patrick.net

…CO PHAM和他的团队确认了McKernan和Buckhaults的结果，并发现所有辉瑞疫苗的所有大量疫苗都在质粒中使用SV40启动子/增强剂/ ORI，包括XBB疫苗。 （并且大概也是儿童的版本也是如此。）…

…CO PHAM and his team confirmed McKernan and Buckhaults’ results and found that all bulk Pfizer vaccines use the SV40 promoter/enhancer/ORI in the plasmid, including the XBB vaccine. (And presumably the children’s version too.)…

…CO PHAM et son équipe ont confirmé les résultats de McKernan et Buckhaults et ont découvert que tous les vaccins Pfizer en vrac utilisent le promoteur/amplificateur/ORI SV40 dans le plasmide, y compris le vaccin XBB. (Et probablement la version pour enfants aussi.)…
… …

https://open.substack.com/pub/mariagutschi/p/health-canada-sv40-and-atips-part

Jessica Rose
Oct 22 · Unacceptable Jessica
Very important compilation here.

Health Canada, SV40 and ATIPs: Part 1 July to August 2023
Insights from the various ATIPs and analysis and an in-depth analysis
WASHED UP PHARMACIST AND SCOOPS MCGOO
OCT 22

READ IN APP

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

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

WHEN DID WE COME TO KNOW?
DID WE CONDUCT AN ANALYSIS TO DETERMINE HOW MUCH OF THE SV40 SEQUENCES ARE IN THE VACCINE/ (ie picograms?)
SHOULD THE SEQUENCE HAVE BEEN DISCLOSED TO US?
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:

HSV TK polyA signal
SV40 polyA signal (not a promoter)
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 杰西卡玫瑰10月22·不可接受的杰西卡在这里非常重要的汇编。 卫生加拿大，SV40和ATIPS：7月1日至8月2023年，各种atips和分析的见解以及深入分析的深入分析，自2024年8月底以来，在App中提出了药剂师和Scoops McGoo OCT 22章 这些atips在自然界中主要由Scoops McGoo提交，也由Epoch Times记者Noe Chrier提交。 我的atips回来空白，所以他们显然知道超过我在提交适当措辞的信息请求自由。 当分析在一起时，这些绘制了试图解决问题，政治干扰，甚至可能对ModRNA疫苗的可能性不足的非常有趣和令人不安的画面。 感谢Scoops McGoo，获得了大部分的atips和我的同事Karen Rucas，他们构建了时间线（赫氏任务），我们都为ATIPS审核的700多页的第1页做出了贡献。 让我们开始开始。 1.凯文·麦克奈纳·基因组专家凯文·麦肯卡纳（Kevin McKernan）向FDA的VRBPAC发布了他的预先印刷品，并向FDA的VRBPAC发表了他的研究结果，从分析辉瑞和现代疫苗 Kevin McKernan向VRBPAC提供的调查结果显示到VRBPAC 2. Noe Chartier来自Epoch Times Canada于7月17日，Noe Charier举行的Health Canada提交了问题，从Epoch Times Canada提出了以下问题加拿大卫生。 由于它们是关于ModRNA疫苗，因此它们被路由到生物制剂和Radiopharmaceutics Disps（BRDD）。 BRDD有几个部门和办事处，包括疫苗中心，临床试验和生物统计（CVCTB）监管事务办公室，这里是NOE的问题。 Noe Charterier凭借他的问题，南卡罗来纳州菲利普博士博士的结果有助于沿麦克纳南的预报 CVCTB部门负责批准ModRNA疫苗。 CO PHAM和他的团队确认了McKernan和Buckhaults的结果，并发现所有辉瑞疫苗的所有大量疫苗都在质粒中使用SV40启动子/增强剂/ ORI，包括XBB疫苗。 （并且大概也是儿童的版本也是如此。）他们注意到辉瑞试图提供每种质粒的所有功能组分的完全注释，但显然没有。 在这种情况下，“功能”是什么意思？ 稍后这将变得重要。 不幸的是，该分析的其余部分被删除。 根据DNA疫苗的指导，以及MRNA疫苗指导状态的疫苗：应提供识别所有ORF的完整注释序列（包括任何意外ORF）和所有其他序列元素（包括使用的理由）。 ......应该指出在mRNA中编码的每个基因序列的预期功能和目的，以及特定的非编码和结构元素的目的，解释它们对整体模式或作用机制的贡献。 哦哦。 4.卫生加拿大疫苗的中心启动了一个问题分析摘要（IAS）7月19日，2023年是什么是IAS？ 问题分析摘要（IAS）通常是指监管或合规框架内使用的文件或过程，以分析和总结与保健品，医疗设备，药品，天然保健品或其他受监管相关的健康有关的问题的问题。 2023年7月19日，验证了SV40序列后的一天，将疫苗中心的主任CO PHAM授权他的团队。 Tong Wu是CVCTB下的质量疫苗分配3号的经理。 这可能是从一开始就评估ModRNA疫苗的团队。 IAS的结果用于mRNA疫苗可包括持续监测疫苗批次的建议，提高报告疫苗中的DNA含量的透明度，甚至在认为必要时去除这些序列的疫苗。 这也意味着加拿大将收集制造商的信息。 由监管机构发起的IAS并不常见，因为监管机构是基于未来自药物公司本身的信息，或者从与mRNA疫苗无关的常规药物检测等发起，这里是HC在PHOTOC上的IAS评估 这导致了新的指导方针，需要测试所有未来的药品。 这个IAS来自1999年，我真的找不到另一个。 具有照片共同致癌潜力的药物制剂监管策略。 所以我相信启动IAS是监管界的一个非常大的交易。 5. BRDD试图回答NOE Chartier的问题199,2023 2003年生物和放射性药物理事会（BRDD）向NOE的问题提出回答。 关于SV40序列，这是第一选秀。 不清楚谁写了这篇文章。 斜体的票据是来自未知（可能的非科学家）人的评论。 （截面缩短）提供全质粒序列，其允许确认公开公开的SV40增强子存在。 [问题是指向EMA披露的信息。 首先，我们应该注意到我们不能与提供给另一个监管机构的信息。 对于我们的回应，如响应于第一个问题所提到的，我所公开的披露所公开的以及确认与完整序列的某些东西之间的差异是什么，由于酶消化步骤，残留的质粒DNA存在于最终产物中的残留质粒DNA。 因此，支持辉瑞疫苗初步批准的原始风险效益分析继续有效。 我猜助理副部长办公室（!!!）虽然我认为它只是在BRDD，而不是加拿大的所有卫生。 Anna Maddison发送此电子邮件，是一名高级媒体顾问，并为加拿大，通信和公共事务局的完全不同的卫生理事会。 安娜也是回答Noe Chartier媒体请求的人。 7月21日，2023年，这里是一个草案（评论后）通知一些招生我们什么时候来了解？ 我们是否进行了分析，以确定疫苗/（即皮科斯的SV40序列是多少，如果序列已经向我们公开了？ 我们的分析早些时候已经完成了吗？ 我认为这是董事会的神圣托莱多时刻。 我也认为疫苗的中心是辉瑞的蓬勃发展。 它仅发行IAS只需要1天，并且通常在监管土地上慢慢移动更慢，哈哈。 也许他们已经担心了，这是最终的稻草？ 7月28日，2023年在这里是在纪念时间发送到Noe Chartier的最终答案。 注意消除第一线，并去除存在小DNA片段的入院。 这些小消化的DNA片段是由McKernan和Buckhaults识别的问题之一。 NOE的其他问题经历了类似的起草，但为了清楚起见，我刚刚包括SV40序列。 6.辉瑞公司XBB疫苗的提交于7月21日收到2023年肯尼斯卡莱/高级监管总监/ BRDD向监管团队审查疫苗的监管团队发出XBB疫苗的提交。 值得注意的是，Kevin McKernan的预印迹附上，因此疫苗部门（至少）中的每个人都知道关于SV40序列和Kevin对残留DNA量的分析。 7.科学家从CVCTB向PFizer出发到2023年7月27日的问题，因为大概是与塘武合作的IAS，迈克尔墙的一部分，并在疫苗中心报告将PHAM报告，开始起草一些语言 这是提出关于SV40序列的PFizer的问题。 请注意，采取监管方法（即您应该告诉我们）而不是安全。 这是因为这需要更多的时间，也可能受到诠释和细微差别。 我认为HC在这里想要细微差别。 他们想要答案。 2023年7月27日同时，Brdd的一名高级顾问的同一天在那同一天，开始质疑他们是否需要讲述媒体请求以及通过疫苗集团来到他们的问题。 注意他们呼吁这种DNA质粒污染，从技术上是不是。 由于需要除去的制造，它是一种与过程相关的杂质。 它不是“污染”添加到药物产品中。 因此，BRDD总干事Sophie Sommerer应根据疫苗，临床试验和生物统计数据（CVCTB）的要求，（可能的CO PHAM）同意通知媒体请求的辉煌，所以他们没有“抓住守卫” 他们的理由是，这是通过Eli Lilly的毒品Donanemab完成的，这是新的争议阿尔茨海默氏药物。 这是拟议的辉煌邮件草案，所以它只花了10天，从Noe Charier的问题中发现了SV40序列，确认是关于发送辉瑞的一致意见，他们将回答这一发现的电子邮件。 非常适合政府，恕我直言。 8.第一个质量克拉夫克斯送到辉瑞和响应7月27日，2023年迈克尔墙建议了质量克拉夫克的第一草案，其中一个科学家们向CVCTB报告了CVCTB（即中心） 当需要制造质量的修订和/或澄清时发出克拉克利法（也可以用于临床试验等）。 在筛选期间发布的澄清请求应在2个日历日内回复[C.05.009]。 如果尚未提供对Clarifax的及时响应，将发出拒绝信。 2023年8月4日至8月4日，2023年8月4日，已经完成了起草，并将质量克拉夫克斯送到加拿大普及的辉瑞，关于XBB疫苗目前正在审查该特定疫苗。 他们为辉瑞公司提供了周末回答，截至8月9日星期三，给他们2个工作日回答。 好的，现在事情变得有趣。 下面我们发布质量Clarifax＃1和Pfizer的答案。 根据我们，我们知道HC询问为什么SV40调节序列存在于质粒中。 问题1的另一部分是缩写的。 在问题2中，他们询问质粒的其他部位的功能，该质粒也未被Kevin McKernan发现，并且可能由HC科学家们发现。 这可能包括：HSV TK PolyA信号SV40 PolyA信号（不是启动子）AMPR启动子最终他们要求残留DNA片段的尺寸分布。 这告诉我们，测量的所有内容是PCR的DSDNA的量，并且没有使用其他分析方法（因此没有关于小碎片<200bp）的想法，以及小瓶中是否存在任何完整的质粒。 辉瑞如何回应？ 问题1他们基本上说，SV40序列没有什么都不做。 这里没什么可见的。 哦，它用于推动他们说的哺乳动物细胞中的新霉素/卡那霉素抗性。 这没有意义。 当然，这种序列与mRNA生产无关，因为它不位于质粒上以驱动mRNA生产。 T7启动子在那里就是这样。 SV40启动子正在推动卡那霉素基因。 Kanamycin放入肉汤中，其中大肠杆菌划分和生长。 通过具有卡那霉素抗性，只有那些含有含有卡那霉素基因基因的质粒的大肠杆菌将生长。 因此，您知道那些大肠杆菌是你想要的。 对于卡那霉素没有启动子，没有mRNA。 问题2哦，没什么可见的。 辉瑞似乎分散了HC与SV40病毒的线条分散注意力，所以没有问题，但这并不是这个SV40序列的问题。 辉瑞刚刚说它不相关，如果它在那里，它处于如此的低水平，这是一个“最小”的风险。 其余的原因是重做。 我想知道为什么。 问题3