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

CDC Says Vaccinated May be as Likely to Spread COVID as Unvaxxed, as Reports of Serious Injuries after Vaccines Surge

“The bottom line was that, in contrast to the other variants, vaccinated people, even if they didn’t get sick, got infected and shed virus at similar levels as unvaccinated people who got infected”

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***

VAERS data released today by the CDC showed a total of 518,770 reports of adverse events from all age groups following COVID vaccines, including 11,940 deaths and 63,102 serious injuries between Dec. 14, 2020 and July 23, 2021.

Data released today by the Centers for Disease Control and Prevention (CDC) showed total reports of serious injuries following COVID vaccination, across all age groups, spiked by 14,717 — to 63,000 — compared with the previous week.

The data comes directly from reports submitted to the Vaccine Adverse Event Reporting System (VAERS), the primary government-funded system for reporting adverse vaccine reactions in the U.S.

Every Friday, VAERS makes public all vaccine injury reports received as of a specified date, usually about a week prior to the release date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.

Data released today show that between Dec. 14, 2020 and July 23, 2021, a total of 518,770 total adverse events were reported to VAERS, including 11,940 deaths — an increase of 535 over the previous week. There were 63,102 serious injuries reported during the same time period — up 14,717 compared with the previous week.

From the 7/23/21 Release of VAERS data

Excluding “foreign reports” filed in VAERS, 435,007 adverse events, including 5,612 deaths and 34,890 serious injuries, were reported in the U.S.

In the U.S., 340.4 million COVID vaccine doses had been administered as of July 23. This includes: 137 million doses of Moderna’s vaccine, 189 million doses of Pfizer and 13 million doses of the Johnson & Johnson (J&J) COVID vaccine.

Of the 5,612 U.S. deaths reported as of July 23, 14% occurred within 24 hours of vaccination, 20% occurred within 48 hours of vaccination and 34% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.

This week’s U.S. data for 12- to 17-year-olds show:

  • 15,086 total adverse events, including 909 rated as serious and 16 reported deathsone less than what VAERS showed last week. Two of the nine deaths were suicides.
  • The most recent reported deaths include a 13-year-old boy (VAERS I.D. 1463061) who died after receiving a Moderna vaccine, a 16-year-old boy (VAERS I.D. 1466009) who died after receiving his second dose of Pfizer and a 16-year-old boy (VAERS I.D. 1475434) who died with an enlarged heart six days after receiving his first Pfizer dose.

Other reports include two 13-year-old boys (VAERS I.D. 1406840  and 1431289) who died two days after receiving a Pfizer vaccine, three 15-year-olds (VAERS I.D. 1187918, 1382906 and 1242573), three 16-year-olds (VAERS I.D. 1420630, 1225942 and 1386841) and three 17-year-olds (VAERS I.D. 1199455, 1388042 and 1420762).

This week’s total U.S. VAERS data, from Dec. 14, 2020 to July 23, 2021, for all age groups combined, show:

Internal CDC document reveals vaccinated, even if not sick, can spread virus

 

The CDC now says even those people fully vaccinated for COVID are able to get, and spread, the virus.

According to internal documents obtained by The Washington Post, the CDC said it’s time to “Acknowledge the war has changed.”

The document outlined unpublished data showing fully vaccinated people might spread the Delta variant at the same rate as unvaccinated people, CNN reported.

It concludes the delta variant is “highly contagious, likely to be more severe” and that “breakthrough infections may be as transmissible as unvaccinated cases.”

The Washington Post reported:

“‘I think the central issue is that vaccinated people are probably involved to a substantial extent in the transmission of delta,’ Jeffrey Shaman, a Columbia University epidemiologist, wrote in an email after reviewing the CDC slides.

“‘In some sense, vaccination is now about personal protection — protecting oneself against severe disease. Herd immunity is not relevant as we are seeing plenty of evidence of repeat and breakthrough infections.’”

Since January, people who got infected after vaccination make up an increasing portion of hospitalizations and in-hospital deaths among COVID patients, according to the CDC documents. That trend coincides with the spread of the Delta variant.

The Post also reported today on a CDC study revealing three-fourths of people infected in a Massachusetts COVID outbreak were vaccinated. The report bolsters the hypothesis that vaccinated people can spread the more transmissible variant, and may be a factor in the summer surge of infections.

The data, detailed in the CDC’s Morbidity and Mortality Weekly Report, provided key evidence that convinced agency scientists to reverse recommendations on mask-wearing and advise that vaccinated individuals wear masks in indoor public settings in some circumstances, The Post reported.

Thus far, researchers have focused on viral load — a term for how much of the virus is present in infected peoples’ bodies — which can affect transmissibility and severity. Infections with the Delta variant lead to higher levels of virus in the body, even in breakthrough cases in fully vaccinated individuals, the document said.

If vaccinated people get infected anyway, they have as much virus in their bodies as unvaccinated people — that means they’re as likely to infect someone else as unvaccinated people who get infected, CNN reported.

“The bottom line was that, in contrast to the other variants, vaccinated people, even if they didn’t get sick, got infected and shed virus at similar levels as unvaccinated people who got infected,” Dr. Walter Orenstein, who heads the Emory Vaccine Center and who viewed the documents, told CNN.

The CDC is scheduled to publish more data today.

Biden says federal workers must get vaccinated or submit to regular testing — postal union, others push back

President Biden on Thursday announced all civilian federal employees will be required to show proof of vaccination against COVID or be forced to submit to regular COVID testing, wear masks and socially distance.

Biden also called on state and local governments to use COVID relief funds to give $100 to residents who get vaccinated. In a statement released by the White House, the administration said the new rules were issued because of the Delta COVID variant, and because unvaccinated people present a problem to themselves, their families and co-workers.

“Every federal government employee will be asked to attest to their vaccination status.  Anyone who does not attest or is not vaccinated will be required to mask no matter where they work; test one or two times a week to see if they have a — they have acquired COVID, socially distance and generally will not be allowed to travel for work,” Biden said.

Biden directed his administration to apply similar standards to all federal contractors. “If you want to do business with the federal government, get your workers vaccinated,” he said.

In one early sign the policy may not go as smoothly as planned, the American Postal Workers Union (APWU) said it opposes the Biden administration’s vaccine mandate as a condition for employment, arguing it isn’t the role of the federal government to mandate vaccines or other testing measures.

“Maintaining the health and safety of our members is of paramount importance,” the APWU said in a statement issued Wednesday. “While the APWU leadership continues to encourage postal workers to voluntarily get vaccinated, it is not the role of the federal government to mandate vaccinations for the employees we represent.”

In advance of Biden’s official announcement, Children’s Health Defense on Thursday issued a statement disagreeing with the new policy.

The statement quoted CHD Chairman Robert F. Kennedy, Jr:

“Coerced medical interventions have been abhorrent to advocates of liberty and human dignity in every age. The fact that these vaccines are shoddily tested, experimental, unapproved and so risky their manufacturers can neither obtain insurance coverage nor indemnify users against grave injuries or death should magnify our ethical revulsion.”

FDA urges Moderna, Pfizer to include thousands more children in clinical trials

Pfizer and Moderna will expand their COVID vaccine clinical trial to include thousands more children prior to seeking EUA, after the U.S. Food and Drug Administration (FDA) told the vaccine makers the size and scope of their pediatric studies, as initially envisioned, were inadequate to detect rare side effects.

The rare side effects cited by the FDA included myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart, multiple people familiar with the trials told The New York Times.

Expanding the pediatric trials means thousands more children as young as 6 months old may soon be recruited and enrolled in COVID vaccine trials. According to the Times, the FDA asked the companies to include 3,000 children in the 5- to 11-year-old group, the group for whom results were expected first.

Moderna’s shot is authorized for emergency use in people 18 and up, and Pfizer’s vaccine is authorized for children as young as 12. No COVID vaccines have yet received EUA approval for children younger than 12.

America’s Frontline Doctors sue UC over vaccine mandates

With supporting declarations from top medical experts and students, America’s Frontline Doctors(AFLDS) filed a civil rights lawsuit in Federal Court against the University of California (UC), targeting the university system’s plan to mandate COVID vaccination for all students regardless of natural immunity.

As The Defender reported July 28, AFLDS, students and even the UC’s own top doctors, are criticizing the rushed mandate as arbitrary, unscientific and medically unnecessary.

Attorneys for the plaintiffs in this civil rights case cite the 14th Amendment to the U.S. Constitution’s protection of bodily integrity, as well as two California civil rights statutes (Cal. Civ. Code sec. 51, Cal. Gov. Code sec. 11135) that prohibit discrimination on the basis of medical or genetic status.

Accordingly, AFLDS is requesting an injunction to restrain the UC from utilizing coercion and segregation of naturally-immune and unvaccinated people in violation of Federal and State law.

The primary target of the lawsuit is the UC’s unscientific one-size-fits-all vaccine mandate where the UC rejects scientifically accepted prescreening for natural immunity.

The CDC, NIH pull in millions from licensing deals, including COVID-related technologies

Aggregated data for fiscal year 2020 show the National Institutes of Health (NIH) and CDC collected a combined $63.4 million in royalty revenues under a business model that allows the NIH to grant technology licenses to the private sector.

As The Defender reported earlier this week, with 27 different institutes and centers housed under the NIH umbrella — including the National Institute of Allergy and Infectious Diseases (NIAID) — NIH is the largest biomedical research agency in the world with an annual budget of nearly $42 billion.

Within NIH, the Office of Technology Transfer plays a “strategic role” in supporting patenting and licensing for inventions that emerge from laboratories at the NIH and CDC. In a win-win business model, the NIH routinely grants technology licenses to the private sector for use or commercialization of its inventions, with those licenses then driving billions of dollars in royalties back to the NIH.

In fiscal year 2020 alone — October 2019 through September 2020 — aggregated data for NIH and CDC show the agencies collected $63.4 million in royalty revenues.

Where public health agencies are concerned, COVID appears to be very good for business, with a flurry of unprecedented funding — conveniently mobilized by the pandemic — ushering in profound and likely permanent changes in a public health infrastructure once lamented as weak and fragmented.

As The Defender reported this week, Pfizer now projects $33 billion in COVID vaccine revenues, a sharp increase over earlier projections. The vaccine maker anticipates booster shots, a vaccine designed for the Delta variant and pending authorization of COVID vaccines for children will drive sales even higher next year.

144 days and counting, CDC ignores The Defender’s inquiries

According to the CDC website, “the CDC follows up on any report of death to request additional information and learn more about what occurred and to determine whether the death was a result of the vaccine or unrelated.”

On March 8, The Defender contacted the CDC with a written list of questions about reported deaths and injuries related to COVID vaccines. We have made repeated attempts, by phone and email, to obtain a response to our questions.

Despite multiple phone and email communications with several people at the CDC, and despite being told that our request was in the system and that someone would respond, we have not yet received answers to any of the questions we submitted. It has been 144 days since we sent our first email to the CDC requesting information.

Children’s Health Defense asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.

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Megan Redshaw is a freelance reporter for The Defender. She has a background in political science, a law degree and extensive training in natural health.

Featured image is from CHD

NOTE FROM Expanding Awareness Relations:

NECESSARY QUESTIONS TO REFLECT ON:

“If vaccinated people get infected anyway, they have as much virus in their bodies as unvaccinated people — that means they’re as likely to infect someone else as unvaccinated people who get infected”

– So why the incessant continual push to get people vaccinated who are willing to risk the virus symptoms? Instead of just dealing with potential symptoms of COVID, the vaccinated individuals are under the risk of NOT ONLY COVID, but ALSO the possibility of DANGEROUS SIDE EFFECTS from the vaccine. Why can’t individuals make the decision to only risk the COVID infection? Especially since there are BENEFICIAL TREATMENTS to help cure COVID (that is, unironically, being attacked on mainstream media/big tech platforms)? Not to mention that the CDC studies are showing that the vaccine MAY only reduce symptoms in the individual vaccinated – without any benefit to not spreading the virus?

And even if the report from the CDC turns out to be incorrect, do we still want to leave our health in the hands of corporations/organizations who have proven to be not only inept at every single guideline they have initiated during this “pandemic”, but also the numerous times they have flip-flopped, backtracked, retracted, reversed, changed their mind, etc. on their incorrect assessment of the situation, but who is also implementing growing endorsement for an experimental vaccine that has not yet been tested for genuine safety and efficacy? (And on that matter, according to the alarmingly increasing numbers of adverse events reported to VAERS, these vaccines are proving undoubtedly that they are NOT SAFE AND EFFECTIVE.)

Science does not change. And with their (the government health agencies) ever-pervasive push on others to “trust the science”, yet show incredible incompetence as the “experts”, while at the same time denouncing thousands of doctors who HAVE BEEN CORRECT in their conclusions of this COVID/vaccine narrative, I’d say their roles in offering their “expertise” needs to be revoked and more attention needs to be focused on the TRUTHFUL doctors who are giving us more accurate statements than the NIH, CDC, NIAID, WHO, UN, etc.

Of course, in an honest world, this would happen. As it is, the world is seeing a corruption/collusion of unprecedented proportion, that is slowly but surely jolting multiple people awake, yet unfortunately not nearly enough. But the more of us that recognize this deception and who are spreading this awareness will eventually reach those who have remained in the dark, even if it may seem like a fruitless endeavor, and we can continue to make informed decisions while helping others break out of this manipulative system.