September 15, 2021

September 15, 2021

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Absence of Due Process in COVID-19 Vaccine Approval – Propaganda in Open View

by | Aug 27, 2021 |

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August 23, 2021, will be recorded in history for schools of public health and classes in regulatory science to reveal how a highly regimented and codified process for a new drug or biologic approval can be manipulated, corrupted, and then falsely represented to the public in order to promote more forced use of a product that is ineffective and unsafe on a reluctant population.  

On this day, the US FDA met with representatives of Pfizer and BioNTech to evaluate the Pfizer-BioNTech vaccine after eight months of use in the public program. What happened was one of the most amazing sleight-of-hand maneuvers performed in pharmaceutical history. 

This product, which is a joint effort from two companies, was split into two legally distinct entities, having minor differences as products, and then moved forward as a pair to leverage the Emergency Use Authorization and the FDA approval processes simultaneously. There were no publicly available briefing booklets from the sponsor(s) or the FDA (usually 80-120 pages), no post-marketing report of safety from the public program, and no corroboration of statistical analysis or missing data. There was no committee of academic and statistical experts to review the results. Instead, a meeting was held between the pharmaceutical companies and the FDA, and legacy data, preceding the Delta outbreak was reviewed, giving the meeting participants the knowingly false impression of high vaccine efficacy which clearly has been lost as the SARS-CoV-2 had mutated. 

Instead of a full committee hearing and a thumbs up or down procedure, a decision was made, and separate letters were issued: 

1) Pfizer was not granted full approval, but instead was given continuance of the EUA and enabling more use of the now ineffective 30 mcg dose of mRNA coding for the extinct wild-type spike protein.

2) BioNTech was granted conditional approval but is required to do post-marketing studies not for efficacy, but for looming serious safety issues, most notably myocarditis. The BioNTech product, now called Comirnaty, is not currently produced, distributed, or marketed, and for Americans, fundamentally will not exist as a distinct product for years. 

This is what the FDA said to the world after the meeting:  

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

All the data from the VAERs system on the Pfizer BNT-162b2 was swept under the rug and not even mentioned in the letters or the proposed package insert. As of August 13, 2021, 13,068 deaths and 225,602 vaccine-related hospitalizations, emergency, and office visits that were carefully reported by concerned health care workers to the CDC and subsequently verified and given permanent VAERS numbers were completely ignored. Not all, but ~45% of these events must have happened as a result of Pfizer BNT-162b2. We will spend the backside of the show on this development.

Our show kicks off with the monologue and inserts from Dr. Christina Parks at the Michigan State hearings on HB 4471 banning employer mandates for vaccines. She impressed me as an articulate young African American scientist as she explained how ~70% of employed African Americans might lose their jobs due to vaccine discrimination.

Next, I have Dr. Ang Peng from Malaysia, who will give us insight on how the government is stonewalling any information on safety or efficacy from the citizens of this Asian country. Finally, on the backside, we have Dr. David Wiseman, a former JNJ scientist who will unpack the historic FDA misconduct and wide-open propagandized talking point of “vaccine approval” when indeed it never happened for the Pfizer product in use today.  

So let’s get real, let’s get loud, on America Out Loud Talk Radio, this is The McCullough Report!

The McCullough Report: Sat/Sun 2 PM ET Encore 7 PM – Internationally recognized Dr. Peter A. McCullough, known for his iconic views on the state of medical truth in America and around the globe, pierces through the thin veil of mainstream media stories that skirt the major issues and provide no tractable basis for durable insight. Listen on iHeart Radio, our world-class media player, or our free apps on AppleAndroid, or Alexa.

 https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
 https://www.youtube.com/watch?v=Jktvh6k0qys

Dr. Peter McCullough

Dr. Peter McCullough is an internist, cardiologist, epidemiologist, in academic medical practice in Dallas, Texas, USA. He maintains ABIM certification in internal medicine and cardiovascular diseases. He practices both internal medicines including the management of common infectious diseases as well as the cardiovascular complications of both the viral infection and the injuries developing after the COVID-19 vaccine.

Since the outset of the pandemic, Dr. McCullough has been a leader in the medical response to the COVID-19 disaster and has published “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine.

He has 46 peer-reviewed publications on the infection and has commented extensively on the medical response to the COVID-19 crisis in TheHill and on FOX NEWS Channel.

On November 19, 2020, Dr. McCullough testified in the US Senate Committee on Homeland Security and Governmental Affairs and throughout 2021 in the Texas Senate Committee on Health and Human Services, Colorado General Assembly, and New Hampshire Senate concerning many aspects of the pandemic response. Dr. McCullough has had one full year of dedicated academic and clinical efforts in combating the SARS-CoV-2 virus and in doing so, has reviewed thousands of reports, participated in scientific congresses, group discussions, press releases, and has been considered among the world's experts on COVID-19.

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concerned med student
concerned med student
18 days ago

I am a medical student currently in the middle of my 3rd year. I want to thank you for all the work that yourself and the members of your COVEXIT group have done for humanity. We applaud your courage and appreciate your dedication to our medical profession.

My clinical-coordinators are mandating that we take the covid vaccines despite medical allergies or religious exemptions. Although I have a documented medical allergy to flu-vaccines, I will be facing dismissal from medical school if I do not comply with covid-vaccination. I have a wife and three small children, and I cannot afford to have any adverse reactions that would affect my health or future career path.
Any advice is appreciated.

Rob
Rob
Reply to  concerned med student
18 days ago

Your health trumps everything else

Crystal
Crystal
Reply to  Rob
17 days ago

staying where your at” means NOTHING, receiving poison ‘ Its NOT a vaccine ” You Say NO” , or get a form ask questions for them to sign off, answer. last part of form You agree if response is satisfactory “” They can’t answer questions

go to thehealthyamerican.org. get Vaccine form

then your Not excaky refusing
don’t take “‘
best of wishes

kim
kim
Reply to  concerned med student
17 days ago

Check out Liberty Counsel website. Attorneys offer legal counsel – I believe at no cost.

Claire Potter
Claire Potter
Reply to  concerned med student
16 days ago

Most states have laws allowing medical exemptions to vaccines. Look into the laws in your state. Robert Barnes at Barnes_Law offers this letter to use https://vivabarneslaw.locals.com/post/889925/vaccine-mandate-protest-letter
The science is on your side. The vaccines are not designed to address the delta variant.

Claire Potter
Claire Potter
Reply to  concerned med student
16 days ago

Can you offer an alternative to take a daily prophylactic? Ivermectin is a proven effective prophylactic against COVID. It is safe and more effective than the vaccines, which wane over time. Here is the protocol: https://covid19criticalcare.com/wp-content/uploads/2020/11/FLCCC-Alliance-I-MASKplus-Protocol-ENGLISH.pdf. The covid19criticalcare.com website has the studies showing effectiveness of ivermectin.

pat
pat
Reply to  concerned med student
16 days ago

Please look into Functional Medicine. https://www.ifm.org/

Dawn
Dawn
Reply to  concerned med student
16 days ago

Hi I recently came across someone who mentioned a governmental agency, an Equal Rights agency where we do have rights and workplaces must work with us to accommodate our situations. I have attached a small photo of the agency website with phone numbers. I hope this helps.
Dawn

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Pam
Pam
Reply to  concerned med student
14 days ago

Sounds like they don’t deserve you. Become a Naturopath or NP and start tour own practice!

Vicky
Vicky
16 days ago

Most people –including scientists, doctors, and other formally educated folks– are rather profoundly perplexed and befuddled by the various absurdities of the Covid crisis (e.g., the back-and-forth shifting of scientific decrees, the censorship of valid data, the presence of toxic graphene oxide nanoparticles in Covid vaccines, etc.). They cannot really make sense out of it all.  At best, they can DESCRIBE the absurdities but they cannot explain why it is happening.

Why is that? It is because they lack pieces of vital knowledge, whose lack hinders and disables accurate coherent full understanding (therefore, it impairs the proper decision-making process and the potential for profound constructive action).

Those “missing” pieces of knowledge right in front of our noses are described in a comprehensive article  called “The 2 Married Pink Elephants In The Historical Room –The Holocaustal Covid-19 Coronavirus Madness: A Sociological Perspective  & Historical Assessment Of The Covid “Phenomenon”” by Rolf Hefti at https://www.rolf-hefti.com/covid-19-coronavirus.html

Without a proper understanding, and full acknowledgment, of the true problem and reality, no real constructive change is possible.

EG
EG
15 days ago

I am being told Comirnaty is the same formulation as the Pfizer vaccine?

Judys
Judys
8 days ago

Bet the dr got a shot. No matter what is published and by whom it has been proved that those with the vaccine who get infected have only a 10% chance of ending up in the ICU much different than those not vaccinated at all. Ask any nurse in ICU

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