Tag Archives: SV40

Do DNA Fragments In mRNA Vaccines Cause Cancer?!

Are DNA fragments in mRNA vaccines dangerous, and can they cause cancer?!

Take a look at the viral claim, and find out what the facts really are!

 

Claim : DNA Fragments In mRNA Vaccines Can Cause Cancer!

People are sharing video clips and articles about Florida Surgeon General Joseph Ladapo calling for a halt to mRNA vaccines as they can possibly cause cancer.

Circulating on WhatsApp, with Fox 35 video clip attached : Florida Surgeon General calls for halt to COVID-19 vaccine, citing possible cancer risks

Recommended : Are Residual DNA In mRNA Vaccines Dangerous?!

 

No Evidence DNA Fragments In mRNA Vaccines Cause Cancer!

Let’s take a closer look at these claims about DNA fragments in mRNA vaccines causing cancer, and find out what the facts really are!

Fact #1 : Claims Were Made By Joseph Ladapo

First, I should point out that these videos and articles are based on a 3 January 2024 bulletin sent by the Florida Department of Health, in which its Surgeon General Joseph A. Ladapo called for a halt in the use of mRNA COVID-19 vaccines over concerns that they could cause cancer.

The Surgeon General outlined concerns regarding nucleic acid contaminants in the approved Pfizer and Moderna COVID-19 mRNA vaccines, particularly in the presence of lipid nanoparticle complexes, and Simian Virus 40 (SV40) promoter/enhancer DNA. Lipid nanoparticles are an efficient vehicle for delivery of the mRNA in the COVID-19 vaccines into human cells and may therefore be an equally efficient vehicle for delivering contaminant DNA into human cells. The presence of SV40 promoter/enhancer DNA may also pose a unique and heightened risk of DNA integration into human cells.

Fact #2 : SV40 Promoter Does Not Cause Cancer

Many people are attempting to link the SV40 promoter to the Simian Virus 40, which was suspected to potentially cause cancer in humans after it was found to have contaminated some polio vaccines manufactured from 1955 to 1963.

Decades later, there is still no conclusive evidence that the SV40 virus can cause cancers in humans. However, out of an abundance of caution, the SV40 virus is considered to potentially cause cancer in humans.

Even so, the SV40 promoter is just a DNA fragment from the SV40 virus, that is now used as a genetic tool. It is similar to how botulinum toxin is a treatment derived from the bacteria, Clostridium botulinum. The SV40 promoter itself cannot cause cancer, because it does not include the SV40 virus portion that can potentially cause cancer – the T-antigen.

It’s just the volume knob that drives high level expression of anything put under its control, which in this case is just an antibiotic resistance marker.

The fear about the SV40 sequences is total nonsense. The vaccine is not going to cause cancer. There is no cancer causing gene in the vaccine.

– Phillip Buckhaults, director of the Cancer Genetics Lab at the University of South Carolina

Recommended : Are mRNA Vaccines Contaminated With SV40 DNA?!

Fact #3 : DNA Fragments Not Limited To mRNA Vaccines

So many articles have been written about the residual DNA fragments in mRNA vaccines that one may think that it’s exclusive to the mRNA vaccine technology. That’s not true.

Residual DNA fragments are found in all vaccines and biological products manufactured in any kind of biological cell. The risk of residual DNA has also been investigated for about 60 years now.

To be clear – residual DNA isn’t new or exclusive to mRNA vaccine technology. It is a byproduct of using biological cells to produce biological products.

Fact #4 : DNA Fragments Shown To Be Harmless

In the beginning, some studies raised potential safety issues with residual DNA. So, the FDA set an upper limit of just 10 picograms of residual DNA per medicinal dose in 1985.

In 1986, a WHO study group looked into new cell substrates that are being used to produce biological products, and concluded that the risk is negligible when the amount of residual DNA is 100 picograms per dose.

Then 10 years later – the WHO Expert Committee on Biological Standardization (ECBS) increased the limit to 10 nanograms (ng) per purified dose, albeit not for microbial, diploid, or primary cell cultures.

In 1997, the European Medicines Agency (EMA) said that further data of DNA from continuous mammalian cell lines showed that it poses even less risk than previously thought.

Currently, the WHO and US FDA guidelines recommend that residual DNA in vaccines and other biological products should not exceed 10 nanograms (ng) per purified dose, and the DNA fragments should be no greater than 200 bp in length.

Even that limit appears to be out of an abundance of caution, as studies have not shown any actual danger from residual DNA, as they are tiny fragments.

Recommended : New Study Proves Pfizer mRNA Vaccine Causes Turbo Cancer?!

Fact #5 : DNA Fragments Can’t Integrate With Our Genome

The presence of residual DNA fragments does not mean that they will integrate into our genome. For one thing – these are DNA fragments that have been broken down by the DNase enzyme.

Think of them as parts of a factory which were used to build the mRNA vaccine, but dismantled once the vaccine has been manufactured. Sure, the disposal team may have left a couple of bolts and screws lying on the floor, but can they be used to recreate the factory? No.

In addition, these DNA fragments can only enter the cell nucleus if there is an enzyme called integrase, is not present in any COVID-19 vaccine. So they simply cannot enter the cell nucleus, never mind integrate with DNA.

On top of that, the mRNA vaccines are injected into the muscle, whose cells are “post-mitotic”, which means they are no longer able to change.

Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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Are Residual DNA In mRNA Vaccines Dangerous?!

Are residual DNA impurities in mRNA vaccines dangerous, and can they integrate into our DNA?!

Take a look at the viral claims, and find out what the facts really are!

 

Claim : Residual DNA In mRNA Vaccines Are Dangerous!

Anti-vaccine activists are sharing and/or promoting an article by The Epoch Times, which claimed / suggested that residual DNA in mRNA vaccines are dangerous, and can potentially integrate into our DNA! Here is an excerpt:

Billions of Copies of Residual DNA in a Single Dose of COVID-19 mRNA Vaccine: Preprint

Recommended : Are mRNA Vaccines Contaminated With SV40 DNA?!

 

No Evidence Residual DNA In Vaccines Are Dangerous

Let’s take a closer look at these claims about Residual DNA in vaccines, and find out what the facts really are!

Fact #1 : mRNA Vaccines Were Proven Safe + Effective

First, I should point out that the mRNA vaccines underwent large clinical trials before they received their Emergency Use Authorisation (EUA), and even after that, they continue to be monitored for safety and efficacy.

So health regulators and health authorities are well-aware of how safe and effective the mRNA vaccines are. That’s why new mRNA vaccines continue to be approved by health regulators around the world.

Fact #2 : Residual DNA Is Not New

These papers and articles may suggest that residual DNA is a new kind of contaminant, or one that is only found in mRNA vaccines. Neither are true.

Residual DNA is found in all vaccines and biological products manufactured in any kind of cell. The risk of residual DNA has also been investigated for about 60 years now.

To be clear – residual DNA isn’t new, and it is a byproduct of using cells to produce biologicals, and not part of mRNA vaccine technology.

Recommended : mRNA Vaccines Created Spike Protein In Human Heart?!

Fact #3 : No Evidence Residual DNA Is Dangerous

In the beginning, some studies raised potential safety issues with residual DNA. So, the FDA set an upper limit of just 10 picograms of residual DNA per medicinal dose in 1985.

In 1986, a WHO study group looked into new cell substrates that are being used to produce biological products, and concluded that the risk is negligible when the amount of residual DNA is 100 picograms per dose.

Then 10 years later – the WHO Expert Committee on Biological Standardization (ECBS) increased the limit to 10 nanograms (ng) per purified dose, albeit not for microbial, diploid, or primary cell cultures.

In 1997, the European Medicines Agency (EMA) said that further data of DNA from continuous mammalian cell lines showed that it poses even less risk than previously thought.

Currently, the WHO and US FDA guidelines recommend that residual DNA in vaccines and other biological products should not exceed 10 nanograms (ng) per purified dose, and the DNA fragments should be no greater than 200 bp in length.

Even that limit appears to be out of an abundance of caution, as studies have not shown any actual danger from residual DNA, as they are tiny fragments.

Fact #4 : Residual DNA Is Fragmented Into Tiny Pieces

The production of mRNA vaccines at scale do not use any animal cells, but is done through in vitro transcription (IVT). The enzyme DNase is then used to destroy the DNA template and polymerase used in the reaction, and further filtration can be performed to reduce the amount of DNA fragments.

In other words – the DNA used to produce the mRNA vaccines are broken into tiny pieces, and most of it is filtered out. Think of the remnants as pieces of scrap metal left over from a dismantled chemical factory.

Sure, the workers left a ton of scrap metal pieces behind, but so what? The scrap metal may be an eyesore, but it’s not going to give you cancer, or turn you into Spiderman!

In short – there is no evidence that these tiny fragments of DNA will integrate into your genome, or cause your cells to become cancerous.

Recommended : New Study Proves Pfizer mRNA Vaccine Causes Turbo Cancer?!

Fact #5 : mRNA Vaccines Meet Residual DNA Limits

The David J Speicher et al. preprint (which has not yet peer-reviewed) actually showed that the amount of residual DNA “contamination” was far below FDA regulatory limits.

As Professor David Gorski noted, the study authors found that the residual DNA in the mRNA vaccines was far below regulatory limits, and used a logarithmic scale to make them appear much closer to the limit than they really are:

Basically, by the authors’ own measurements, the amount of DNA/vial fell below the FDA guidance of 10 ng DNA/dose.

Did you also notice the little trick they did? They used a log scale to make the total DNA appear to be much closer to the FDA-recommended limit than it really is.

For instance, in all the Moderna vials, the amount of DNA isn’t half of the recommended limit, it’s less than one-tenth the recommended limit, and, in the case of the ori sequence, well under 1/100 of the limit.

The abstract itself even notes that the authors found DNA at “0.28 – 4.27 ng/dose and 0.22 – 2.43 ng/dose (Pfizer), and 0.01 -0.34 ng/dose and 0.25 – 0.78 ng/dose (Moderna), for ori and spike respectively measured by qPCR.”

So, from McKernan and Rose’s own data, the vial with the very highest concentration of DNA was one Pfizer vial that had less than one-half the maximum DNA amount recommended by the FDA, while the Moderna vial with the most plasmid DNA contamination had less than one-tenth the maximum recommended by the FDA.

In short – even the much touted Speicher preprint itself showed that the amount of residual DNA in mRNA COVID-19 vaccines are far below regulatory limits.

The whole controversy is really much ado about nothing. What a bloody waste of time!

Perhaps that’s why they are repackaging the drama in terms of “billions of copies of residual DNA”, instead of just telling us about the actual quantity they found.

The truth is – there are billions of fragments because the DNA was chopped up pretty damn small to ensure that it would pose no threat. And because the fragments so small, it’s pretty impossible to filter them all out.

Recommended : Did Health Canada Confirm SV40 DNA In Pfizer Vaccine?!

Fact #6 : VAERS Reports Are Unverified

Hilariously, the Speicher et al. preprint suggested that mRNA vaccine vials with higher doses of residual DNA correlated with more adverse reactions, as reported in the Vaccine Adverse Reaction Reports System (VAERS).

As I pointed out many times before, VAERS data is unverified, and notoriously susceptible to abuse, and false reporting. That’s because it’s an open system that anyone – not just doctors, can report anything they want.

In addition, the reports may be duplicated and have not been verified to be related to the vaccine or drug in question. Hence, VAERS specifically warns against using its reports to reach any conclusion about the risks or safety of vaccines / drugs in question.

But that is precisely why anti-vaccination activists love using VAERS data – it’s unverified, and very susceptible to abuse and false reporting.

Fact #7 : Study Showed Fewer Adverse Events With More DNA Fragments!

Even more hilariously, the Speicher et al. preprint actually showed that the detection of more DNA fragments (as determined by Qubit fluorometry) correlated with fewer serious adverse events (SAEs).

In other words – this study has inadvertently “proven” that getting mRNA vaccines with more residual DNA will result in fewer adverse effects!

I meant that only in jest, because the study simply does not prove any correlation. It’s just asinine to even attempt to correlate unverified VAERS reports with quantity of residual DNA fragments in any vaccine.

Recommended : Did EMA Confirm Pfizer Hid SV40 DNA In Vaccine?!

Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!

Protect yourself and your family, by vaccinating against COVID-19 and other preventable diseases!

 

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Support my work through a bank transfer /  PayPal / credit card!

Name : Adrian Wong
Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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Did EMA Confirm Pfizer Hid SV40 DNA In Vaccine?!

Did the EMA (European Medicines Agency) just confirm that Pfizer hid the presence of SV40 DNA in its mRNA COVID-19 vaccine?!

Take a look at the viral claim, and find out what the facts really are!

 

Claim : EMA Confirmed Pfizer Hid SV40 DNA In Vaccine!

Some people are sharing an article by The Epoch Times, which claimed / suggested that the European Medicines Agency just confirmed that Pfizer “hid” the presence of SV40 (Simian Virus 40) DNA in its mRNA vaccine for COVID-19!

Here is an excerpt from that article by The Epoch Times:

European Regulator Confirms Pfizer Did Not Highlight DNA Sequence in COVID-19 Vaccine

Recommended : Are mRNA Vaccines Contaminated With SV40 DNA?!

 

Truth : EMA Did Not Say Pfizer Hid SV40 DNA In Vaccine!

Let’s take a closer look at what the EMA and Health Canada actually said about the presence of SV40 DNA in the Pfizer mRNA vaccine for COVID-19!

Fact #1 : SV40 Promoter Is Not SV40 Virus

First, I should point out that the SV40 promoter is not the SV40 virus. It is unknown if the writers are aware of the difference, or are simply trying to conflate the two to confuse readers.

What you need to know is that gene enhancers and promoters are DNA sequences that stimulate gene expression, and have long been used in molecular biology. The SV40 promoter is merely a DNA sequence that was derived from the SV40 (Simian Virus 40) virus, and is not the same thing as the SV40 virus.

Think of the SV40 promoter as a genetic tool obtained from the SV40 virus, just like how botulinum toxin is a treatment derived from the bacteria, Clostridium botulinum.

Finding botulinum toxin in a vial of Botox does not mean there is bacteria in that vial. Similarly, finding the SV40 promoter in the Pfizer vaccine does not mean there is SV40 virus in the vaccine.

There is no evidence to indicate the presence of SV40, a virus found in monkey kidneys that can potentially cause cancer in humans, in the formulation of COVID-19 vaccines.

– Alessandro Faia, spokesperson for the European Medicines Agency (EMA)

To be clear – mRNA vaccines do not contain the SV40 virus. And the SV40 promoter is not the same thing as the SV40 virus.

Recommended : Are mRNA Vaccines Contaminated With SV40 DNA?!

Fact #2 : Pfizer Submitted Entire Plasmid DNA Sequence

Both Health Canada and EMA pointed out to The Epoch Times that Pfizer submitted the entire DNA sequence of the plasmid, as part of the approval process, but did not highlight the SV40 promoter sequence because it was a non-functional part of the plasmid.

It is unknown if The Epoch Times forgot / missed what Health Canada or the EMA wrote, or they were trying to confuse readers by insinuating that the SV40 promoter sequence was somehow being hidden from regulators.

EMA : We can confirm that an SV40 sequence is present in the DNA plasmid. The sequence is not directly relevant for plasmid production in E. coli or for the mRNA production process so it is considered to be a non-functional part of the structure of the source plasmid.

While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorisation application for Comirnaty, the applicant did not specifically highlight the SV40 sequence, as it was considered to be a non-functional part of the plasmid. They have since clarified this information in response to questions raised by EMA.

Health Canada : Health Canada expects sponsors to identify any biologically functional DNA sequences within a plasmid (such as an SV40 enhancer) at the time of submission. Although the full DNA sequence of the Pfizer plasmid was provided at the time of initial filing, the sponsor did not specifically identify SV40 sequence. When the presence of the SV40 enhancer was raised publicly by McKernan and Buckhaults, it was possible for Health Canada to confirm the presence of the enhancer based on the plasmid DNA sequence submitted by Pfizer against the published SV40 enhancer sequence.

the residual plasmid DNA is present in the final product as DNA fragments, due to the enzyme digestion step in the downstream process. As such, the original risk benefit analysis that supported the initial approval of the Pfizer vaccine continues to be valid.

Recommended : New Study Proves Pfizer mRNA Vaccine Causes Turbo Cancer?!

Fact #3 : Plasmid DNA Are Broken Down + Removed

The production of mRNA vaccines at scale do not use any animal cells, but is done through in vitro transcription (IVT). The enzyme DNase is then used to destroy the DNA template and polymerase used in the reaction, and further filtration can be performed to reduce the amount of DNA fragments.

Health Canada actually wrote a detailed explanation (archive) of why DNA fragments are expected in mRNA vaccine manufacturing, and why the quantity in the vaccines is not a concern.

Plasmids are an essential starting material for the production of mRNA vaccines. During the downstream process in mRNA vaccine manufacturing, the plasmid DNA is digested with enzymes to small fragments, and further removed to a level of not more than 10 ng/human dose, which is in line with the World Health Organization’s recommendation concerning residual DNA in biological drugs. The DNA is digested with enzymes post-transcription.

The European Medicines Agency (EMA) also concurred, stating that the plasmid is broken down and removed during the manufacturing process:

We would also like to point out that during the manufacturing process, this sequence and other plasmid DNA sequences are broken down and removed. Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled.

The WHO has set a recommended limit of 10 ng of residual DNA per dose.

Recommended : Is FDA Refusing To Release Vaccine Myocarditis Results?!

Fact #4 : McKernan Paper Shows Vaccines Meet Regulatory Limit!

The McKernan et al. preprint (which has not yet peer-reviewed) that fuelled the SV40 promoter DNA in Pfizer vaccine controversy, actually showed that the amount of residual DNA “contamination” was far below regulatory limits.

As Professor David Gorski noted, the study authors found that the residual DNA in the mRNA vaccines was far below regulatory limits, and used a logarithmic scale to make them appear much closer to the limit than they really are:

Basically, by the authors’ own measurements, the amount of DNA/vial fell below the FDA guidance of 10 ng DNA/dose.

Did you also notice the little trick they did? They used a log scale to make the total DNA appear to be much closer to the FDA-recommended limit than it really is.

For instance, in all the Moderna vials, the amount of DNA isn’t half of the recommended limit, it’s less than one-tenth the recommended limit, and, in the case of the ori sequence, well under 1/100 of the limit.

The abstract itself even notes that the authors found DNA at “0.28 – 4.27 ng/dose and 0.22 – 2.43 ng/dose (Pfizer), and 0.01 -0.34 ng/dose and 0.25 – 0.78 ng/dose (Moderna), for ori and spike respectively measured by qPCR.”

So, from McKernan and Rose’s own data, the vial with the very highest concentration of DNA was one Pfizer vial that had less than one-half the maximum DNA amount recommended by the FDA, while the Moderna vial with the most plasmid DNA contamination had less than one-tenth the maximum recommended by the FDA.

In short – even the much touted McKernan preprint itself showed that the amount of residual DNA in mRNA COVID-19 vaccines are far below regulatory limits.

The whole controversy is really much ado about nothing. What a bloody waste of time!

Recommended : Did CDC Say COVID Vaccines Cause AIDS + Cancer?!

Fact #5 : Residual DNA Won’t Integrate Into Our Genome

The presence of residual DNA itself does not mean that they will integrate into our genome. For one thing – these are DNA fragments that have been broken down by the DNase enzyme.

Think of the residual DNA as parts of a factory which were used to build the mRNA vaccine, but dismantled once the vaccine has been manufactured. Sure, the disposal team may have left a couple of bolts and screws lying on the floor, but can they be used to recreate the factory? No.

To be clear – neither the COVID-19 vaccines, not any residual DNA they may contain, can change our genome. On top of that, the vaccines are injected into the muscle, whose cells are “post-mitotic”, which means they are no longer able to change.

Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!

 

Please Support My Work!

Support my work through a bank transfer /  PayPal / credit card!

Name : Adrian Wong
Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
Credit Card / Paypal : https://paypal.me/techarp

Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

Recommended Reading

Go Back To > Fact Check | HealthTech ARP

 

Support Tech ARP!

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Are mRNA Vaccines Contaminated With SV40 DNA?!

Are mRNA COVID-19 vaccines from Pfizer and Moderna contaminated with SV40 virus DNA that can cause turbo cancer and other health problems?!

Take a look at the viral claims, and find out what the facts really are!

 

Claim : mRNA Vaccines Are Contaminated With SV40 DNA!

Some people are sharing video clips, messages, and articles which claim that the mRNA COVID-19 vaccines from Pfizer and Moderna are contaminated with SV40 virus DNA that can cause turbo cancer and other health problems!

Jikkyleaks : BOOM 💥💥
Yet another lab confirms therapeutic levels of DNA and SV40 contamination of Pfizer and Moderna “vaccines”

This time, @DJSpeicher & @JesslovesMJK show that the DNA contamination correlates to adverse events (and presumably deaths).

Criminal prosecutions are needed

💙Lyndsey, RN🐭 : Do NOT take Pfizer or Moderna as plasmid dna contamination and SV40 found in the vials that were distributed to the population. BUT the dna and sv40 were not found in the trial vials. HUGE REGULATORY ISSUE THERE FOR YOUR BIG MOMMA AND POP POP!

#VaxInjuries #VaxDeaths

Chuck Callesto : BREAKING REPORT: Pfizer accused of NOT DISCLOSING the presence of the Simian Virus 40 [SV40] DNA sequence in its mRNA COV-D-19 vaccine.

The complete SV40 virus was ELIMINATED from Polio vaccines during the 1950s and 1960s because of concerns about its association with CANCER.

Recommended : Did Health Canada Confirm SV40 DNA In Pfizer Vaccine?!

 

Truth : mRNA Vaccines Are Not Contaminated With SV40 DNA!

This is yet another example of FAKE NEWS created / propagated by anti-vaccine proponents, and here are the reasons why…

Fact #1 : SV40 Promoter Is Not SV40 Virus

First, I should point out that gene promoters are DNA sequences that stimulate gene expression, and have long been used in molecular biology.

The SV40 promoter is a DNA sequence that was derived from the SV40 (Simian Virus 40) virus, and is not the same thing as the SV40 virus DNA. Think of it as a genetic tool obtained from the SV40 virus, just like how botulinum toxin is a treatment derived from the bacteria, Clostridium botulinum.

Finding botulinum toxin in a vial of Botox does not mean there is bacteria in that vial. Similarly, finding the SV40 promoter in the Pfizer vaccine does not mean there is SV40 virus in the vaccine.

According to Professor David Gorski, a professor of surgery and oncology at the Wayne State University School of Medicine, “the SV40 promoter-enhancer is often used in plasmids because it is a very strong promoter that can drive the production of lots of the desired mRNA encoded by the cDNA sequence attached to it.

Fact #2 : SV40 Promoter Is Not Dangerous

Michael Imperiale, a molecular biologist at the University of Michigan Medical School, explained that the SV40 promoter, on its own, can’t cause cancer. The part of SV40 that’s potentially cancer-causing, known as the T-antigen, isn’t present in the vaccine.

Even the scientist whose testimony to the South Carolina Senate has been used to drive this controversy, has come out to dismiss the concerns that the SV40 promoter is dangerous, or can cause cancer:

It’s just the volume knob that drives high level expression of anything put under its control, which in this case is just an antibiotic resistance marker.

The fear about the SV40 sequences is total nonsense. The vaccine is not going to cause cancer. There is no cancer causing gene in the vaccine.

– Phillip Buckhaults, director of the Cancer Genetics Lab at the University of South Carolina

Fact #3 : mRNA Vaccines Are Not Contaminated With SV40 Virus

To be clear – mRNA vaccines do not contain the SV40 virus, because they were manufactured using in vitro transcription (IVT) technology.

The presence of the SV40 virus in some of the polio vaccine manufactured from 1955-1963 occurred because that vaccine was manufactured in monkey kidney cell cultures that were contaminated with the SV40 virus.

Even then, decades later, there is still no conclusive evidence that the SV40 virus can cause cancers in humans. However, out of an abundance of caution, the SV40 virus is considered to potentially cause cancer in humans.

There is no evidence to indicate the presence of SV40, a virus found in monkey kidneys that can potentially cause cancer in humans, in the formulation of COVID-19 vaccines.

– Alessandro Faia, spokesperson for the European Medicines Agency (EMA)

Recommended : Is FDA Refusing To Release Vaccine Myocarditis Results?!

Fact #4 : Health Canada + EMA Confirm Residual DNA Meet Regulations

Health Canada actually wrote a detailed explanation (archive) of why DNA fragments are expected in mRNA vaccine manufacturing, and why the quantity in the vaccines is not a concern.

Plasmids are an essential starting material for the production of mRNA vaccines. During the downstream process in mRNA vaccine manufacturing, the plasmid DNA is digested with enzymes to small fragments, and further removed to a level of not more than 10 ng/human dose, which is in line with the World Health Organization’s recommendation concerning residual DNA in biological drugs. The DNA is digested with enzymes post-transcription.

Health Canada was aware of the presence of residual plasmid DNA as a process-related impurity during review and prior to the authorization of the mRNA COVID-19 vaccines. In addition, the release testing data for every COVID-19 vaccine lot released into the Canadian market were reviewed and deemed to meet the requirements approved by Health Canada. Furthermore, different assays assessing the same vaccine property, or even the same assay being performed in different laboratories, may generate different results.

It is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots are comparable to lots shown to be safe and efficacious in clinical studies.

The European Medicines Agency (EMA) also concurred, stating that the SV40 sequence is considered “a non-functional part” of the DNA plasmid that was used to manufacture the mRNA vaccines:

We can confirm that an SV40 sequence is present in the DNA plasmid. The sequence is not directly relevant for plasmid production in E. coli or for the mRNA production process so it is considered to be a non-functional part of the structure of the source plasmid.

Specific sequences for the non-infectious parts of SV40 are commonly present in plasmids used for manufacturing of biological active substances. The sequence for non-infectious parts of SV40 is only a small fraction of the entire SV40 sequence.

While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorisation application for Comirnaty, the applicant did not specifically highlight the SV40 sequence, as it was considered to be a non-functional part of the plasmid. They have since clarified this information in response to questions raised by EMA.

We would also like to point out that during the manufacturing process, this sequence and other plasmid DNA sequences are broken down and removed. Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled.

In short – the mRNA vaccines meet regulatory limits for residual DNA. This isn’t new or shocking to Health Canada, or the EMA, or other regulatory agencies.

Recommended : Did CDC Say COVID Vaccines Cause AIDS + Cancer?!

Fact #5 : mRNA Vaccines Meet Residual DNA Limits

The production of mRNA vaccines at scale do not use any animal cells, but is done through in vitro transcription (IVT). The enzyme DNase is then used to destroy the DNA template and polymerase used in the reaction, and further filtration can be performed to reduce the amount of DNA fragments.

In Canada, the limit was set at 10 ng of DNA per dose, which is in line with WHO recommendations. According to Health Canada, the mRNA vaccines all comply with this requirement.

The David J Speicher et al. preprint (which has not yet peer-reviewed) actually showed that the amount of residual DNA “contamination” was far below FDA regulatory limits.

As Professor David Gorski noted, the study authors found that the residual DNA in the mRNA vaccines was far below regulatory limits, and used a logarithmic scale to make them appear much closer to the limit than they really are:

Basically, by the authors’ own measurements, the amount of DNA/vial fell below the FDA guidance of 10 ng DNA/dose.

Did you also notice the little trick they did? They used a log scale to make the total DNA appear to be much closer to the FDA-recommended limit than it really is.

For instance, in all the Moderna vials, the amount of DNA isn’t half of the recommended limit, it’s less than one-tenth the recommended limit, and, in the case of the ori sequence, well under 1/100 of the limit.

The abstract itself even notes that the authors found DNA at “0.28 – 4.27 ng/dose and 0.22 – 2.43 ng/dose (Pfizer), and 0.01 -0.34 ng/dose and 0.25 – 0.78 ng/dose (Moderna), for ori and spike respectively measured by qPCR.”

So, from McKernan and Rose’s own data, the vial with the very highest concentration of DNA was one Pfizer vial that had less than one-half the maximum DNA amount recommended by the FDA, while the Moderna vial with the most plasmid DNA contamination had less than one-tenth the maximum recommended by the FDA.

In short – even the much touted Speicher preprint itself showed that the amount of residual DNA in mRNA COVID-19 vaccines are far below regulatory limits.

The whole controversy is really much ado about nothing. What a bloody waste of time!

Recommended : New Study Proves Pfizer mRNA Vaccine Causes Turbo Cancer?!

Fact #6 : Residual DNA Won’t Integrate Into Our Genome

The presence of residual DNA itself does not mean that they will integrate into our genome. For one thing – these are DNA fragments that have been broken down by the DNase enzyme.

Think of them as parts of a factory which were used to build the mRNA vaccine, but dismantled once the vaccine has been manufactured. Sure, the disposal team may have left a couple of bolts and screws lying on the floor, but can they be used to recreate the factory? No.

To be clear – neither the COVID-19 vaccines, not any residual DNA they may contain, can change our genome. On top of that, the vaccines are injected into the muscle, whose cells are “post-mitotic”, which means they are no longer able to change.

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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Did Health Canada Confirm SV40 DNA In Pfizer Vaccine?!

Did Health Canada just confirm the presence of SV40 DNA in the Pfizer mRNA vaccine for COVID-19?!

Take a look at the viral claim, and find out what the facts really are!

 

Claim : Health Canada Confirmed SV40 DNA In Pfizer Vaccine!

Some people are sharing an article by The Epoch Times, which claimed / suggested that Health Canada just confirmed the presence of SV40 (Simian Virus 40) DNA in the Pfizer mRNA vaccine for COVID-19!

Chuck Callesto : BREAKING REPORT: Pfizer accused of NOT DISCLOSING the presence of the Simian Virus 40 [SV40] DNA sequence in its mRNA COV-D-19 vaccine.

The complete SV40 virus was ELIMINATED from Polio vaccines during the 1950s and 1960s because of concerns about its association with CANCER.

Health Canada CONFIRMS Undisclosed Presence of DNA Sequence in Pfizer Shot. -The Epoch TImes

Here is an excerpt from that article by The Epoch Times:

EXCLUSIVE: Health Canada Confirms Undisclosed Presence of DNA Sequence in Pfizer Shot

Recommended : New study shows Cardiac Side Effects of mRNA Vaccines?!

 

Truth : Health Canada Only Confirmed SV40 Enhancer Sequence In Pfizer Vaccine!

Let’s take a closer look at what Health Canada said about the presence of SV40 DNA in the Pfizer mRNA vaccine for COVID-19!

Fact #1 : SV40 Promoter Is Not SV40 Virus

First, I should point out that gene enhancers and promoters are DNA sequences that stimulate gene expression, and have long been used in molecular biology.

The SV40 promoter is a DNA sequence that was derived from the SV40 (Simian Virus 40) virus, and is not the same thing as the SV40 virus DNA. Think of it as a genetic tool obtained from the SV40 virus, just like how botulinum toxin is a treatment derived from the bacteria, Clostridium botulinum.

Finding botulinum toxin in a vial of Botox does not mean there is bacteria in that vial. Similarly, finding the SV40 promoter in the Pfizer vaccine does not mean there is SV40 in the vaccine. To be clear – mRNA vaccines do not contain the SV40 virus:

There is no evidence to indicate the presence of SV40, a virus found in monkey kidneys that can potentially cause cancer in humans, in the formulation of COVID-19 vaccines.

– Alessandro Faia, spokesperson for the European Medicines Agency (EMA)

Fact #2 : Pfizer DNA Plasmid Won’t Integrate With Genome

In response to The Epoch Times‘ question about SV40 plasmids integrating into the genome, Health Canada explained why that is simply not possible (archive):

The Pfizer DNA plasmid used to produce the COVID-19 vaccine is distinct from DNA adenovirus vectors in sequence and biological functions.

Furthermore, the Pfizer plasmid does not contain sequences corresponding to SV40 proteins studied in the paper cited. Therefore, the integration mechanisms described are not applicable.

Recommended : Is FDA Refusing To Release Vaccine Myocarditis Results?!

Fact #3 : Health Canada Confirms mRNA Vaccines Meet Regulatory Limit

Health Canada actually wrote a detailed explanation (archive) of why DNA fragments are expected in mRNA vaccine manufacturing, and why the quantity in the vaccines is not a concern.

Plasmids are an essential starting material for the production of mRNA vaccines. During the downstream process in mRNA vaccine manufacturing, the plasmid DNA is digested with enzymes to small fragments, and further removed to a level of not more than 10 ng/human dose, which is in line with the World Health Organization’s recommendation concerning residual DNA in biological drugs. The DNA is digested with enzymes post-transcription.

Health Canada was aware of the presence of residual plasmid DNA as a process-related impurity during review and prior to the authorization of the mRNA COVID-19 vaccines. In addition, the release testing data for every COVID-19 vaccine lot released into the Canadian market were reviewed and deemed to meet the requirements approved by Health Canada. Furthermore, different assays assessing the same vaccine property, or even the same assay being performed in different laboratories, may generate different results.

It is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots are comparable to lots shown to be safe and efficacious in clinical studies.

In short – the mRNA vaccines approved in Canada meet regulatory limits for residual DNA. This isn’t new or shocking to Health Canada, or other regulatory agencies.

Fact #4 : McKernan Study Is In Dispute

The Epoch Times had earlier written about the McKernan et al. preprint (which has not yet peer-reviewed that fuelled the SV40 promoter DNA in Pfizer vaccine controversy.

The problem though was – the study tested vials of “unknown provenance” which were sent to the authors “anonymously in the mail without cold packs“. Even though they claimed that the vials were “unopened”, it was impossible to know if they were tampered with.

In addition, qualifying residual DNA levels is based on measurements relative to RNA levels. Because the vials were not kept cold, their contents would certainly have been degraded. Since RNA is less stable than DNA and would degrade far more under such conditions, it would likely have resulted in abnormal DNA-RNA levels by the time the tests were conducted.

Finally, the McKernan preprint itself showed that the amount of residual DNA in mRNA COVID-19 vaccines are far below regulatory limits. So it was really much ado about nothing!

Recommended : Did CDC Say COVID Vaccines Cause AIDS + Cancer?!

Fact #5 : SV40 Promoter Does Not Cause Cancer

The Epoch Times article suggested that there is a risk of the SV40 promoter causing cancer. That has been refuted by scientists:

It’s just the volume knob that drives high level expression of anything put under its control, which in this case is just an antibiotic resistance marker.

The fear about the SV40 sequences is total nonsense. The vaccine is not going to cause cancer. There is no cancer causing gene in the vaccine.

– Phillip Buckhaults, director of the Cancer Genetics Lab at the University of South Carolina

The SV40 promoter, on its own, can’t cause cancer. The part of SV40 that’s potentially cancer-causing, known as the T-antigen, isn’t present in the vaccine.

– Michael Imperiale, molecular biologist at the University of Michigan Medical School

Fact #6 : mRNA Vaccines Meet Residual DNA Limits

The production of mRNA vaccines at scale do not use any animal cells, but is done through in vitro transcription (IVT). The enzyme DNase is then used to destroy the DNA template and polymerase used in the reaction, and further filtration can be performed to reduce the amount of DNA fragments.

It was the use of an incorrect DNase stock that resulted in a batch of Pfizer vaccines having more residual DNA than usual – 815 ng of DNA per mL of RNA. Other than that one batch, all other batches had at most – 211 ng of DNA per mL of RNA, which was below the “commercial acceptance criterion” of the European Medicines Agency of ≤330 ng of DNA / per mg of RNA.

In Canada, the limit was set at 10 ng of DNA per dose, which is in line with WHO recommendations. According to Health Canada, the mRNA vaccines all comply with this requirement.

Here is the takeaway – any mRNA vaccine that does not meet regulatory limits would not be allowed to be used.

Recommended : New Study Proves Pfizer mRNA Vaccine Causes Turbo Cancer?!

Fact #7 : Residual DNA Won’t Integrate Into Our Genome

The presence of residual DNA itself does not mean that they will integrate into our genome. For one thing – these are DNA fragments that have been broken down by the DNase enzyme.

Think of them as parts of a factory which was used to build the mRNA vaccine, but dismantled once the vaccine has been manufactured. Sure, the disposal team may have left a couple of bolts and screws lying on the floor, but can they be used to recreate the factory? No.

To be clear – neither the COVID-19 vaccines, not any residual DNA they may contain, can change our genome. On top of that, the vaccines are injected into the muscle, whose cells are “post-mitotic”, which means they are no longer able to change.

Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!

 

Please Support My Work!

Support my work through a bank transfer /  PayPal / credit card!

Name : Adrian Wong
Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
Credit Card / Paypal : https://paypal.me/techarp

Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

Recommended Reading

Go Back To > Fact Check | HealthTech ARP

 

Support Tech ARP!

Please support us by visiting our sponsors, participating in the Tech ARP Forums, or donating to our fund. Thank you!