Unacceptable Jessica cross-posted a post from Maria Gutschi
Jessica Rose Oct 28 · Unacceptable Jessica Please read!
Health Canada, SV40 and ATIPs: Part 2 September to October 2023 Insights from the various ATIPs and an in-depth analysis WASHED UP PHARMACIST AND SCOOPS MCGOO OCT 28
This is a continuation of Part 1 which documents the ATIPs at Health Canada and the presence of SV40 sequences. I’ve been asked to write a brief Executive Summary which I am generally reluctant to do, since you can lose detail and context, and then these statements can be used against the writer. However, we wrote a very short summary. Please scroll to the end.
Thank you again to Karen Rucas who organized the emails by data and pointed out some important changes in the drafting of Health Canada responses to media.
In Part 1, we left at the completion of the XBB vaccine review by the Quality division of the Centres Vaccines, Clinical Trials and Biostatistics (CVCTB)
Health Canada, SV40 and ATIPs: Part 1 July to August 2023 Health Canada, SV40 and ATIPs: Part 1 July to August 2023 WASHED UP PHARMACIST AND SCOOPS MCGOO · OCT 21 Read full story 1. Dr Phillip Buckhaults Presents to the US South Carolina Senate
September 12, 2023
This video was shared widely on social media. I suspect Health Canada was also aware of Dr Buckhaults’ presentation. Dr Buckhaults does a lot of sequencing of the human genome and what can lead to cancer and what does not. He calls himself a “cancer gene jockey.”
Video of Dr Buckhaults presentation
He explains how pieces of naked DNA allowed in protein vaccines at a certain threshold were not so problematic in a different era but with encapsulation in liposomes/nanoparticles, they can now easily get into cells. If they get into cells they can integrate in the genome which is permanent, long lasting, and has a theoretical risk of causing cancer depending on where in the genome they integrate. He says short pieces of DNA are analogous to buckshot and therefore can increase the hazard of genomic integration.
These are his short and well explained slides that he used at that presentation. Worth viewing, imho.
2. Health Canada Officially Approves the XBB 1.5 Vaccines
September 12, 2023
Dr Supriya Sharma gives a Press Conference on the approval of the Moderna XBB 1.5 vaccine ONLY. Regarding the Pfizer vaccine she says that Pfizer (and Novavax) are being reviewed on a priority basis and that there are “many factors” which could influence the timing of their approval. She also states HC uses the most robust evidence ONLY from “trusted and reliable” sources. Well, could it be that Kevin McKernan is a trusted and reliable source since his work was included in Pfizer’s XBB vaccine assessment?
September 28, 2023
Health Canada approves Pfizer’s XBB 1.5 vaccine.
I find the fact that there was NO Press Conference for the approval of the Pfizer XBB 1.5 vaccine very telling.
3. The EMA Reaches Out Pfizer and Then to Health Canada and the FDA Regarding DNA levels and the SV40 Sequences
October 12, 2023
What is your perspective? Well I think the EMA knows what HC’s perspective is so I believe this is directed to the FDA. And has anyone taken action? Does the EMA know what HC has done so far? Also, what about you FDA? And who are the EXTERNAL PARTIES? McKernan? Buckhaults? Scientists in Germany? Media?
October 13, 2023
The FDA responds, very early in the morning.
Tracking all these external parties discussion?? Probably the fallout from Buckhaults’ testimony is my guess. Things are heating up. Notice, “if helpful” line.
The EMA concurs, and would like the FDA on board.
Note the concern about “navigating the communication challenge.” It’s the COMMUNICATION CHALLENGES that is the real issue. Not safety?? Though I can appreciate that media and other inquiries can be a challenge when you are working in government. Maybe it’s a way to get the FDA involved?
Dean Smith then updates his contacts in the FDA and EMA on what HC has been doing.
HELLO. They are talking about the probability of integration and those DNA fragment sizes. But what is in those redactions? The removal of the SV40 sequences? Anything else? Dean Smith informs the FDA of Pfizer’s gaslighting we saw previously in Part 1. “They commented on the fact that HC was the ONLY AGENCY raising these issues…” and that the involvement of EMA in discussions with Pfizer is appreciated, hinting that having FDA on board will be important. The FDA knew since June 2023, and still in October it appears they are dragging their feet. WHY?
(and they forgot a redaction. David is the EMA contact?….)
4. Pfizer Inc Sends a Letter to the South Carolina Senate
October 16, 2023
Maybe the reason the FDA is somewhat reluctant is this letter by Pfizer, which has to be read in full to be appreciated. Holy Toledo.
The Committee heard remarks “that are incorrect” that the vaccine contains plasmid DNA that could be a theoretical cancer risk. Well there are no intact plasmids in the vaccine that Kevin McKernan could find. This is true, but besides the point. It is the DNA FRAGMENTS. Then they trot out the WHO and FDA guidelines and how they are meeting those 10ng/dose guidelines. And NOTHING about the SV40 sequences.
Does anyone else finds this letter just a bit intimidating?
5. Meeting with the EMA and FDA on the SV40 Sequences
October 16, 2023
A meeting must have occurred shortly after those emails because Dean Smith reports back that it went well.
So finally all the major regulators are aligned and will be discussed at the next Cluster Meeting December 1st. Remember, that is also the date Pfizer was due with their report on the DNA fragment size, possible integration in bacteria and whether there were any intact plasmids etc etc.
Dean Smith tells his boss Co Pham that HC is further along discussing with Pfizer than either the EMA or FDA.
7. Noé Chartier and Matt Harwood Publish their Report on the DNA ‘Contamination’ and the SV40 Sequences in Epoch Times
October 19, 2023 at approx 11:00AM
EXCLUSIVE: Health Canada Confirms Undisclosed Presence of DNA Sequence in Pfizer Shot
Noé also drops the emails we saw in Part 1 to authenticate what he was reporting since many scientists were in disbelief.
8. Health Canada is Flooded with Inquiries from News Agencies Throughout the World
October 19, 2023
By 2pm on October 19th, 2023 Health Canada has received a large number of media requests on the Epoch Times article. I guess media does read Epoch Times.
Here is Reuters Fact-Checking. It can’t be true, can it Health Canada?
On the other hand, the British Medical Journal asks all the right questions.
Well I checked BMJ. Nothing regarding the contamination or residual DNA in the vaccines that I can find on BMJ Open website.
And Reuters Fact Check wrote an article which states Posts misrepresent Health Canada statement on DNA in Covid vaccines
The organization points to an October 19 article from the Epoch Times, a website that has previously spread misinformation about vaccination and the pandemic.
The claims stem from what experts say is a flawed paper following up on a similar report from earlier in 2023 -- neither of which is peer-reviewed.
"The preprint paper cited here has numerous methodological and interpretation issues," said Pakes of the University of Toronto. "I would certainly wait until it was published in a peer-reviewed journal before giving it any credence."
A little mendacious, wouldn’t you say? Co Pham, the head of CVCTB at Health Canada is much fairer.
9. Speicher et al Publishes Their Preprint on the Same Day
October 19, 2023 available HERE
10. Noé Chartier has a Few More Questions Regarding the Speicher Paper
October 23, 2023 Chartier sends his questions and the Speicher preprint to Health Canada. Here are the questions and the draft responses. You can also see how Co Pham and their group revised the answers to be accurate and detailed.
Note the issues regarding Qubit (ie a fluorometry method) and the fact that the measurements are more than 2,000 fold difference. They do not believe that fluorometry should be used from previous experience. Also note they no longer talk about the 1 TRILLION copies of the DNA template to make the modRNA which is obviously incorrect (its a lot more and then the template is broken up into more pieces).
Co Pham chastises the Health Canada drafters’ response and says, regarding the fact that it is not peer reviewed:
“we cannot be dismissive here” “we need to be precise in responding”
Forget about plasmids….it is the DNA FRAGMENTS WHICH ARE PROTECTED BY THE LNPs. “should we not have a line?” He gets it.
I like this guy.
This is the final response. “…Health Canada will not issue any public statement”.
10. Pfizer Provides its Response to the Request of Health Canada on the Size Distribution of the DNA Plasmid Fragments and Possible Integration of Plasmid in Bacteria
October 20, 2023
While trying to answer all the media requests, Pfizer submits the required report that was due December 1st, EARLY. Unfortunately most of this 56 page report is redacted. However, there are a few points that I would like to comment on.
A MULTIPURPOSE PLASMID? Multipurpose plasmids containing SV40 sequences? Is it because one of its ‘purposes’ includes using this plasmid as gene therapy? Pfizer admits it themselves, in a paper published in 2022
PFIZER USED A MULTIPURPOSE PLASMID FROM ITS GENE THERAPY PROGRAM. HOLY TOLEDO. Is this a de facto admission that the vaccine is gene therapy?
It gets worse. They try justifying that the DNA in the LNPs do not get into the nucleus. I am pretty certain that Co Pham and his group asked Pfizer for this assessment regarding the possibility of the DNA fragments getting in the nucleus. This is part of Pfizer’s answer.
What is really ironic, is that reference 12, is written by David Dean in 2004 notes
This result suggests that SV40 DNA contains some element that allows preferential nuclear import of the DNA. Indeed, when as little as 50 bp of the SV40 enhancer was cloned into these other plasmids, they were able to enter nuclei with the same kinetics as the entire SV40 genome
PFIZER USED A REFERENCE THAT SHOWS THE SV40 ENHANCER ALLOWED NUCLEAR IMPORT EVEN IN NON-DIVIDING CELLS AS JUSTIFICATION that DNA fragments in the cytoplasm, are not a risk.
I have no words.
For a further more in depth discussion, please see:
Scoops' Gazette Pfizer admits: DNA "intrinsic impurity" in covid vaccines with "hypothetical function", "potential genomic integration", "theoretical safety concerns" & "ongoing evaluation" to remove "SV40 elements" (Possibly unconnected) update — 4 Sep 2024, CTV… Read more 2 months ago · 29 likes · 8 comments · Scoops McGoo Note: A complaint has been filed with Office of the Information Commissioner (IOC) to get this ATIP unredacted. Stay tuned.
11. The US CDC Gets Involved, Tries to be ‘Helpful’ with ‘Messaging.’
October 26, 2023
Well the reporting and admission of the presence of the SV40 sequence has reached the Centres of Disease Control (CDC), and they contact Matthew Tunis at the Public Health Agency of Canada (PHAC), the Canadian equivalent of the US CDC regarding this RioTimes article
Matthew Tunis is the Executive Secretary of the National Advisory Committee on Immunization (NACI) which is the committee which makes and advises on immunization practices in Canada. The American equivalent would be the Advisory Committee on Immunization Practice (ACIP). Note the “if it exists” comment.
Matthew answers his CDC contact (which turns out to be the LEAD at ACIP…)
Oh, it’s accurate but lacking ‘context’. As if the adenovirus virus sequences have anything to do with the mRNA vaccines. And that no ‘peer reviewed literature’ regarding fragmented DNA which Pfizer itself admitted is possible, but at very low rates. Co Pham at the CVCTB was much more honest and scientific. Matthew tells his contact, that the Communications branch is preparing a response to all the media outlets which the CDC might like.
The CDC contact is worried about the ACIP meeting coming up and want to direct any questions to Matthew so that the context can be maintained.
Matthew Tunis plans to give LINES TO THE CDC so they ‘can get the story straight’ and provide context (so they can downplay the admission by Pfizer, etc)
Now the CDC then tries to give LINES TO Matthew Tunis at PHAC. OMG. Really.
Safe and Effective. Safe and Effective. Keep it broad. Doesn’t matter about the SV40 sequences, the amount of DNA fragments, the fact Pfizer lied. Nope. Safe and effective and you Canadians should make sure to stay in line.
But SORRY, NOT SORRY, Marie-Michele Caux, the Director of Public Health Communications at PHAC tells the CDC and Matthew Tunis that the communique won’t be ready (so there won’t be any ‘lines’ to give the CDC).
Was Health Canada concerned that perhaps the CDC would hijack their responses?
12. Health Canada Crafts the Response to Media/CDC Inquiries
This actually took some time. First of all, the rest of Health Canada, specifically PHAC and Dr Supriya Sharma, Chief Medical Advisor to Health Canada, needs to understand the basic technical aspects of these findings.
October 26, 2023 09:53
So this is what Co Pham, the Director of the CVCTB, or Vaccine Division is telling his superiors.
SV40 promoter/enhancer DRIVES GENE EXPRESSION there is no real purpose for it to be there to manufacture the COVID-19 vaccine (he likely knows the AmpR promoter is already there?) This promoter HAS NEVER BEEN USED IN THE MANUFACTURING OF VACCINES You can’t remove all the DNA fragments but you CAN get rid of the SV40 sequences Oh, and what is that redacted portion? That Moderna didn’t need the SV40? The presence of the AmpR promoter and other sequences ? Any other ideas?
Keep these points in mind when you see the final communique or response.
October 26, 2023 1:50 PM
Marianne van Oosten, who is from Communications and Public Affairs at Health Canada (and NOT AT PHAC) drafts a statement on the SV40 DNA fragments.
Health Canada authorized the use of the first Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and has authorized several versions of the updated vaccine since then. Each time, Health Canada determined that the vaccine meets the Department's stringent safety, efficacy and quality requirements for use in Canada, and we continue to have full confidence in these vaccines. (THIS WILL BE EDITED OUT IN SUBSEQUENT DRAFTS)
As a regulator of vaccines, Health Canada sets quality standards and requirements for manufacturers to follow, including providing comprehensive and detailed information about the vaccine itself, and about the manufacturing process. In the manufacture of any vaccine, it is expected that there may be variability or residual elements that are produced during the manufacturing process. To manage this, Health Canada has strict limits and controls for the presence of these residual fragments to ensure that the vaccine continues to be safe, and that any residual fragments are both inactive and have no functional role in the vaccine.
In the case of the Pfizer-BioNTech Covid-19 vaccine, the SV40 promoter enhancer was found to be a residual DNA fragment of the manufacturing process, however it is inactive, has no functional role, and was measured to be consistently below the limit approved by Health Canada, which is not more than 10 ng/human dose. This is in line with the World Health Organization's recommendation concerning residual DNA in biological drugs.
Health Canada confirms that the presence of the SV40 promoter enhancer as a residual DNA product does not affect the safety or efficacy of the Pfizer-BioNTech Covid-19 mRNA vaccines and does not change Health Canada's benefit-risk assessment for the vaccine's use.
With respect to unsubstantiated reports of the simian virus 40 in vaccines and a potential link to cancer, we wish to emphasize that there is no evidence to indicate that these Covid-19 vaccines cause or accelerate cancer. To be clear, the vaccine does not contain the SV40 virus; the presence of the SV40 promoter enhancer sequence is not the same as the presence of the whole virus. Monitoring of the residual DNA fragments is done by the manufacturers using methods that have been reviewed and validated by Health Canada as appropriate for its purposes. All Pfizer-BioNTech's Covid-19 vaccine commercial batches released in Canada complied with the requirements approved by Health Canada, including the residual DNA.
It is precise and fairly clear. The context of “inactive” and no “functional role” is with respect to not being required in the plasmid as we see Co Pham explain earlier, but it gets watered down here and it appears HC is saying the SV40 sequences have no activity at all. The presence of the sequences does not affect the benefit risk calculations???? Not sure the vaccine scientists see it this way.
October 26, 2023 2:06 PM
Well, yes indeed, Co Pham suggests further edits.
Health Canada authorized the use of the first Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and has authorized several versions of the updated vaccine since then. Each time, Health Canada determined that the vaccine meets the Department's stringent regulatory safety, efficacy and quality requirements for use in Canada, and we continue to have full confidence that the benefits outweigh the risks for these vaccines. As a regulator of vaccines, Health Canada sets quality standards and requirements for manufacturers to follow, including providing Health Canada authorized the use of the first Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and has authorized several versions of the updated vaccine since then. Each time, Health Canada determined that the vaccine meets the Department's stringent regulatory safety, efficacy and quality requirements for use in Canada, and we continue to have full confidence that the benefits outweigh the risks for these vaccines. As a regulator of vaccines, Health Canada sets quality standards and requirements for manufacturers to follow, including providing comprehensive and detailed information about the vaccine itself, and about the manufacturing process. In the manufacture of any vaccine, it is expected that there may be variabilities or residual elements that are part of the standard manufacturing process. To manage this, Health Canada requires strict quality limits and controls for the presence of these residual fragments to ensure that the vaccine continues to be safe, and that any residual fragments are both inactive and have no functional role in the vaccine.
In the case of the Pfizer-BioNTech Covid-19 vaccine, the SV40 promoter enhancer was found to be a residual DNA fragment in the vaccine, however it is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada for approval, which is not more than 10 ng/human dose. This is in line with the World Health Organization's recommendation concerning residual DNA in biological drugs, and consistent with the quality limits by other international regulators. Pfizer has confirmed with Health Canada that the presence of the SV40 promoter enhancer as a residual DNA product that does not affect the safety or efficacy of the Pfizer-BioNTech Covid-19 mRNA vaccines and does not change Health Canada's benefit-risk assessment for the vaccine's use.
With respect to unsubstantiated reports of the simian virus 40 in vaccines and a potential link to cancer, we wish to emphasize that there is no evidence to indicate that these Covid-19 vaccines cause or accelerate cancer. To be clear, the vaccine does not contain the SV40 virus; the presence of the SV40 promoter enhancer sequence is not the same as the presence of the whole virus. Monitoring of the residual DNA fragments is conducted by the manufacturers using methods that have been reviewed and validated by Health Canada as appropriate for its purposes. All PfizerBioNTech's Covid-19 vaccine commercial batches released in Canada complied with the requirements approved by Health Canada, including the residual DNA.
Happy to discuss.
Thanks
C
Co Pham makes sure the “full confidence” is moderated by the “benefits outweigh the risks” line. Also, see how he says Health Canada “requires…that any residual fragments are both inactive and have no functional role in the vaccine?” Not that Health Canada has determined that to be true? And he says that it is PFIZER, who says the SV40 promoter/enhancer does not affect the “safety or efficacy” of the vaccine? He is being very very careful here. No evidence these particular vaccines cause or accelerate cancer? Yes, strictly true, no current evidence, but no discussion either that there is a potential RISK for cancer.
October 26, 2023 3:09
Well that response does not fly with the Communications Branch. Here is the final draft sent out to all the 12 media outlets asking about the Epoch Times article on the 19th of October, 2023
Health Canada initially authorized the Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and subsequently has authorized updated versions, including the most recent vaccine targeting the XBB Omicron subvariant in September 2023. Each assessment included a determination that the vaccine met the Department's stringent regulatory safety, efficacy and quality requirements for use in Canada. As a regulator, Health Canada sets quality standards and requirements for manufacturers to follow, including providing comprehensive and detailed information about the vaccine itself, and about the manufacturing process. In the manufacture of any vaccine, residual elements that are part of the standard manufacturing process may remain. There are strict limits and controls for the presence of these residual fragments to ensure that there is no effect on the safety or effectiveness of the vaccine. The Pfizer-BioNTech COVID-19 vaccine does not contain simian virus 40 (SV40). The presence of the SV40 promoter enhancer sequence is not the same as the presence of the whole virus itself.
The SV40 promoter enhancer sequence was found to be a residual DNA fragment in Pfizer-BioNTech COVID-19 vaccine. The fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators. Any claims that the presence of the SV40 promoter enhancer sequence is linked to an increased risk of cancer are unfounded. There is also no evidence to support that the presence of the full SV40 in any vaccine increases the risk of cancer or the acceleration of cancer in individuals.
Health Canada continues to monitor the COVID-19 vaccines to ensure that they continue to meet the highest standards for safety, effectiveness and quality and that their benefits continue to outweigh any potential risks.
I do not see Co Pham on the email header. Did he know of this Response released from the Communications Branch? Look at the lack of precision and the change in tone of this response. The SV40 sequence “was found”…note the passive tense. Not that Pfizer initially hid its presence and, when caught, later admitted to it. The inactive and no functional role is taken out of context with respect to manufacturing and is referred to as a DNA fragment that isn’t doing anything in the vaccine. And they also state that the “full SV40” in any vaccine does not increase or accelerate cancer. I am not so sure Co Pham and his team would agree with this statement without qualifiers. Holy Toledo. Here’s a comprehensive review of Simian Virus 40 and let’s not forget about Drayman et al who showed than the SV40 promoter binds to p53 considered the guardian of the genome.
Well at least there is no “we continue to have full confidence” in the vaccine.
13. Health Canada Sends Out Statement to the CDC
October 27, 2023 5:03 PM
The DAY AFTER the ACIP meeting, and late in the day to boot, Marie-Michele Caux, who is at Communications at PHAC, sends out the Response from Health Canada to the CDC AND Matthew Tunis. This was just after they had sent it out to all the media outlets who had asked for comment earlier. Yowza. What does everyone think? Do you read these emails the same way?
So does everyone think that there may be a bit of a struggle between Health Canada, especially the vaccine branch, and PHAC and/or CDC?
POLL Is there a war going on between Health Canada vaccine branch and PHAC/CDC yes no Don't know they're both incompetent EXECUTIVE SUMMARY
Scientists at the vaccine division of Health Canada verify the presence of the SV40 promoter/enhancer immediately after finding out about it from Noé Chartier at the Epoch Times who sent them Kevin McKernan’s preprint from April 2023. They then initiate an Issue Analysis Summary (IAS) to investigate with the goal of removing these sequences and possibly restricting or removing the vaccine altogether. Several questions are sent to Pfizer for explanation and justification, but Pfizer tells Health Canada, they feel there is no problem and that no other regulator is asking these questions. Health Canada then takes the next 3 months trying to get the EMA and FDA on board. The EMA is willing but the FDA drag their feet until October (sometime after Dr. Phillip Buckhaults’ presentation to the South Carolina Senate, which went viral). Finally they agree that Pfizer needs to “remedy” the situation.
Pfizer submits the required documentation on the DNA fragments and role of the SV40 enhancer/promoter to Health Canada and admit they used a multipurpose plasmid (which could also conceivable be used for gene therapy). They also do not appear to present data regarding the risk of the DNA fragments and possible entry into the nucleus. In fact some of the references used as justification that there is no problem, actually show a risk. When Noé Chartier and Matt Harwood publish their report in Epoch Times, Health Canada is inundated with requests from media outlets to confirm this finding. On the same day, the second preprint by Speicher et al confirms the SV40 sequences and residual DNA in Ontario vials.
The CDC and PHAC try to provide “lines” to Health Canada which would mitigate and downplay these findings but Health Canada does not provide the CDC with the statement in time prior to the ACIP meeting. Emails show the amount of editing and crafting of the response by Health Canada Communications sent out to media and the CDC that altered the original intent and tone, though still confirming the presence of the SV40 sequences.
As for the outcome of the Issue Analysis Summary (IAS), that information is redacted and we know it was quashed. We are digging into that as well as having all of Pfizer’s report on the risk of DNA fragments and the SV40 sequences unredacted as well as an ATIP on that December 1st cluster meeting with the FDA and EMA. Wish us luck!
Thanks for reading, please share and oh Pray the Rosary.
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Maria Gutschi Washed Up Pharmacist Subscribe Independent researcher. Independent thinker. Washed Up Pharmacist. Wife, mother, grandmother, Catholic
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Jessica Rose
Oct 28 · Unacceptable Jessica
Please read!
Health Canada, SV40 and ATIPs: Part 2 September to October 2023
Insights from the various ATIPs and an in-depth analysis
WASHED UP PHARMACIST AND SCOOPS MCGOO
OCT 28
https://open.substack.com/pub/mariagutschi/p/health-canada-sv40-and-atips-part-5e7
READ IN APP
This is a continuation of Part 1 which documents the ATIPs at Health Canada and the presence of SV40 sequences. I’ve been asked to write a brief Executive Summary which I am generally reluctant to do, since you can lose detail and context, and then these statements can be used against the writer. However, we wrote a very short summary. Please scroll to the end.
Thank you again to Karen Rucas who organized the emails by data and pointed out some important changes in the drafting of Health Canada responses to media.
In Part 1, we left at the completion of the XBB vaccine review by the Quality division of the Centres Vaccines, Clinical Trials and Biostatistics (CVCTB)
Health Canada, SV40 and ATIPs: Part 1 July to August 2023
Health Canada, SV40 and ATIPs: Part 1 July to August 2023
WASHED UP PHARMACIST AND SCOOPS MCGOO
·
OCT 21
Read full story
1. Dr Phillip Buckhaults Presents to the US South Carolina Senate
September 12, 2023
This video was shared widely on social media. I suspect Health Canada was also aware of Dr Buckhaults’ presentation. Dr Buckhaults does a lot of sequencing of the human genome and what can lead to cancer and what does not. He calls himself a “cancer gene jockey.”
Video of Dr Buckhaults presentation
He explains how pieces of naked DNA allowed in protein vaccines at a certain threshold were not so problematic in a different era but with encapsulation in liposomes/nanoparticles, they can now easily get into cells. If they get into cells they can integrate in the genome which is permanent, long lasting, and has a theoretical risk of causing cancer depending on where in the genome they integrate. He says short pieces of DNA are analogous to buckshot and therefore can increase the hazard of genomic integration.
These are his short and well explained slides that he used at that presentation. Worth viewing, imho.
2. Health Canada Officially Approves the XBB 1.5 Vaccines
September 12, 2023
Dr Supriya Sharma gives a Press Conference on the approval of the Moderna XBB 1.5 vaccine ONLY. Regarding the Pfizer vaccine she says that Pfizer (and Novavax) are being reviewed on a priority basis and that there are “many factors” which could influence the timing of their approval. She also states HC uses the most robust evidence ONLY from “trusted and reliable” sources. Well, could it be that Kevin McKernan is a trusted and reliable source since his work was included in Pfizer’s XBB vaccine assessment?
September 28, 2023
Health Canada approves Pfizer’s XBB 1.5 vaccine.
I find the fact that there was NO Press Conference for the approval of the Pfizer XBB 1.5 vaccine very telling.
3. The EMA Reaches Out Pfizer and Then to Health Canada and the FDA Regarding DNA levels and the SV40 Sequences
October 12, 2023
What is your perspective? Well I think the EMA knows what HC’s perspective is so I believe this is directed to the FDA. And has anyone taken action? Does the EMA know what HC has done so far? Also, what about you FDA? And who are the EXTERNAL PARTIES? McKernan? Buckhaults? Scientists in Germany? Media?
October 13, 2023
The FDA responds, very early in the morning.
Tracking all these external parties discussion?? Probably the fallout from Buckhaults’ testimony is my guess. Things are heating up. Notice, “if helpful” line.
The EMA concurs, and would like the FDA on board.
Note the concern about “navigating the communication challenge.” It’s the COMMUNICATION CHALLENGES that is the real issue. Not safety?? Though I can appreciate that media and other inquiries can be a challenge when you are working in government. Maybe it’s a way to get the FDA involved?
Dean Smith then updates his contacts in the FDA and EMA on what HC has been doing.
HELLO. They are talking about the probability of integration and those DNA fragment sizes. But what is in those redactions? The removal of the SV40 sequences? Anything else? Dean Smith informs the FDA of Pfizer’s gaslighting we saw previously in Part 1. “They commented on the fact that HC was the ONLY AGENCY raising these issues…” and that the involvement of EMA in discussions with Pfizer is appreciated, hinting that having FDA on board will be important. The FDA knew since June 2023, and still in October it appears they are dragging their feet. WHY?
(and they forgot a redaction. David is the EMA contact?….)
4. Pfizer Inc Sends a Letter to the South Carolina Senate
October 16, 2023
Maybe the reason the FDA is somewhat reluctant is this letter by Pfizer, which has to be read in full to be appreciated. Holy Toledo.
The Committee heard remarks “that are incorrect” that the vaccine contains plasmid DNA that could be a theoretical cancer risk. Well there are no intact plasmids in the vaccine that Kevin McKernan could find. This is true, but besides the point. It is the DNA FRAGMENTS. Then they trot out the WHO and FDA guidelines and how they are meeting those 10ng/dose guidelines. And NOTHING about the SV40 sequences.
Does anyone else finds this letter just a bit intimidating?
5. Meeting with the EMA and FDA on the SV40 Sequences
October 16, 2023
A meeting must have occurred shortly after those emails because Dean Smith reports back that it went well.
So finally all the major regulators are aligned and will be discussed at the next Cluster Meeting December 1st. Remember, that is also the date Pfizer was due with their report on the DNA fragment size, possible integration in bacteria and whether there were any intact plasmids etc etc.
Dean Smith tells his boss Co Pham that HC is further along discussing with Pfizer than either the EMA or FDA.
7. Noé Chartier and Matt Harwood Publish their Report on the DNA ‘Contamination’ and the SV40 Sequences in Epoch Times
October 19, 2023 at approx 11:00AM
EXCLUSIVE: Health Canada Confirms Undisclosed Presence of DNA Sequence in Pfizer Shot
Noé also drops the emails we saw in Part 1 to authenticate what he was reporting since many scientists were in disbelief.
8. Health Canada is Flooded with Inquiries from News Agencies Throughout the World
October 19, 2023
By 2pm on October 19th, 2023 Health Canada has received a large number of media requests on the Epoch Times article. I guess media does read Epoch Times.
Here is Reuters Fact-Checking. It can’t be true, can it Health Canada?
On the other hand, the British Medical Journal asks all the right questions.
Well I checked BMJ. Nothing regarding the contamination or residual DNA in the vaccines that I can find on BMJ Open website.
And Reuters Fact Check wrote an article which states Posts misrepresent Health Canada statement on DNA in Covid vaccines
The organization points to an October 19 article from the Epoch Times, a website that has previously spread misinformation about vaccination and the pandemic.
The claims stem from what experts say is a flawed paper following up on a similar report from earlier in 2023 -- neither of which is peer-reviewed.
"The preprint paper cited here has numerous methodological and interpretation issues," said Pakes of the University of Toronto. "I would certainly wait until it was published in a peer-reviewed journal before giving it any credence."
A little mendacious, wouldn’t you say? Co Pham, the head of CVCTB at Health Canada is much fairer.
9. Speicher et al Publishes Their Preprint on the Same Day
October 19, 2023 available HERE
10. Noé Chartier has a Few More Questions Regarding the Speicher Paper
October 23, 2023 Chartier sends his questions and the Speicher preprint to Health Canada. Here are the questions and the draft responses. You can also see how Co Pham and their group revised the answers to be accurate and detailed.
Note the issues regarding Qubit (ie a fluorometry method) and the fact that the measurements are more than 2,000 fold difference. They do not believe that fluorometry should be used from previous experience. Also note they no longer talk about the 1 TRILLION copies of the DNA template to make the modRNA which is obviously incorrect (its a lot more and then the template is broken up into more pieces).
Co Pham chastises the Health Canada drafters’ response and says, regarding the fact that it is not peer reviewed:
“we cannot be dismissive here” “we need to be precise in responding”
Forget about plasmids….it is the DNA FRAGMENTS WHICH ARE PROTECTED BY THE LNPs. “should we not have a line?” He gets it.
I like this guy.
This is the final response. “…Health Canada will not issue any public statement”.
10. Pfizer Provides its Response to the Request of Health Canada on the Size Distribution of the DNA Plasmid Fragments and Possible Integration of Plasmid in Bacteria
October 20, 2023
While trying to answer all the media requests, Pfizer submits the required report that was due December 1st, EARLY. Unfortunately most of this 56 page report is redacted. However, there are a few points that I would like to comment on.
A MULTIPURPOSE PLASMID? Multipurpose plasmids containing SV40 sequences? Is it because one of its ‘purposes’ includes using this plasmid as gene therapy? Pfizer admits it themselves, in a paper published in 2022
PFIZER USED A MULTIPURPOSE PLASMID FROM ITS GENE THERAPY PROGRAM. HOLY TOLEDO. Is this a de facto admission that the vaccine is gene therapy?
It gets worse. They try justifying that the DNA in the LNPs do not get into the nucleus. I am pretty certain that Co Pham and his group asked Pfizer for this assessment regarding the possibility of the DNA fragments getting in the nucleus. This is part of Pfizer’s answer.
What is really ironic, is that reference 12, is written by David Dean in 2004 notes
This result suggests that SV40 DNA contains some element that allows preferential nuclear import of the DNA. Indeed, when as little as 50 bp of the SV40 enhancer was cloned into these other plasmids, they were able to enter nuclei with the same kinetics as the entire SV40 genome
PFIZER USED A REFERENCE THAT SHOWS THE SV40 ENHANCER ALLOWED NUCLEAR IMPORT EVEN IN NON-DIVIDING CELLS AS JUSTIFICATION that DNA fragments in the cytoplasm, are not a risk.
I have no words.
For a further more in depth discussion, please see:
Scoops' Gazette
Pfizer admits: DNA "intrinsic impurity" in covid vaccines with "hypothetical function", "potential genomic integration", "theoretical safety concerns" & "ongoing evaluation" to remove "SV40 elements"
(Possibly unconnected) update — 4 Sep 2024, CTV…
Read more
2 months ago · 29 likes · 8 comments · Scoops McGoo
Note: A complaint has been filed with Office of the Information Commissioner (IOC) to get this ATIP unredacted. Stay tuned.
11. The US CDC Gets Involved, Tries to be ‘Helpful’ with ‘Messaging.’
October 26, 2023
Well the reporting and admission of the presence of the SV40 sequence has reached the Centres of Disease Control (CDC), and they contact Matthew Tunis at the Public Health Agency of Canada (PHAC), the Canadian equivalent of the US CDC regarding this RioTimes article
Matthew Tunis is the Executive Secretary of the National Advisory Committee on Immunization (NACI) which is the committee which makes and advises on immunization practices in Canada. The American equivalent would be the Advisory Committee on Immunization Practice (ACIP). Note the “if it exists” comment.
Matthew answers his CDC contact (which turns out to be the LEAD at ACIP…)
Oh, it’s accurate but lacking ‘context’. As if the adenovirus virus sequences have anything to do with the mRNA vaccines. And that no ‘peer reviewed literature’ regarding fragmented DNA which Pfizer itself admitted is possible, but at very low rates. Co Pham at the CVCTB was much more honest and scientific. Matthew tells his contact, that the Communications branch is preparing a response to all the media outlets which the CDC might like.
The CDC contact is worried about the ACIP meeting coming up and want to direct any questions to Matthew so that the context can be maintained.
Matthew Tunis plans to give LINES TO THE CDC so they ‘can get the story straight’ and provide context (so they can downplay the admission by Pfizer, etc)
Now the CDC then tries to give LINES TO Matthew Tunis at PHAC. OMG. Really.
Safe and Effective. Safe and Effective. Keep it broad. Doesn’t matter about the SV40 sequences, the amount of DNA fragments, the fact Pfizer lied. Nope. Safe and effective and you Canadians should make sure to stay in line.
But SORRY, NOT SORRY, Marie-Michele Caux, the Director of Public Health Communications at PHAC tells the CDC and Matthew Tunis that the communique won’t be ready (so there won’t be any ‘lines’ to give the CDC).
Was Health Canada concerned that perhaps the CDC would hijack their responses?
12. Health Canada Crafts the Response to Media/CDC Inquiries
This actually took some time. First of all, the rest of Health Canada, specifically PHAC and Dr Supriya Sharma, Chief Medical Advisor to Health Canada, needs to understand the basic technical aspects of these findings.
October 26, 2023 09:53
So this is what Co Pham, the Director of the CVCTB, or Vaccine Division is telling his superiors.
SV40 promoter/enhancer DRIVES GENE EXPRESSION
there is no real purpose for it to be there to manufacture the COVID-19 vaccine (he likely knows the AmpR promoter is already there?)
This promoter HAS NEVER BEEN USED IN THE MANUFACTURING OF VACCINES
You can’t remove all the DNA fragments but you CAN get rid of the SV40 sequences
Oh, and what is that redacted portion? That Moderna didn’t need the SV40? The presence of the AmpR promoter and other sequences ? Any other ideas?
Keep these points in mind when you see the final communique or response.
October 26, 2023 1:50 PM
Marianne van Oosten, who is from Communications and Public Affairs at Health Canada (and NOT AT PHAC) drafts a statement on the SV40 DNA fragments.
Health Canada authorized the use of the first Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and has authorized several versions of the updated vaccine since then. Each time, Health Canada determined that the vaccine meets the Department's stringent safety, efficacy and quality requirements for use in Canada, and we continue to have full confidence in these vaccines. (THIS WILL BE EDITED OUT IN SUBSEQUENT DRAFTS)
As a regulator of vaccines, Health Canada sets quality standards and requirements for manufacturers to follow, including providing comprehensive and detailed information about the vaccine itself, and about the manufacturing process. In the manufacture of any vaccine, it is expected that there may be variability or residual elements that are produced during the manufacturing process. To manage this, Health Canada has strict limits and controls for the presence of these residual fragments to ensure that the vaccine continues to be safe, and that any residual fragments are both inactive and have no functional role in the vaccine.
In the case of the Pfizer-BioNTech Covid-19 vaccine, the SV40 promoter enhancer was found to be a residual DNA fragment of the manufacturing process, however it is inactive, has no functional role, and was measured to be consistently below the limit approved by Health Canada, which is not more than 10 ng/human dose. This is in line with the World Health Organization's recommendation concerning residual DNA in biological drugs.
Health Canada confirms that the presence of the SV40 promoter enhancer as a residual DNA product does not affect the safety or efficacy of the Pfizer-BioNTech Covid-19 mRNA vaccines and does not change Health Canada's benefit-risk assessment for the vaccine's use.
With respect to unsubstantiated reports of the simian virus 40 in vaccines and a potential link to cancer, we wish to emphasize that there is no evidence to indicate that these Covid-19 vaccines cause or accelerate cancer. To be clear, the vaccine does not contain the SV40 virus; the presence of the SV40 promoter enhancer sequence is not the same as the presence of the whole virus. Monitoring of the residual DNA fragments is done by the manufacturers using methods that have been reviewed and validated by Health Canada as appropriate for its purposes. All Pfizer-BioNTech's Covid-19 vaccine commercial batches released in Canada complied with the requirements approved by Health Canada, including the residual DNA.
It is precise and fairly clear. The context of “inactive” and no “functional role” is with respect to not being required in the plasmid as we see Co Pham explain earlier, but it gets watered down here and it appears HC is saying the SV40 sequences have no activity at all. The presence of the sequences does not affect the benefit risk calculations???? Not sure the vaccine scientists see it this way.
October 26, 2023 2:06 PM
Well, yes indeed, Co Pham suggests further edits.
Health Canada authorized the use of the first Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and has authorized several versions of the updated vaccine since then. Each time, Health Canada determined that the vaccine meets the Department's stringent regulatory safety, efficacy and quality requirements for use in Canada, and we continue to have full confidence that the benefits outweigh the risks for these vaccines. As a regulator of vaccines, Health Canada sets quality standards and requirements for manufacturers to follow, including providing Health Canada authorized the use of the first Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and has authorized several versions of the updated vaccine since then. Each time, Health Canada determined that the vaccine meets the Department's stringent regulatory safety, efficacy and quality requirements for use in Canada, and we continue to have full confidence that the benefits outweigh the risks for these vaccines. As a regulator of vaccines, Health Canada sets quality standards and requirements for manufacturers to follow, including providing comprehensive and detailed information about the vaccine itself, and about the manufacturing process. In the manufacture of any vaccine, it is expected that there may be variabilities or residual elements that are part of the standard manufacturing process. To manage this, Health Canada requires strict quality limits and controls for the presence of these residual fragments to ensure that the vaccine continues to be safe, and that any residual fragments are both inactive and have no functional role in the vaccine.
In the case of the Pfizer-BioNTech Covid-19 vaccine, the SV40 promoter enhancer was found to be a residual DNA fragment in the vaccine, however it is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada for approval, which is not more than 10 ng/human dose. This is in line with the World Health Organization's recommendation concerning residual DNA in biological drugs, and consistent with the quality limits by other international regulators. Pfizer has confirmed with Health Canada that the presence of the SV40 promoter enhancer as a residual DNA product that does not affect the safety or efficacy of the Pfizer-BioNTech Covid-19 mRNA vaccines and does not change Health Canada's benefit-risk assessment for the vaccine's use.
With respect to unsubstantiated reports of the simian virus 40 in vaccines and a potential link to cancer, we wish to emphasize that there is no evidence to indicate that these Covid-19 vaccines cause or accelerate cancer. To be clear, the vaccine does not contain the SV40 virus; the presence of the SV40 promoter enhancer sequence is not the same as the presence of the whole virus. Monitoring of the residual DNA fragments is conducted by the manufacturers using methods that have been reviewed and validated by Health Canada as appropriate for its purposes. All PfizerBioNTech's Covid-19 vaccine commercial batches released in Canada complied with the requirements approved by Health Canada, including the residual DNA.
Happy to discuss.
Thanks
C
Co Pham makes sure the “full confidence” is moderated by the “benefits outweigh the risks” line. Also, see how he says Health Canada “requires…that any residual fragments are both inactive and have no functional role in the vaccine?” Not that Health Canada has determined that to be true? And he says that it is PFIZER, who says the SV40 promoter/enhancer does not affect the “safety or efficacy” of the vaccine? He is being very very careful here. No evidence these particular vaccines cause or accelerate cancer? Yes, strictly true, no current evidence, but no discussion either that there is a potential RISK for cancer.
October 26, 2023 3:09
Well that response does not fly with the Communications Branch. Here is the final draft sent out to all the 12 media outlets asking about the Epoch Times article on the 19th of October, 2023
Health Canada initially authorized the Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and subsequently has authorized updated versions, including the most recent vaccine targeting the XBB Omicron subvariant in September 2023. Each assessment included a determination that the vaccine met the Department's stringent regulatory safety, efficacy and quality requirements for use in Canada. As a regulator, Health Canada sets quality standards and requirements for manufacturers to follow, including providing comprehensive and detailed information about the vaccine itself, and about the manufacturing process. In the manufacture of any vaccine, residual elements that are part of the standard manufacturing process may remain. There are strict limits and controls for the presence of these residual fragments to ensure that there is no effect on the safety or effectiveness of the vaccine. The Pfizer-BioNTech COVID-19 vaccine does not contain simian virus 40 (SV40). The presence of the SV40 promoter enhancer sequence is not the same as the presence of the whole virus itself.
The SV40 promoter enhancer sequence was found to be a residual DNA fragment in Pfizer-BioNTech COVID-19 vaccine. The fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators. Any claims that the presence of the SV40 promoter enhancer sequence is linked to an increased risk of cancer are unfounded. There is also no evidence to support that the presence of the full SV40 in any vaccine increases the risk of cancer or the acceleration of cancer in individuals.
Health Canada continues to monitor the COVID-19 vaccines to ensure that they continue to meet the highest standards for safety, effectiveness and quality and that their benefits continue to outweigh any potential risks.
I do not see Co Pham on the email header. Did he know of this Response released from the Communications Branch? Look at the lack of precision and the change in tone of this response. The SV40 sequence “was found”…note the passive tense. Not that Pfizer initially hid its presence and, when caught, later admitted to it. The inactive and no functional role is taken out of context with respect to manufacturing and is referred to as a DNA fragment that isn’t doing anything in the vaccine. And they also state that the “full SV40” in any vaccine does not increase or accelerate cancer. I am not so sure Co Pham and his team would agree with this statement without qualifiers. Holy Toledo. Here’s a comprehensive review of Simian Virus 40 and let’s not forget about Drayman et al who showed than the SV40 promoter binds to p53 considered the guardian of the genome.
Well at least there is no “we continue to have full confidence” in the vaccine.
13. Health Canada Sends Out Statement to the CDC
October 27, 2023 5:03 PM
The DAY AFTER the ACIP meeting, and late in the day to boot, Marie-Michele Caux, who is at Communications at PHAC, sends out the Response from Health Canada to the CDC AND Matthew Tunis. This was just after they had sent it out to all the media outlets who had asked for comment earlier. Yowza. What does everyone think? Do you read these emails the same way?
So does everyone think that there may be a bit of a struggle between Health Canada, especially the vaccine branch, and PHAC and/or CDC?
POLL
Is there a war going on between Health Canada vaccine branch and PHAC/CDC
yes
no
Don't know they're both incompetent
EXECUTIVE SUMMARY
Scientists at the vaccine division of Health Canada verify the presence of the SV40 promoter/enhancer immediately after finding out about it from Noé Chartier at the Epoch Times who sent them Kevin McKernan’s preprint from April 2023. They then initiate an Issue Analysis Summary (IAS) to investigate with the goal of removing these sequences and possibly restricting or removing the vaccine altogether. Several questions are sent to Pfizer for explanation and justification, but Pfizer tells Health Canada, they feel there is no problem and that no other regulator is asking these questions. Health Canada then takes the next 3 months trying to get the EMA and FDA on board. The EMA is willing but the FDA drag their feet until October (sometime after Dr. Phillip Buckhaults’ presentation to the South Carolina Senate, which went viral). Finally they agree that Pfizer needs to “remedy” the situation.
Pfizer submits the required documentation on the DNA fragments and role of the SV40 enhancer/promoter to Health Canada and admit they used a multipurpose plasmid (which could also conceivable be used for gene therapy). They also do not appear to present data regarding the risk of the DNA fragments and possible entry into the nucleus. In fact some of the references used as justification that there is no problem, actually show a risk. When Noé Chartier and Matt Harwood publish their report in Epoch Times, Health Canada is inundated with requests from media outlets to confirm this finding. On the same day, the second preprint by Speicher et al confirms the SV40 sequences and residual DNA in Ontario vials.
The CDC and PHAC try to provide “lines” to Health Canada which would mitigate and downplay these findings but Health Canada does not provide the CDC with the statement in time prior to the ACIP meeting. Emails show the amount of editing and crafting of the response by Health Canada Communications sent out to media and the CDC that altered the original intent and tone, though still confirming the presence of the SV40 sequences.
As for the outcome of the Issue Analysis Summary (IAS), that information is redacted and we know it was quashed. We are digging into that as well as having all of Pfizer’s report on the risk of DNA fragments and the SV40 sequences unredacted as well as an ATIP on that December 1st cluster meeting with the FDA and EMA. Wish us luck!
Thanks for reading, please share and oh Pray the Rosary.
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Maria Gutschi
Washed Up Pharmacist
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Independent researcher. Independent thinker. Washed Up Pharmacist. Wife, mother, grandmother, Catholic
不可接受的Jessica Cross-Post-张来自Maria Gutschi Jessica Rose Oct 28·不可接受的Jessica请阅读！ 卫生加拿大，SV40和ATIPS：第2部分9月2日至10月2023年的洞察力来自各种ATIPS和深入分析的洞察力在APP中提交了药剂师和SCOOPS MCGOO 10月1日，这是第1部分的延续，这是第1部分，在健康中删除ATIPS 我被要求编写一个简短的执行摘要，我一般不愿意做，因为你可以丢失细节和上下文，然后可以针对作者使用这些陈述。 但是，我们写了一个非常简短的摘要。 请滚动到最后。 再次感谢您通过数据组织电子邮件的Karen Rucas，并指出了起草健康加拿大对媒体的重要变化。 在第1部分，我们留下了XBB疫苗审查，由中心疫苗，临床试验和生物统计学（CVCTB）卫生加拿大，SV40和ATIPS：第1部分至7月1日至8月2023日卫生加拿大， 我怀疑加拿大卫生也意识到Buckhaults博士的演示。 Buckhaults博士对人类基因组进行了大量序列，什么可以导致癌症，什么都没有。 他称自己为“癌症基因骑师” Dr Buckhaults演示文稿的视频他解释了在不同时代的某个阈值下蛋白质疫苗中允许的肉体DNA是何种问题，而是在脂质体/纳米颗粒中的包封，它们现在可以容易地进入细胞。 如果它们进入细胞，它们可以在基因组中整合，这是永久性的，持久的持久性，并且根据它们整合的基因组中的位置具有理论风险。 他说，短片的DNA类似于球蛋白，因此可以增加基因组集成的危害。 这些是他在那个演示文稿中使用的简短而解释的幻灯片。 值得观看，恕我直言。 2.卫生加拿大正式批准XBB 1.5疫苗9月12日，2023年Supriya Sharma博士仅批准了现代XBB 1.5疫苗的新闻发布会。 关于辉瑞疫苗，她表示，辉瑞公司（和诺瓦斯）正在优先审查，并且有“许多因素”，可能会影响其批准的时间。 她还陈述HC仅使用“可信赖和可靠”来源的最强大的证据。 嗯，可以是Kevin McKernan是一个值得信赖和可靠的来源，因为他的工作被列入辉瑞的XBB疫苗评估？ 9月28日，2023年健康加拿大批准辉瑞的XBB 1.5疫苗。 我发现没有新闻发布会批准辉煌XBB 1.5疫苗非常讲述。 3. EMA达到辉瑞，然后达到健康加拿大和FDA关于DNA水平和SV40序列10月12日，您的角度是什么？ 好吧，我认为EMA知道HC的角度是这样，所以我相信这是针对FDA的。 有人采取行动吗？ EMA是否知道迄今为止的HC已经完成了什么？ 另外，你的FDA怎么样？ 谁是外部方？ 嗯？ 巴克夫斯？ 德国的科学家？ 媒体？ 10月13日，2023年，FDA在早上很早回应。 跟踪所有这些外部方的讨论？ 可能是巴库夫斯证词的堕落是我的猜测。 事情正在升温。 注意，“如果有用”线。 EMA COMECURS，并希望FDA在船上。 注意“导航沟通挑战”的关注 这是真正问题的沟通挑战。 不安全？ 虽然我可以欣赏媒体和其他询问可能是在政府工作时的挑战。 也许这是一个涉及的FDA的方法？ Dean Smith然后在FDA和EMA中更新他的联系人，并在HC正在做什么。 你好。 他们正在谈论集成的概率和那些DNA片段尺寸。 但这些重量是什么？ 去除SV40序列？ 还有别的吗？ 迪恩史密斯通知辉瑞公司的FDA，我们在第1部分中看到了我们在第1部分看到的事实。“他们评论了HC是提出这些问题的唯一机构......”并认为EMA参与与辉瑞公司的讨论，暗示具有FD FDA自6月2023年以来就知道，而且在10月份仍然拖着他们的脚。 为什么？ （并且他们忘记了重写。大卫是EMA联系？......）4。普德里公司向南卡罗来纳州参议员发信10月16日，2023年可能是FDA有点不情愿的原因是辉瑞的这封信，必须是 神圣的托莱多。 委员会听取了“这是不正确”的言论，疫苗含有质粒DNA，这可能是理论癌症风险。 好吧，凯文麦克奈兰可以发现疫苗中没有完整的质粒。 这是真的，但除了这一点。 它是DNA片段。 然后他们跑出了世卫组织和FDA指导方针以及它们如何达到那些10ng /剂量指南。 没有关于SV40序列的任何东西。 有没有人发现这封信只是有点恐吓？ 5.在SV40序列上与EMA和FDA会面10月16日，2023年的会议必须在那些电子邮件后不久发生会议，因为Dean Smith报告了它进展顺利。 最后，所有主要监管机构都对齐，并将在12月1日的下一个集群会议上讨论。 请记住，也是日期辉瑞的日期辉煌的报告是对DNA片段大小的报告，细菌中可能的融合以及是否存在任何完整的质粒等。迪恩史密斯告诉他的BOSS CO PHAM，HC进一步讨论辉煌而不是辉瑞比EM讨论 7.NoéChartier和Matt Harwood在2010年10月19日10月19日的OPOCH时间内发布了关于DNA'污染'和SV40序列的报告，大约11:00 AM独家：Health Canada确认在辉瑞疫苗中没有明确存在DNA序列Note 8.加拿大卫生加拿大在全球新闻机构的询问中遭到10月19日，2023年10月19日的2023年10月19日，2023年卫生加拿大已收到大量媒体请求在纪念时段文章。 我猜媒体确实读取了纪念时间。 这是路透社的事实检查。 它不能真实，可以健康加拿大吗？ 另一方面，英国医学期刊询问了所有正确的问题。 好吧，我检查了BMJ。 在BMJ开放网站上可以找到疫苗中的污染或残留DNA没有任何内容。 路透社事实检查写了一篇文章，这些文章在Covid疫苗的DNA发布了Misrepresent Health Canada宣言，该组织从纪念时间到10月19日的一篇文章，这是一个以前传播了关于疫苗接种和大流行的错误信息。 该权利要求源于专家说是在2023年早些时候的类似报告之后的缺陷纸 - 既不是同行评审。 “在此引用的预印纸有许多方法论和解释问题，”多伦多大学令人叹为观。 “我当然会等到它在送到任何信任之前在同行评审期刊上发表。” 有点貂，你不会说吗？ Co Pham，Canada卫生CVCTB负责人更公平。 9. Speicher等人在这里提供的同一天发布了他们的预先印刷品，2023年10月10日。NoéChretier有一些关于Speicher Paper 23日的疑问，2023年Chartier向加拿大卫生发出的问题和美国专家师前列。 以下是问题和答复草案。 您还可以看看Co Pham及其组如何修改准确和详细的答案。 注意关于Qubit（即荧光法）的问题以及测量值超过2,000倍的事实。 他们不认为荧光测量应该从以前的经验中使用。 另请注意，他们不再讨论了1万亿副本的DNA模板，使ModRNA显然不正确（它更多，然后将模板分成更多碎片）。 CO PHAM Chamastises Canada起草人的回答，并说明它不是同行评审：“我们不能解除这里”“我们需要精确地回应”忘记质粒......是受保护的DNA片段 “我们不应该有一条线吗？” 他得到它。 我喜欢这个家伙。 这是最终的反应。 “......健康加拿大不会发出任何公开声明”。 10.辉瑞公司向加拿大卫生部的要求提供了对DNA质粒碎片的规模分布的响应，并在试图回答所有媒体请求的情况下，在2023年10月20日的细菌中融合质粒的可能集成，辉瑞提交了12月1日到期的所需报告 不幸的是，这56页报告的大部分都是重做的。 但是，我想评论几点。 多功能质粒？ 含有SV40序列的多功能质粒吗？ 是因为它的一个“目的”之一包括使用这种质粒作为基因治疗？ 辉瑞公司本身承认，在2022年发布的纸质中，辉瑞的纸张使用来自其基因治疗计划的多功能质粒。 神圣的托莱多。 这是疫苗是基因治疗的事实上吗？ 它变得更糟。 他们试图证明LNP中的DNA没有进入细胞核。 我很肯定，CO PHAM和他的小组要求辉瑞用于这种评估，有关DNA片段进入核心的可能性。 这是PFizer答案的一部分。 什么是真正的讽刺意味着，参考文献12是由David Dean于2004年写的，这结果表明SV40 DNA包含一些允许优先核导入DNA的元素。 实际上，当SV40增强子的50bp克隆到这些其他质粒中时，它们能够进入核，随着整个SV40基因组PFizer使用表现出SV40增强剂允许的核进口的参考 我没有言语。 对于进一步的深度讨论，请参阅：Scoops'Gazette Pfizer承认：DNA“内在杂质”在Covid疫苗中，具有“假设功能”，“潜在基因组集成”，“理论安全问题”和“持续评估” 保持调整。 11.美国CDC参与其中，试图与“消息”进行“乐于助人”.201，2023年10月26日，报告和入院SV40序列的存在已达到疾病控制（CDC）的中心，他们联系马太基斯在公众 美国等价物将是免疫实践咨询委员会（ACIP）。 请注意“如果存在”注释。 马修回答他的CDC联系（原来是acip的领导......）哦，它准确但缺乏“上下文”。 好像腺病毒病毒序列与mRNA疫苗有任何关系。 并且没有关于普遍派遣本身的分段DNA的“同伴审查的文献”是可能的，但在非常低的情况下。 CVCTB的CO PHAM更诚实和科学。 Matthew告诉他的联系人，通信分支正在为CDC可能喜欢的所有媒体网点做出响应。 CDC联系人担心即将到来的ACIP会议，并希望将任何问题引导到Matthew，以便可以维持上下文。 Matthew Tunis计划向CDC提供线条，以便他们“直接地弄错”并提供上下文（所以他们可以通过PFizer等展望）现在，CDC然后尝试在PHAC中拨到Matthew Tunis的线条。 omg。 真的。 安全有效。 安全有效。 保持广泛。 对于SV40序列无关紧要，DNA片段的量，事实辉稿伴随着。 不。 安全有效，你加拿大人应该确保留在线。 但对不起，不抱歉，PHAC公共卫生通信总监Marie-Michele Caux告诉CDC和Matthew Tunis，通报不会准备好（因此不会有任何“线路”给予CDC）。 加拿大有担心的是，也许疾病委员会会劫持他们的回应吗？ 12.卫生加拿大工艺对媒体/疾病疾病委员会查询的回应，这实际上需要一些时间。 首先，加拿大卫生部的其余部分，特别是Phac和卫生加拿大卫生部首席医疗顾问Supriya Sharma博士，需要了解这些调查结果的基本技术方面。 10月26日，2023年09:53所以这是CVCTB的主任或疫苗部门的CO PHAM是什么意思。 SV40启动子/增强剂驱动基因表达没有真正的目的是在那里制造Covid-19疫苗（他可能知道AMPR启动子已经存在？）这种启动子从未用于制造疫苗，你不能去除所有D 那个现代人不需要SV40？ AMPR启动子和其他序列的存在？ 任何其他想法？ 当您看到最终的公报或响应时，请记住这些点。 10月26日，2023年1:50下午5:50来自加拿大卫生的通信和公共事务的PM Marianne Van Oosten（而不是在PHAC上）向SV40 DNA碎片发出陈述。 卫生加拿大授权在2020年12月使用第一个PFizer-Biontech Covid-19 mRNA疫苗，并从那时起，授权了几个更新的疫苗。 每次，保健加拿大都确定疫苗符合加拿大的严格安全，疗效和质量要求，我们继续充分信心这些疫苗。 （这将在随后的草案中被编辑）作为疫苗的监管机构，卫生加拿大为制造商提供了遵循的质量标准和要求，包括提供有关疫苗本身的全面和详细信息，以及制造过程。 在任何疫苗的制造中，预期可能存在在制造过程中产生的可变性或残留元件。 为了管理这一点，保健加拿大对这些残留片段的存在具有严格的限制和对照，以确保疫苗继续是安全的，并且任何残留碎片都不是无活性的并且在疫苗中没有功能性作用。 在辉瑞 - Biontech Covid-19疫苗的情况下，发现SV40启动子增强剂是制造过程的残留DNA片段，但它不活性，没有功能性作用，并测量持续低于限制批准的限制 这符合世界卫生组织关于生物药物残留DNA的建议。 卫生加拿大证实，SV40启动子增强子作为残留的DNA产物的存在不会影响辉瑞 - Biontech Covid-19 mRNA疫苗的安全性或功效，并且不会改变加拿大卫生的卫生风险评估 关于Simian病毒40在疫苗中的未经证实的报告和癌症的潜在联系，我们希望强调没有证据表明这些Covid-19疫苗导致或加速癌症。 很清楚，疫苗不含SV40病毒; SV40启动子增强子序列的存在与整个病毒的存在不同。 制造商使用卫生加拿大卫生的方法适合其目的，由制造商进行残留DNA片段的监测。 所有PFizer-Biontech的Covid-19疫苗商业批次在加拿大发布符合加拿大卫生批准的要求，包括残留DNA。 这是准确而相当明确的。 “无效”和没有“功能角色”的背景是在质粒中不需要在诸如PHAM之前的质粒，但在这里浇水，它看起来HC表示SV40序列根本没有活动。 序列的存在不会影响益处风险计算???? 不确定疫苗科学家以这种方式看到它。 10月26日，2023年2:06 PM嗯，是的，CO PHAM表明进一步编辑。 卫生加拿大授权在2020年12月使用第一个PFizer-Biontech Covid-19 mRNA疫苗，并从那时起，授权了几个更新的疫苗。 每次，加拿大卫生都确定了疫苗符合加拿大的严格监管安全，疗效和质量要求，我们继续充分信心，使得这些疫苗的益处超过了风险。 作为疫苗的监管机构，卫生加拿大为厂家奠定了质量标准和要求，包括提供健康加拿大授权在2020年12月使用第一个PFizer-Biontech Covid-19 mRNA疫苗，并有几个版本的更新VICC 每次，加拿大卫生都确定了疫苗符合加拿大的严格监管安全，疗效和质量要求，我们继续充分信心，使得这些疫苗的益处超过了风险。 作为疫苗的监管机构，卫生加拿大为制造商奠定了质量标准和要求，包括提供有关疫苗本身的全面和详细信息，以及制造过程。 在任何疫苗的制造中，预期可能有变量或残余元素是标准制造过程的一部分。 为了管理这一点，保健加拿大需要严格的质量限制和对照，用于存在这些残留碎片，以确保疫苗继续是安全的，并且任何残留碎片都不是无活性的，并且在疫苗中没有功能性作用。 在PFizer-Biontech Covid -19疫苗的情况下，发现SV40启动子增强子是疫苗中的残留DNA片段，但它是无活性的，但没有功能性作用，并且测量以始终如一地低于所需的限制 这符合世界卫生组织关于生物药物中残留DNA的建议，并符合其他国际监管机构的质量限制。 辉瑞公司已经确认了卫生加拿大，SV40启动子增强子作为残留的DNA产物的存在，不会影响辉瑞 - Biontech Covid-19 mRNA疫苗的安全性或功效，并且不会改变加拿大卫生的利益风险 关于Simian病毒40在疫苗中的未经证实的报告和癌症的潜在联系，我们希望强调没有证据表明这些Covid-19疫苗导致或加速癌症。 很清楚，疫苗不含SV40病毒; SV40启动子增强子序列的存在与整个病毒的存在不同。 制造商使用卫生加拿大卫生的方法适用于其目的，制造商进行残留DNA片段的监测。 所有PFirederbiontech的Covid-19疫苗商业批次在加拿大发布符合加拿大卫生批准的要求，包括残留的DNA。 乐于讨论。 谢谢C CO PHAM确保“充满信心”受到“福利占风险”线的主持。 此外，看看他如何说加拿大健康“需要......任何残留碎片都是无效的，并且在疫苗中没有功能性作用？” 不是那个健康加拿大已经确定了这是真的吗？ 他说它是辉瑞，他说SV40启动子/增强剂不会影响疫苗的“安全性或疗效”？ 他在这里非常小心。 没有证据这些特定疫苗导致或加速癌症？ 是的，严格真实，没有目前的证据，但没有讨论癌症的潜在风险。 10月26日，2023年3:09那么响应与通信分支没有飞行。 以下是最终草案向所有12次媒体网点发出的询问，询问2010年10月19日的时代文章2023年卫生加拿大最初授权于2020年12月20日授权辉瑞 - Biontech Covid-19 mRNA疫苗，随后已授权更新 作为监管机构，保健加拿大为制造商提供了遵循的质量标准和要求，包括提供有关疫苗本身的全面和详细信息，以及制造过程。 在制造任何疫苗的任何疫苗中，可以保留是标准制造过程的一部分的残余元素。 存在这些残留片段的存在严格的限制和对照，以确保对疫苗的安全性或有效性没有影响。 PFizer-Biontech Covid-19疫苗不含Simian病毒40（SV40）。 SV40启动子增强子序列的存在与整个病毒本身的存在不同。 发现SV40启动子增强子序列是辉瑞 - Biontech Covid-19疫苗中的残留DNA片段。 片段不活跃，没有功能性作用，并衡量持续低于加拿大卫生所需的限额和其他国际监管机构。 任何要求SV40启动子增强子序列的存在与癌症的风险增加有关。 还没有证据表明，任何疫苗中完整SV40的存在会增加癌症的风险或个体癌症的加速度。 保健加拿大继续监测Covid-19疫苗，以确保他们继续满足安全，有效性和质量的最高标准，并且它们的利益继续超过任何潜在的风险。 我没有在电子邮件标题上看到CO PHAM。 他是否知道从通信分支发布的这种反应？ 看看这种反应的缺乏精度和变化。 SV40序列“被发现”...注意被动时态。 并非辉煌最初隐藏它的存在，并且在捕获时，后来被录取。 非活动和无功能作用是关于制造的上下文中的上下文中的，并且被称为在疫苗中不做任何事物的DNA片段。 他们还认为任何疫苗中的“完整SV40”不会增加或加速癌症。 我不是那么肯定有责任，他的团队会同意这个陈述而没有限定员。 神圣的托莱多。 这是对Simian病毒40的全面审查，让我们不要忘记比SV40启动子的Drayman等人与P53结合而认为是基因组的监护人。 至少在疫苗中至少没有“我们继续充分信心”。 13.卫生加拿大向CDC发表陈述10月27日，2013年10月27日下午5:03下午5:03在攻丝的日期前，迈尔·米歇尔卡伊克斯在PHAC通信时发出卫生加拿大卫生的回应 这是在他们向早些时候提出评论的所有媒体网点之后。 yowza。 每个人都在想什么？ 你以同样的方式阅读这些电子邮件吗？ 所以每个人都认为卫生加拿大之间可能有一点斗争，尤其是疫苗分支和pHAC和/或CDC？ 民意调查是在卫生部之间进行的战争，保健疫苗分支机构和PHAC / CDC之间是不知道他们既不称之为卫生疫苗司疫苗部门的执行摘要科学家在从NOÉCHAREIER发现它后立即核实SV40启动子/增强剂 有几个问题被发送到辉瑞以获取解释和理由，但辉瑞提出了加拿大的健康，他们觉得没有问题，没有其他监管机构询问这些问题。 卫生加拿大，然后需要接下来的3个月试图在船上获得EMA和FDA。 EMA愿意，但FDA拖到10月（菲利普博士博士博士的某个时候介绍了南卡罗来纳州参议院，这是病毒的。 最后，他们同意辉瑞需要“补救”的情况。 辉瑞提交了DNA片段的所需文档和SV40增强剂/启动子对卫生加拿大的作用，并承认它们使用多功能质粒（也可以想到用于基因治疗）。 它们还没有似乎呈现关于DNA片段的风险以及可能进入细胞核的风险的数据。 事实上，一些引用用作没有问题的理由，实际上表现出风险。 当NoéChartier和Matt Harwood在纪念时代发布报告时，加拿大卫生加拿大与媒体网点的要求淹没，以确认这一发现。 在同一天，Speicher等的第二个预印刷药在安大略省小瓶中确认SV40序列和残留DNA。 CDC和PHAC试图向健康加拿大提供“线路”，这将减轻和揭示这些调查结果，但加拿大卫生保健不会在APIP会议之前及时向CDC提供陈述。 电子邮件显示了卫生加拿大通信响应的编辑和制作的数量，以媒体和改变原始意图和语调的CDC，尽管仍然确认了SV40序列的存在。 至于问题分析摘要（IAS）的结果，该信息被编辑，我们知道它被Quashed。 我们正在挖掘它，并拥有所有关于DNA片段风险的辉瑞和SV40序列的报告，并在12月1日与FDA和EMA会面上进行的ATIP。 祝我们运气！ 谢谢阅读，请分享和哦祈祷念珠。 分享订阅，如评论restack最初发布于on
maria gutschi，洗过药剂师订阅独立研究人员。 独立的思想家。 洗了药剂师。 妻子，母亲，祖母，天主教