key studies did not meet good laboratory practice (GLP). GLPs, are of paramount importance for quality and ultimately for patient safety. If such important steps are skipped, the risk-benefit analysis would need to be compelling.”
Additionally, the EMA document states, “Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute rather non-specifically to several organs such as spleen, heart, kidney, lung and brain. In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern.” This EMA observation corresponds with a growing number of adverse events and aligns with data TrialSite obtained through FOIA showing concentrations of LNP-formulated RNAs in the spleen, ovaries, other tissues and organs.
A quick review the Toxicology Section (2.3.3) of the EMA Assessment Report on Comirnaty (BNT162b2) issued on 19 Feb. 2021, raises concerns about data applicability of preclinical study findings to clinical use: “To determine the biodistribution of the LNP-formulated modified mRNA (modRNA), the applicant did study distribution of the modRNA in two different non-GLP studies, in mice and rats, and determined the biodistribution of a surrogate luciferase modRNA. Thus, one might question the validity and applicability of non-GLP studies conducted using a variant of the subject mRNA vaccine. “In addition, no genotoxicity data were provided to EMA [& to MHRA].”

Pre-clinical studies showing BNT162b2’s active part (mRNA-lipid nanoparticles) — which produce the spike protein — did not stay at the injection site and surrounding lymphoid tissue as scientists originally theorized, but spread widely throughout the body and accumulated in various organs, including the ovaries and spleen. Research suggests this could lead to the production of spike protein in unintended places, including the brain, ovaries and spleen, which may cause the immune system to attack organs and tissues resulting in damage, and raises serious questions about genotoxicity and reproductive toxicity risks associated with the vaccine.

Whilst MHRA REG 174 (on BNT162b2) states that the studies performed and submitted by Pfizer all fulfilled the GLP standards: they were actually non-GLP. Moreover, MHRA provided Pfizer an exception to this GLP regulatory rule: despite that BNT162b is based on a radically new life science-based technology, and that Pfizer having been fined several times for being dishonest in the data they supplied.
Now that the MHRA is explicitly informed about Pfizer having withheld, forged and frauded essential GLP data concerning its vaccine biodistribution and pharmacokinetics; MHRA’ conclusion that BNT162b is safe is false. The MHRA should interpretate that its Adverse Drug Reaction results on its yellow card report to be related to BNT162b2’ biodistribution and pharmacokinetics.
Whereas Pfizer’s vaccine BNT162b’s risk-benefit analysis is negative; therefor should BNT162b’ Emergency Use Authorization approval be withdrawn.
Yet if the MHRA does not do make such interpretation and withdraw: then what are MHRA’ reasons?

Yours sincerely,
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

Visible links
1. https://www.gov.uk/government/collection...