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Steve Kirsch - FDA Review

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Steve Kirsch - FDA Review

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Pfizer vaccine kills
more people than it saves
Steve Kirsch
Executive Director
COVID-19 Early Treatment Fund
stk@treatearly.org
VRBPAC Meeting
September 17, 2021
1
I agree with all their reasons.
Here are some new ones you haven’t
heard...
2
Nobody is paying
attention
to the elephant in
the room
All-cause mortality
(D:L ratio)
3
CDC:
Furthermore, a review of available clinical information,
including death certificates, autopsy, and medical
records, has not established a causal link to COVID-19
vaccines, says the CDC.
Over 14,000 death reports in VAERS and no causality?!?
All attempts to meet with the FDA and CDC to discuss
this have been stonewalled.
Reference: If Vaccine Adverse Events Tracking Systems Do Not Support Causal Inference, then
“Pharmacovigilance” Does Not Exist
4
Agenda
1. Excess Death:Life calculations→ Unacceptable
2. Elevation of Severe Adverse Events → Unacceptable
3. Pfizer clinical trial fraud never investigated → Unacceptable
4. Early treatment: the better alternative
5. What is happening in “the real world”
5
Excess Death:Life ratio is UNACCEPTABLE
Study source Excess deaths
required to save
COVID life
Lives saved
Pfizer 6 month* 5 1
VAERS 2 1
Nursing home (booster)* 6 1
People killed > People saved
* Not statistically significant
6

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Steve Kirsch - FDA Review

  • 1. Pfizer vaccine kills more people than it saves Steve Kirsch Executive Director COVID-19 Early Treatment Fund stk@treatearly.org VRBPAC Meeting September 17, 2021 1
  • 2. I agree with all their reasons. Here are some new ones you haven’t heard... 2
  • 3. Nobody is paying attention to the elephant in the room All-cause mortality (D:L ratio) 3
  • 4. CDC: Furthermore, a review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines, says the CDC. Over 14,000 death reports in VAERS and no causality?!? All attempts to meet with the FDA and CDC to discuss this have been stonewalled. Reference: If Vaccine Adverse Events Tracking Systems Do Not Support Causal Inference, then “Pharmacovigilance” Does Not Exist 4
  • 5. Agenda 1. Excess Death:Life calculations→ Unacceptable 2. Elevation of Severe Adverse Events → Unacceptable 3. Pfizer clinical trial fraud never investigated → Unacceptable 4. Early treatment: the better alternative 5. What is happening in “the real world” 5
  • 6. Excess Death:Life ratio is UNACCEPTABLE Study source Excess deaths required to save COVID life Lives saved Pfizer 6 month* 5 1 VAERS 2 1 Nursing home (booster)* 6 1 People killed > People saved * Not statistically significant 6
  • 7. Pfizer Phase 3: 6 month study result THE most definitive study on all-cause mortality benefit is NEGATIVE Group Deaths Placebo 14 Vaccine 18 Excess Death:Life = 5:1 We killed 5 people to save a COVID death (net 18-14=4 lives lost) but this is not statistically significant 7
  • 8. VAERS excess deaths calculation 1. (2927-500)*41= 99,507 actual deaths 2. 99507/217 = 458 D/M doses Notes: 1. 217M is the number of Pfizer doses delivered 2. 41 is the under-reporting factor (URF) in VAERS this year for the COVID vaccines computed from anaphylaxis rates from the JAMA paper. 3. 458 Deaths per Million Doses is just above the worldwide average of 411 which is demonstrated multiple independent ways. 8
  • 9. VAERS D:L calculation Last 6 month COVID deaths assuming 90% death reduction = 91,868 *.90 = 82,681 lives saved per 360M doses -82.681/360000*1000000 = -230 D/M 458/230=2 per 6 month efficacy period Category Deaths per M doses Est lives saved per M doses (last 6 mo) -230 Excess deaths per M VAERS (Pfizer only) 458 Death:Life = 2:1 9
  • 10. Nursing home 4 dead/7 hospitalized after Pfizer Booster Save .68 life from COVID in 6 mo Death:Life = 6:1 Assumptions: 1. 3% IFR for elderly and 30% get COVID in a year 2. Booster lasts for 6 months Sunnycrest nursing home Whitby, Ontario 136 beds 10
  • 11. ~411 deaths/M doses Confirmed using five different methods comprising 35% of the world’s population ~ 150,000 excess deaths in America caused by the vaccine 11
  • 12. Adverse event table (partial list) Symptom X factor Pulmonary embolism 473 Stroke 326 Deep vein thrombosis 264.3 Thrombosis 250.5 Fibrin D dimer increased 220.8 Appendicitis 145.5 Tinnitus 97.3 Cardiac arrest 71 Death 58.1 Parkinson’s disease 55 Slow speech 54.3 Aphasia (inability to talk) 52.3 Full list: Estimating the number of COVID vaccine deaths in America 12
  • 13. Cardiac arrest example 71X elevated vs. baseline (avg over 5 years for all vaccines; 57/4*5=71) NB: VAERS reporting propensity is unchanged from previous years→ These are real elevations Note: The 71X factor is in a period shortly after vaccination and not the entire year! 13
  • 14. STEMIs elevated by 2x to 3x after vaccine rollout “I’ve NEVER seen that before.” Dr. Vinay Julapalli, MD Interventional Cardiology Houston Methodist 14
  • 15. Note: Two dose calc: 1000000/((5.2+71.5)*41)=317 (note 41 is the URF) Third dose calc: 1000000/(71.5*13.75*41) = 25 Assumes each dose increases SAE rate by 13.75 (=71.5/5.2) in that age range Reference: John Su, Safety update for COVID-19 vaccines: VAERS 1 in 317 boys (16-17) will get myocarditis from the vaccine After the booster it could be 1 in 25 15
  • 16. Guess when Israel started their booster program? Yup. July 30. 16
  • 17. More booster deaths This is a brief from a regional association of physicians in Germany to their members. Informing them about an incident in a nursing home where 90 inhabitants were given the third booster shot. Out of this resulted 1 death, two resuscitations, and 9 critically ill with cardiopulmonary symptoms. “Given the fact that neither German authorities (PEI) nor European Medicines Agency EMA has approved this booster,” the association is urging the members to seriously reconsider the need for a booster as of now.
  • 18. Why didn’t anyone ask any questions about the gaming in the Phase 3 trial?!? This is unlikely to happen by chance (p.< 0.00001). 18
  • 19. Why hasn’t the FDA investigated the Maddie de Garay trial fraud? 1. She was in the Pfizer Phase 3 12-15 year old trial 2. She was 1 of just 1,131 kids in treatment arm 3. She was paralyzed less than 24 hours after her second Pfizer shot, but Pfizer reported her case as “abdominal pain” rather than “permanent paralysis.” 4. Today, she has no feeling below her waist, she can’t hold her head up on her own, she has to eat through a feeding tube. 5. It isn’t clear she will improve over time. 6. Physicians don’t know how to treat her. 7. She was never ejected from the trial. 8. FDA Commissioner Janet Woodcock promised an investigation. 9. She’s never been contacted by the FDA or CDC on the fraud allegation. 10. She has received $0 in compensation. ZERO. 19
  • 20. Early treatment benefits 1. Higher relative risk reduction (over 99%) 2. Simple prophylaxis protocols be used to prevent infection with up to 100% success without the use of any drugs whatsoever 3. Greater safety (minor temporary side effects, known safety profile) 4. They lower both all-cause mortality and all-cause morbidity 5. They work equally well on all variants 6. They do not promote escape variants 7. They do not cause vaccine enhanced infectivity/replication 8. They do not risk original antigenic sin (linked-epitope suppression) 9. They do not cause prion diseases 10. They prevent long-haul COVID syndrome nearly 100% of the time 11. They enable people to acquire recovered immunity which is both 13X to 27X stronger and more durable than vaccine-induced immunity 20
  • 21. People are trying to send you a message … are you listening? See WXYZ-TV’s Facebook post for > 10,000 stories like these 21
  • 22. What do you say to the victims? 22
  • 23. 23
  • 25. Dr. Peter Schirmacher 1. Chief pathologist at the University of Heidelberg 2. One of top 100 pathologists in the world 3. Member German National Academy of Sciences 4. h-index: 100 (38,730 citations) 5. Did autopsy on 40 people who died within 2 weeks of vaccine→ “30% to 40% died from the vaccine” → “Nobody has died from the vaccine” is a lie. Why isn’t this covered in the US mainstream media? Reference: Chief pathologist insists on more autopsies of vaccinated people 25