Pfizer refused to serialize its SARS-CoV-2 injections, even though it was a legal requirement
Pfizer refused to serialize its SARS-CoV-2 injections, even though it was a legal requirement
What is Serialization?
Serialization is a mandatory requirement in the pharmaceutical industry. It was introduced in order to protect against counterfeit or other misbranded products entering the legitimate supply chain.
This article, Serialization in the Pharmaceutical Industry, provides useful information, including this extract:
The precondition for protection against counterfeit medicines is to produce a barcode (2d data matrix) that gives all production data (GTIN [Global Trade Item Number], expiration date, lot number) for one unit medicine. This distinctive marking ensures the authenticity and integrity of the medicine so that the manufacturer ensures that all the medicines are protected from intervention.”
Note the reference to one unit medicine. This means that the manufacturer must apply a 2D barcode to every unit of finished product produced and upload their manufacturing information to a central database. As the product moves through the distribution to patients, the barcode can be scanned and checked for authenticity, or not.
A subscriber made the connection
I was aware that this could not have happened with the Pfizer and Moderna vaccines, because they left the manufacturer frozen and in vials containing 5 doses, not a single dose. What I didn’t know was this comment in the Newsletter below, from a subscriber
““Curious to note the leaked Pfizer contract(s) state "the Participating Member State acknowledges that the Vaccine shall not be serialized."“
Read more here, or skip on:
FDA definition of batch and batch number
Now we need to go onto FDA definitions:
Batch means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
Lot number, control number, or batch number means any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.
Hedley explains with the help of wallpaper (recording):
Key takeaway
The mRNA vaccines were only part-finished, and not unit doses, when they left the manufacturer, so could not have been serialized. They also had to bypass the long-established wholesale distribution networks in the various countries, because they were not geared up for frozen or ultra-frozen temperatures. These wholesale distributors must have licenses, based on compliance with Good Distribution Practice (GDP), before they are allowed to operate. This all amounts to gross non-compliance with safe working practices, in place to keep patients safe from errors and malintent.
Aside from the mRNA technology, this was my biggest concerns about the shots. Quality control processes that are common across the manufacturing and production of safety critical parts or finished products regardless of type - pharmaceutical, nuclear, aerospace or any other product where failure results in a significant risk of loss of human life.
I have significant experience in both nuclear power and jet engine technologies; quality processes during the manufacturing and production activities are critical to ensuring safe and effective products in both industries. For instance, the high pressure turbine disc in a jet engine is a safety critical part that has extremely meticulous manufacturing and inspection requirements. Each disc is serialized and the manufacturing pedigree is documented throughout production. A high pressure turbine disc is located in the "core" of a jet engine, which is where combustion takes place and engine power is generated. High pressure turbine blades are attached to the high pressure turbine disc. There are multiple blade-disc assemblies in the core and they spins at roughly 12,000 to 16,000 RPMs. There is an incredible about of kinetic energy stored and moving through the blade-disc assembly during operation. That energy tends to want to pull the disc apart due to centrifugal forces - many experience this phenomenon on amusement park rides such as the tilt-a-whirl or spider, where riders are thrust to the outside of the carriage while the ride spins on multiple axis'. Jet engines are designed to be as light as possible, so material strength and conformance to specified manufacturing geometries and tolerances is critical in ensuring that the disc holds together during operation. If the disc fails, the resulting effect looks like an explosion similar to a fragmentary grenade. There are also fan discs and low-pressure turbine discs in a jet engine. They all have similar quality requirements. United Airlines Flight 232 Crash in Sioux City was probably the most notable example of a mid-flight disc failure. The failure happened in the fan disc on the engine located in the tail section. That flight was actually somewhat lucky as some of the passengers survived the crash. During that flight, a fan disc failed and the resulting fragments cut the airplane's hydraulic lines. The lucky part is that the failure happened in the tail engine and the fragments did not catastrophically damage the fuselage and fuel tanks, enabling the pilots to attempt an emergency landing, albeit with little to no control over the airplane control surfaces (rudder, flaps, ailerons etc...) due to the loss of hydraulic power. Even a small scratch on the surface of a disc can render the disc unsafe and unusable. I am talking about a surface scratch less than 1 inch long and 0.001" deep, for reference, the average human hair is about 0.005" in diameter. The NTSB report can be seen here https://www.ntsb.gov/investigations/AccidentReports/Reports/AAR-90-06.pdf
Skip to page 74 for the accident sequence and description of the failure. The pilot's and crew's actions were heroic and impressive. The movie "Crash Landing in Sioux City" tells the story well https://www.imdb.com/title/tt0697258/
Quality processes in manufacturing, handling, and assembly are paramount in ensuring that critical parts and products are safe. In the COVID Vax tragedy, doctors and medical staff are like the pilots and flight crew of an airplane, they are responsible for the safety if patients. Unfortunately, unlike the heroes of flight 232, the vast majority of doctors and nurses are villains and co-conspirators in a crime against humanity.
Over time reports have been given about the vials being kept at -70oC and kept at special units that could cope with these temperatures and then as time went by there didn't seem to be the need for temperatures so low?
Were the vaccines designed like this to get around GDP?