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covid-19_vaccines:covid-19_vaccine_trials [2022/04/12 19:33]
pamela [Pfizer Informed Consent Documents] 		covid-19_vaccines:covid-19_vaccine_trials [2022/10/13 03:04] (current)
mathew
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 ==== Moderna Vaccine Trials ==== ==== Moderna Vaccine Trials ====
-[[Moderna]]+[[:pharmaceutical_companies:Moderna]]
 [[https://www.nejm.org/doi/full/10.1056/NEJMoa2035389|Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine]] [[https://www.nejm.org/doi/full/10.1056/NEJMoa2035389|Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine]]
  
 ==== Pfizer Vaccine Trials ==== ==== Pfizer Vaccine Trials ====
 [[pharmaceutical_companies:pfizer|Pfizer]] [[pharmaceutical_companies:pfizer|Pfizer]]
 +
 +  * Pfizer BNT162b2 mRNA vaccine [[https://restoringtrials.org/covid-19/|trial protocols and other details]].
 +  * Pfizer trial [[https://t.co/4YJnjTfOyU|datasets in .csv format]].
  
 [[https://www.nejm.org/doi/full/10.1056/NEJMoa2034577|Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine]] [[https://www.nejm.org/doi/full/10.1056/NEJMoa2034577|Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine]]
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 === Major Problems With Pfizer COVID-19 Vaccine Trials === === Major Problems With Pfizer COVID-19 Vaccine Trials ===
-Though transparency was promised, Pfizer has never released the raw data from its trials. The FDA fought to keep the data collected by Pfizer that informed its decisions on vaccination hidden from the public for up to 75 years.+Though transparency was promised, Pfizer has never released the raw data from its trials, which was called for in a Peter Doshi opinion piece in the BMJ. ((January 4, 2021 | [[:Peter Doshi]] | [[:BMJ]] | [[https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-we-need-more-details-and-the-raw-data/|Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data]])) 
 +The FDA fought to keep the data collected by Pfizer that informed its decisions on vaccination hidden from the public for up to 75 years.
  
   * Public Health and Medical Professionals for Transparency Documents ([[https://phmpt.org/pfizers-documents/|Pfizer documents released]])   * Public Health and Medical Professionals for Transparency Documents ([[https://phmpt.org/pfizers-documents/|Pfizer documents released]])
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 The phase III COVID-19 vaccine trials were never set up to demonstrate reduction in serious outcomes or interruption of transmission of the [[:SARS-CoV-2]] virus.((October 21, 2020 | [[:Peter Doshi]] | [[:The British Medical Journal]] | Will covid-19 vaccines save lives? Current trials aren’t designed to tell us | [[https://www.bmj.com/content/371/bmj.m4037|doi: https://doi.org/10.1136/bmj.m4037]])) The phase III COVID-19 vaccine trials were never set up to demonstrate reduction in serious outcomes or interruption of transmission of the [[:SARS-CoV-2]] virus.((October 21, 2020 | [[:Peter Doshi]] | [[:The British Medical Journal]] | Will covid-19 vaccines save lives? Current trials aren’t designed to tell us | [[https://www.bmj.com/content/371/bmj.m4037|doi: https://doi.org/10.1136/bmj.m4037]]))
  
-==== Regulator Concerns ====+==== Problems in Animal Trials ==== 
 +In a Texas Senate hearing, it was stated on record that animal testing of COVID-19 vaccines were stopped because too many of the animals were dying.((May 16, 2021 | [[Great Game India]] | [[https://greatgameindia.com/covid-animal-trials-stopped/|COVID Vaccine Trials In Animals Were Stopped Because They Kept Dying, Revealed In Texas Senate Hearing]])) 
 + 
 +==== Critical Data Concerns ==== 
 +In a speech delivered at the [[:FDA]]'s Vaccines and Realted Biological Products Advisory Committee, [[:Mathew Crawford]] summarized flaws in both the COVID-19 vaccine trials by stating, "These trials never met basic standards of evidence."((April 6, 2022 | [[:Mathew Crawford]] | [[:Rounding the Earth]] | [[https://roundingtheearth.substack.com/p/vrbpac-presentation-the-ultimate?s=w|VRBPAC Presentation: The Ultimate Vaccine Red Pill Summary]])) 
 + 
 +=== Lopsided Data Exclusions === 
 +The data exclusions in many of the trials (perhaps all that have been made public) outweigh all reported effect sizes calling into question the wisdom of ascribing any trust to the reports.((April 6, 2022 | [[:Mathew Crawford]] | [[:Rounding the Earth]] | [[https://roundingtheearth.substack.com/p/vrbpac-presentation-the-ultimate?s=w|VRBPAC Presentation: The Ultimate Vaccine Red Pill Summary]])) 
 +  * In Figure S3 of the J&J trial report, there were 96 participants prematurely withdrawn after receiving placebo as compared to 49 after receiving the vaccine, a statistically significant differential. There were 2101 other placebo recipients excluded from the placebo group relative to 2216 in the vaccine group.((June 9, 2021 | [[chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.nejm.org/doi/suppl/10.1056/NEJMoa2101544/suppl_file/nejmoa2101544_appendix.pdf]])) 
 +  * In Figure 1 of the Pfizer trial report, there were 95 participants in the placebo group who discontinued after receiving their second dose, but only 48 in the vaccine group. 
 + 
 +=== Lack of Transparency === 
 +[[:Aaron Siri]] has documented how the [[:Food and Drug Administration|FDA]] has actively participated in obscuring data and documents related to COVID-19 vaccine trials. 
 +https://aaronsiri.substack.com/p/fda-doubles-down-asks-federal-judge?justPublished=true 
 + 
 +==== Regulatory Concerns ====
 An article was published in the British Medical Journal on March 21, 2021, 'The EMA covid-19 data leak, and what it tells us about mRNA instability' by Serena Tinari,((https://www.bmj.com/content/372/bmj.n627)) looking at some of the 40MB of data that was hacked from the European Medicines Agency and sent to the BMJ. Some of the leaked emails express significant concern, in late November 2020, about the stability of the mRNA found in the products, worrying about “truncated and modified mRNA species present in the finished product” that would compromise efficacy.  An article was published in the British Medical Journal on March 21, 2021, 'The EMA covid-19 data leak, and what it tells us about mRNA instability' by Serena Tinari,((https://www.bmj.com/content/372/bmj.n627)) looking at some of the 40MB of data that was hacked from the European Medicines Agency and sent to the BMJ. Some of the leaked emails express significant concern, in late November 2020, about the stability of the mRNA found in the products, worrying about “truncated and modified mRNA species present in the finished product” that would compromise efficacy. 
  
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 By late December, the Agency had decided that “the quality of this medicinal product (Comirnity), submitted in the emergency context of the current (covid-19) pandemic, is considered to be sufficiently consistent and acceptable.”((https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf)) By late December, the Agency had decided that “the quality of this medicinal product (Comirnity), submitted in the emergency context of the current (covid-19) pandemic, is considered to be sufficiently consistent and acceptable.”((https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf))
- 
- 
-==== Lack of Transparency ==== 
-[[:Aaron Siri]] has documented how the [[:Food and Drug Administration|FDA]] has actively participated in obscuring data and documents related to COVID-19 vaccine trials. 
-https://aaronsiri.substack.com/p/fda-doubles-down-asks-federal-judge?justPublished=true 
  
  
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-==== Pfizer Earnings Report ==== +===== Meta-Analysis of COVID-19 Vaccine Trials =====
- +
-PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2021 RESULTS +
-▪ Full-Year 2021 Revenues of $81.3 Billion, Reflecting 92% Operational Growth; Excluding Contributions from Comirnaty(1) and Paxlovid, Revenues Grew 6% Operationally to $44.4 Billion +
- +
-▪ Fourth-Quarter 2021 Revenues of $23.8 Billion, Reflecting 106% Operational Growth; Excluding Contributions from Comirnaty(1) and Paxlovid, Revenues Declined 2% Operationally Driven Primarily by the +
-Impact of Fewer Selling Days Compared to the Prior-Year Quarter +
- +
-▪ Full-Year 2021 Reported Diluted EPS(2) of $3.85, Adjusted Diluted EPS(3) of $4.42; Fourth-Quarter 2021 +
-Reported Diluted EPS(2) of $0.59, Adjusted Diluted EPS(3) of $1.08 +
- +
-▪ Provides Full-Year 2022 Record-High Guidance(4) for Revenues of $98.0 to $102.0 Billion and Adjusted Diluted EPS(3) of $6.35 to $6.55, Reflecting 23% and 46% Year-Over-Year Growth at the Midpoints, +
-Respectively +
- +
-– Raises 2022 Revenue Guidance for Comirnaty(1) to Approximately $32 Billion, Reflecting Doses Expected to be Delivered Under Supply Contracts Signed as of Late-January +
- +
-– Issues Initial 2022 Revenue Guidance for Paxlovid of Approximately $22 Billion, Reflecting Treatment +
-Courses Expected to be Delivered Primarily Under Supply Contracts Signed or Committed as of Late-January +
-▪ Provides Updates and New Data for Select Clinical Programs Spanning Vaccines, Hospital, Oncology, Rare +
-Disease and Internal Medicine on Analyst Conference Call +
- +
- +
-NEW YORK, NY, Tuesday, February 8, 2022 – Pfizer Inc. (NYSE: PFE) reported strong financial results for +
-fourth-quarter and full-year 2021 and provided 2022 total company financial guidance(4). In addition, Pfizer raised its previous 2022 revenue guidance for Comirnaty(1), the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, and provided for the first time 2022 revenue guidance for its oral COVID-19 treatment, Paxlovid. +
-The fourth-quarter 2021 earnings presentation and accompanying prepared remarks from management as well as +
-the quarterly update to Pfizer’s R&D pipeline can be found on the Pfizer website. +
- +
-EXECUTIVE COMMENTARY +
-Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: “In the early days of the COVID-19 pandemic, +
-we committed to use all of the resources and expertise we had at our disposal to help protect populations globally against this deadly virus, as well as to offer treatments to help avoid the worst outcomes when infections do occur.+
  
-//We put billions of dollars of capital on the line in pursuit of those goals, not knowing whether those investments would ever pay off. Now, less than two years since we made that commitment, we are proud to say that we have delivered both the first FDA-authorized vaccine against COVID-19 (with our partner, BioNTech) and the first FDA-authorized oral treatment for COVID-19.”// ((https://web.archive.org/web/20220410162510/https://s28.q4cdn.com/781576035/files/doc_financials/2021/q4/Q4-2021-PFE-Earnings-Release.pdf)) +==== Danish Study Comparing mRNA to Adenovirus-Vector Vector Vaccine Results ==== 
-{{ :covid-19_vaccines:pfizer_2021_revenue.png?800|}}+In a study that went to preprint on April 5, 2022, researcher Christine Benn and colleagues point out that mRNA vaccines showed no reduction in mortality while adenovirus-vector vaccines showed substantial and statistically significant reductions in mortality.((April 5, 2022 | Christine Benn et al | preprint | Randomised Clinical Trials of COVID-19 Vaccines: Do Adenovirus-Vector Vaccines Have Beneficial Non-Specific Effects? | [[https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4072489|DOI?]]))
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