Fact Check: Addressing misinformation about excessive DNA in the mRNA vaccines

The TGA puts out a page calling science misinformation.

The TGA has put a new misinformation page up on their website. This will undoubtedly be one day taken down, but we have archived it, so their actions will not be forgotten by history….

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Let us examine some of the TGA claims and see if they might be twisting the truth a little:

• Some of these studies use a very small sample number, for example only three vials. The studies also used samples that were well past their use by date. Some samples had already been opened and used. These samples were not suitable for testing.

In fact Speicher et al, who published their results on a preprint server, surveyed 12 lots, which included 8 vials of Moderna and 4 vials of Pfizer. The expiration dates are shown below.

The study was actually done around April 2024, which is when the three Moderna remnant vials were found, so some of the unopened samples (particularly Pfizer) were in fact more than a year past their expiry date. Nonetheless, according to the study they had been stored properly in a pharmacy fridge for all this time.

• The provenance of the samples is also not clear. This means that significant information is not known about the vials used:

  • where the vials were sourced

  • their location, custody, or temperature before or during testing.

  Regulatory testing is conducted within tightly controlled frameworks to ensure that test samples cannot be manipulated, and results can be relied upon. Processes that do not ensure traceability and certainty about the integrity and provenance of test samples impact the reliability of findings.

• Vaccine vials are required to be shipped via ‘cold chain’ where the temperature must be within a specified range and monitored during transportation. Vials shipped to Australia must adhere to these requirements and the TGA checks that this is done. However, the samples used in these studies were not kept in cold chain and usually did not have temperature loggers with them.

The TGA is being quite disingenuous here: provenance is actually outlined in the article in some detail:

The unopened vials were untampered as they had intact flip-off plastic caps with printed lot numbers and expiration dates. Vials had been stored in a purpose-built vaccine unit at +2-8oC in the pharmacies and were transported in insulated containers with frozen gel packs and placed in the testing laboratory fridge within 5 hours.

The Moderna XBB.1.5 vials were similarly stored by the pharmacy. Vials were removed from the refrigerator, warmed for ~20 minutes, and administered by the pharmacist to patients over ~30 minutes. The remnant vials were placed in an insulated container with frozen gel packs and transported to the testing laboratory fridge within 12 hours.

The TGA claims they have tested the vaccines and found them to be within the limit of residual DNA: in fact, they have not issued the results of these tests, and we don’t even know the provenance or chain of custody of their vials or the source or lot number or anything more about these tests apart from their assertion on this webpage that they are “safe and effective”.

• The manufacturing protocol and test results must be provided to the TGA for each batch of vaccine released in Australia. Every final batch of the mRNA COVID-19 vaccines released in Australia has met the regulatory requirements for residual DNA concentration. To date, the TGA has also independently tested 27 batches of COVID-19 mRNA vaccines by qPCR to confirm the residual DNA concentration in the final product. The vaccines met the required limits for residual DNA.

• The quality limits ensure that there is less than 10 ng present per dose - or less than ten billionths of a gram in each dose. These limits are used by the TGA, the World Health Organization, the United States Food and Drug Administration and other international regulatory agencies.

Speicher et al make the point that qPCR testing does not pick up DNA fragments shorter than 200bp:

The FDA guidelines are also written to only quantitate DNA fragments of 200 bp or greater, in part because fragments smaller than this were not considered to be able to produce a functional gene. However, Klinman et al., suggests that fragments as small as 7bp can pose integration risks. Furthermore, the guidelines may also have considered that fragments of naked DNA shorter than 200 bp would be more rapidly hydrolyzed by host nucleases activity than larger molecules. This accelerated destruction cannot be assumed of the vaccines due to the DNA being encapsulated and protected by the LNPs.

Furthermore the TGA completely fails to mention the presence of an SV40 promoter sequence in the vaccines, the short DNA sequence derived from the Simian Virus 40 that enables DNA that has entered the cell to be integrated into the genome of the host.

Speicher et al have been very careful in what they claim: they actually call for more testing and more rigour. On their webpage the TGA has not matched the academic rigour of Speicher et al, with rigour of their own: instead they essentially brush it all under the carpet, and say “there’s nothing to see here.”

In the past, and still in the present, they have been lying about how many people died from the vaccines, consciously hid vaccine deaths from the public; considering there are over 1000 Covid vaccine deaths in DAEN, their own database, and they acknowledge less than 15 as related to the vaccine, how can we take their word on the DNA contamination, if they won’t even release the details of their own testing?

And the government gave 23 million doses of this poison: and only tested 27 batches? How many vials in each batch did they test? What was the chain of custody? And they didn’t even happen to notice the presence of the SV40 promoter sequence in Pfizer, something that has now been independently verified by 4 researchers, as well as several government health departments (Ontario and one other)?

I anticipate this webpage will eventually go missing, just like they trashed their webpage saying that the vaccines weren’t rushed and changed their mind about Ivermectin (their stupid reason for not allowing Ivermectin to be used to treat Covid was that it might not be available for people who had scabies — gee let’s ban people from using Ivermectin for a [supposedly] deadly virus in case we don’t have enough to treat a non-lethal mite infection.)

When trust has been broken, it must be earned again. Calling skeptical science misinformation is not the way to earn the trust of the Australian public. I was just reading an excellent article by Kevin DeJong, “Is every sin the same in God’s eyes?” The sins of public figures and those in positions of power are much worse in God’s eyes, according to the Bible. The Australian misinformation legislation — if it gets in — will punish the little guy like me for purveying ‘misinformation’ and lets the big fish get away scot free.

And the fact is, that there certainly was SV40 sequences in the vaccine manufacturing process was confirmed by Pfizer in 2023:

CONFIRMATION - ATIP requests to Canada in 2023

Due to the persistence of “Washed up Pharmacist” Maria Gutschi, Scoops McGoo, and Noe Chartier of the Epoch Times’s freedom of information requests (ATIPs) to Health Canada, Pfizer confirmed the presence of SV40 promotersin the vaccine manufacturing process in 2023. They also admitted that they do not know the size of the fragments of DNA in the vials.

Maria Gutschi gives a great, detailed summary in her substack here.

Noe Chartier’s record of events may be found on his X (formerly Twitter) feed here.

The History

Kevin McKernan published his findings on preprint in April of 2023, and made a presentation to the VRBAC (the US Vaccine and Related Biologicals Product Advisory Committee ) committee meeting on June 15, 2023.

Noe Chartier from Epoch Times made a freedom of information request to Health Canada on July 17 2023, asking the following questions:

He also sent them McKernan’s first paper, as well as links to Buckhault’s confirmation of McKernan’s findings.

Pfizer gave a heavily redacted reply confirming the presence of the SV40 promoter in all plasmids used to manufacture Cominarty. (As you may know, the Pfizer vaccine manufacturing process used to make the vaccines that were put into people’s arms was different from the manufacturing process that was used in the vaccines that were initially approved by Canada, Australia, NZ, Great Britain, US, etc. )

Health Canada issued an Issue Analysis Summary one day later demanding that Pfizer clarify the issue of SV40 promoter sequences in the manufacturing process/vaccines.

Noe Chartier from Epoch Times then asked Health Canada to clarify: Health Canada replied that they didn’t know that SV40 sequences were in the vaccines, because Pfizer didn’t tell them.

On July 21, 2023, Kenneth Garry, the chief regulatory officer of the BRDD sent the submission to the regulatory team reviewing the vaccine, including Kevin McKernan’s preprint.

On July 27, 2023, Michael Wall starting drafting the Issue Analysis Summary, concentrating on the fact that Pfizer did not disclose the presence of SV40 promoters in the vaccine.

On August 4, 2023, Health Canada sent a “Quality Clarifax” (Legal clarification document) to Pfizer requesting the following:

Pfizer replied:

Epoch Times’ Noe Chartier sent more questions on August 16:

After more to-ing and fro-ing, the QEES (Quality Evaluation Executive summary) came in on September 25, 2023:

The presence of the SV40 promoter was considered not a concern or a risk to human health…!!!!

In October 2023, the EMA reached out to the FDA on this issue:

Health Canada apologising to CDC for not notifying them sooner of the presence of the SV40 promoter in the vaccine:

Meanwhile, Pfizer was withdrawing the XBB vaccines. Why? If the SV40 promoter sequence was safe, why?

Noe asked this question:

Meanwhile Health Canada was still demanding clarification from Pfizer.

Subscribe if you like these articles — unless I have AU$100,000 in income this year from this substack, I am not technically a news organisation under stupid Australian law, and therefore will be open to $1.6 million fines from the MAD Australian misinformation legislation, should it be voted in next month, and all these articles will disappear and I will be broke and homeless.

Or don’t bother — I am happy to give away these articles for free to most of you — and the truth is even if every one of my subscribers was paying, I would still not be making enough to get near to the $100,000 news organisation figure, but if the MAD legislation gets in I guess I’ll have to close it all down. So Australians please sign the petitions!

God bless you all.

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ADDENDUM: Removed section saying “What a joke” and giving away how much I actually make from the substack, which is not much! God bless.

Speicher, D. J., Rose, J., Gutschi, L. M., Wiseman, D. M., PhD, & McKernan, K. (2023, October 19). DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events. https://doi.org/10.31219/osf.io/mjc97

MAD must Go....