Health Canada, SV40 and ATIPs: Part 1 July to August 2023

Insights from the various ATIPs and analysis and an in-depth analysis

Since the end of August 2024 there have been a whole series of ATIPs (Access to Information) requests, which are Canada’s equivalent to the US’s FOIA, that have become available regarding the SV40 promoter/enhancer in the Pfizer vials, as well as other data. These ATIPs, which are Federal in nature, have mostly been filed by

Scoops McGoo

and also by the Epoch Times reporter Noe Chartier. My ATIPs come back blank, so they obviously know more than I do on filing appropriately worded freedom of information requests. When analyzed together, these paint a very interesting and disturbing picture of scientists trying to fix the problem, political interference, and even a potentially insufficient understanding of the modRNA vaccines.

Thanks to Scoops McGoo who obtained most of these ATIPs and to my colleague Karen Rucas who constructed the time line (a herculean task), we all contributed to this Part 1 of the 700+ pages in the ATIPs reviewed.

Lets start at the beginning.

1. Kevin McKernan publishes his preprint and presents to the FDA’s VRBPAC

In April 2023, Kevin McKernan, genomics expert, published his preprint on his findings from analyzing the Pfizer and Moderna vaccine which can be found HERE

The US Vaccine and Related Biologicals Product Advisory Committee (VRBPAC) met on June 15, 2023 “to discuss and make recommendations on the selection of strain(s) to be included in periodic updated COVID-19 vaccines for the 2023–2024 vaccination campaign” In that meeting, Kevin presented his results to the committee which can be seen here. Kevin McKernan presents findings to VRBPAC

2. Noe Chartier From Epoch Times Canada Submits Question to Health Canada

On July 17, 2023, Noe Chartier, from Epoch Times Canada submits the following questions to Health Canada. Since they are about the modRNA vaccines, they are routed to the Biologics and Radiopharmaceutics Drugs Directorate (BRDD). The BRDD has several Divisions and Offices including

1. Centre for Vaccines, Clinical Trials and Bio-statistics (CVCTB)

2. Office of Regulatory Affairs

Here are Noe’s questions.

Noe Chartier helpfully sends along McKernan’s Preprint with his questions and also the results of Dr. Philip Buckhaults from South Carolina

3. Health Canada Fact Checks the SV40 enhancer/promoter

The VERY NEXT DAY, scientists from the Centre for Vaccines, Clinical Trials and Biostatistics (CVCTB) division, headed by Co Pham, initiate an investigation into the the plasmids used by Pfizer to manufacture the modRNA present in the vials. The CVCTB division is responsible for the approval of the modRNA vaccines.

Co Pham and his team confirm the results of McKernan and Buckhaults and find that ALL lots of the Pfizer vaccine use the SV40 promoter/enhancer/ori in the plasmid, including the XBB vaccine. (and presumably the children’s versions as well.)

Here they note that Pfizer was supposed to provide a full annotation of all functional components of each plasmid, but obviously did not. In this context, what does “functional” mean? This will become important later. Unfortunately the remainder of this analysis is redacted. As per guidelines for DNA vaccines, and for mRNA vaccines as per the WHO in their mRNA vaccine guidance state:

The complete annotated sequence identifying all ORFs (including any unexpected ORFs) and all other sequence elements (including their justification for use) should be provided. ……The anticipated function and purpose of each gene sequence encoded in the mRNA should be indicated, as well as those of specific noncoding and structural elements, explaining their contribution to the overall mode- or mechanism-of-action.

Uh oh.

4. Health Canada’s Centre for Vaccines Initiates an Issues Analysis Summary (IAS)

July 19, 2023

What is an IAS?

An Issue Analysis Summary (IAS) typically refers to a document or process used within regulatory or compliance frameworks to analyze and summarize issues related to health products, medical devices, pharmaceuticals, natural health products, or other regulated health-related items.

On July 19, 2023, the day after the SV40 sequences were verified, Co Pham the director of the Centre for Vaccines, authorizes an IAS to his team. Tong Wu is the Manager of Quality Vaccine Divison 3 under the CVCTB. This is likely the team that has been assessing the modRNA vaccines from the beginning.

The outcome of an IAS is for the mRNA vaccine could include recommendations for ongoing monitoring of vaccine lots, enhanced transparency in reporting DNA content in vaccines, or even potential reformulation of vaccines to remove these sequences if deemed necessary. This also means Health Canada will gather information from the manufacturer. An IAS initiated by a regulatory authority is not common because it is initiated BY the regulator based on information that did NOT come from the drug company itself, or from routine pharmacovigilance etc. Unrelated to the mRNA vaccines, here is an IAS assessment by HC on the photocarcinogenic potential of drugs. This resulted in new guidelines requiring testing for all future drug products. This IAS is from 1999 and I really can’t find another one. Regulatory Strategy for Pharmaceutical Products with Photo Co-carcinogenic Potential. So I believe initiating an IAS is a very big deal in regulatory circles.

5. BRDD Try to Answer Noe Chartier’s Questions

July 19, 2023

The Biological and Radiological Drugs Directorate (BRDD) drafts responses to Noe’s questions. With respect to the SV40 sequences here is the first draft. It is unclear who wrote this. The notes in italics are comments from an unknown (likely non-scientist) person.

(SECTION REDACTED) the full plasmid sequence was provided, which permitted the confirmation of the publicly disclosed presence of SV40 enhancer. [the question refers to information disclosed to the EMA. First we should note that we can't speak to information provided to another regulator. Then for our response, it's not clear to me what was disclosed and what the difference between confirming something versus having the full sequence is] As mentioned in response to the first question, 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.

I guess there was lots of input from the Assistant Deputy Ministers Office (!!!) though I think it was just at BRDD and not all of Health Canada. Anna Maddison, who sent this email, is a Senior Media Advisor and works for an entirely different Directorate of Health Canada, the Communications and Public Affairs Directorate. Anna was also the one who answered Noe Chartier’s media requests.

July 21, 2023

And here is a draft (after comments)

Notice a few admissions

1. WHEN DID WE COME TO KNOW?

2. DID WE CONDUCT AN ANALYSIS TO DETERMINE HOW MUCH OF THE SV40 SEQUENCES ARE IN THE VACCINE/ (ie picograms?)

3. SHOULD THE SEQUENCE HAVE BEEN DISCLOSED TO US?

4. SHOULD OUR ANALYSIS HAVE BEEN DONE EARLIER?

I think this is a HOLY TOLEDO moment for the Directorate. I also think that the Centre for Vaccines is royally upset with Pfizer. It took only 1 day for the IAS to be issued, and usually things move much more slowly in regulation land, lol. Maybe they already had concerns and this was the final straw?

July 28, 2023

Here is the final answer sent to Noe Chartier at Epoch Times. Notice the elimination of the first line, and removal of the admission that small DNA fragments are present. These small digested DNA fragments is one of the issues identified by both McKernan and Buckhaults.

The other questions by Noe undergo similar drafting, but for the sake of clarity, I have just included the SV40 sequences.

6. The Submission for Pfizer’s XBB Vaccine is Received

On July 21, 2023

Kenneth Garay/Senior Regulatory Officer/BRDD sends the submission of the XBB vaccine by Pfizer to the regulatory team reviewing the vaccine. Of note, Kevin McKernan’s preprint is attached and thus everyone in the vaccine division (at least) knows about the SV40 sequences and Kevin’s analysis of the amount of residual DNA.

7. Scientists from CVCTB Draft Questions to Pfizer to Explain Themselves

July 27, 2023

As part of what is presumably the IAS, Michael Wall who works with Tong Wu and reports to Co Pham in the Centre for Vaccines, starts drafting some language around the IAS. This is to ask questions of Pfizer regarding the SV40 sequences.

Notice that a regulatory approach was taken (ie you were supposed to tell us) and not on safety. This is because that would take more time and also subject to interpretation and nuance. I don’t think HC wanted nuance here. They wanted answers.

July 27, 2023

Meanwhile on that same day, Poovadan Anoop, a Senior Advisor at BRDD starts to question as to whether they need to tell Pfizer about the media request and what questions will be coming to them via the Vaccine group. Note they are calling this DNA plasmid contamination, which technically it is not. It is a process-related impurity as a result of the manufacturing which needs to be removed. It is not “contamination” ADDED to the drug product.

So Sophie Sommerer , the DIRECTOR GENERAL of BRDD, on request of the Centre for Vaccines, Clinical Trials and Biostatistics (CVCTB), (likely Co Pham) agrees with informing Pfizer of the media request so they do not get “caught off guard”, but not what their answer will be. Their justification is that this was done with Eli Lilly’s drug donanemab, the new controversial Alzheimer’s drug.

And here is the proposed draft email to Pfizer

So it only took 10 days, from finding out about the SV40 sequences from Noe Chartier’s questions, confirming that yes, they are in agreement regarding sending Pfizer an email that they are going to respond to this discovery. Pretty quick for government, imho.

8. The First Quality Clarifax is Sent To Pfizer and Responses

July 27, 2023

The first draft of a Quality Clarifax was suggested by Michael Wall, one of the scientists who reports to Tong Wu and then to Co Pham of the CVCTB (ie the Centre for Vaccines)

What is a CLARIFAX?

A Clarifax is issued when revisions and/or clarifications regarding manufacturing quality are required (can also be for clinical trials, etc). Requests for clarification that are issued during screening should be responded to within 2 calendar days [C.05.009]. A Rejection Letter will be issued if a timely response to a Clarifax has not been provided.

August 4, 2023

By August 4, 2023, the drafting had been done and a Quality Clarifax was sent to Pfizer in Canada regarding the XBB vaccine as they were currently reviewing that particular vaccine. They gave Pfizer the weekend to answer, due Wednesday, August 9th, giving them 2 business days to answer.

OK now things are getting interesting. Below we post the Quality Clarifax #1 and Pfizer’s answers.

From this we know HC is asking why the SV40 regulatory sequences are present in the plasmid. The other part of Question 1 is redacted. In Question 2, they are asking for the functions of other parts of the plasmid which was also NOT disclosed as found by Kevin McKernan, and presumably by the HC Scientists. This likely includes:

1. HSV TK polyA signal

2. SV40 polyA signal (not a promoter)

3. AmpR promoter

Finally they ask for the size distribution of the residual DNA fragments. This tells us that all that is measured is the quantity of dsDNA by PCR and no other analytical methods were used, (so no idea about small fragments <200 bp), and whether there is any intact plasmids in the vials.

How did Pfizer respond?

QUESTION 1

They basically say, SV40 sequences not doing nothing. Nothing to see here. Oh it is used to drive neomycin/kanamycin resistance in mammalian cells they say. This does not make sense. Of course this sequence is not relevant to the mRNA production since it is not situated on the plasmid to drive mRNA production. The T7 promoter is there for that reason. The SV40 promoter is driving the kanamycin gene. Kanamycin is put in the broth where the E coli divide and grow. By having kanamycin resistance then only those E coli with the plasmid containing the kanamycin gene will grow. Thus you know those E coli are the ones you want. No promoter for kanamycin, no mRNA.

QUESTION 2

Oh nothing to see here. Pfizer seems to be distracting HC with the line that it is not the SV40 virus so there is not issue, but that is NOT what the problem with this SV40 sequence. Pfizer just says it is not relevant and oh and IF it is there it is in such LOW levels it is a “minimal” risk. The rest of their reason is redacted. I wonder why.

QUESTION 3

This is a BIG admission by Pfizer. They don’t even know what the size distribution of the DNA fragments are? They don’t know if there are whole plasmids? Also the gaslighting they do and whipsawing by intimidating HC scientists by saying NO ONE else is asking us so we don’t need to answer you quickly. This is typical of Pfizer and other drug companies, actually. I have seen this personally as a clinical manager in hospital and in my other government jobs.

For more interpretation on what Pfizer is saying here in all their responses, refer to Kevin McKernan’s substack on this portion of the ATIP as requested by

Scoops McGoo

.

Scoops Mcgoo reveals a bombshell

8. Noe Chartier Submits Follow-up Questions

August 16th and 18th, 2023

Meanwhile, Noe Chartier keeps the Communications department of BRDD busy with more follow-up questions. Noe has not written any report yet for Epoch Times. He is still collecting data.

Noe sent his follow-up questions August 16, 2023 with the responses given August 18th.

Note, Dr Supriya Sharma MD is aware of the issues and concerns with the SV40 sequences and the level of residual DNA. Does she not realize how serious this is? Dr Sharma is the Chief Medical Advisor for Health Canada and is a pediatric physician so very pro-vaccine, with a masters in public health. Supriya Sharma interview

9. Health Canada Tries to Get the EMA and FDA Interested in the SV40 Sequences

August 17, 2023

Meanwhile, Dean Smith who is the liaison from the Vaccine group to outside regulatory agencies has reached out to his counterpart at the European Medicines Agency (EMA) to talk about the SV40 sequences. It appears they want to meet after the RAG meeting. Note, this is ONLY with the EMA, and not the FDA (at first).

RAG=Regulatory Advisory Group which is a group co-led by WHO and CEPI. The RAG has members from Regulatory Agencies covering all WHO regions, including Argentina, Australia, Brazil, Canada, Europe, US, etc. RAG was set up to give feedback on regulatory science questions of an agnostic nature raised by the COVAX SWAT teams in order to promote regulatory preparedness among COVID-19 vaccine developers. Here is a technical brief from May 2021

The meeting took place with the EMA contact after the RAG meeting, but there was no record of this meeting that was included in the ATIPs. However, some action was planned since this contact at the EMA continues discussing the SV40 with Dean Smith

August 21, 2023

Who is the person in the redacted section? Likely his contact at the FDA. The Ad-Hoc Cluster Meetings are a long-standing working-level collaborative meetings between the EMA, HC and FDA which started in 2003. There are several of them such as pediatrics, pharmacovigilance, drug shortages and of course vaccines. For the Vaccine group, cluster meetings were mostly about the COVID-19 vaccines and regulatory matters since the start of the pandemic. Multilateral COVID-19 'cluster' meetings

However, the EMA contact thinks buy-in from the FDA might be a problem. Why would that be?

It is a public topic now. HC and the EMA want to know if they, and the FDA are on the same page. What had HC and the EMA discussed? Re Pfizer? Why do they seem uncertain that the FDA will be interested?

August 23, 2024

Dean Smith reaches out to his counterpart at the FDA, trying to get the SV40 sequences on the agenda. These are remarkable emails.

I think the redacted name is the EMA contact with which he discussed the SV40 sequences after the RAG meeting earlier in the month. Dean Smith does not see the need for the SV40 sequences to be in the plasmid so he’s not buying what Pfizer was selling. However, Health Canada doesn’t see it as URGENT? What does URGENT mean in this context? However, he does suggest that collectively they can try to get Pfizer to REMEDY the situation. Remember that Pfizer was not really willing to provide information as was requested in Clarifax #1 because no other agency was asking the same. Here is the answer from his FDA contact. What does REMEDY the situation mean here? Remove the sequences from the plasmid? Oh and it would be so unfortunate if it increases vaccine hesitancy. Really?

So it is OK to add it to the cluster meeting. But it doesn’t appear to be a burning issue. And who is the redacted name? My guess, based on the size is MARKS. That is Dr. Peter Marks, the head of the Centre for Biologics and Evaluation Research or CBER at the FDA. What do you think? Health Canada’s equivalent would be Celia Lourenco or Sophie Sommerer (don’t know when Sophie took over Celia’s role). Plus, since the FDA and CBER knew about the SV40 sequences since JUNE 15th, 2023 when Kevin McKernan presented his results to VRBAC. One would have hoped there were discussions on this topic since Dr Marks was almost certainly present during the presentation, as he was seen several times during the 8+ hours of recorded video. Yet, nothing was happening at the FDA. Did they BLAST the sequences like HC did, or have the sequences annotated with SnapGene or other programs to verify?

August 22, 2023

On a related note, on August 22, 2023, during the middle of all this planning for the cluster meeting, Dr Janci Lindsay, a molecular biologist and toxicologist, calls up Dr. Keith Peden at CBER. This remarkable exchange can be found on Dr Lindsay’s twitter feed.

https://twitter.com/JanciToxDoc/status/1782981261969051768

Janci reports Keith Peden was aware and stated it was likely an “artifact” and a lab contaminant. Holy Toledo. What is important to note is that Dr Peden is a senior FDA scientist, Office of Vaccines Research and Review (OVRR), Division of Viral Products, Laboratory of DNA Viruses at CBER who has done some serious work on DNA vaccines. This includes this 2009 paper by Sheng-Fowler and Peden, Issues associated with residual cell-substrate DNA in viral vaccines which discuss the risks of the amounts of residual DNA and the sizes of the DNA fragments which can be oncogenic or infectious. Kevin and others quote this paper all the time. How ironic. Did the FDA verify Kevin McKernan’s and Buckhault’s findings?

August 24, 2023.

The cluster meeting takes place. Co Pham, Tong Wu and Dean Smith and other HC scientists attend along with representatives of the EMA and the FDA. The agenda is mostly about pediatric dosing and intervals between doses between the last dose and then new updated vaccines. There is nothing on the Agenda re SV40 sequences or “other” agenda items.

10. Tong Wu from the CVCTB (Vaccines) Sends Out Clarifax #2 to Pfizer

August 22, 2023

Meanwhile, it appears Health Canada is not happy with Pfizer’s responses regarding the SV40 sequences and their so-called justification. Tong Wu asks for ANOTHER Clarifax #2 to be sent out to Pfizer just after the RAG meeting (but before the cluster meeting with the FDA and EMA). The due date for a response from Pfizer is August 24th, 2023.

August 24, 2023. Pfizer’s response.

Pfizer is just repeating what they answered for Clarifax #1. What does the SV40 sequences have to do with VIRAL CONTAMINATION? This is not an uncommon tactic. This answers another question but not the actual question being asked. And why is HC saying no peer-reviewed evidence for residual SV40 sequences causing safety issues? Likely technically true, since NO currently approved vaccines have any part of the SV40 virus as part of its manufacturing process. Still, it appears these vaccine scientists don’t have a full appreciation of what these sequences are capable of, especially in context of transfection along with other DNA fragments.

Pfizer reiterates these sequences are “non-functional.” Then why are they present in the plasmid? Is this a design failure? Normally, one doesn’t put elements into the manufacturing process that doesn’t need to be there if you have to remove them later. Extra work. More risk.

And again, Pfizer does not know the size distribution of the residual DNA fragments, and yes, they will get back to Health Canada whenever they get around to it, no later than December 1st. Which is laughable since this would take what, 2 weeks max? Though replication in bacteria may take more.

Remember that the Vaccine group was at the Cluster Meeting when the answers from Pfizer came in. It appears HC requested removal of the SV40 sequences in the redacted portions because Pfizer’s response is basically “get lost.” This was not a surprise to the team.

Dean Smith is relieved he raised this issue with the other regulators at the cluster meeting the day before because it appears removing the SV40 sequences can’t be done unless the FDA agrees. But what is this about “minimal” risk that Dean puts in brackets? Sarcasm?

“In this current climate” Yowza. What are the implications of that statement?

11. Tong Wu (Centre for Vaccines) Sends Out a Comment to Pfizer (Clarifax #3)

August 29, 2024

Well, I think the team wants to respond to Pfizer, but how and what? One of the team members proposes a draft Clarifax #3.

What is that redacted part? Was there any mention that this is a gene therapy plasmid and that the SV40 sequences are used for gene therapy? Do they know?

It’s now official. Health Canada will be working with the other regulators on removal of these elements but Tong feels that telling Pfizer that discussions with the EMA and FDA are ongoing in this regard is premature. Why would this be? Why do they feel they cannot inform Pfizer at this time?

“We can not say nothing!” You can see the frustration.

Dean Smith suggests a hybrid which is of course, redacted.

August 30, 2023

There must have been more discussion, because they refrained from sending out a formal Clarifax since that requires a response, and instead sent out this Comment.

HC calling out Pfizer’s obfuscation. No these sequences are not needed for the structural integrity of the plasmid. Prove it Pfizer. If you can.

12. The Quality Review of the new XBB Vaccine is Completed

Sept 5, 2023

The Quality Evaluation Executive Summary (QEES) of the CVCTB Final Assessment of the XBB Vaccine is completed. Here Tong Wu, Division Manager reminds Pfizer of its commitments regarding quality

1. the commitment to the characterization of the DNA fragments

2. certified product information document

Finally Tong Wu reminds Pfizer must report and fix their OUT OF SPECIFICATIONS results for stability monitoring of the vaccine.

HOLY TOLEDO. Still, after 3 full years they are still having trouble with stability and specifications. Sometime in early August 2023, inspectors were sent to Pfizer’s Kirkland Quebec facility and performed an inspection. You can read it here. They get a PASS but read the actual report yourself and tell me what you think.

INSPECTION REPORT CARD SUMMARY

So more of a serious warning. Not quite at the level of yanking their establishment license but this report does not makes us feel warm and cuddly.

Here is the QEES. (Why do governments have all these acronyms???)

Well, look at this. HC vaccine quality division does not believe the SV40 sequences are a concern because “guidelines” and Pfizer is going to give them more data. Oh and no peer-reviewed data. Oh and the other quality issues are redacted. What are they?

Well, what else can they say? That it is dangerous and shouldn’t be there and should be taken out? Then that means no approval for the XBB vaccine and it appears from this email, that would not be possible given “the climate” and lack of interest from other parties like the FDA.

And maybe they really don’t know? Is that possible? These scientists are primarily immunologists and molecular biologists who may not have much knowledge in the area of genomics or gene therapy technologies.

BUT

The gene therapy regulators are in the same building. In the same Directorate. Was no one consulted? No emails from the Centre for Oncology, Radiopharmaceuticals and Research?

Here is what they do.

The Centre for Oncology, Radiopharmaceuticals and Research (CORR) is responsible for the regulatory and scientific evaluation of the quality parameters (chemistry and manufacturing) and clinical data for oncology products, radiopharmaceuticals and gene therapies at the pre-market application stages. It also evaluates cells and cell-based medicines, tissues and organs for transplantation as well as sperm and ova for use in assisted human reproduction. In addition, the CORR conducts regulatory-based scientific research, supporting BRDD in areas that include vaccines, stem cells, nanomedicines, glycobiology, cellular immunology, gene therapies, antimicrobial resistance, as well as protein structure and analytical biotechnologies. The CORR supports common services to BRDD laboratories.

They do research? For the rest of the Directorate? And have labs? Expertise in nanomedicines?

HOLY TOLEDO

Why were they not asked about the SV40 sequences? I am pretty certain they were not asked from private conversations I can not divulge at this time.

Part 2 will include from September to December 2023. Stuff with the CDC, the media, the EMA, etc. Things really start heating up.

Here is Noe Chartier's article in the Epoch Times October 19, 2023 to summarize what he received from Health Canada from July-September.

Thanks for reading and pray the rosary.