Vaccine Efficacy Questions for Dr. Anthony S. Fauci

Vaccine Efficacy Questions for Dr. Anthony S. Fauci

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

Dr. Ron Brown

May 29, 2021

Dear Readers: Please forward the following information about COVID-19 mRNA vaccines to your U.S. Congressional representatives. Five critical questions are listed concerning vaccine efficacy. Your Congressional representatives should direct these questions to Dr. Anthony S. Fauci of the National Institute of Allergy and Infectious Diseases. The questions, along with suggested answers, are based on information from Medicina | Free Full-Text | Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials (mdpi.com).

  1. What does vaccine efficacy mean in a COVID-19 mRNA vaccine clinical trial?
    Vaccine efficacy, also known as the relative risk reduction, is a measure of how effective a vaccine is in reducing a COVID-19 infection under the strictly controlled experimental conditions of a randomized trial.
  2. What are the vaccine efficacy measures for the COVID-19 mRNA vaccines from Pfzier/BioNTech and Moderna?
    The vaccine efficacy for the Pfzier/BioNTech vaccine is 95.1%, and the vaccine efficacy for the Moderna vaccine is 94.1%.
  3. In addition to vaccine efficacy, how is the vaccine absolute risk reduction calculated in a clinical trial?
    The vaccine absolute risk reduction is calculated by subtracting the percentage of people who became infected in the trial’s vaccine group from the percentage of people who became infected in the trial’s placebo group. 
  4. What are the absolute risk reduction measures for the COVID-19 mRNA vaccines from Pfzier/BioNTech and Moderna?
    The absolute risk reduction for the Pfzier/BioNTech is 0.7%, and the absolute risk reduction for the Moderna vaccine is 1.1%.
  5. Why should both absolute and relative risk reduction measures from COVID-19 mRNA clinical trials be reported to the public?

Reporting relative risk reductions alone can cause misleading interpretations of vaccine efficacy. Absolute risk reduction measures provide more meaningful information for clinical and public health purposes, while relative risk reductions are more often used by researchers to compare results from different trials. FDA recommendations for communicating trial findings to the public include reporting both relative risk reduction and absolute risk reduction measures, which are equally important to meet legal and ethical obligations of informed consent for a treatment.

Lead Research/Investigator

Ron B. Brown, School of Public Health and Health Systems, University of Waterloo, Waterloo, ON Canada

Call to ActionCheck out Dr. Brown’s piece titled “Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials; also see an interview on TrialSite Podcast.

Responses

  1. Thank you Dr. Brown. It is unconscionable that FDA guidelines of reporting both efficacy measures has been ignored and is yet another reason to stop this crazy charade from our government. They were aware if safe and effective early treatments that would have saved thousands of lives and they actively stopped those options.

  2. This article states” “The absolute risk reduction for the Pfzier/BioNTech is 0.7%, and the absolute risk reduction for the Moderna vaccine is 1.1%. Why is there no citation for that calculation including the sources of data utilized?

    What is the point of this article? It seems to ask for readers to contact their congressman, but the “call to action” is to read Dr. Brown’s article. Huh? Forwarding this to my congressman makes no sense whatsoever. It seems that it is intended (at least by its heading) to engineer a way to make Dr. Fauci squirm in a public hearing. Sorry, but I don’t think that is an effective way to approach the alleged reporting bias.

    I cannot begin to imagine how the “public” could possible make a decision on whether or not to get vaccinated based on some technical difference between relative risk and absolute risk. I’m pretty sure most docs couldn’t articulate the relevance. Dr. Brown has a point in that ARR might be relevant in deciding some broad scale public health decisions, but for individual decisions I think not.

    As a side note, I know Ron Brown’s original article on this topic was limited to data that was available for mRNA vaccines Since this seems to be more of a generic criticism, it might well apply to the other vaccines as well.

    1. The “call to action” is to have U.S. Congressional representatives direct critical questions on vaccine efficacy to Dr. Fauci. The intention is to hold the country’s top infectious disease expert accountable for disseminating public information that is transparent, honest, and necessary for informed consent. What the public does with this information, if they ever receive it, is up to them, but the public has a right to full disclosure of the information.
      Ron

    2. The real world, actual efficacy of these products in preventing Covid-19 was originally overstated and remains so in the public mind. The fact that most citizens and even most physicians could not explain the difference between RRR and ARR, is testament to how confusing relaying this information accurately is to the public at large, but it doesn’t mean it shouldn’t be made available in language we can understand in order to attempt to tabulate and stratify our risks. Breakthrough cases after full vaccination numbered over 10,000 before the CDC announced recently that it no longer will collect data on all the many infections occurring after full vaccination with these “leaky” products, unless they lead to hospitalizations or deaths. This is absolutely shameful! We need this data, not just for genetic sequencing of possible immune escape variants, but also because we need data on the actual risk reductions we can reliably expect by injecting these investigational products, so as to better protect ourselves. The public has a right to full disclosure on so very many things surrounding these injections, that it has become almost dizzying trying to keep up with all the ways it isn’t happening!! Reporting adverse events truthfully in the media would be a start, but just like all their other obfuscations, they’ll keep these to themselves until they no longer can…. that day is soon approaching, no matter how much cooking of their books and lying about adverse events occurs. Apex predator “healthcare” agencies need major public pushback! It can’t come soon enough.