Australia's Experience with COVID-19 Vaccine Batch Variability

The cynical side of me always wonders about the actual content of those vaccine vials that are used when politicians and other high profile people get their COVID-19 vaccines as part of a publicity stunt.  Perhaps there is "nothing to see here, just move along" but recent information from Australia that was released as part of a Freedom of Information request suggests that all may not be what it appears to be.  Thanks to a relatively recent Twitter thread by Jikkyleaks, we now have data from a Freedom of Information Request made to the Australian Government's Department of Health, Therapeutic Goods Administration back in December 2021 which has just been released which may help us to better understand the rollout of the COVID-19 vaccines.

 

On the Australian Government's Department of Health, Therapeutic Goods Administration's (TGA) website, we find the "Batch release assessment of COVID-19 vaccines" which the TGA uses to 

"...ensure(s) there is an independent quality assessment of every batch vaccine supplied in Australia".  

To ensure that manufacturing standards are maintained and to set up how the quality of the vaccine will be maintained in future batches, the batch assessment involves one or both of the following steps:

 

1.) A review of documents supplied by the Sponsor which describe the manufacturing process (how the vaccine is made, tested, shipped and stored).

2.) TGA laboratory testing (and/or review of testing results from an overseas regulatory laboratory that has been recognised by the TGA) to ensure the vaccine has been manufactured according to the required standards.

The TGA's laboratory may carry out a range of tests, including assessments for composition, identity, potency, purity and adventitious agents (contamination with microorganisms).

 

The TGA notes that batch release assessment is particularly important for provisionally approved vaccines like the COVID-19 vaccines and has provided the public with their assessment of 382 different batches of Pfizer's Comirnaty COVID-19 vaccine

 

This is what the TGA's batch assessment database looks like, noting that the database includes the manufacturer's batch number, what was tested and whether it passed:

 

Now, let's look at some interesting anomalies:

 

 

Batches FF0884, FA 4598FE3064, FA7338, FA7812, FC8736 and FC 3558 were (at least in part) reserved for use in Pfizer Australia's employee vaccination program, were all limited quantity batches that were not tested by TGA Laboratories, rather, the TGA accepted overseas certification from the Official Control Authority Batch Release or OCABR process in Europe.  One would wonder why this would be the case.  Can anyone explain why vials from these seven batches were reserved for Pfizer insiders?  

  

Perhaps we have part of the answer here which was released under Freedom of Information request 4077 dated December 6, 2021 as shown here:

 

...which reports dose batch number and deaths associated with each batch keeping in mind that this is only a small fraction of the total number of deaths reported to the TGA and that each row in the spreadsheet represents a person who died:

 

It looks like Comirnaty batch FL5333 was a particularly nasty one when it came to death after vaccination which was passed by TGA Laboratories on November 4, 2021 as shown here

In case you weren't aware, it appears that certain batches of COVID-19 vaccines had more reports of adverse reactions as reported on the How Bad is My Batch website as shown here:

I'll let you mull this information over and I'm open to any comments about whether or not we should all remain cynical about the veracity of the COVID-19 vaccination program for the global ruling class.

What Big Pharma Doesn't Know About the COVID-19 Vaccines

While the mainstream media, public health officials and politicians would have us believe that the COVID-19 vaccines are well understood and that any negative side effects are either minimal or inconsequential in fact, as you will see in this posting, such decrees could not be further from the truth.

  

Here is a screen capture showing the lead page of a document entitled Summary Basis for Regulatory Action that appeared on the Food and Drug Administration website dated November 8, 2021, keeping in mind that this is nearly 11 months after the first COVID-19 vaccine was administered in the United States (December 14, 2020):

 

This is the FDA's approval document for the COMIRNATY vaccine manufactured by Pfizer and BioNTech and, in this case, was in response to BioNTech's application for approval dated May 18, 2021.

  

The 30 page-long document goes on to outline the chemistry, manufacturing and controls of COMIRNATY, clinical and nonclinical pharmacology, toxicology as well as safety and pharmacovigilance information.  

 

Before we go any further and so that you can understand one of the terms in this posting, let's look at the definition for "humoral response" also known as humoral immune response:

 

"The humoral immune response fights pathogens that are free in the bodily fluids, or “humours”. It relies on antigens (which are also often free in the humours) to detect these pathogens. An antigen is a biomolecule, such as a protein or sugar, that binds to a specific antibody. An antibody/antigen interaction may stimulate an immune response. Not every biomolecule is antigenic and not all antigens produce an immune response. B cells are the major cell type involved in the humoral immune response. When a foreign antigen (one coming from a pathogen, for example) is detected, B cells in the body that recognize that antigen will begin to produce antibodies as a means of fighting off the foreign invader."

  

Basically, humoral immunity is the human body's response to the detection of foreign material (antigens).

  

Now, let's look at section 5 "Clinical Pharmacology" as found on page 15 in the aforementioned document.  Here is the page in its entirety with a pertinent section highlighted:

 

The manufacturer of the COMIRNATY mRNA COVID-19 vaccine is aware that the human body responded to the administration of the vaccine by creating an immune response against the SARS-CoV-2 spike protein however, "the exact immunologic mechanism that confers protection against SARS-CoV-2 is unknown."

 

Let's boil this down.  Despite the fact that Big Pharma doesn't understand the immunological mechanism behind their COVID-19 vaccine, they went ahead and requested (and received) approval for widespread administration of COMIRNATY.  That said, it would also be the case that they can't possibly understand the mechanisms that create negative side effects of this product as well, particularly over the medium- and long-term.

 

But, we won't hear that from the mainstream media, public health officials or politicians, will we?  Their philosophy has been to force us to get our COVID-19 vaccines so that we can get some of ourr rights back.

Pfizer's Comirnaty and the Great Unknowns

On its COVID-Vaccine website, the Canadian government recently posted an updated product monograph dated June 1, 2022 for Comirnaty, the Pfizer-BioNTech mRNA COVID-19 vaccine that has been heavily promoted by the Canadian government and provincial public health officials:

 

Let's look at some of the interesting sections/subsections, keeping in mind that Canadians have been repeatedly assured that the vaccine is perfectly safe for virtually everyone:

  

1.) Pregnant Women:

 

2.) Breastfeeding:

 

Here is what the Canadian government has to say about COVID-19 vaccination, pregnancy and breastfeeding:

 

Apparently, Health Canada knows more about Comirnaty's safety than the manufacturer knows about its own product!

 

3.) Drug Interactions:

 

The fine folks at the Mayo Clinic have some ideas on drug interactions with COVID-19 vaccines:

 

 

...as do those at the Cleveland Clinic:

 

...this research that appears on the NIH website:

 

...and even the physicians in Manitoba, Canada offer conflicting/confusing advice on potential drug interactions:

 

4.) Genotoxicity: defined as the ability of a chemical compound to cause alterations at the genetic level

5.) Carcinogenicity:

How on earth does Pfizer know that both genotoxicity and carcinogenicity are not "relevant to this vaccine" if the drug has been administered for less than two years?

Pfizer has had over two years to fully understand the possible contraindications of its COVID-19 vaccine and since December 14, 2020 when the first Canadian received the vaccine to explore four of the key variables that could impact post-vaccination patient health.  But then again, as Canada's high school drama teacher and current Prime Minister Justin Trudeau said back in May 2021:

 

"Make sure you get your shot when it's your turn. We are continuing to recommend to everyone to get vaccinated as quickly as possible so we can get through this…”

...because he knows all about vaccine "syense".