Dr. Naomi Wolf: My Mind Blown by 1560 Geneva Bible

I was searching for the earliest English translation of the Bible from the Hebrew — because, of course, I am seeking guidance and comfort in a time of chaos and crisis. The Great Bible is the earliest translation. But the 1560 Geneva Bible, which I have been reading, has completely astonished me.

It was compiled by Protestant dissidents who had fled England under Queen Mary Tudor’s (“Bloody Mary’s”) reign — seeking to avoid martyrdom. They put together this translation from the Hebrew while gathered in Switzerland. They wrote it so that anyone literate could understand it — and added, for the first time, cross-references and marginal notes, and even maps.

This version is the one used by William Shakespeare, John Donne, John Milton — but also by the Puritans, and by our own Founders.




As I read it, I understood why the Geneva Bible was banned by King James, who commissioned the official — beautiful but state-sanctioned — King James Version. The Geneva Bible is incredibly subversive and liberating, and awe-inspiring, just as the original Hebrew is transformational and liberating and awe-inspiring. Reading it, I understood why the Puritans would give up everything and sail across unknown seas to create a sacred community in the wilderness. I understood what gave our Founders the courage to challenge the greatest Empire on earth at that time.

I also saw that many mistranslations appeared in later editions of the Bible (I read Hebrew, a skill set I never thought I would use again) — I call attention to some here in the 1966 Jerusalem Bible. Stunning mistranslations, most of which tend to serve to remove people from intimacy with God and to foreground the need for institutions and intermediaries.

I never felt compelled by the Hebrew Bible before, when reading other translations; it was hard to feel connected to the Being that seemed Quixotic, distant and even irrational. But in this version, the Geneva Bible, we have a God who longs for a communion with humans, and we have a much less lonely, much less punitive set of circumstances in which human development is meant to unfold. In later translations, God is made much more abstract, and much more rigidly judgmental; and priests and religious institutions are foregrounded. In this early version (and in the Hebrew), it is a heart-wrenching, challenging love story between the Lord and his creation, human beings. A very very serious relationship; but very very intimate and tender.

I’ll be reading it right through, on audio, as it is hard to find on audio and it is hard to read directly if you don’t happen to have been trained in Elizabethan typography (oddly enough, I had to take that class to get my Oxford MPhil. Like my Hebrew familiarity, I never thought I would use that skill set again; but life is funny that way.)

-End-

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The Greatest Crime In Human History Ever Recorded Is Coming Soon in Paperback Form

The damning information that Pfizer, and as such, what the FDA knew, and wanted to keep hidden for 75 years, has been thoroughly documented and compiled into a paperback book.

These important summaries, which detail astonishing ranges of deaths, disabilities, and other systematic harms to subjects, contain vastly important headlines: twenty forms of menstrual damage to women — how Pfizer covered up a flood of adverse events — PEG in breast milk — within a month of rollout, Pfizer knew the mRNA vaccines did not work.

All funds and proceeds raised go to the research project — and put food on the table for those devoting their time to this noble cause. So, please, show your support and get your (or a loved one’s) hands on this critical information in one place — by ordering your copy today.

Pre-Order the Paperback Version

Pick Up Your Digital Copy on Amazon

Or our website.

The post Dr. Naomi Wolf: My Mind Blown by 1560 Geneva Bible appeared first on DailyClout.

“Where’s my cycle?” v. European Commission: Tens of Thousands of European Women Demand Answers Regarding Undesirable Menstrual Effects Following COVID-19 Vaccination.

Attorney Diane Protat is “counsel for the collective “Where is my cycle?,” which groups together tens of thousands of women in Europe who suffer from the undesirable effects of the Covid 19 vaccination on their menstrual cycle: amenorrhea, menorrhagia, adenomyosis, endometriosis, polycystic ovarian syndrome, miscarriage or even hysterectomy.”

In October 2022, “Where’s my cycle?” asked Ursula von der Leyen, President of the European Commission, “to refer the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) so that it can open a procedure for examining the safety of vaccines against COVID 19 (‘EU referral procedures for safety reasons’) and organize a public hearing with the EMA to allow the European institutions and pharmaceutical companies to answer women’s questions but also so that women can make their views known on the acceptability of the gynecological risks associated with vaccination against Covid 19.”

Despite the fact that “…the PRAC acknowledged at its October 28, 2022 meeting that the Comirnaty and Spikevax mRNA vaccines could cause menorrhagia and added this effect to the list of side effects for these two products: ‘Comirnaty and Spikevax: heavy menstrual bleeding added as a side effect’, but nevertheless considered them generally temporary and benign” [https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-october-2022], Ms. von der Leyen’s November 3, 2022, response stated, “At this point, no review of the safety of COVID 19 vaccines is underway.” The European Medicines Agency’s (EMA) response on that same date stated:

  • “The PRAC…concluded in October 2021 that the evidence did not support a causal link between these vaccines and menstrual disorders.”
  • “With respect to amenorrhea, which also includes early menopause and cycle interruption, the PRAC concluded in June 2022, based on evaluation of the available data, that there was insufficient evidence to suggest a causal action with mRNA vaccines.”
  • “In general, menstrual disorders are very common in the general population…with COVID-19 vaccines having been used in large vaccination campaigns worldwide…the high number of reports of suspected side effects is not surprising. In addition, media attention to this issue may also have led to an increase in spontaneous reports of these events.”
  • “…the high number of reported events observed after vaccination does not automatically mean that there is a causal relationship between that event and vaccination…they may have occurred due to other factors or simply by coincidence…”
  • “…we would like to point out that data from safety databases such as Eudravigilance cannot be used to calculate the frequencies or incidences of potential side effects…please also note that self-reported data cannot be used to compare vaccines and their reactogenicity.”
  • “…We want to reassure you that rigorous safety monitoring is in place for all COVID 19 vaccines.”

On November 10, 2022, the EMA published a safety update on COVID-19 vaccines confirming the addition of heavy menstrual bleeding as a potential adverse event and added, “There is no evidence to suggest that menstrual changes experienced by some people following vaccination have any impact on fertility…” [https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccines-safety-update-10-november-2022_en.pdf]

In contrast, the testimonies collected by “Where’s my cycle” show that “[heavy menstrual bleeding after COVID-19 vaccination] is painful, repetitive and affects the quality of life of women in Europe.” Moreover, the French demographics report by National Institute of Statistics and Economic Studies (INSEE) shows a historic decline in the birth rate in France [https://www.francetvinfo.fr/replay-radio/question-de-societe/bilan-demographique-un-pays-qui-se-depeuple-est-un-pays-qui-s-affaiblit-et-qui-a-moins-de-gens-pour-cotiser-pour-les-retraites-souligne-jean-viard_5586708.html], and “[t]he same observation is made throughout Europe.”

“Where’s My Cycle” maintains its request for a public hearing “…for an exchange between all the actors, European and national institutions, pharmaceutical laboratories and patients, and [to] make it possible to shed light in all transparency on the causes and consequences of the disorders of the cycle undergone by women in Europe since the launch of the mass vaccination against Covid 19 and to answer their questions:

  • What is the database that the EMA uses to establish the frequency of side effects of mRNA vaccination if it is not Eudravigilance?
  • On what basis did the PRAC conclude in June 2022 that there was insufficient evidence to suggest a causal action of mRNA vaccines on amenorrhea (which also includes early menopause and cycle interruption) reported by women as a side effect? Does the PRAC now stand by this conclusion and if so on the basis of what safety data?
  • Can we exclude any risk of infertility in connection with post-vaccination menorrhagia?
  • Can we exclude any link between the drop in the birth rate observed in Europe in the year 2022 and mass vaccination against COVID 19?
  • Do COVID 19 treatments with fewer gynecological side effects than mRNA vaccines exist and are they available in Europe?”

Please read this important five-page letter below.


23.3.10 A VLD Audition Publique en-US

The post “Where’s my cycle?” v. European Commission: Tens of Thousands of European Women Demand Answers Regarding Undesirable Menstrual Effects Following COVID-19 Vaccination. appeared first on DailyClout.

Foreword for the War Room/DailyClout Pfizer Documents Analysis Reports Paperback

Foreword

The following book represents an extraordinary historical achievement in the reporting of events in science and medicine.

It also appears to be a record of a great crime against humanity.

In 2022, the Pfizer documents, a tranche of 55,000 documents, many of them thousands of pages long, were released via a court order. This was due to a successful lawsuit by attorney Aaron Siri. The US Food and Drug Administration had asked the court to keep these documents hidden for 75 years — until after most of us alive now would be dead and gone.

Luckily, the court did not concur.

We at DailyClout.io, a website devoted to civic transparency, realized that the raw documents were impossible to cover in normal journalistic ways. One reason was the massive scope of the documentation. But another reason was that the documents are written for scientists and medical researchers, in language that only specialists in those fields could really understand properly or explain.

We sent out a call for expert volunteers from those fields on our own platforms, and we did so also on the video and podcast platform, War Room Pandemic, hosted by Stephen K. Bannon. A global audience thus recognized how important it was for an informed public — who had been harried, bullied, and “mandated” to receive Pfizer’s and Moderna’s mRNA injections in 2021-2022 — to understand what was really revealed inside of the Pfizer documents.

As a result of our calls for expert help, we received 2000, then 2500, and finally 3500 responses from volunteers, many of whom are experts in their fields. Biostatisticians, lab clinicians, pathologists, anesthesiologists, sports medicine physicians, cardiologists, research scientists, RNs, and many other related disciplines are represented among these decent, highly-skilled people who offered to read through these difficult, technical documents — pro bono, as a service to humanity (and out of respect as well, in many cases, for their own lifelong commitment to real science, real medicine, and truth in general). Many of them were not only published, peer-reviewed academic authors in their fields, but some were peer reviewers themselves. There was no way, with a group this distinguished in science and medicine doing the labor, that the interpretation of these documents could be dismissed as “fringe,” subjective, or as the work of “conspiracy theorists.”

Of course, managing a project in which 3500 highly trained specialists from all over the world work together virtually on unpacking and reporting on such a massive trove of material, would have been impossible for mere mortals.

At first, indeed, we did not know how to organize the thousands of specialists who offered their help.

Enter Amy Kelly, who is also a heroine of this story. She is a talented project manager, and now DailyClout’s COO; and she has a distinguished background in complex organizational projects in various fields.

Ms. Kelly managed, seemingly effortlessly, to organize the volunteers into six working teams, with subcommittees of expert readers. Under her extraordinary leadership, the thousands of specialists around the globe started to communicate with one another, share their findings, and draft their reports. I trained the volunteers in writing for a general audience, and I also trained our DailyClout editors in editing what was often dense medical language, but with extremely important findings, into accessible reports that anyone with any level of education could follow and understand.

For all of us, but mostly for the volunteers and Ms. Kelly, the next year represented a Herculean effort to turn this material, that one of the most powerful companies in the world trusted would never be made public, into fifty readable reports sharing the most urgent headlines of all — the reports that are now in your hands.

You will see that the 50 reports document what may be a massive crime against humanity. You will see that Pfizer knew, as it appears, that the mRNA vaccines did not work. You will see that the ingredients, including lipid nanoparticles, in the mRNA injections bio-distributed throughout the body in a couple of days, accumulating in the liver, adrenals, spleen — and ovaries. You will see that Pfizer and the FDA knew that the injections damaged the hearts of minors — and yet waited months to inform the public. You will see that Pfizer sought to hire over a thousand new staffers simply to manage the flood of “adverse events” reports that they were receiving and that they anticipated receiving. You will see that 61 people died of stroke — half of the stroke adverse events being within a couple of days after injection — and that five people died of liver damage with, again, many of the liver damage adverse events sustained shortly after the injection. You will see neurological events, cardiac events, strokes, brain hemorrhages, and blood clots, lung clots and leg clots at massive scale. You will see that headaches, joint pain, and muscle pain are rampant as adverse events, though these are not disclosed as routine side effect warnings by our agencies.

Most seriously of all, you will see a 360-degree attack on human reproductive capability: with harms to sperm count, testes, sperm motility; harms to ovaries, menstrual cycles, placentas; you will see that over 80 per cent of the pregnancies in one section of the Pfizer documents ended in spontaneous abortion or miscarriage. You will see that 72 per cent of the adverse events in one section of the documents were in women, and that 16 percent of those were “reproductive disorders,” in Pfizer’s own words. You will see a dozen or more names for the ruination of the menstrual cycles of women and teenage girls. You will see that Pfizer defined “exposure” to the mRNA vaccine as including skin contact, inhalation and sexual contact, especially at the point of conception.

History has not yet concluded its assessment of what Pfizer — and the FDA, who were in custody of all of these documents — has done. We are at the very start of that assessment.

But to me it is clear that the following documents, written by impeccably skilled experts, and linked to primary sources, show that a crime has likely been committed against humanity that is unprecedented in its scale.

We owe the War Room/DailyClout Pfizer Documents Research Volunteers — some named, most of them unnamed — who labored for a year, and do so to this day, and for nothing more than the privilege of serving humanity, science, medicine and the actual truth — a tremendous debt. We thank Mr. Bannon and his team for so often supporting our call for experts and for helping us to announce the results in real time, as the reports came in. We thank all of the other news outlets, of all kinds, who risked reprisals from Big Pharma or even from the government — which recent lawsuits have shown allied with Big Pharma — who have also showcased the work of the Volunteers, in an effort truly to inform their viewers.

Please share this document with your loved ones if you also find it to be important.

Everyone by law deserves informed consent when it comes to medical interventions — it is actually a crime to withhold it (really many crimes appear to be represented here, but history will sort that out as well).

It has been a privilege to report on this team’s work, and to do all I can as CEO of DailyClout, to help sustain their, and the remarkable Ms. Kelly’s, work on humanity’s behalf.

Sincerely,

Dr. Naomi Wolf

CEO, DailyClout.io

March 21, 2023

Salem, Massachusetts

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The post Foreword for the War Room/DailyClout Pfizer Documents Analysis Reports Paperback appeared first on DailyClout.

To Be, or “NAAT” To Be? – A Physician’s Questions to the FDA.

Nasal swab nucleic acid amplification tests (NAATs) are “a type of viral diagnostic test for SARS-CoV-2, the virus that causes COVID-19.” [https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html and https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics]

Although certain NAAT tests have now been authorized for emergency use (EUA) for screening purposes (in asymptomatic persons), the three NAAT tests used at the time of the pivotal Pfizer trial did not have this as an “intended use.” Rather, the respective “Intended Use[s]” were only for “individuals suspected of COVID-19” or “individuals who meet COVID-19 clinical and/or epidemiological criteria.” [https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html, https://www.cepheid.com/Package Insert Files/Xpress-SARS-CoV-2/Xpert Xpress SARS-CoV-2 Assay ENGLISH Package Insert 302-3750 Rev. G.pdfhttps://www.molecular.abbott/content/dam/add/molecular/products/infectious-disease/realtime-sars-cov-2-assay/Abbott RealTime SARS-CoV-2 Assay Package Insert.pdf, and https://web.archive.org/web/20200316175553/https://www.fda.gov/media/136049/download]

To receive vaccine in Pfizer’s clinical trial, individuals had to be asymptomatic. Subjects were checked for “current symptoms that could represent a potential COVID-19 illness.” The NAAT test was performed “at the time of each dose” to provide evidence of no current infection for the subsequent efficacy analysis. [https://docs.house.gov/meetings/IF/IF02/20200930/111063/HHRG-116-IF02-20200930-SD007.pdf]

In light of the then “Intended Use” of the respective package inserts, I ask two questions of the Food and Drug Administration (FDA) regarding the use of NAAT testing in asymptomatic subjects in the pivotal Pfizer COVID-19 vaccine trial. Please see my March 17, 2023, letter below to Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration.


March 17, 2023

Dear Dr. Marks,

In organizing my files, I recently stumbled across some notes of mine following the first Emergency Use Authorization (EUA) of the COVID-19 vaccines in early December 2020. For some reason unclear to me, I did not share these concerns with you then, but I am now.

My questions:

1)  Were the nasal swab nucleic acid amplification test (NAAT) package inserts’ “Intended Use,” i.e., “individuals suspected of COVID-19,” appropriately followed in the pivotal Pfizer COVID-19 vaccine trial?

2) If not appropriately followed, what is the impact on the EUA authorization of the COVID-19 vaccines (and subsequent Biologics License Application [BLA] approval)?

 As of September 3, 2020, “only a few tests [had] received EUA for screening asymptomatic individuals.” 1 Most of the COVID-19 tests in the United States had only received EUA for testing of symptomatic individuals “(ie, for diagnostic testing).” 1 This was the case for the lab tests which had “not been FDA cleared or approved” to “detect SARS-CoV-2” in the Pfizer-BioNTech vaccine trial subjects.  Today, the three NAAT tests remain under EUA. 2,3,4,5,6,7

Yet both of the two primary efficacy endpoints in this pivotal trial rely on incidence of COVID-19 in participants “without evidence of [SARS-CoV-2] infection before vaccination” (subjects would naturally be asymptomatic with lab tests to ‘confirm’):  2,3,4

If symptomatic, the subject’s vaccination was to be delayed until “the [following] condition(s) has/have resolved”: “Current febrile illness (body temperature ≥100.4°F [≥38°C]) or other acute illness within 48 hours before study intervention administration. This includes current symptoms that could represent a potential COVID-19 illness.” 2

The infection status prior to vaccination was determined as follows: “…to qualify for the first primary efficacy endpoint evaluation, individuals needed to have no evidence of prior or current infection before each dose. And that was determined either by obtaining a swab at the time of each dose, to identify evidence of SARS-CoV-2 by nucleic acid amplification testing [NAAT], or obtaining a blood specimen for N-antigen antibodies at the time of the first dose to indicate evidence of prior infection that may have preceded vaccination by months.”  3,5

In my opinion, by using EUA lab tests not “FDA cleared or approved” in an investigational vaccine trial, a ‘study within a trial’ is effectively created; such a study “must not affect the scientific integrity of the host trial, its rationale or outcome measures.” 6

But back to the main focus of this letter, here are the stated “Intended Use[s]” of the respective NAAT package inserts employed in the asymptomatic trial subjects prior to vaccination: 2,4

  • Intended Use: Cepheid Xpert Xpress SARS-CoV-2: individuals suspected of COVID-19 by their healthcare provider 7
  • Intended Use: The Abbott RealTime SARS-CoV-2 assay: individuals suspected of COVID-19 by their healthcare provider 8
  • Intended Use (note: Intended Use revised May 2021, see screenshot below): cobas® SARS-CoV-2 : individuals who meet COVID-19 clinical and/or epidemiological criteria 9,10

 

I look forward to your response, Dr. Marks, and appreciate acknowledgment of receipt of this letter,

Sincerely,

Carol Taccetta, MD, FCAP

References

1 https://documents.cap.org/documents/Screening-and-Surveillance-Testing-for-COVID-19-Questions-and-Answers.pdf

 

2 https://docs.house.gov/meetings/IF/IF02/20200930/111063/HHRG-116-IF02-20200930-SD007.pdf

 

3: https://www.youtube.com/watch?v=owveMJBTc2I

 

4 https://www.fda.gov/media/144245/download

5 https://fda.report/media/144859/VRBPAC-12.10.20-Meeting-Transcript.pdf

 

6 https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2535-5

7 https://www.cepheid.com/Package Insert Files/Xpress-SARS-CoV-2/Xpert Xpress SARS-CoV-2 Assay ENGLISH Package Insert 302-3750 Rev. G.pdf

8https://www.molecular.abbott/content/dam/add/molecular/products/infectious-disease/realtime-sars-cov-2-assay/Abbott RealTime SARS-CoV-2 Assay Package Insert.pdf

 

9 https://www.fda.gov/media/136049/download

 

10https://web.archive.org/web/20200316175553/https://www.fda.gov/media/136049/download

The post To Be, or “NAAT” To Be? – A Physician’s Questions to the FDA. appeared first on DailyClout.

NAATs Used in Pfizer Clinical Trial to Test Asymptomatic Patients Despite Not Being Approved (or Even Emergency Use Authorized) for Asymptomatic Testing.

Nasal swab nucleic acid amplification tests (NAATs) are “a type of viral diagnostic test for SARS-CoV-2, the virus that causes COVID-19.” [https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html and https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics]

Although certain NAAT tests have now been authorized for emergency use (EUA) for screening purposes (in asymptomatic persons), the three NAAT tests used at the time of the pivotal Pfizer trial did not have this as an “intended use.” Rather, the respective “Intended Use[s]” were only for “individuals suspected of COVID-19” or “individuals who meet COVID-19 clinical and/or epidemiological criteria.” [https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html, https://www.cepheid.com/Package Insert Files/Xpress-SARS-CoV-2/Xpert Xpress SARS-CoV-2 Assay ENGLISH Package Insert 302-3750 Rev. G.pdfhttps://www.molecular.abbott/content/dam/add/molecular/products/infectious-disease/realtime-sars-cov-2-assay/Abbott RealTime SARS-CoV-2 Assay Package Insert.pdf, and https://web.archive.org/web/20200316175553/https://www.fda.gov/media/136049/download]

To receive vaccine in Pfizer’s clinical trial, individuals had to be asymptomatic. Subjects were checked for “current symptoms that could represent a potential COVID-19 illness.” The NAAT test was performed “at the time of each dose” to provide evidence of no current infection for the subsequent efficacy analysis. [https://docs.house.gov/meetings/IF/IF02/20200930/111063/HHRG-116-IF02-20200930-SD007.pdf]

In light of the then “Intended Use” of the respective package inserts, I ask two questions of the Food and Drug Administration (FDA) regarding the use of NAAT testing in asymptomatic subjects in the pivotal Pfizer COVID-19 vaccine trial. Please see my March 17, 2023, letter below to Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration.


March 17, 2023

Dear Dr. Marks,

In organizing my files, I recently stumbled across some notes of mine following the first Emergency Use Authorization (EUA) of the COVID-19 vaccines in early December 2020. For some reason unclear to me, I did not share these concerns with you then, but I am now.

My questions:

1)  Were the nasal swab nucleic acid amplification test (NAAT) package inserts’ “Intended Use,” i.e., “individuals suspected of COVID-19,” appropriately followed in the pivotal Pfizer COVID-19 vaccine trial?

2) If not appropriately followed, what is the impact on the EUA authorization of the COVID-19 vaccines (and subsequent Biologics License Application [BLA] approval)?

 As of September 3, 2020, “only a few tests [had] received EUA for screening asymptomatic individuals.” 1 Most of the COVID-19 tests in the United States had only received EUA for testing of symptomatic individuals “(ie, for diagnostic testing).” 1 This was the case for the lab tests which had “not been FDA cleared or approved” to “detect SARS-CoV-2” in the Pfizer-BioNTech vaccine trial subjects.  Today, the three NAAT tests remain under EUA. 2,3,4,5,6,7

Yet both of the two primary efficacy endpoints in this pivotal trial rely on incidence of COVID-19 in participants “without evidence of [SARS-CoV-2] infection before vaccination” (subjects would naturally be asymptomatic with lab tests to ‘confirm’):  2,3,4

If symptomatic, the subject’s vaccination was to be delayed until “the [following] condition(s) has/have resolved”: “Current febrile illness (body temperature ≥100.4°F [≥38°C]) or other acute illness within 48 hours before study intervention administration. This includes current symptoms that could represent a potential COVID-19 illness.” 2

The infection status prior to vaccination was determined as follows: “…to qualify for the first primary efficacy endpoint evaluation, individuals needed to have no evidence of prior or current infection before each dose. And that was determined either by obtaining a swab at the time of each dose, to identify evidence of SARS-CoV-2 by nucleic acid amplification testing [NAAT], or obtaining a blood specimen for N-antigen antibodies at the time of the first dose to indicate evidence of prior infection that may have preceded vaccination by months.”  3,5

In my opinion, by using EUA lab tests not “FDA cleared or approved” in an investigational vaccine trial, a ‘study within a trial’ is effectively created; such a study “must not affect the scientific integrity of the host trial, its rationale or outcome measures.” 6

But back to the main focus of this letter, here are the stated “Intended Use[s]” of the respective NAAT package inserts employed in the asymptomatic trial subjects prior to vaccination: 2,4

  • Intended Use: Cepheid Xpert Xpress SARS-CoV-2: individuals suspected of COVID-19 by their healthcare provider 7
  • Intended Use: The Abbott RealTime SARS-CoV-2 assay: individuals suspected of COVID-19 by their healthcare provider 8
  • Intended Use (note: Intended Use revised May 2021, see screenshot below): cobas® SARS-CoV-2 : individuals who meet COVID-19 clinical and/or epidemiological criteria 9,10

 

I look forward to your response, Dr. Marks, and appreciate acknowledgment of receipt of this letter,

Sincerely,

Carol Taccetta, MD, FCAP

References

1 https://documents.cap.org/documents/Screening-and-Surveillance-Testing-for-COVID-19-Questions-and-Answers.pdf

 

2 https://docs.house.gov/meetings/IF/IF02/20200930/111063/HHRG-116-IF02-20200930-SD007.pdf

 

3: https://www.youtube.com/watch?v=owveMJBTc2I

 

4 https://www.fda.gov/media/144245/download

5 https://fda.report/media/144859/VRBPAC-12.10.20-Meeting-Transcript.pdf

 

6 https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2535-5

7 https://www.cepheid.com/Package Insert Files/Xpress-SARS-CoV-2/Xpert Xpress SARS-CoV-2 Assay ENGLISH Package Insert 302-3750 Rev. G.pdf

8https://www.molecular.abbott/content/dam/add/molecular/products/infectious-disease/realtime-sars-cov-2-assay/Abbott RealTime SARS-CoV-2 Assay Package Insert.pdf

 

9 https://www.fda.gov/media/136049/download

 

10https://web.archive.org/web/20200316175553/https://www.fda.gov/media/136049/download

The post NAATs Used in Pfizer Clinical Trial to Test Asymptomatic Patients Despite Not Being Approved (or Even Emergency Use Authorized) for Asymptomatic Testing. appeared first on DailyClout.

Report 62: Acute Kidney Injury and Acute Renal Failure Following Pfizer mRNA COVID Vaccination. 33% of Patients Died. Pfizer Concludes, “No New Safety Issue.”

The War Room/DailyClout Pfizer Documents Analysis Project Post-Marketing Group (Team 1) – Joseph Gehrett, MD; Barbara Gehrett, MD; Chris Flowers, MD; and Loree Britt – produced an alarming review of the Renal (Kidney) System Organ Class (SOC) adverse events found in Pfizer document 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-FEB-2021 (a.k.a., “5.3.6“). This SOC includes acute kidney injury and acute renal failure.

It is important to note that the adverse events (AEs) in the 5.3.6 document were reported to Pfizer for only a 90-day period starting on December 1, 2020, the date of the United Kingdom’s public rollout of Pfizer’s COVID-19 experimental mRNA “vaccine” product.

Key points in this report include:

  • 69 patients, including one infant, suffered acute kidney injury or acute renal failure. The vaccine was not authorized for infants during this time.
  • Pfizer’s renal adverse event reports screen only for the most severe damage but miss important, less severe kidney damage. Thus, Pfizer’s post-marketing kidney adverse events are likely significantly underreported.
  • Half of the severe renal adverse events were reported within four days of vaccination.
  • 67% of kidney adverse event patients were women, and 33% were men.
  • The very short range of latency shows the severity of the damage in this SOC.
  • Pfizer reported that surveillance would continue for this SOC, yet no information on subsequent surveillance has been publicly released to date.

 

Post Marketing Renal AESI micro report

https://dailyclout.io/wp-content/uploads/Post-Marketing-Renal-AESI-micro-report.pdf

Get Your Copy of the Pfizer Reports PDF eBook.

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The post Report 62: Acute Kidney Injury and Acute Renal Failure Following Pfizer mRNA COVID Vaccination. 33% of Patients Died. Pfizer Concludes, “No New Safety Issue.” appeared first on DailyClout.