The Pfizer mRNA COVID “Vaccine” Manufacturing Processes Lack Transparency and Consistency. Small Details Matter in Good Manufacturing Processes (GMP).
We are taught that small things matter, that details matter. Do they? In this paper we’ll consider some examples from the past few years where the small things did matter. Some of these stories will be familiar, some not. We’ll consider some root cause failures and then consider how these small failures led to major catastrophes. Then we will consider just one supply chain protocol requirement for the delivery of Pfizer’s COVID-19 vaccine. We also make a call to the regulatory institutions and pharmaceutical companies to provide transparency so that we may pause and assess what appears to be the biggest product failure in history.
Are you aware that Pfizer wrote down $450 million of COVID-19 product inventory in Q3 2022 that had exceeded or was expected to exceed Pfizer’s approved shelf-lives? [Pfizer Security Exchanges Commission FORM 10-Q, period ended Oct. 2, 2022, page 46.] We will help the reader with why manufacturing, transportation, and product shelf life are so important to Pfizer and to the people who have taken their COVID-19 products.
Sadly, these small failures are most acutely measured in deaths. The examples below are definitive. However, the COVID-19 “vaccine” deaths and adverse events are an open book, both in terms of what we know as provided from Pfizer’s own documents and what we do not yet know based upon the growing prior shots and on-going boosters’ data. Let us examine why the small details matter.
In late 2018 and early 2019, two Boeing 737 MAX aircraft crashed leading to the worldwide grounding of the entire fleet of 737 MAX aircraft. Tragically, 189 people died on Lion Air flight 610, and 157 died on the Ethiopian Airlines flight 302.[ Boeing 737 Max crashes: everything you need to know – The Verge] What happened? What led to the grounding of the entire line of Boeing MAX aircraft? Full stop. Grounding. The entire worldwide fleet of 737 MAX aircraft was taken out of service. Why? The post-crash analysis determined that both crashes were caused by a new software system failure of the Maneuvering Characteristics Augmentation System (MCAS). The software activated the MCAS and drove the aircraft to catastrophic failure. Software code. So, a total of 346 people died within five months due to failed software. The entire worldwide fleet was effectively recalled in order to find out what went wrong. Lives were presumably saved by pulling the aircraft out of service to determine and correct the root cause of the problem.
You may not know that according to Pfizer’s “5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021” study [https://www.phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf] that at least 1,200 people died due to the Pfizer “vaccine” within the first 90 days of receiving the shot. Yet the product, approved by the FDA as “safe and effective,” was not recalled. The shipments did not halt. Instead, over 3.6 billion doses were produced and shipped through the second quarter of 2022 including shipments to forty-five “lower income” countries.[ Pfizer Second Quarter 2022 Earnings Highlights]
Many recall the awful moment in January of 1986 when the Space Shuttle Challenger broke apart just over one minute after launch killing all seven crew members.[ The Space Shuttle Challenger Explosion and the O-ring – Priceonomics] We had media coverage 24/7 assessing the crew members’ backgrounds, the potential cause of failure, speculation on the future impact on NASA, the contractors responsible for the failure, and the future of manned flight. What caused this failure? It was determined, after much study and analysis, that an O-ring, a circular gasket that sealed one of the rocket boosters, was the root cause of the failure. It failed due to the low outside air temperature (31◦F/-.5◦C) leading up to the launch. What was noteworthy in this example is that several engineers noted the risk, but those warnings were ignored by NASA management.
Similarly, there are Pfizer whistleblowers. Let’s now consider one element of Pfizer’s process controls. We now know the Pfizer “vaccine” clinical trial data were faulty. Whistleblowers came forward. One, Brook Jackson, was fired. In addition to the ignored red flags that the trials were terribly flawed, we are learning that Pfizer’s packaging and shipping protocol is also problematic. Pfizer also required a specific temperature range and cold storage specifications for the “vaccines” to ensure that the “vaccine” remained robust. Yet, as of this writing, we do not know what is in the “vaccine,” what happens when the product falls out of specification, and who ensures the packaging, shipping, and pre-use of the vials meets the specifications. Simply put, we do not know if any audits were performed to ensure the specifications matter.
Most do not know what a jackscrew is, or why it is a small but significant part for aircraft. On January 30, 2000, Alaskan Air Flight 261 from Puerto Vallarta, Mexico, to Seattle, Washington, crashed into the Pacific killing eighty-eight.[CNN.com – Screw blamed for Alaska Airlines crash – Dec. 9, 2002] The investigation isolated a jackscrew – a single, inexpensive component of the assembly. The jackscrew is essential to keep the aircraft flying in a stable manner since it is a part of the horizontal stabilizer. A lack of lubrication of the jackscrew caused excessive wear and caused the gimbal nut — which moves the two-foot jackscrew up and down to adjust the stabilizer — to fail. Contributing factors, including a lack of Federal Aviation Administration (FAA) oversight of Alaska Airlines maintenance operations and faulty design of the jackscrew assembly, left no backup system when the jackscrew failed.
Unlike the FAA, there is apparently little to no oversight over the Pfizer clinical trial or 5.3.6 post-marketing study. That study indicates over eight full pages of almost twelve hundred adverse events and over twelve hundred deaths within the first ninety days of the “vaccine” rollout, which started in the United Kingdom on December 1, 2020. And yet it appears with growing certainty we have a much, much bigger problem.
Does it matter where a sub-component is produced? Who tests to ensure quality specifications are met throughout an extended supply chain. Several years ago, there was a problem with some toothpaste. In China, a supplier used diethylene glycol in the manufacturing process because it was less expensive than the specified glycerin.[China Investigates Contaminated Toothpaste – The New York Times (nytimes.com)] “You know, if you’re in the export market, the margins are small, so people use the substitute,” Hu Keyu, the manager at Goldcredit International, said. “Even one percent or half a percent price difference can matter to people here.” Diethylene glycol is the same poison that the Panamanian government unwittingly mixed into cold medicine killing 115 people [https://www.nytimes.com/2008/02/14/world/americas/14panama.html]. In that case, the poison falsely labeled as glycerin, a harmless syrup, originated in China, shipping records show. Diethylene glycol is generally less expensive than its chemical cousin glycerin. Process controls matter.
All Pfizer-BioNTech COVID-19 “vaccine” products, including the bivalent “vaccine” product, can be transported globally at ultra-cold or refrigerated temperatures. We are assured the “vaccine” was transported using a portable freezer, refrigerator, or a container qualified to maintain appropriate temperatures. Each container should have a temperature monitoring device with a digital data logger that displays minimum and maximum temperatures. The Transport Temperature Log is necessary to record minimum and maximum temperature. At shipment? No. Recordings are at the start of transport, when the storage container is opened, upon arrival, at the end of transport, and at the time used for transport. Significantly, the logger is also supposed to be used at the clinic sites as part of any beyond-use timeframes. The protocol is granular in nature. For example, the transport container loaded with the “vaccines” must be delivered in the passenger compartment, and not the trunk, of the vehicle. How does that work with trucks and aircraft?
An on-site storage unit is required at the clinic site. These containers must maintain required temperatures. If no storage unit is available, then the product must be kept in the transport container to maintain the appropriate temperatures. That does not sound comforting — especially if you were one of the many who received the “vaccine” in a parking lot after waiting in a carpool line. I did not see a freezer, refrigerator, or transport container. Did you?
Someone is supposed to ensure there is an adequate number of temperature-controlled storage containers that can maintain the required storage temperature. And these specialty containers must be located in the preparation area and vaccine administration stations. Service providers are instructed to ”…only transport and prepare the amount of vaccine needed.” How did they know those numbers in advance? Like an accounting inventory management system, the service providers are to ensure the “vaccine” that is prepared first is administered first.[Vaccines Storage and Handling Toolkit | CDC] Where are the audit reports for the shipping controls and inventory management?
For some unknown reason, on February 25, 2021, the U.S. health regulators would “soon give Pfizer and its partner BioNTech permission to store their coronavirus vaccine at standard freezer temperatures instead of ultra-cold conditions.” [https://www.webmd.com/vaccines/covid-19-vaccine/news/20210224/fda-may-allow-pfizer-to-lower-vaccine-storage-temps] Why? According to Pfizer data submitted to the Food and Drug Administration (FDA), their product could be “stored for up to two weeks at -25 to -15 degrees Celsius, or -13 to 5 degrees Fahrenheit.” The labels on the Pfizer/BioNTech “vaccine” require the product to be stored in ultra-cold freezers at temperatures between -80ºC and -60ºC (-112ºF to -76ºF). Those temperatures allow for the product to be stored up to six months. Do we know who is monitoring how long these “vaccine” products are stored and where? Stunningly, Pfizer claims in their news release requesting permissions to store the “vaccines” in standard containers that may use dry ice, but only if the container is refilled every five days, to extend the product life for thirty days.
It is worth pointing out that dry ice is considered a “dangerous good” for transport purposes.[Dry Ice Tip Sheet | Environment, Health and Safety (cornell.edu)] Precautions include wearing closed toed shoes, a lab coat that covers the ankles, eye protection, and loose fitting thermal gloves, with containers that are appropriate. We have no way of knowing if Pfizer informed those subjected to any use of dry ice of the common safety precautions for safe handling. I certainly did not see ultra-cold refrigerators in the parking lot where my “vaccines” were administered. It is also very comforting to know that Pfizer chairman and CEO, Albert Bourla, stated, “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”[https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-data] Notice the lack of concern about the patient or the service providers administering their product.
This complex process gets a bit stickier. Though Pfizer submitted data to the FDA to demonstrate that their COVID-19 “vaccine” remains stable after storage of the undiluted vials for up to two weeks at standard freezer temperature, the “alternative temperature for storage of frozen vials is not applicable to the storage of thawed vials before dilution (which can be held in the refrigerator for up to 5 days), or on the storage of thawed vials after dilution (which can be held at refrigerator temperature or room temperature for use within 6 hours)”.[Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine | FDA] Did you receive informed consent regarding the known adverse events associated with the “vaccine?” How many are comfortable that those administering the “vaccine” were consistently meeting the alternate frozen vial storage steps listed above?
Is this storage protocol important? It is to Pfizer. In their own third quarter 2022 10-Q financial filing, they reported they “had a $450 million inventory write-off for COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives.”[https://s28.q4cdn.com/781576035/files/doc_financials/2022/q3/05c570ca-2592-481c-adfc-0d98e644db88.pdf]
To add to the confusion, Pfizer implemented a color-coding system for their vials. Ages 12 and older are purple, while ages six months through four years are maroon. “Use storage labels to help staff easily identify the correct product (monovalent or bivalent) based on the recipient’s age” may not be as easy as suggested.[https://ab1ee995966d418da4b12a48bc7a4390.marketingusercontent.com/m/messagecontent/Jmp0O3c8nmkxefBmkd1nGfMmcOglhky6LPeiOgnxw58x] Where I come from maroon is a shade of purple. Pfizer’s “best practice,” as explained on page 21 of their Storage Handling Toolkit [https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, p. 20], instructs providers to “check the vial to ensure it is the correct vaccine.” There is no mention of the color. How many billions of these vials were shipped?
Do we know the entire supply chain for the “vaccines?” How can we, when we do not know what is in the “vaccines” or who supplied enabling technologies? Who checked to ensure the vials doses meet the specifications at each stop in the supply chain? We do not know. We do know, according to the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS) that over 31,000 people have died from the “vaccine” — not from COVID-19, but from the “vaccine.” Yet the “vaccines” continue; they have not been halted. Should the experimental “vaccine” have been halted based upon the faulty trial? Should it have been halted after Pfizer released their own 5.3.6 “CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS” indicating more deaths than the total of each example provided above that did lead to product recalls?
Is product degradation due to lack of shipping controls one root cause for this catastrophic medical failure? Keep in mind that in 2001 Bayer, A.G.’s voluntarily pulled Baycol, a cholesterol-lowering drug after it was tied to thirty-one deaths in the U.S. [https://www.nytimes.com/2001/08/09/us/anticholesterol-drug-pulled-after-link-with-31-deaths.html]
Shockingly, the only thing FDA did was halt release of the clinical trial data. They had it sealed for seventy-five years. We now know why. Only a lawsuit by Aaron Siri forced the FDA to release the documents. Consider the number of unexpected deaths across age groups in the 5.3.6 “CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021.” Within 90 days, Pfizer was aware of 1,223 deaths from their “vaccine,” yet administration of the drug to the public was not halted. There was no further study to determine on-going harms. Over 31,000 deaths and 250,000 serious injuries have been reported to the CDC’s Vaccine Adverse Event Reporting System (VAERS) through the end of October 2022.
It should be clear that details matter, small enabling components matter, quality assurance matters, and process audits matter, especially when lives are on the line and extended supply chains are a key to high-value assets like aircraft and pharmaceuticals. It now is becoming increasingly clear the Pfizer COVID-19 “vaccines” are a health disaster, a disaster unlike any before, a disaster that defies belief. Consider that the 31,000 “vaccine” deaths, as reported in VAERS equates to 157 Boeing 737 MAX aircraft crashes since December of 2020. It took two for the FAA to ground those aircraft. Yet the FDA and CDC have not halted COVID “vaccines.” They have instead approved them for children. Let that sink in.
We are now learning of lipid nanoparticles, spike proteins, and other components in the “vaccine,” but we do not receive any transparency on what else is included. Nor do we have full disclosure on the growing number of deaths and serious adverse events that may be caused, not by COVID-19, but by the “vaccines” authorized under an Emergency Use Authorization (EUA). We learn of supply chain partners from China, but we have no transparency on the quality control of their manufacturing processes and subsequent audits to ensure adherence to Good Manufacturing Practices (GMP). We learn of complicated cold storage requirements and strict controls, but we have not received any transparency on quality controls or subsequent audits to ensure adherence.
And what does Pfizer do? Supply chain audits? Cold chain integrity reports to affirm protocols are met and patients are safe? No. They promote their unchallenged process through Gartner. Did you know Gartner awarded Pfizer their “Customer of Patient Innovation of the Year and Breakthrough of the Year?” For what? Why, for “Deep-freezing the Supply Chain to Bring the COVID -19 Vaccine to the World.”[Gartner Power of the Profession™ Supply Chain Awards | Semi-finalists & Finalists] Technology — that is why.
Why have these drugs been approved? Why are they continuing to be approved? Why have they not been recalled? Why is Pfizer winning awards for their deep-freezing methodology? We have no insight into safety audits. Those charged with protecting our health have consistently and continuously claimed, even to this day, that the “vaccines” are” safe and effective.” It is quite clear they are not.
Little things do matter. Jackscrews, software code, O-rings, and even maintaining the temperature on pharmaceutical products being injected into a global population that now includes children. Do we have any documentation that temperature controls, very stringent temperature controls, can be met? No, we do not. We also do not have any studies that explain what exactly happens when those products, the Pfizer COVID “vaccine” products, fall out of the stringent temperature specification. What we do have is an ever-increasing number of people dropping dead unexpectedly or having permanent health issues.
Sadly, so many are now seeing the ramifications of the “vaccine,” a “vaccine” from a virus that almost everyone has a 99% chance of surviving. Details do matter, ask anyone who was on the receiving side of an adverse event or knows of a loved one who died due to the “vaccine.”
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