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

Company Name # of Total Participants # Infected / # in Treatment Arm # Infected / # in Placebo Arm Ref
Pfizer BioNtech 46,331 8 / 21,720 162 / 21,728 1)
Moderna 30,415 55 / 15,206 744 / 15,209 2)
J&J (Janssen) 43,783 116 / 19,630 348 / 19,691 3)
Astra-Zeneca 11,636 73 / 17,662 130 / 8,550 4)
Bharat Biotech 16,973 24 / 8,471 106 / 8,502 5)
Gamaleya Research Inst. (Sputnik V) 18,695 13 / 14,094 47 / 4,601 6)
Novovax 25,452 14 / 17,312 63 / 8,140 7)
Sinovac 9,823 85 / 4,953 168 / 4,870 8)
Sinopharm WIV04 25,480 26 / 12,743 95 / 12,737 9)

COVID-19 Vaccine Trials by Vaccine Name or Manufacturer

Clean this section up using just the vaccine names.

Moderna Vaccine Trials

Pfizer Vaccine Trials

Major Problems With Pfizer COVID-19 Vaccine Trials

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. 10) 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.

Nonrandomization of Primary Comorbidity
Lack of Blinding

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

Ventavia Whistleblower

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.11)

Sinovac Vaccine Trials

The Sinovac inactivated vaccine (candidate) was tested on rhesus macaques with reportedly good results.12)

AstraZeneca Vaccine Trials

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.13)

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

CanSinoBIO Vaccine Trials

  • 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 14)

Janssen Vaccine Trials

Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-1915)

Mix and Match Trials

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

Critiques of COVID-19 Vaccine Trials

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.16)

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.”17)

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.18)

  • 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.19)
  • 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 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,20) 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.”21)

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.”22)

Trial Manipulation

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

Rushed Time Scale

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

COVID-19 Vaccine Trials and Variants of Interest

Document Review by Naked Capitalism

Sloppy Pfizer Booster Clinical Trial Consent Form Provides Way to Exclude Reactions That Require Emergency Care Posted on August 3, 2021 by Yves Smith

Bloomberg Law complained recently that the consent forms for Covid 19 vaccine clinical trials are larded with unimportant information and difficult to understand. Based on our reading of a Pfizer consent form for a trial of a third shot of its Covid-19 vaccine, those aren’t the biggest causes for pause.

We’ve embedded a Pfizer consent form for a Covid-19 booster vaccine clinical trial below, which as of posting time was available at careidresearch.com.23) We strongly encourage you to read it in full.

We’ll discuss first how the form does not appear to have been reviewed by the oversight body tasked by the FDA to do so, and then will discuss why key parts are troubling.

The biggest issue, flagged in our headline, is that the consent form allows for participants who need emergency care and go straight to their doctor or hospital to be ejected from the study. But it’s not the only one.

Pfizer Consent Form Too Obviously Not Reviewed, Let Alone Negotiated, by FDA-Designated Overseer, the Institutional Review Board. 24)

Naked Capitalism con't The document is on the website of a research company that has engaged a doctor as the investigator and is working with Pharma companies to recruit patients. What is striking is that there is no attempt to pretend that the consent form is anything other than a Pfizer document. IM Doc stresses that every IRB he was ever involved with would at a minimum rework the drug company templates and create their own documents.

Confirming IM Doc’s view that this document was simply rubber stamped: The Pfizer ICD date is July 2, a Friday. The IRB “approval” date is July 7, the following Wednesday, after the Federal July Fourth holiday on Monday July 5. There is no way a request for changes in language could have been developed, sent to Pfizer, reviewed, and approved (or a letter explaining the rejection generated) in such short period.

The FDA has tasked Institutional Review Boards, aka IRBs, to provide independent oversight of biomedical research projects to protect study participants, as you can see on the agency’s website.

Historically, academic medical centers and large local hospitals operated most IRBs. IM Doc, who was on an IRB for nearly two decades and its chairman for several years, explains how major drug companies have successfully shifted many over to private sector players to gut oversight:

In our IRB we oversaw usually between 250-400 active trials at any one time. There was a staff of 6 RNs dealing with all the documents, the patient contacts, and any other work needing to be done.

The Board itself consisted of a committee of LOCAL individuals. There were 15 people on ours. 3 were doctors, 3 were nurses, 3 were clergy, 3 were professional people from the community (lawyers, accountants, business owners) and 3 were blue collar workers. You notice the majority was ALWAYS NON-MEDICAL. We were tasked with going over any new research studies in our center, and coming up with a document called an “Informed Consent”. The researcher always had a template for this from either the NIH or other agency or Big Pharma.

While one has to assume that this Pfizer form is pretty typical, it’s alarming as a statement of the disdain Big Pharma and its hired hands have for clinical trial participants.

As IM Doc described, what has happened over time is that the major drug companies have turned the IRB watchdogs into lapdogs. The evisceration of independent oversight has the effect of elevating the importance of the consent form as a vehicle of informing and protecting study participants. But the consent form retains its apparent original form of being a user-friendly document describing the clinical trial process and risks. The teeth were intended to be at the IRBs, not in the consent forms.

Nevertheless, the consent form is clearly meant to have legal significance, as in most importantly to shield Pfizer from liability. Yet it is slipshod and incomplete. For instance, it fails to define terms and is inconsistent in the way it refers to concepts, does not specify governing law, and has no dispute resolution process.

The latter issue matters because Pfizer says the study doctor will “provide or arrange for” medical treatment for what is refers to as a “study-related” or “research” injury (it at least does define “research injury” on p. 17, if not all that crisply). But what if a study participant thinks he has suffered a “research injury” and the study doctor disagrees? Or the participant believes the level of care Pfizer provided is inadequate?

It’s not hard to wonder if the sloppiness of this document is deliberate, that it’s the Big Pharma answer to Nigerian scam letter. As professor of information and spam expert Finn Brunton put it:

By making them really obviously fraudulent, you’re weeding out the skeptics. You’re only getting truly gullible responses.

This consent letter looks designed to put off the legally savvy…who could be effective trouble-makers if anything went seriously wrong.

Below are some eyebrow-raising provisions. Note that these shortcomings have the potential of impairing the health of participants and their close contacts, by not giving them the most complete information about whether the participant has Covid, as well as the completeness and integrity of this Covid booster study.

1. Unlike the Moderna clinical trials, where participants were checked for Covid weekly, Pfizer participants are tested for Covid-19 only if they report symptoms to a study doctor and then the doctor deems they warrant testing. That assures asymptomatic cases will not be tracked.

4. The study is designed to minimize reporting of side effects. Remember that the study doctor is to be contacted only in the event of Covid-19 symptoms, and not other symptoms that have been attributed to the vaccines, like worsening of autoimmune symptoms or early and very heavy menstrual periods. From p. 825)

Meta-Analysis of COVID-19 Vaccine Trials

Danish Study Comparing mRNA to Adenovirus-Vector Vector Vaccine Results

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.26)

12)
May 6, 2020 | Qiang Gao et al | Science (journal) | Development of an inactivated vaccine candidate for SARS-CoV-2 | DOI: 10.1126/science.abc1932
14)
Zhu, F.-C., Guan, X.-H., Li, Y.-H., Huang, J.-Y., Jiang, T., Hou, L.-H., Li, J.-X., Yang, B.-F., Wang, L., Wang, W.-J., Wu, S.-P., Wang, Z., Wu, X.-H., Xu, J.-J., Zhang, Z., Jia, S.-Y., Wang, B.-S., Hu, Y., Liu, J.-J., & Zhang, J. (2020). 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. The Lancet, 396(10249), 479–488. https://doi.org/10.1016/s0140-6736(20)31605-6
16)
October 21, 2020 | Peter Doshi | The British Medical Journal | Will covid-19 vaccines save lives? Current trials aren’t designed to tell us | doi: https://doi.org/10.1136/bmj.m4037
19)
June 9, 2021 | chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.nejm.org/doi/suppl/10.1056/NEJMoa2101544/suppl_file/nejmoa2101544_appendix.pdf
26)
April 5, 2022 | Christine Benn et al | preprint | Randomised Clinical Trials of COVID-19 Vaccines: Do Adenovirus-Vector Vaccines Have Beneficial Non-Specific Effects? | DOI?
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