Absence of Due Process in COVID-19 Vaccine Approval – Propaganda in Open View
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 Apple, Android, or Alexa.
– https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
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