For the public record: Critical questions FDA must address about vaccine safety

For the public record: Critical questions FDA must address about vaccine safety

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. FREE to read and SHARE without paying.

By Steve Kirsch

On October 26, I was invited by the FDA to give a 3-minute slide presentation during the Open Public Hearing session at the meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) which is the outside committee of the FDA that reviews vaccine safety and efficacy.

Today’s meeting is focused on whether or not to extend the EUA of the Pfizer vaccines for children aged 5 to 11.

Since I was only given 3 minutes of talk time, I prepared just 30 slides at the meeting. All the slides were questions that I believed needed to be fully answered before any vote to authorize vaccination for 5 to 11 year olds. After all, once you’ve been vaccinated, you can never be unvaccinated.

Since I had prepared over 100 questions for the committee, I thought it would be useful for both the VRBPAC committee, as well as the public, to post my slides publicly.

Here they are.


  1. Thank you for asking so many important questions. I live in San Diego. CA. Our Government is out of control with mandates. Have you already addressed the following issue?

    Did the FDA vote on partial data referencing the benefits of vaccines outweigh adverse events?

    3 children contracted C19 in the vaccinated group
    16 children contracted C19 in the placebo group

    Absolute Risk Reduction (ARR) = Control Group (minus) Intervention Event Rate

    = (16/663) – (3/1305) = 0.0218 (2.18%)

    Covid Vaccine

    NNT = Number of people vaccinated to prevent 1 C19 case

    NNT = 1/ARR = 1/2.18% = 45.8 ~46

    1/46 vax = cases/1 million vaxed

    1.9 million reported C19 cases
    8200 hospitalizations
    18% CDC admitted not due to C19
    = 6806 hospitalizations of 1.9 million
    ⅓ cases had no comorbidities = 2246 healthy cases

    Out of 1.9 million cases the rate is 0.12%

    1 case/ 46 vaxed. = X case /1 million vexed

    X= 21739 cases/×0.12%

    Vaccines may prevent ~=26 per million hospitalizations of healthy kids

    Based on models used by FDA, it was estimated that vaccines result in 156 per million of myocarditis hospitalizations of healthy kids after taking the vaccination.

    These calculations were made by a Dr. Hong.

    Thank you!

  2. Steve, my analysis of the data also indicates the vaccines will cause more harm than good. As a CA high school math teacher, I am a mandated reporter of child abuse. Should Gov. Newsom enact his COVID-19 vaccine mandate for all students, I will be obligated to file an official report under California Penal Code Section 11166.
    I tried my best in the 3 minutes allotted to explain my obligation and provide information for parents at last week’s school board meeting,
    Any feedback would be much appreciated.
    Thank you for your testimony and tireless efforts.

    1. This is huge. Straight to mass scale testing on children, never mind those pesky trials. Mengele took the same approach at Auschwitz. That ended well…

    1. “Of 18 members, 17 voted yes and one abstained”

      Looks like $33bn in sales and counting greases a lot of palms. It’s clearly either a) greed, corruption, regulatory capture and RICO type practises on an unprecedented scale or b) a worldwide population cull led by Gates, GAVI, WEF et al or c) all of the above…


    ‘Severe concerns’: Israeli scientists sound alarm to FDA concerning COVID vaccine – The Jewish Voice

    86% of Children suffered an Adverse Reaction to the Pfizer Covid Vaccine in Clinical Trial – Rights and Freedoms

    BREAKING: Israeli physicians, scientists advise FDA of ‘severe concerns’ regarding reliability and legality of official Israeli COVID vaccine data – America’s Frontline Doctors

  4. Steve Kirsch
    I sincerely thank you and all the other brave intelligent men and women that are mentioned on slide 134 for leading the charge against this insanity.

  5. I read something interesting: you don’t need to do any research to know there is something wrong. While that’s true, research like this is vital if there is to be a way out of this, so thank you for it, Steve. You’ve probably seen this from a WHO funded study demonstrating that ivermectin is 80+% effective in prevention of COVID: I show it to anyone who speaks against ivermectin. I also sent it to the Free Press. Now I have your information to give to those who want truth.

  6. “Adults” are advocating to vaccinate children for two reasons.
    1. Some adults are afraid children will give them COVID
    2. Some adults are subservient to big pharma, the CDC, and Fauci

  7. Latest (15th) edition of the Daily Skeptic’s vaccine safety report just published, it’s a corker:

    Reporting the Australia figures for the first time, next to the usual VAERS headlines and UK Yellow Card breakdowns.

    Australia had less than 1500 Covid deaths ever. Launch of the collateral murder so-called vaccine programme with draconian mandates implemented to push same has resulted in 589 deaths to date. Give it a few more weeks and the death spike cocktail will cause the same number of deaths as the virus it was supposed to counter.

    Can’t make it up. Maybe the Australians haven’t quite figured out how to suppress or underreport their gene therapy fatalities in the way that more seasoned systems like VAERS and Yellow Card do.

    Nuremberg 2.0 needed ASAP.

      1. Excellent list of questions, and resources! Did you see the letter from the Israeli scientists (“The Israeli Professional Ethics Front”) debunking Israeli data used to justify the vaccine dated October 21, 2021, to the FDA?