Did Pfizer Do Any Safety Studies for mRNA Injections?

IN COVID-19 Vaccines
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A pharmaceutical data analyst dove into the Pfizer preclinical studies released by the FDA. This is what she found:

Recently, some of the documents used by FDA to approve Pfizer’s mRNA platform based Covid-19 Vaccine have been obtained via Freedom or Information lawsuits, overcoming FDA and Pfizer’s motions to keep this information secret for 75 years. One package of these documents, titled “BNT162b2 Module 2.4. Nonclinical Overview” (466 pages) was obtained by Judicial Watch from HHS. (01)

In regards to the documents that Pfizer and FDA were trying to keep secret for 75 years (Pfizer’s preclinical studies that were recently released by FIOA lawsuit) – here is this pharmaceutical data analyst’s problems that she found:

“The FDA should be disbanded after this.”

Did Pfizer Do Any Safety Studies for mRNA Injections? Part 1 | Part 2 | Part 3 | Part 4 (02)

Who are we listening to in the video?

  • Sasha Latypova built two businesses in pharma over 20+ years, supporting companies like Pfizer and J&J in running clinical trials.
  • She sold both businesses, and in 2014, retired to spend more time on the ski slopes. Fast-forward to 2020, and SARS-CoV-2 drags her back into an industry she thought she had waved goodbye to forever. 
  • She has more than two decades of experience in pharmaceutical and medical device R&D. She specialized in collecting and analyzing data from global clinical trials.
Review

  1. POWERPOINT : Pfizer Biodistribution and Toxicolocy Non-clinical Studies
  2. DOC : Did Pfizer perform adequate safety testing for its Covid-19 mRNA Vaccine in Preclinical Studies?
  3. PDF : Pfizer non-clinical studies data released by FDA
  4. CATALOG : Pfizer documents released so far

Extracts from her report (download full report above & see screenshots below for closer look):

The rushed “warp speed” development and approval of completely novel Covid-19 mRNA and DNA vaccines pushed on millions of people has resulted today in millions of reported injuries and thousands of deaths according to public health databases such as VAERS (US), EudraVigilance (EU), Yellow Card (UK) and others.

Here is a review of some of the publicly available documents on Pfizer’s non-clinical development program and points to its deficiencies, omissions and gaps that were clearly visible, yet never questioned by the regulators or other health authorities.

The cursory nature of the entire preclinical program can be briefly summarized as:

“we did not find any safety signals because we did not look for them”.

The omissions of standard safety studies and glaring scientific dishonesty in the studies that were performed are so obvious that they cannot be attributed to the incompetence of the manufacturers and regulators. Rather, the question of wilful negligence should be raised.

Goal in this review is to illustrate the complete breakdown of the previously known to be rigorous ethical drug development process as well as the shocking negligence on the part of the regulatory agencies that are supposed to keep the pharmaceutical manufacturers honest. It turns out that both were highly dishonest and pushed an entirely novel technology and product on millions of people without a single well designed safety assessment.

In summary, she has identified the following:

Finding 1: Pfizer relied on studies for different versions of its product and different formulations of the lipid nanoparticle (LNP) delivery platform. The program did not include a comprehensive test of all components of the final product.

Finding 2: The safety of the vaccine’s mRNA active ingredient was never studied!

Finding 3: Pfizer claimed absence of potential for enhanced covid illness in a study where no covid illness was observed.

Finding 4: CDC, FDA and Pfizer lied about “vaccine staying in the injection site”.

Finding 5: Pfizer skipped major categories of safety testing altogether.

Finding 6: Pfizer used dishonest and self-serving interpretation of regulatory guidelines to avoid routine safety testing.

Screenshots & comments:

(Click to expand/toggle and click image to open fullscreen in lightbox)

Monkey Study Fraud

  • Pfizer chose the animal model that does not develop covid illness from Sars-Cov-2 even when it’s sprayed in their noses and throats.
  • The monkeys had viral RNA load but no covid-19 illness, neither in immunized nor in placebo control groups.
  • Pfizer made the conclusion that the immunization is successful/confers protection and there is no ADE. Science!

Rat Studies done with different product

  • What are the differences between V8 and V9? We later learn that none are the same as the ultimately licensed product.

Used Irrelevant WHO Ref to evade Safety studies

  • mRNA injections do not meet the WHO 2005 definition of the vaccine, and therefore WHO guidelines for vaccines from 2005 are irrelevant.

Injected substance distributes to the liver, spleen, ovaries

  • Pfizer, CDC and FDA lied repeatedly about “vaccine staying in the injection site”.
  • The substance is clearly getting distributed into the liver, spleen, ovaries and other organs.
  • Yet, no safety pharmacology or drug-drug interactions studies were done and therefore we have no knowledge of the safety margins!
  • E.g. liver is a primary site for observing safety issues: compromise of the liver as a metabolizing organ for drugs with resulting drug-drug interactions and, also direct hepatic cytotoxicity.

Using Novel Excipients without standard regulatory toxicokinetic studies

  • No GLP methods of analysis for toxicokinetic studies of the completely novel components of BNT!
  • This means we cannot ever be certain of what those components are, how to detect them, in what quantities they appear, what metabolites they produce, etc. etc.
  • “Qualified LC/MS method” is a fancy way of describing a non-validated non-GLP method – a “quick and dirty” methodology that is acceptable only for early feasibility studies.
  • The non-GLP studies of completely novel excipients are not acceptable by FDA guidelines in general, even for Phase II/III studies, much less for approval.
  • This is an example of FDA ignoring its own guidelines.

Rat Study - Large quantity of excipients ended up in the liver

  • Pfizer was expecting the injections to be reaching blood stream directly.
  • CDC specifically issued recommendation to providers to NOT aspirate the needle, increasing the probability of this.
  • The excipients are getting to the liver in large quantities, yet we have no safety pharmacology studies!

Irrelevant WHO refs (again) & substance goes to the liver

  • This product does not meet the definition of a vaccine in 2005 or 2014.
  • The injected substance enters blood stream and goes to the liver.

Proposed - Expected (terminology raises questions)

  • Is this a hypothesis only?

No Pharmacokinetic Drug Interaction studies were conducted

  • Why was this allowed?

Reproductive tox study used different product than the one that was EUA granted

  • The reproductive tox study in rats was non-GLP compliant, ie not suitable for full FDA approval or for clinical phase of product development – that’s probably why Pfizer’s protocol required contraception for persons of reproductive potential. CDC however advertised this product directly to pregnant women even before the EUA was granted.
  • 2 variants of product (V8 and V9) – none of which are the ultimately “authorized” or licensed product! The V8 is “pretty close” though, so we just have to take Pfizer’s word for it?
  • Note that the reproductive tox study was done with V9 version, not even “pretty close” to the product that was licensed.
  • This is fraud, as all studies must be done with exactly the same product that is being reviewed and approved by the FDA.

No Genotoxicity or Carcinogenicity was done

  • WHO guidelines from 2005 are not applicable to mRNA products which are completely novel technology and did not exist back then.
  • Based on the recent Swedish study it was demonstrated that mRNA does incorporate into DNA via reverse transcription.

Go to https://howbadismybatch.com/ or https://howbad.info/

3 More Videos goes in-depth into the above findings:

Detailed Review

Did Pfizer Do Any Safety Studies For Mrna Injections?

Part 2 ‘DID PFIZER DO ANY SAFETY STUDIES FOR MRNA INJECTIONS?’

Video Description: (March 23, 2022)

This is a more in-depth look of previously uncovered lack of safety studies with discussion of applicable regulatory guidelines. Pfizer used self-serving, dishonest interpretation of regulatory requirements to give themselves a blanket waiver for any reasonable safety testing. This resulted in massive numbers of deaths immediately following the injections rollout in 2021. Please visit www.howbad.info to learn more.

Correction: there are 2 versions of the product, V8 and V9 mentioned in the package of documents. Pfizer states that V9 is the final vaccine candidate. Specifically that it is BNT162b2 (V9). I am still investigating the issue of multiple versions of products being included in various stages of development. For example, I already found that in the Phase I/II human clinical trial Pfizer used BNT162b1 (not BNT162b2 as they claim being final vaccine candidate). This is extremely concerning and not allowed practice under the same IND (Investigational New Drug) application.

Note: some slides at the end of the presentation without voice recording – these are relevant but I will discuss them in another video. They got accidentally added.

Pharmacokinetics

Part 3 ‘PHARMACOKINETICS’

Video Description: (March 26, 2022)

This is the 3rd installment of discussion about Pfizer Non-Clinical Studies used by FDA to approve the product. We are focusing on Pharmacokinetics, a branch of science studying the distribution of drugs/biologics through the body, the metabolism and clearance and the implications for product safety. Some important relevant material about what Pfizer knew about risks of adverse events at the time of clinical trials can be found here: https://www.icandecide.org/ican_press/pfizers-own-informed-consent-documents-undermine-fda-and-cdcs-cries-of-safe-and-effective/

Correction: there are 2 versions of the product, V8 and V9 mentioned in the package of documents. Pfizer states that V9 is the final vaccine candidate. Specifically that it is BNT162b2 (V9). I am still investigating the issue of multiple versions of products being included in various stages of development. For example, I already found that in the Phase I/II human clinical trial Pfizer used BNT162b1 (not BNT162b2 as they claim being final vaccine candidate). This is extremely concerning and not allowed practice under the same IND (Investigational New Drug) application.

Bait/switch and Lie about Results

Part 4 ‘BAIT/SWITCH AND LIE ABOUT RESULTS’

Video Description: (April 2nd, 2022)

This is the final installment of the series about Pfizer Non-Clinical Program. I am including a more detailed discussion about biodistribution and toxicology results. Putting the scope of the human tragedy in context, I am adding histopathology slides from Dr. Burkhard from autopsies of vaccinated people. https://swprs.org/covid-vaccine-injuries-the-german-pathologists-findings/

Had Pfizer conducted real safety studies, these slides would have been from rats and this product would not have been approved. Now we have thousands of dead people, and millions of horrific often permanent injuries due to this fraudulently “approved” product.

(I may transcribe or take notes of these videos at a future date (way too many tabs open right now and too much going on). The contents are important to refer back to in many different discussions that we have when providing evidence to people who just can’t believe this is happening. ~ Penny)

Team Enigma

Team Enigma is a group of independent researchers analyzing government vaccine databases, including VAERS as well as ones in Europe, Australia, and Japan. The researchers are anonymous except for Sasha. Team Enigma researchers, along with Craig Paardekooper (Telegram and Bitchute), add new database information daily to the vaccine toxicity lookup site howbad.info.

Team Engima researcher Alexandra “Sasha” Latypova says widely varying vaccine batch toxicity registered in the US Vaccine Adverse Event Reporting System (VAERS) is real despite the presence of many data artefacts in batch numbers.

Sasha has two video presentations on batch toxicity, here and here.

I’ve also done a couple of blog posts about this, here and here.

She says the worst US vaccine batches (lots) have:

  • Over 600 serious adverse events registered per lot
  • Over 5,000 overall adverse events registered per lot

See substacks about Sasha’s findings:

See also:

Australian Medical Network – Open Letter To Atagi & TGA – a year in the making – a long list of concerns from Australian health professionals, including the topics on this post.

See also:

BMJ Rapid Response to Novel Excipients / Pharmacokinetic studies

BMJ Rapid Response “Re: The EMA covid-19 data leak, and what it tells us about mRNA instability” referring to both the leaked EMA emails and to the point above in regards to Novel Excipients and “No Pharmacokinetic Drug Interaction studies were conducted”

Novel Excipients and Pharmacokinetic studies

15 March 2021

Dear Editor

Reading this important article has reminded me of a concern I had when reading what the MHRA’s Public Assessment Report [1] on the Pfizer/BioNtech vaccine said about the lipid nanoparticles used as excipients – ALC-0315 and ALC-0159.

They are novel excipients (at least in UK-authorised medicinal products) and the justification for not having conducted pharmacokinetic (PK) studies is that they “are generally not considered necessary to support the development and licensure of vaccine products for infectious diseases (WHO, 2005; WHO, 2014)”.

But on reading WHO, 2005 – which is a reference to WHO Guidelines on nonclinical evaluation of vaccines [2]- I see that PK studies are not normally needed but should be considered on a case-by-case basis (para 4.2.6) ), and toxicity studies should be performed where new excipients (and preservatives) are used for which no toxicological data exist (para 5.2).

I also note that the still extant EMA 2006 guidance [3] states “Pharmacokinetic studies are usually not required for vaccines. However, such studies might be applicable when new delivery systems are employed or when the vaccine contains novel adjuvants or excipients. The need for PK studies and their design should be considered on a case by case basis and it is recommended that applicants should obtain scientific advice from EU Competent Authorities” (para 4.1). The 2006 guidance is being revised, and this text is missing from the current draft revised version [3].

I would have expected therefore at least an explanation as to why PK studies were not considered necessary.

I also see that the EMA’s Public Assessment Report [4] states that in January 2021 (and April 2021) “additional information about the synthetic process and control strategy for” ALC-0315 and ALC-0159 “should” be provided by BioNTech, with final reports in July 2021, in order to “confirm the purity profile and ensure comprehensive quality control and batch-to-batch consistency throughout the lifecycle of the finished product”.

I have no pharmacological expertise, but it seems to me that an explanation should be given as to why PK studies were not considered necessary, and the additional information that was due to be provided in January 2021 should be disclosed, along with the April and July updates when provided. The EMA should also explain why paragraph 4.1 of its 2006 guidance has been dropped from its draft revised guidance.

Yours sincerely,

Peter E. Roderick
Principal Research Associate
Newcastle University
Population Health Sciences Institute

  1. MHRA Authorisation for Temporary Supply BNT162b2 RNA (PDF)
  2. WHO guidelines on nonclinical evaluation of vaccines – WHO Technical Report Series No. 927, Annex 1, (PDF, Archive.org)
  3. EMA Clinical evaluation of new vaccines
  4. EMA – Comirnaty : EPAR – All Authorised presentations (PDF | Web)

Competing interests: No competing interests

See also: Posts tagged ‘Pfizer

References[+]

Penny... on Health
Penny... on Health

DISCLAIMER: The information on this website is not medical science or medical advice. I do not have any medical training aside from my own research and interest in this area. The information I publish is not intended to diagnose, treat, cure or prevent any disease, disorder, pain, injury, deformity, or physical or mental condition. I just report my own results, understanding & research.