200,000 Unvaccinated Military Members Denied Temporary Restraining Order as Commanders Threaten Those Who Refuse COVID-19 Vaccines

Egregious abuse of power of those in “authoritative” positions.

This article has been cross-posted from globalresearch.ca
Written by Brian Shilhavy / Health Impact News (September 7, 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).

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Several military members told Health Impact News today that their commanders are coercing members of their unit to get the COVID-19 shot TODAY (September 7, 2021) or face the consequences of disobeying a direct order.

One member stated that when they went by the local pharmacy in a drug store, there were many military members lined up to get the shots today, fearful of the consequences if they don’t.

And this is in spite of the fact that military officials are saying publicly that service members still have 2 to 3 months to comply, according to Military.com.

Sailors and Marines Have 90 Days to Get Vaccinated or Face Punishment

2 Sep 2021
Military.com | By Konstantin Toropin

Sailors and Marines now have 90 days to get vaccinated against COVID-19 or risk disobeying a lawful order, a violation of the Uniform Code of Military Justice, the maritime branches’ top leaders said in a series ofmessagesreleased Tuesday and Wednesday.

Airmen Have Less than Two Months to Get Fully Vaccinated

7 Sep 2021
Military.com | By Stephen Losey

The Department of the Air Force has set a tight two-month deadline for active-duty troops to be fully vaccinated against COVID-19. Those who don’t get the shot in time could be punished under the Uniform Code of Military Justice.

Airmen and Space Force Guardians must be fully vaccinated – including a two-week period after a final shot – by Nov. 2, the Air Force said in a press release Friday. Air National Guardsmen and reservists have until Dec. 2.

Apparently the military commanders are following their own schedule, regardless of what is being stated publicly by the various branches.

Lawmakers in the U.S. House of Representatives have now proposed legislation that would prevent the military from issuing dishonorable discharges for service members who refuse the COVID-19 vaccine.

Lawmakers Try to Ban Dishonorable Discharges for Troops Who Refuse Mandatory COVID-19 Vaccines

2 Sep 2021
Military.com | By Travis Tritten

House lawmakers have backed legislation prohibiting dishonorable discharges for troops who refuse the COVID-19 vaccine, as the Navy gave its sailors 90 days to get the shot this week and the Army and Air Force were poised Thursday to enforce their own timetables.

Legislation sponsored by Rep. Mark Green, R-Tenn., an Army veteran, requires only honorable discharges for anyone who is separated from the military over refusing to be vaccinated. It was added to the fiscal 2022 defense authorization bill, passed by the House Armed Services Committee on Thursday.

“No American who raises their hand to serve our Nation should be punished for making a highly personal medical decision,” Green said in a statement after the committee vote.

However, service members are telling Health Impact News that this is what some of them are being threatened with, dishonorable discharge, while others have said they have been threatened with demotions and being barred from reenlisting.

Judicial System Again Fails to Protect Constitutional Rights of Citizens by Denying 200,000 Unvaccinated Military a Temporary Restraining Order

On August 17, 2021, two military members filed a lawsuit in federal court in the State of Colorado, claiming that they represented 200,000 service members who were not vaccinated for COVID-19, but that they had previously contracted COVID-19 and recovered, and that therefore there was no need to be vaccinated against COVID-19, as they had “natural immunity.”

On August 24, 2021, Secretary of Defense Lloyd Austin issued a Memorandum for “SENIOR PENTAGON LEADERSHIP COMMANDERS OF THE COMBATANT COMMANDS DEFENSE AGENCY AND DOD FIELD ACTIVITY DIRECTORS” which stated:

I therefore direct the Secretaries of the Military Departments to immediately begin full vaccination of all members of the armed Forces under DoD authority on active duty or in the Ready Reserve, including the National Guard, who are not fully vaccinated against COVID-19. (Source.)

So on August 31, 2021, Todd Callender, counsel for the military Plaintiffs, filed a motion for a Temporary Restraining Order (TRO) to stop this directive from being enforced, which was heard by Judge Raymond P. Moore, who then denied the TRO on September 1, 2021.

The Plaintiffs had expert testimony from an affidavit by Dr. Peter McCullough, stating that “people who have the naturally created antibodies resulting from contracting and recovering from the Virus” should not be vaccinated because “it will do more harm than good.”

Judge Moore rejected his testimony and the evidence provided by the plaintiffs, because it was contrary to what the CDC states.

But Plaintiffs ignore all contrary opinion evidence, including obviously relevant guidance from the Centers for Disease  Control and Prevention (“CDC”) recommending vaccination regardless of whether a person has already had COVID-19 because research has not yet shown people are protected once they recover from the virus.

See Frequently Asked Questions about COVID-19 Vaccination, CDC Website, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html (last visited Sept. 1, 2021).

The Court is not compelled to view Plaintiffs’ evidence in a vacuum or an echo chamber. As a result, the evidence cited by Plaintiffs coupled with their unsubstantiated insistence on their own natural immunity is insufficient to establish a clear and unequivocal right to a TRO under the circumstances of this case. (Read full opinion here.)

Again, to expect relief from COVID-19 vaccine mandates from the judiciary is just not reasonable. The system is rigged. They will quote the CDC, Anthony Fauci, and a whole host of other corrupt government agencies and leaders to deny facts and keep the COVID-19 narrative going that benefits the Pharmaceutical industry and their Wall Street Billionaires and Bankers.

The judiciary works for these Wall Street Billionaires and Bankers, not for the public.

Mass non-compliance is what is needed now, and while there are signs that those in law enforcement and other government agencies are now forming groups to resist (See: Police, Firefighters In LA Form Group To Resist Vaccine Mandates, for example), where are the military commanders who take seriously the oath they took to protect this country and their citizens??

One of the military members that Health Impact News corresponded with today wrote:

As much as I value my uniform, my time in service and fighting back against such obvious abuses of power I’m coming more and more to the realization that this is the new world order, so to speak.

These vaccines aren’t going away no matter how long or how bitterly we fight this in the courts.

It’s time to tell the system to go **** itself and start figuring out how to best take care of ourselves and our families outside of the system.

Our military leadership has no concern for our wellbeing and they have made it clear that they will punish those who can’t see things from their perspective.

I signed up to defend the Constitution and freedom and now my military leadership is intent on violating both. I’m no longer interested in serving my country in this capacity. It’s time to leave while I can still walk to the door.

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Featured image: Pfc. Shaniah Edwards, Medical Detachment, prepares to administer the Moderna COVID-19 vaccine to soldiers and airmen at the Joint Force Headquarters, February 12, 2021. (U.S. Army National Guard photo by Sgt. Leona C. Hendrickson – Source.)

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.

Fair use disclaimer: Some of the links from this article are provided from different sources/sites to give the reader extra information and cite the sources, but does not necessarily mean that I endorse the contents of the site itself. Additionally, I have tried to provide links to the contents that I used from other sites as an educational and/or entertainment means only; if you feel that any information deserves further citation or request to be clarified, please let me know through the contact page.

Featured image by Ahmad Ardity from Pixabay

Hawaiian Whistleblower Claims of Massive Corruption Inside COVID/Nursing Units | “I’ve seen more people pass away from the vaccine than I have on COVID units.”

Faulty PCR tests, mislabeling COVID, and withholding treatment.

With so much uncertainty and censorship going on currently, especially with the COVID/vaccine narrative, it’s incredibly important to allow people’s experiences to be heard. What some may be dealing with in one arena, may not fully encompass what everyone else is going through. Yet the obvious and intrusive manipulation of suppressing people’s testimonies and first-hand accounts has reached an alarming height.

Those who engage themselves in social media and the tech platforms, such as youtube, twitter, facebook, instagram, etc. may find that certain information they’re trying to share is deleted, or shadow-banned, and/or their whole account targeted for “misinformation”.

It’s during these times that it’s more crucial than ever to spread awareness and let these people’s voices be heard.

Mr. Abrien Aguirre shares his experiences and what he sees as what can only be described as malfeasance and misconduct going on at the nursing facility that he works at. I would be willing to bet that he’s not the only one who sees all this corruption. But it takes honesty and compassion to break the silence and admit the truth, even at the risk of one’s career to go against the status quo.

The below video is a transcript of the incredibly important information that Abrien Aguirre shares with an HFSN reporter. Thank you to both HFSN and Mr. Aguirre for bringing this to attention.

All text below is from Abrien Aguirre unless otherwise stated. Some embellishment has been added for emphasis.

Source: bitchute | Hawaii Free Speech News | Abrien Aguirre Hawaii Covid Whistleblower

“My name is Abrien Aguirre, and I’m a board certified, occupational therapy practitioner. And I’m here because I have experience on COVID units. I’ve worked on 3 COVID units, 2 isolation COVID unit, and 1 step down unit. And um, so I’ve witnessed a lot of what I guess the media’s been talking about. And I see how they misrepresented the truth on COVID. The truth on the testing.

For instance, at my facility, I work at the biggest skilled nursing facility here in Oahu, and I work with the geriatric population. The people that were moved to the COVID unit, didn’t have COVID. They tested positive with the PCR test, but most of them were asymptomatic and only suffering from their preexisting conditions. None of them had exacerbated symptoms. Most of them weren’t sick, other than what they were already dealing with. End stage renal failure, diabetes, COPD, congestive heart failure, things of that nature.

I also saw how some of the hospice patients that were moved to the COVID unit, that died of terminal illness were actually put on the COVID death list. Which is complete fraud. And facilities were facilitating this, and doing this the whole time.

More people survived and had no issues and were asymptomatic that were well into their 80’s and 90’s, then that passed away. My entire experience on these COVID units, I think there were… 12 deaths? And none of those deaths could fully be attributed to COVID. It was all preexisting conditions or terminal illness.

Since the rollout of the vaccine, at my facility, Moderna was the vaccine that they administered, I’ve seen 32 elderly people pass away immediately after taking the Moderna vaccine.

None of that is being talked about on the news. None of that is being spoken about, you know, on the media. It doesn’t fit their narrative. I’ve seen more people pass away from the vaccine than I have on COVID units; which is really weird. Seeing that, supposedly we have really high COVID case numbers.

A lot of the patients that I treat are suffering from stroke, and heart attack, hip replacement, knee replacement, things of that nature. So when these people get admitted to the hospital, they have to take a PCR test first. So someone experiencing a heart attack will be picked up by the ambulance, taken to the hospital, the hospital will administer the PCR test; if the PCR test comes back positive, they admit this patient as a COVID patient. They don’t admit them as a heart attack patient. They don’t admit them for myocardial infarction. That’s kind of weird.

I’ve had stroke patients that I’ve treated that were admitted to – or taken to the hospital for stroke but when they get there, PCR test says ‘positive’ so they’re labeled as a COVID admission. Even though when they were there they were never treated for COVID, they were asymptomatic, and they were only treated for their stroke.

So there’s just this huge misrepresentation. Just a complete fraud with this system, with the healthcare system. I worked as a director of rehab for 5 months at another skilled nursing facility here in Kalihi, on Oahu, and at that facility, during my time as being the director of rehab, I’ve seen where the billing department would have my therapist change the ICD-10 medical diagnosis billing code from a pulmonary disorder or COPD, to COVID. Because of higher reimbursement.

Now these people were asymptomatic, some of them may have had a positive PCR, and some of them didn’t have a positive PCR test. But we were still forced to change those ICD-10 diagnosis codes to a COVID code because we get higher reimbursement for those patients.

So it’s just fraud on every level. Just higher reimbursement at medical facilities for someone that’s labeled COVID, whether you treat them for COVID or not. You’re gonna get higher reimbursement. I know this for a fact.

Reporter @4:16: “There’s an ambulance coming, right now.”

Abrien Aguirre: “Oh yeah, so that person, whatever they’re experiencing as soon as they get there, they’re not going to be allowed to be triaged, or admitted, until they have PCR. And if that PCR comes back positive, that person, if they’re having a heart attack, a cerebral vascular accident, anything, it’s going to immediately be labeled COVID instead of what they’re truly experiencing. Absolutely. Yep.

I, I’ve treated patients with heart attack that told me, “Yeah! I had a heart attack. My neighbor found me. They called the ambulance, the ambulance picked me up, resuscitated me, brought me back to life. I went to the hospital; the hospital wouldn’t admit me until I had a PCR test, the PCR test came back positive. I was no longer considered ‘heart attack’ or ‘myocardial infarction’. I was considered “COVID” from that point on.”

Even though they were never treated for COVID, never administered any therapeutics for COVID; treated for their heart attack, sent to our facilities so we can rehab them for those, you know, the weakness and stuff caused by their heart attack. But on our, when they come in, on our medical history, we see them as a COVID admission.

So it’s, it’s just weird fraud on every level, man. And that’s how we’re getting these spike numbers in COVID. Is because, heart attack: “COVID”. Cerebral vascular accident/stroke? You know, bleed in the brain: “COVID”. Like, everything’s coming back COVID. Broken hip/positive PCR: “COVID”.

@5:51: So the funny thing is, I’ve reached out to these politicians. I’ve reached out to Ige, I’ve reached out to Governor Josh Green, I’ve reached out to Rick Blangiardi. I’ve e-mailed, I’ve messaged these people letting them know what’s going on, and it’s silence. None of them get back to me. None of them correspond with me whatsoever. I hear no feedback from them.

I’ve talked to Rick Blangiardi, and Governor Ige – or, I messaged them, and I messaged Josh Green about the hospice patients that were terminally ill that were labeled as COVID deaths; no one’s ever gotten back to me about it. No one’s ever investigated this.

When I worked on the COVID unit, you know who ran the COVID unit? There was no infectious disease nurse. There was no infectious disease doctor. There was no representative from the DOH, Department of Health, that met with us to tell us what the protocol was. It was two certified nurse assistants, two therapists, a physical therapist/occupational therapist, and a registered nurse. That’s who ran the COVID department at Oahu’s biggest skilled nursing facility with the geriatric patients.

I never corresponded or met with Governor, Lieutenant Governor Josh Green. He never assessed the situation. That’s very weird. Why wouldn’t you assess this situation? With this deadly virus? We had no representative from the DOH come down and speak with us. There was no protocol, other than “Move these patients to the COVID unit, isolate them for 14 days. Some of them will make it, some of them won’t.”

Treatment was withheld. They weren’t given treatment. Because they had a positive PCR test, if a person had pneumonia or a flu, there’s this thing called ‘off-labeling’. They’re no longer allowed to be treated for flu or pneumonia. So they weren’t given any antivirals and they weren’t given any antibiotics. Which would normally fight those things. They were moved to a unit, they were told there was no treatment for them; whoever made it, made it – whoever didn’t, you know, didn’t.”

@7:53: “- they are testing us. This one’s from August 25, 2020. Right here, it even states on the printout, it says, “A positive result does not rule out bacterial infection or co-infection with other viruses.The rt-PCR test can’t differentiate between any viruses. It’s in the fine print! In the printout of the rt-PCR test. The inventor of the PCR test admitted that it won’t differentiate between any viruses. Recently, the CDC has even admitted that the rt-PCR test doesn’t differentiate between viruses.

So you have three sources stating that it doesn’t differentiate between viruses. Yet, yet that’s the test we’re using for this case count. That’s the, that’s the test that we’re using; it’s a faulty test. And that’s the one that Governor Green, and all these medical facilities, and it’s my facilities too that I work at, are using to claim these, these COVID statistics. That’s just false. It’s false. It’s a faulty test, it doesn’t differentiate between anything, yet that’s the gold standard right now. And it’s sad. Because there’s so many false positives. There’s so many people that are asymptomatic because it doesn’t differentiate between anything.

@9:09: This is just an infringement on our medical freedom. This is an infringement on our kupuna’s [grandparent/elder/senior citizen] health. I mean, no one’s looking after the health of our kupuna. You know? I’ve seen more death come from the vaccine. 32 kupuna, immediately after taking the Moderna shot, either the 1st or 2nd shot, pass away from this. So who’s looking out for their care?

The people that try to speak up and look out for their care? It falls on deaf ears. No one – no one corresponds back with us. No one wants to hear it cause it doesn’t fit the current narrative. It’s horrible. And I think it’s just going to continue to get worse.

You know, my advice to people, I work in a skilled nursing facility and my advice to people is, if your kupuna are sick, if your elderly are sick, your grandmother, your great-grandmother, your mom, don’t send them to a skilled nursing facility. They’re not going to receive adequate care. Treatment is going to be withheld from them. They’re going to be forced to wear a mask all day. And social distance. They’re going to become depressed and want to commit suicide, because that’s what I’m seeing in our facilities. That’s what’s been going on.”

Reporter: “Thank you so much.”

Abrien Aguirre: “You’re welcome, bro. You’re welcome.”

For more information on treatment, there are many doctors who vouch for the Ivermectin/nutraceutical bundle that may be beneficial in treating these respiratory issues. I am not a doctor, but would encourage more research on this as a possibility to help. One thing that I will say, while the FDA has approved Remdesivir as a treatment for COVID, I would HIGHLY encourage one to do research on this drug (and organization) as well before choosing this as a course…

As it stands currently, the FDA has been accused several times of engaging in corrupt practices, accepting bribes from drug companies, and approving drugs that do more harm than good.

CORRUPTION IN THE FDA
An FDA Whistleblower’s Documents: Commerce, Corruption, and Death

Another notice, seeing as how accurate information is highly suppressed, while only one side of the narrative is highly endorsed, I would suggest using this as a guideline in determining what may be “actual misinformation”, as opposed to “information they don’t want you to see”. Yet with any level of research, discernment and critical thinking is needed, so please keep this in mind.

With that being said, I don’t want to derail the topic too much, I appreciate Abrien Aguirre and the HFSN (Hawaii Free Speech News) for sharing his experience, but also wanted to point out the unnecessary and unhelpful judgements that some people make to try and delegitimize some people’s accounts because of their credentials, or some other strawman excuse to refute credibility.

For instance, because Abrien Aguirre doesn’t work in “infectious diseases” or isn’t a PhD medical doctor, some people will use that as an excuse to automatically dismiss this man’s claims.

However, one of the top leading voices in this whole “pandemic” drive is that of Bill Gates. And what are his credentials? …Well… he’s a college dropout, accused of stealing software tech, and, according to wikipedia: William Henry Gates III is an American business magnate, software developer, investor, author, and philanthropist. He is a co-founder of Microsoft Corporation, along with his late childhood friend Paul Allen.”

So why would these credentials make Bill Gates one of the biggest spokespersons for a mandatory vaccine?

Oh, I forgot to mention his dad, William Gates Sr. – who was head of Planned Parenthood – which is a company born from a history of eugenics and whose founder, Margaret Sanger, specifically aimed for taking out the black population and those deemed “unfit”.

But I’m sure that’s all just a misunderstanding and even though Mr. Bill Gates himself has talked about reducing the population, obviously he doesn’t really mean it that way, right? I mean, that’s just ridiculous. …

And while Abrien Aguirre has been taking care of hospital patients and seeing all of the corruption going on within, where has Bill Gates been? Has he been taking care of patients one on one? Has he been directly in the hospitals, seeing patients being shuffled back and forth; who are being sent in for heart attacks/stroke/leg surgery/kidney stones/etc., etc., etc. yet being labeled as a COVID specific patient if the PCR tests (which are fraudulent to begin with) come back positive? Has he seen the malfeasance and manipulation of data just to get higher reimbursement from the government?

(Oh wait. Who am I kidding? He’s well aware of all the corruption going on, because he’s a key part of it.)

Or has he been in another simulation event planning out the next big cyber/biologic attack? Or meeting with all of his billionaire friends to laugh about the gullible and foolish human beings that believe he’s doing all of this out of the kindness of his heart and that he truly, honestly cares about us all – or perhaps he’s discussing more “philanthropic” ventures that just so happen to make him and his cohorts even richer?

Maybe he’s been hiding in his bunker, hoping that more and more people will take this deadly vaccine so that he can roam free after the chaos dies down. Perhaps he’s working on finalizing his divorce and trying to shut down “rumors” about his connection with Jeffrey Epstein… Going on more news channels to declare that these vaccines are the holy grail and that everyone and their dog needs to get it…

So once again I have to bring up, why would Bill Gates’ words be more credible in relation to this vaccine push, than someone who has firsthand account and eye-witness testimony? Why are the people who are experiencing the horrors of vaccine side effects/deaths in person being silenced and ignored in the media, while a “tech mogul” is plastered all over the news?

My best common sense guess: $$$

I apologize. I derailed quite a bit.

Thank you again to Abrien Aguirre, HFSN, and everyone else who has been speaking out about the corruption going on with this narrative. Yours is the voice that needs to be heard, and I appreciate your courage and integrity to do so. God bless.