COVID-19 Vaccine Trials

Since mid-2020, COVID-19 vaccine trials have taken place around the world for numerous vaccines.

Summary Table of Phase III Clinical Trials

Clean this section up using just the vaccine names.

Moderna Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Pfizer

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine https://market-ticker.org/akcs-www?post=244109 https://www.nakedcapitalism.com/2021/08/sloppy-pfizer-booster-clinical-trial-consent-form-provides-way-to-exclude-reactions-that-require-emergency-care.html

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.

• Public Health and Medical Professionals for Transparency Documents (Pfizer documents released)

Researcher David Wiseman, PhD walks through how Pfizer trials were unblinded, and details the problems associated. https://podcasts.apple.com/us/podcast/ep-989-how-pfizer-completely-fudged-its-safety-and/id1065050908?i=1000541261581

Pfizer employed third party companies to conduct their vaccine trials, as has become common in the pharmaceutical industry. A trial observer working for Ventavia, Brook Jackson, took note of a number of serious problems affecting the conduct of the trial. She emailed her observations to the Food and Drug Administration at which point she was promptly fired. Her story was not told publicly until over a year later in the British Medical Journal.¹⁰⁾

The Sinovac inactivated vaccine (candidate) was tested on rhesus macaques with reportedly good results.¹¹⁾

In animal trials, Oxford's AstraZeneca vaccine failed to prevent infection by SARS-CoV-2, though there were signs of reduced disease in some of the animals.¹²⁾

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

• Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial ¹³⁾

Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19¹⁴⁾

Trials are ongoing to determine the effectiveness of mixing and matching different COVID-19 vaccine products, such as the MOSAIC study in Canada.

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.¹⁵⁾

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,¹⁶⁾ 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.

“The complete, intact mRNA molecule is essential to its potency as a vaccine,” professor of biopharmaceutics Daan J.A. Crommelin and colleagues wrote in a review article in The Journal of Pharmaceutical Sciences. “Even a minor degradation reaction, anywhere along a mRNA strand, can severely slow or stop proper translation performance of that strand and thus result in the incomplete expression of the target antigen.”¹⁷⁾

Crommelin and colleagues note that specific regulatory guidance for mRNA based vaccines has yet to be developed, and The BMJ’s attempts to clarify current standards were unsuccessful.

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.”¹⁸⁾

Aaron Siri has documented how the 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

Dr. James Chestnut takes 15 minutes to critique the structure of the Pfizer and Moderna trials.

Mar 11, 2020 (statnews) Researchers rush into human trials before animal trials complete.

Mathew Crawford has noted the temporal and geographical coincidence of vaccine trial sites and emerging SARS-CoV-2 variants of interest.

¹⁹⁾

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.” ²⁰⁾