Pfizer-BioNTech/COMIRNATY Vaccine Is Still Under “STUDY” Runs to be Completed at Different Intervals Between 2022-2026

” – known serious risks of myocarditis and pericarditis”

In addition to the many debates and conflicts surrounding the “approval” of the Pfizer/BioNTech/Comirnaty vaccine, there is interesting information to glean from the documents involved surrounding this controversy.

The below documents, some from the FDA’s own website, sheds further light into what seems to be a product still in its experimental/study phase. Some of the revelations are chilling, and doesn’t quite give the reassurance that an “approved” drug of this magnitude is more beneficial to us than what it is purported to be saving us from.

Screenshot of the FDA NEWS RELEASE: FDA Approves First COVID-19 Vaccine
taken on August 31, 2021
[ https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine ]
Content current as of August 23, 2021

Selected quotes in gray text boxes are from the above document:

“Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.”

There are a couple of notes to take away from this document. In the above quote, it doesn’t quite specify how long the clinical trial lasted. Only that more than half of the clinical trial participants were followed for safety outcomes for 4 months after the second dose. It also states that 12,000 of the recipients were followed for at least 6 months.

Both of these numbers (4 and 6) are incredibly low quantities when taking into account pregnant women who are at the beginning of their pregnancy. The length of the clinical trial does not take into account the full 9 months needed to determine a healthy pregnancy, nor does it allow for any time to safely assess the development of the baby once born.

The data in this document also does not include differences between those of the placebo group compared to that of the “vaccine” group. In addition, if we are to only take the 12,000 participants into account, which from the wording of the document seems to allude that these are the recipients of the vaccine, that would still leave 10,000 participants unaccounted for. Just from the amount of vaccine recipients (22,000), this is 45% of their study that the data does not reflect. If we are to include the 22,000 of the participants who received the placebo, the data that was not tracked would rise to 72%.

There is also the challenge of how they determined that the vaccine actually prevented COVID. Were these recipients exposed to someone with COVID or were deliberately inoculated with the disease to see if they would get infected? Many people, myself included, have gone on for more than a year without developing COVID, or at least “COVID symptoms”. Since this data only involved a 4-6 month trial period, how many of us (vaccinated, placebo, or otherwise) can say that we have not contracted COVID during this time-frame either? Is this implying that unless you’re vaccinated, you will most likely get COVID every 4-6 months?

Another consideration to take into account are the many testimonies from well-respected and renowned doctors/scientists/virologists who are adamant in their assessment that these vaccines are unnecessary and instead further harms the immune system rather than help it.

In the same regard, those who are unvaccinated will obviously then not contract any of the possible side effects that are listed in this document as well as the many adverse events that are reported to VAERS. Which leaves one to wonder if the benefits really outweigh the risks of the COVID vaccines.

There is also the slight alteration on a different page of the FDA website that gives further clarification as to the efficacy of the COVID vaccines – which does not reflect that of what many people are influenced to believe:

Under the heading:

Q: What safety information did FDA evaluate to authorize the Pfizer-BioNTech COVID-19 Vaccine for emergency use and approve Comirnaty?

Screenshot of the Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions
taken on August 31, 2021
[ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine-frequently-asked-questions ]
Content Current as of August 23, 2021

UPDATE on September 6, 2021: Since the FDA website decided to remove this particular section from their FAQ (as of 9/1/2021), here is a screenshot taken from the web archive showing its existence:

“While the vaccine may not prevent infection, symptoms or transmission of the virus from person to person – “

This seems to be the heart of the matter, and although it continues with, “it is effective in preventing hospitalization and death.” it is in direct conflict with what we were led to believe this whole time. Most of the mainstream media, big tech platforms, health agencies, etc. have insisted that vaccines are needed to stop transmission of the virus and to protect those around us. However, this one simple statement defies everything that people were coerced into believing.

And with the last part of the sentence concluding that it prevents hospitalization and death, which even that is debatable when looking at the scope of the situation, it leaves one to wonder why this would not be an option for people to decide to take that risk on their own account. When comparing data of young individuals as well and their extremely low risk of hospitalization and death in the COVID setting, there ARE acknowledged threats when they are injected with the vaccine.

“Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.”

The FDA is also acknowledging that there are higher risks involved with the Pfizer-BioNTech COVID-19 vaccine and myocarditis and pericarditis, especially in males aged 12-17, and up to age 40.

“Information is not yet available about potential long-term health outcomes.”

“In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.”

The document is also stating that the possibility of myocarditis and pericarditis is an accepted issue and will continue to be monitored after the marketing of the Comirnaty vaccine.

And in a rather blunt admission, FDA states on their own website that Comirnaty is not required to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy. This would explain why the initial trial run was only monitored for 4-6 months. An outline in the BLA (Biologics License Approval) also states that Comirnaty will conduct studies on this group as we see in a later section.

BLA documents state Comirnaty vaccine studies to be conducted for the next several years

Screenshot taken from from the FDA BLA Approval on August 31, 2021
[ https://www.fda.gov/media/151710/download ]
Document dated August 23, 2021

Text below is page 5 of the FDA BLA Approval document

Your deferred pediatric studies required under section 505B(a) of the Federal Food,
Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of
these postmarketing studies must be reported according to 21 CFR 601.28 and section
505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70
require you to report annually on the status of any postmarketing commitments or
required studies or clinical trials.

Label your annual report as an “Annual Status Report of Postmarketing Study
Requirement/Commitments”
and submit it to the FDA each year within 60 calendar
days of the anniversary date of this letter until all Requirements and Commitments
subject to the reporting requirements under section 506B of the FDCA are released or
fulfilled. These required studies are listed below:

1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of
COMIRNATY in children 12 years through 15 years of age.

Final Protocol Submission: October 7, 2020

Study Completion: May 31, 2023

Final Report Submission: October 31, 2023

2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of
COMIRNATY in infants and children 6 months to <12 years of age.

Final Protocol Submission: February 8, 2021

Study Completion: November 30, 2023

Final Report Submission: May 31, 2024

3. Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of
COMIRNATY in infants <6 months of age.

Final Protocol Submission: January 31, 2022

Study Completion: July 31, 2024

Final Report Submission: October 31, 2024

Submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN
BL 125742 explaining that these protocols were submitted to the IND. Please refer to
the PMR sequential number for each study/clinical trial and the submission number as
shown in this letter.

Submit final study reports to this BLA STN BL 125742. In order for your PREA PMRs to
be considered fulfilled, you must submit and receive approval of an efficacy or a labeling supplement. For administrative purposes, all submissions related to these required
pediatric postmarketing studies must be clearly designated as:

• Required Pediatric Assessment(s)

As the document states, the completion study of Comirnaty postmarketing (after approval) is not due until May 31, 2023 / Novermber 20, 2023 / July 31, 2024 respective of older to lower age groups. There is also another important acronym to consider, which is the IND, which stands for Investigational New Drug.

With this knowledge in hand, it’s important to note that the clinical trial run was monitored for 4-6 months after the second dose on around 55% of the recipients, while the actual “approved” drug still in its investigational/study stages is set to be monitored for 2-3 years. This is a sizeable difference in the amount of time to determine safety and efficacy, especially when considering the many events already reported to VAERS. And according to the Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions page from the FDA website:

Screenshot taken from the FDA Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions
on August 31, 2021
[ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine-frequently-asked-questions ]
Content current as of August 23, 2021

Q: Are vaccine providers required to report side effects?
A: Providers administering Comirnaty or Pfizer-BioNTech COVID-19 Vaccine must report to the Vaccine Adverse Event Reporting System (VAERS) and to Pfizer the following information associated with the vaccine of which they become aware:
  • Vaccine administration errors whether or not associated with an adverse event
  • Serious adverse events (irrespective of attribution to vaccination)
  • Cases of Multisystem Inflammatory Syndrome
  • Cases of COVID-19 that result in hospitalization or death

Acknowledged myocarditis and pericarditis issues being studied on children

” – known serious risks of myocarditis and pericarditis”

Screenshot taken from from the FDA BLA Approval on August 31, 2021
[ https://www.fda.gov/media/151710/download ]
Document dated August 23, 2021

Text in the gray box below are from pages 6-8 of the FDA BLA Approval documents
[ https://www.fda.gov/media/151710/download ]

We have determined that an analysis of spontaneous postmarketing adverse events
reported under section 505(k)(1) of the FDCA will not be sufficient to assess known
serious risks of myocarditis and pericarditis and identify an unexpected serious risk of
subclinical myocarditis.

Furthermore, the pharmacovigilance system that FDA is required to maintain under
section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.

Therefore, based on appropriate scientific data, we have determined that you are
required to conduct the following studies:

4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of
the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate
the occurrence of myocarditis and pericarditis following administration of
COMIRNATY.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: August 31, 2021

Monitoring Report Submission: October 31, 2022

Interim Report Submission: October 31, 2023

Study Completion: June 30, 2025

Final Report Submission: October 31, 2025

5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study
Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis
and pericarditis following administration of COMIRNATY.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: August 11, 2021

Progress Report Submission: September 30, 2021

Interim Report 1 Submission: March 31, 2022

Interim Report 2 Submission: September 30, 2022

Interim Report 3 Submission: March 31, 2023

Interim Report 4 Submission: September 30, 2023

Interim Report 5 Submission: March 31, 2024

Study Completion: March 31, 2024

Final Report Submission: September 30, 2024

6. Study C4591021 substudy to describe the natural history of myocarditis and
pericarditis following administration of COMIRNATY.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: January 31, 2022

Study Completion: March 31, 2024

Final Report Submission: September 30, 2024

7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for
potential long-term sequelae of myocarditis after vaccination (in collaboration
with Pediatric Heart Network).

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: November 30, 2021

Study Completion: December 31, 2026

Final Report Submission: May 31, 2027

8. Study C4591007 substudy to prospectively assess the incidence of subclinical
myocarditis following administration of the second dose of COMIRNATY in a
subset of participants 5 through 15 years of age.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this assessment according to the following schedule:

Final Protocol Submission: September 30, 2021

Study Completion: November 30, 2023

Final Report Submission: May 31, 2024

9. Study C4591031 substudy to prospectively assess the incidence of subclinical
myocarditis following administration of a third dose of COMIRNATY in a subset of
participants 16 to 30 years of age.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: November 30, 2021

Study Completion: June 30, 2022

Final Report Submission: December 31, 2022

It is interesting that the timing to be considered for approval of these vaccines was only a 4-6 month timeframe, however, known dangers/risks, identified as “serious”, are still allowed to be approved and to be studied for 2+ years.

The document also recognizes that myocarditis and pericarditis is enough of a concern to happen after administration of the Comirnaty vaccine, since it mentions several studies just for this specific adverse event, and to continue to assess these reports.

In addition to all of the substudies to be conducted, there is a study to be initiated on a select group of participants to administer a third dose of the Comirnaty vaccine.

All of this information leads credence to the fact that even though the Comirnaty vaccine has “officially been approved” by the FDA, it is still in the investigational stages and being experimented upon on the public. And it goes without saying, but if myocarditis and pericarditis (on top of other reported side effects) are serious risks especially in children (“The observed risk is highest in males 12 through 17 years of age.”), then for this known risk to be offered to infants/toddlers defies any ethically moral boundaries and is in direct violations of the Nuremberg Code.

The next section also provides further evidence that there have been NO studies in the safety/efficacy of the Pfizer-BioNTech/Comirnaty vaccine on pregnant women.

Pregnancy/Births were not studied during the initial Pfizer-BioNTech/Comirnaty trial runs

Another snippet from the FDA Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions website page, states the following:

Screenshot taken from the FDA Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions
on August 31, 2021
[ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine-frequently-asked-questions ]
Content current as of August 23, 2021

Q: Can pregnant or breastfeeding women receive the Comirnaty or Pfizer-BioNTech COVID-19 Vaccine?

A: While there have been no specific studies in these groups, there is no contraindication to receipt of the vaccine for pregnant or breastfeeding women. Pregnant or breastfeeding women should discuss potential benefits and risks of vaccination with their healthcare provider.

The acknowledgement above seems to indicate that the FDA and Pfizer-BioNTech/Comirnaty company have side-stepped this particular group in their vaccine studies, and have left it up to the healthcare provider to determine whether or not to administer this vaccine to pregnant women or women who are breastfeeding. This alone should be enough of a statement that there is no sufficient/professional data to analyze if the Comirnaty is safe during pregnancies/breastfeeding stages.

And if one were to consider the VAERS reporting system, in which the Pfizer-BioNTech company is required to report to, there have been numerous conditions of miscarriages/stillbirths/complications during pregnancy after administration of the COVID vaccine. While it is difficult to determine if these complications were a direct result of the vaccine, it is up to the scientific/healthcare community to investigate these cases in a thorough, unbiased and uninfluenced manner.

Another extremely alarming section of the FDA BLA Approval documents shows the following trial to be monitored in pregnant women:

Screenshot taken from from the FDA BLA Approval on August 31, 2021
[ https://www.fda.gov/media/151710/download ]
Document dated August 23, 2021

Text in the gray box below are from pages 9-10 of the FDA BLA Approval documents
[ https://www.fda.gov/media/151710/download ]
POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS
UNDER SECTION 506B

We acknowledge your written commitments as described in your letter of August 21, 2021 as outlined below:

10. Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during
Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and
Infant Outcomes in the Organization of Teratology Information Specialists
(OTIS)/MotherToBaby Pregnancy Registry.”

Final Protocol Submission: July 1, 2021

Study Completion: June 30, 2025

Final Report Submission: December 31, 2025

There are a couple of key takeaways in this section that are of incredible importance. One major term to focus on is the word “NON-INTERVENTIONAL“.

According to What is a Non Interventional Study?, “In general, a non interventional study (NIS) (also called a non interventional trial) is where a patient takes regular medicine, prescribed according to the label. In an NIS, the researcher sets out to exert as little influence as possible on the patient’s condition while studying a medicine’s “…effectiveness, safety and tolerability under real life conditions” (Mishra & Vora, 2010).”

The article also reiterates multiple times that “non-interventional” studies are observational studies – the researchers are not to interfere with the dosages in any way but to prescribe them exactly as listed on the label. It also seems to imply that even if severe side effects show up, they are to still carry through with the “medicinal product” in that patient as prescribed. Another insinuation that one can make is that in order to not interfere with the study, it is not recommended to prescribe treatments that may help alleviate potential side effects. The term “tolerability” is implying to keep the patient going through the side effects in order to continue to study the long-term effects of the investigational new drug.

However, with the inclusion of “real life conditions”, it doesn’t indicate whether the patient can seek out physicians to investigate what is causing the side effects in their system and engage in therapeutic treatments to alleviate these effects. If a study is to be conducted in real life conditions, then it is to be expected that patients will seek treatments on their own while the researcher is only required to observe the patient to see how the alternative treatments interact with the drug/symptoms.

The same article goes on to state that the UK/EU have different definitions of what “non-interventional” means. “Aronson (2004) states… “the term ‘non-interventional’ in the Directive doesn’t mean non-interventional (i.e. non-interference) at all; it refers to an intervention with a licensed medicinal product.”

There is controversy and conflicts in this statement as another article, Interventional or Non-Interventional? Analyzing the Differences Between Clinical Studies Using Medicines in the European Union points out:

“Although defined in DIR 2001/20/EC, non-interventional studies are outside its scope. Due to the lack of harmonized regulation, some studies designed to be non‑interventional may be considered clinical trials by EU authorities. The two blinded studies described in Table 4 (see PDF) were considered clinical trials in the EU for planning on collection of data to support the marketing authorization application of experimental IMPs, despite no IMP being given and normal clinical practice being kept during the study period. Sponsors are thus advised to consult with authorities when planning studies under these conditions and/or whenever the objectives or design may raise questions.”

Further in the article, it states the following, which again, is not reassuring considering the policies/guidelines/mandates that authorities have been engaging in in order to mandate these investigational new drugs (COVID vaccines) onto the public:

“There is no centralized submission procedure for non-interventional studies with the exception of non-interventional PASSs, imposed as an obligation by an EU competent authority.{9} Because non-interventional studies do not have harmonized legislation, some Member States require submissions to regulatory authorities, while others do not. It is therefore important that sponsors are familiar with the regulatory framework of target EU Member States, and that they consult with local competent authorities and ethics committees (ECs) when justified.”

It’s sad to have to point this out, but the quote does specify “competent” authorities. And even the inclusion of “ethics committees” is not comforting seeing as how one of the leading figures in ethics study is Christine Grady, Chief of the Department of Bioethics at the National Institutes of Health Clinical Center, and wife of Anthony Fauci – Director of the National Institute of Allergy and Infectious Diseases and Chief Medical Advisor to the president, and who is also a large spokesperson for the experimental injections.

The other takeaway from section 10 of the FDA BLA documents is the term “TERATOLOGY“.

Definition of teratology
: the study of malformations or serious deviations from the normal type in developing organisms
merriam-webster/teratology

Teratology, branch of the biological sciences dealing with the causes, development, description, and classification of congenital malformations in plants and animals and with the experimental production, in some instances, of these malformations. Congenital malformations arise from interruption in the early development of the organism. Malformations in human infants, for example, may occur because the infant’s genotype contains mutant genes or includes an abnormal number of chromosomes; they also may occur if early in pregnancy the mother has had German measles (rubella), has taken some injurious drug, or has been exposed to an injurious dosage of radiation. Experimental studies suggest similar types of factors can cause malformations in animals and plants.”
britannica/teratology

Now when you combine the terms “non-interventional” and “teratology” together, it is suggesting that the ongoing studies (that were not conducted to begin with even in a clinical trial setting, as per the FDA’s own response) on pregnant women with Comirnaty and on the developing baby, will be monitored with as little intervention as possible and is mostly to be observed for malformations/genetic defects/miscarriages/etc.

In other words, safety and efficacy were never studied in this particular group, and neither was it studied in infants. It has also not been studied for long-term analysis, as the 4-6 month trial runs proves. The current “approval” it is undergoing now is an authorized experiment on the human population that is posing incredibly unnecessary risks when considering the many effective treatments that are already available to combat respiratory illnesses. And the insistent assertiveness to push this “investigational new drug” onto babies/children who are at extremely low risk for this illness is a disastrous decision from those in an “authoritative” position and should be investigated for malfeasance and misconduct.

This is also not the first time that government agencies/health industries/etc. have conducted experiments on the public.

The Tuskegee/Syphilis experiment was initiated onto a selection of African American men between 1932-1972. The study was only stopped (allegedly) after a publication was released on Associated Press in 1972 about the immorally unethical experiments being conducted on this group:

“Of about 600 Alabama black men who originally took part in the study, 200 or so were allowed to suffer the disease and its side effects without treatment, even after penicillin was discovered as a cure for syphilis. Treatment then probably could have saved or helped many of the experiment participants, PHS officials say.”AP WAS THERE: Black men untreated in Tuskegee Syphilis Study

This study seems to echo the sentiments we see going on with the coronavirus situation, in which only one type of drug is being promoted (the COVID vaccines) while suppression of other treatments that have been proven to work (such as Ivermectin) has been denounced by the very same government/health/medical fields that have conducted these experimental studies.

A study that involved the CDC/FDA’s approval, this time on Black and Latino babies, was conducted in the early 1990’s and involved the measles vaccine:

“1990: CDC Inoculated Black and Latino Babies with an Unlicensed Measles Vaccine
A covert clinical trial by the Center for Disease Control (CDC) and Kaiser Permanente inoculated Black and Latino babies with an experimental measles vaccine without informing parents the vaccine was experimental. More than 1500 six-month old black and Hispanic babies in Los Angeles are given the deadly “experimental” measles vaccine that had never been licensed for use in the United States; a vaccine that had been tested in African and Mexican babies resulting in high death rates. The parents were never informed and they never gave their consent. The CDC harmed babies, violated federal law, and trampled on parental rights with impunity.”
1990 FDA Issued a Waiver From Consent; Covert CDC Experimental Vaccine Test on Black / Latino Babies

It’s interesting that the measles vaccine experiment identifies Kaiser Permanente specifically, because as we see in another section of the FDA BLA Approval for Comirnaty, it seems as if Kaiser Permanente makes another appearance in the role of human experimentation:

Text in the gray box below is from page 10 of the FDA BLA Approval documents
[ https://www.fda.gov/media/151710/download ]

13. Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine
Effectiveness Study – Kaiser Permanente Southern California.”

Final Protocol Submission: March 22, 2021

Study Completion: December 31, 2022

Final Report Submission: June 30, 2023

It would seem that the approval by the FDA of these IND drugs (Pfizer-BioNTech/Comirnaty vaccine) is a way for the government/health agencies to skirt away from liability by stating that since the vaccines are no longer “experimental” by their definition, and that they are FDA “approved”, it is no longer required to gain informed consent of these drugs. In addition, as to the technicality of their terms and protocols, there are a multitude of ways to interpret their “informed consent” rules, which officials can then bend or define in any way that best reflects the use of their study/drug.

[ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent#exceptions ]

Also keeping in mind how long it was determined before the “health agencies” granted approval of the Pfizer-BioNTech/Comirnaty vaccine – (4-6 months) – it would be conclusive to state that the vaccines have NOT sufficiently been studied in young children or pregnant women (or even the rest of the age groups because of the short amount of time the clinical trial study was conducted in), and the subsequent approval of this vaccine is to continue this research on the population who is exceedingly being pressured into taking this investigational new drug.

There is also the matter of the many adverse events that have been reported since the inoculation of these injections, that have largely gone unheeded within the health/medical institutions that are endorsing this drug. Other than the widely acknowledged myocarditis and pericarditis, most common in young males, which is still being studied and allowed to persist onto the public.

So again, taking into account the collusion of the government/health/medical/research fields to conduct experiments on the public, it would be necessary to reflect upon these agencies for additional breaches upon human rights, consent, and ethical behavior.

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Featured image by Ahmad Ardity from Pixabay

Scandal Behind the FDA “Fake Approval” of Pfizer Jab

Corruption and collusions behind the Pfizer/FDA “vaccine” efforts.

This article has been cross-posted from globalresearch.ca
by F. William Engdahl (August 31, 2021)

All Global Research articles can be read in 51 languages by activating the “Translate Website” drop down menu on the top banner of our home page (Desktop version).

Visit and follow us on Instagram at @crg_globalresearch.

***

The US Government regulator for drugs, the Food and Drug Administration, has just announced that it has voted full approval for the mRNA genetic vaccine of Pfizer and BioNTech, or did they? This supposed new status is being used by the Biden Administration and many states and companies to impose mandatory vaccinations. The notoriously conflicted Biden covid adviser, Tony Fauci of the NIAID, using that ruling, is calling for national mandatory vaccination for the country.

What is not being revealed is the cesspool of corruption and conflicts of interest between the FDA and the major drug companies, including Pfizer, that stand behind the rushed approval. And it’s not full approval for Pfizer’s jab, only for BioNTech’s legally different vaccine.

“…final stamp of approval”?

On August 23 as the FDA announced full approval for the Pfizer mRNA gene-edited substance. Or not quite, when the full papers of FDA are studied. Fauci, whose NIAID has financial interest in the vaccine, referred to the FDA decision as the “final stamp of approval.” It is however anything but final or an impartial, scientific rigorous medical evaluation. Rather it is a politically-motivated decision by an FDA that is corrupt beyond the imagination of most people.

Backtracking on its statement in 2020 that it would hold normal FDA advisory committee hearings with independent experts to discuss the Pfizer application for full approval, now the FDA told the British Medical Journal that they did not believe a meeting was necessary ahead of granting full approval of what is the most controversial vaccine in modern history. The BMJ quotes Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, “These [FDA] public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization.”

Witczak continued with the alarming note, “It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years. There is no control group after Pfizer offered the product to placebo participants before the trials were completed.” Read that again, slowly. Pfizer tests destroyed their own control group mid-stream! And its six month rollout of the mRNA jab worldwide has resulted in catastrophic side effects which have been totally officially ignored. Is this “science” Dr Fauci?

The refusal of the FDA and its Acting Director, Janet Woodcock, to convene its Drugs Advisory Committee for discussion of the Pfizer and BioNTech decisions is even more shocking as in June three members of that same panel resigned in protest for being disregarded in another drug approval. NPR network reported, “Three experts have now resigned from a Food and Drug Administration advisory committee after the agency approved an Alzheimer’s drug called Aduhelm against the wishes of nearly every member on the panel.” One of the three, Dr. Aaron Kesselheim, in his resignation letter from the FDA Advisory Committee (June 10, 2021), wrote:

“For both eteplirsen and aducanumab, the decisions by FDA administrators to ignore the Advisory Committee’s clear recommendations led to their approval of two highly problematic drugs that offered little evidence that they would meaningfully benefit patients…With eteplirsen, the AdComm (Advisory Committee) and FDA’s own scientific staff reported that there was no convincing evidence that the drug worked; both groups were overruled by FDA leadership… “

Now the FDA refusal to convene their advisory committee for the Pfizer decision is all the more astonishing in light of the fact that the Government Centers for Disease Control (CDC) in its official VAERS data bank for recording vaccine negative effects has recorded 8,508 reports of fatalities following the Pfizer mRNA shot in the past seven months, a number more than for all vaccines combined in the past 30 years.  By denying a public hearing the FDA avoided any discussion of these alarming fatality numbers, let alone the tens of thousands of serious side-effects including heart attacks, blood clots, miscarriages, permanent paralysis following the Pfizer-BioNTech jabs. The public declaration by Fauci before approval that he expected it, is also unethical influencing, but that is the least of the crimes.

Faked Approval

It seems the FDA executed a clever ruse in which it issued separate rulings for a Pfizer Inc.-BioNTech vaccine which is widely used in the USA, and another ruling for the similar vaccine of Pfizer’s German-based partner and developer of the mRNA platform, BioNTech of Mainz. It is only BioNTech that got FDA approval, but conditioned on completion of a series of further tests on select groups including infants, pregnant women and youth, by 2027. The US vaccine, Pfizer-BioNTech Covid-19 vaccine, only got extension of its Emergency Use Authorization (EUA), not full approval!

In their separate letter to Pfizer, the FDA stated,

“…On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of (Emergency Use) authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses…”(emphasis added).

Buried in a footnote in the letter the FDA admits there are two legally separate entities and vaccines—Pfizer-BioNTech Covid-19 Vaccine and BioNTech GmbH of Mainz with its own vaccine trade-named Comrinaty. The FDA writes that “The products are legally distinct with certain differences…” Legally distinct means two separate vaccines. If you find this confusing it is meant to be. Only under an EUA ruling is Pfizer presently exempt from vaccine liability. Some lawyers are calling the FDA ruse a classic “bait and switch” tactic, a form of fraud based on deception.

US vaccinologist and a developer of the mRNA technique, Dr Robert Malone, has accused the FDA of playing a “bureaucratic shell game” with their supposed early approval of the Pfizer Covid-19 vaccine. He cites the two separate FDA letters,

“There is a letter for Pfizer and a letter for BioNTech. The New York Times and the Washington Post got it wrong. The authorization is not for Pfizer. The authorization is for BioNTech, and it will only be initiated at the time BioNTech product becomes available…”

Adding to the bizarre irregularities, in their two separate letters, one to BioNTech and another to Pfizer, the FDA repeatedly deletes the location of the vaccine manufacturing they approve. Why that? Is it in China where BioNTech has a joint agreement with Fosun Pharma of Shanghai to jointly produce and market Comirnaty vaccine for COVID-19? Why do they need to hide that location data from the public? Would it expose the entire fraud?

FDA-Pfizer Conflicts of Interest

In 2019 Pfizer made a very conflicted appointment to its board of directors. It took Scott Gottlieb, who had just resigned as head of the FDA three months earlier. If this gives an appearance of a huge conflict of interest, it is. Alongside Gottlieb at Pfizer’s Board of Directors sits Dr Susan Desmond-Hellmann, who headed the Bill and Melinda Gates Foundation until 2020. The Gates Foundation is behind every single key part of the covid vaccine rush and owns stock in Pfizer to boot.

Another person who links Pfizer and Gates is Prof. Holly Janes, a bio-statistical expert in Gates’ hometown Seattle, at the Fred Huff cancer research center. Janes is also a member of the FDA Vaccine Committee until 2023. Notably, she co-designed the controversial trials for both Pfizer and Moderna mRNA vaccines for Fauci’s NIAID from her Seattle center, which is also funded by the Gates Foundation.

Janes is Professor at the Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, known as Fred Hutch. Earlier she received Gates Foundation research money for a six year period when she worked for the Gates Foundation from 2006 to 2012 to develop “statistical and study design support for pre-clinical vaccine performance trials.” Prof. Janes also helped develop the program that tracks vaccine data at John Hopkins University.

The person who runs FDA as “Acting Director” is Janet Woodcock. To call her tainted is mild. She has been at FDA since 1986, almost as long as Fauci at NIAID. Woodcock was Biden’s choice to head FDA, but a massive opposition from 28 groups including state attorneys general and citizen groups forced him to name her “acting,” which does not need Congressional scrutiny.

Woodcock was directly responsible for the FDA approval of deadly opioids over the objections of her own scientists and other advisors. Two decades ago as head of the FDA unit responsible, Woodcock was instrumental in the approval of a powerful opioid, Zohydro, even though the FDA’s own scientific advisory committee voted 11-2 to keep the drug off the market because it was unsafe. The online Drugs.com writes, “Hydrocodone (Zohydro) can slow or stop your breathing. Never use Zohydro ER in larger amounts, or for longer than prescribed. .. Swallow it whole to avoid exposure to a potentially fatal dose. Hydrocodone may be habit-forming, even at regular doses.” Woodcock later approved the sale of a high-strength narcotic pill, OxyContin, as “safer and more effective than other painkillers” based on the false claims of the now bankrupt manufacturer, Purdue Pharma. Some 500,000 Americans have since died as a result of opioid addiction.

Woodcock clearly is the key FDA person behind the duplicitous August 23 Pfizer decision, seeing to it that there were no public advisory hearings to review relevant data. It would be relevant to know what discussions or communications went on with her former boss, now Pfizer director, Scott Gottlieb.

Why?

There are many unanswered question in this twisted tale of corruption at FDA and Pfizer. Was this theater rushed through by the Biden Administration to accelerate the forced vaccination of millions of Americans uncertain or skeptical of taking an emergency or experimental jab? Why is there such an incredible pressure from mainstream media and politicians to vaccinate every man, woman and now child in the US? Are the vaccines really safe if there are so many dire cases of adverse events after the Pfizer jab? Why did the FD refuse to allow its independent vaccine committee to weigh in?

It is worth noting that as of August 14 Pfizer does not mandate vaccines for its own employees. Also the Biden White House does not mandate vaccines for its staff. These are all serious issues that demand serious and honest answers.

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F. William Engdahl is strategic risk consultant and lecturer, he holds a degree in politics from Princeton University and is a best-selling author on oil and geopolitics, exclusively for the online magazine “New Eastern Outlook” where this article was originally published. 

He is a Research Associate of the Centre for Research on Globalization.

Featured image is from NEO



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Year: 2007
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Dr. Michael Yeadon (Former Pfizer Chief Scientist) Warns Pregnant Women of the Dangers of Taking The Experimental COVID Vaccine

Study on women showed “vaccine induced autoimmune attack, on their own placenta.”

Dr. Michael Yeadon, a former Chief Scientist and VP of the Allergy and Respiratory Unit of Pfizer, has been very outspoken in his assessment of these “vaccines”, and has called this agenda out several times for being deliberate crimes against humanity. The following video below is an explanation and warning to people – specifically for women who are pregnant or who are of child-bearing potential, to avoid these dangerous injections.

Source: bitchute | WHAT IS TRUTH?/WAS IST WAHRHEIT? |
3 THINGS WOMEN SHOULD KNOW ABOUT THE COVID JAB – DR. MICHAEL YEADON

The following text is transcribed from the above video with some embellishment added for emphasis. All words are from Dr. Michael Yeadon.

“You’re being lied to. I’m being lied to. We’re not being treated like adults. And the authorities are not giving us full information about the, the risks of these products. And so I’m going to try and do a non-science presentation, um, because I really want to speak to you who are probably not scientists. You’ll be a lay audience. So I’m going to do my best.

So, uh, three things to tell you about my concerns about the impact of these vaccines in reproductive health, fertility and pregnancy.

The first thing, is so obvious, that you’ll agree with me when I tell you. And that’s, we never, EVER, give experimental medicines to pregnant women. Why do we not do that? Well, you’ll probably will have heard of the word ‘thalidomide’. 60 years ago, through, I think an ignorant failure of medicines regulation, we were more exposed to a new product for morning sickness called thalidomide. And it led to at least 10,000 birth malformations. And we didn’t know at the time, that the studies they were doing at the time simply wouldn’t pick out thalidomide as the actual toxin in the womb.

And I think it also taught us that babies are not safe and protected inside the uterus, which is what we used to think. But in fact, there are a miracle of minute development, critical stages, especially in the early stages, where if they interfered with biochemicals or something else, it can change the course of development to that child irreparably.

So that’s the thing to tell you. You never ever give, really inadequately tested medicines, medicinal products, to a pregnant woman. And that’s exactly what is happening. Our government is urging pregnant women, and women of child-bearing age, to get vaccinated. And they’re telling them they’re safe. And that’s a lie. Because those studies have simply not been done.

So reproductive toxicology has not been undertaken with any of these products. Certainly not a full battery of tests that you would want. So here we are, dosing potentially hundreds of millions of women of child-bearing potential, with products which are untested in terms of impacts on fertilization and development of a baby. That’s bad enough, because what that tells me is that there’s recklessness; no one cares. The authorities do not care what happens. But it’s much worse than that. And remember, I’m a toxicologist as well as a research scientist.

Two things to tell you.

The first only came to light because of a Freedom of Information request made by somebody to the Japanese medicines regulator. So the Japanese medicines regulator had required Pfizer to do a study where they looked at how the vaccine distributed around the body, in this case of a rat, over time. It’s a distribution pharmacokinetic study. And they were not required in America or Europe, because that’s not what you do with vaccines. Another – for another day. But the Japanese regulators required it.

Now I’ve seen a copy of that report, and I’m entirely able to read and interpret it. And to my horror, what we find is the vaccine doesn’t just distribute around the body and then wash out again. Which is what you hope. It concentrates in ovaries of rats. And it concentrates, at least, twenty-fold over the concentration in other background tissues like muscles.

Um, what’s it doing there? Well I don’t know. You don’t want this product in your ovaries. It’s simply not necessary to induce immunity to have a vaccine in your ovaries. And, as it’s concentrating in the ovaries, getting higher concentrations over time, they have not even defined what the maximum levels are or when that occurs.

So, so now we’ve got a second problem; that the vaccine, at least in rats, distributes in the ovaries. And I’ll tell you, a general rule of thumb in toxicology, is if you don’t have any data to counter contradict what you’ve learned, that’s the assumption you make for humans. So my assumption at the moment, is that’s what’s happening to every female who’s been given these vaccines. These vaccines are concentrating in her ovaries.

That’s very worrying. So we don’t know what that will do, but it cannot be benign. And it could be seriously harmful. Because the vaccines will then express the coronavirus spike protein and we know that there are unwanted biologies from that spike proteins. That’s the second one.

I’ve got another one now, and it’s even worse! Because it’s actually, this time an experiment in humans. In females.

I wrote with a German doctor 8 months ago, a petition to the European Medicines Agency. And amongst several concerns we had, one was that the spike protein is faintly similar, not very strongly, but faintly similar to an essential protein in your placenta. Something that’s absolutely required for both fertilization and formation and maintenance of the placenta. So you can’t get pregnant and have a successful pregnancy if this protein is damaged in any way. And we noticed that the coronavirus spike protein is similar. Similar enough that I would worry.

And I wanted them to do some experiments, hopefully to rule out the possibility that when you vaccinate the person, who then makes spike proteins, and they develop an immune response against this spike protein; my worry was that there would be an echo. You know. A faint signal that would potentially bind this similar protein in the placenta. And the studies just came out a few weeks ago and it says, exactly, what I was worried about.

15 women were given Pfizer vaccines, they drew blood samples every few days, and they measured antibodies against the spike protein; which took several weeks to appear. They also measured antibodies against the placenta. And they found within the first 1-4 days an increase of two and a half to three times – a 300% increase, in the antibodies against their own placenta. In the first 4 days. Um, so, I’m sorry to say this, but that is a vaccine induced autoimmune attack, on their own placenta.

And I think you can only expect that that is happening in every woman of child-bearing potential, is generating antibodies against this critical protein required for fertilization and successful pregnancy. Now, what the effect will be we can’t be certain. Again it can’t be benign. I don’t know whether it’s enough to cause first trimester losses. But I would think it would, because I’ve looked at the literature, and women who are unfortunate enough to have what are called autoimmune diseases, tend to have a higher rate of first trimester losses. And what this vaccine’s done is induced an autoimmune response.

So, I’m here to warn you that if you are of child-bearing potential, or younger – so, not at menopause, I would strongly recommend you do not accept these vaccines. Thank you.”

Thank you to Dr. Michael Yeadon for bringing this awareness and research to the forefront and warning people of the potential dangers to this COVID vaccine.

I also want to point out that most vaccine trials take 10-15 years, if not more, to determine safety and efficacy. Yet with the COVID vaccine, it was developed in 2 MONTHS since word of the outbreak hit (some sources are claiming it is because of the wonderful advancements being made in tech and the “stupendous foresight of the NIH” to predict a similar outbreak would happen… if that’s what you would like to believe…) and the clinical trials started soon after. With emergency authorized use only, NOT APPROVED, 9 months later.

With this in mind, even if it becomes “approved” – in which this little caveat has caused more drama and confusion than what was necessary – are we going to still continue to trust the FDA, the CDC, NIH, NIAID on these incredibly unnecessary vaccines, when we can now see the results of this rushed mRNA/spike protein experiment? Not to mention, there are treatment regiments available that are KNOWN to treat this illness, in which the EUA would not be required since under their own regulations they state:

“Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

Doctors have proven, IN COURT, that Ivermectin, an already approved medicine, works and nutraceutical bundles are beneficial in treating these respiratory syndromes. Yet they are being SUPPRESSED by the very health agencies that are promoting vaccines every where we turn, even though the vaccines are not approved and are causing thousands upon thousands of side effects and deaths.

Please do your research and use critical thinking and discernment. Doctors like Michael Yeadon get nothing from trying to save your life and help you (except censorship and ridicule from the mainstream media and big tech platforms) and shows genuine concern for our well-being. While pharmaceutical companies have gained BILLIONS from pushing these experimental vaccines onto the population.

Thank you again to all of the sincere doctors/scientists/healthcare workers/researchers who are bringing all of this information to light.