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COVID-19 Vaccine Safety: Focus on Vaccine-Induced Myocarditis

Peter A. McCullough, MD, MPH, FACC, FAHA, FASN, FNKF, FNLA

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Chief Medical Advisor, Truth for Health Foundation

Editor-in-Chief, Reviews in Cardiovascular Medicine

Senior Associate Editor, American Journal of Cardiology

Tagline: https://americaoutloud.com/the-mccullough-report/

@PeterMcCulloughMD

 

Dr. McCullough is an internist, cardiologist, epidemiologist. He maintains ABIM certification in internal medicine and cardiovascular diseases.  He practices both internal medicine including the management of common infectious diseases as well as the cardiovascular complications of both the viral infection and the injuries developing after the COVID-19 vaccine in Dallas TX, USA.  Since the outset of the pandemic, Dr. McCullough has been a leader in the medical response to the COVID-19 disaster and has published “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine.  He has 51 peer-reviewed publications on the infection and has commented extensively on the medical response to the COVID-19 crisis in TheHill, FOX NEWS Channel, NewsMax, Real America, and America Out Loud.  On November 19, 2020, Dr. McCullough testified in the US Senate Committee on Homeland Security and Governmental Affairs and throughout 2021 in the Texas Senate Committee on Health and Human Services, Colorado General Assembly, New Hampshire Senate, and South Carolina Senate concerning many aspects of the pandemic response.  Dr. McCullough has dedicated his academic and clinical efforts in combating the SARS-CoV-2 virus and in doing so, has reviewed thousands of reports, participated in scientific congresses, group discussions, press releases, and has been considered among the world's experts on COVID-19.  

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After months of negative media coverage, the Guillain-Barre reports brought an overdue end to the swine flu affair. Ford’s programme was suspended in December 1976 with only some 20% of the US population (55M) vaccinated leaving 550 cases of Guillain-Barre and 25 deaths And since the US government had offered liability coverage to the pharmaceutical manufacturers that summer, hundreds of compensation claims from Guillain-Barre claimants followed for years afterward.

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Outline

  • New biological products
  • COVID-19 Vaccine Safety Review
  • Myocarditis
  • Conclusions

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Outline

  • New biological products
  • COVID-19 Vaccine Safety Review
  • Myocarditis
  • Conclusions

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Clinical Concerns

-mRNA or adenoviral DNA induce production of the Spike protein

-Cell, tissue, organ endothelial damage

-Spike protein circulation (body fluids, donated blood)

-No genotoxicity, teratogenicity, or oncogenicity studies

-Concerning ovarian biodistribution study (Pfizer, Japan)

-Concerning reduced fertility study (Moderna, EMA)

-No EAC, DSMB, Human Ethics Committee

-No restriction of properly excluded groups from RCTs

-Pregnant women, women of childbearing potential

-COVID survivors, previously immune

-No effort to restrict vaccination according to risk for COVID-19 hospitalization and death

-No attempts to present or mitigate risks for public

EAC=events adjudication committee; DSMB=data safety monitoring board; EMA=European Medicines Agency

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Outline

  • New biological products
  • COVID-19 Vaccine Safety Review
  • Myocarditis
  • Conclusions

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Emerging COVID-19 Vaccine Mortality Signal by Jan 22, 2021 (~27.1 M)

All vaccines before 2020

~158 total deaths/yr

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Historical PreCOVID ~280M Injections/year:

All ~70 vaccines average expected 16,320 VAERS total reports/yr, ~158 total deaths/yr

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Day of Death after

COVID-19 Vaccination

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86% of deaths had no other explanation other than the vaccine

McLachlan, Scott & Osman, Magda & Dube, Kudakwashe & Chiketero, Patience & Choi, Yvonne & Fenton, Norman. (2021). Analysis of COVID-19 vaccine death reports from the Vaccine Adverse Events Reporting System (VAERS) Database Interim Results and Analysis. 10.13140/RG.2.2.26987.26402.

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https://www.researchgate.net/publication/352837543_Analysis_of_COVID-19_vaccine_death_reports_from_the_Vaccine_Adverse_Events_Reporting_System_VAERS_Database_Interim_Results_and_Analysis

Mclachlan, Scott & Osman, Magda & Dube, Kudakwashe & Chiketero, Patience & Choi, Yvonne & Fenton, Norman. (2021). Analysis of COVID-19 vaccine death reports from the Vaccine Adverse Events Reporting System (VAERS) Database Interim Results and Analysis. 10.13140/RG.2.2.26987.26402.

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COVID-19 Respiratory Infection Deaths

COVID-19 Vaccine Deaths

“A novel best-case scenario cost-benefit analysis showed very conservatively that there are five times the number of deaths attributable to each inoculation vs those attributable to COVID-19 in the most vulnerable 65+ demographic”

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From 0-20 weeks post injection there were 146-187k vaccine associated deaths

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Outline

  • New biological products
  • COVID-19 Vaccine Safety Review
  • Myocarditis
  • Conclusions

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213 cases

10 years

5.5 M People

4 cases/1M/Yr

( J Am Heart Assoc. 2017;6:e005306. DOI: 10.1161/JAHA.116.005306.)

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Outline

  • New biological products
  • COVID-19 Vaccine Safety Review
  • Myocarditis
  • Conclusions

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Conclusions

  • COVID-19 vaccination program has not had adequate safety monitoring
  • Deaths and injuries after vaccination are alarming
  • COVID-19 vaccine-induced myocarditis cases are “tip of the iceberg” and are serious
  • FDA warnings on myocarditis should guide away from vaccination
  • Long-term rates of heart failure, arrhythmias, and cardiac death after vaccine-induced myocarditis are unknown. Events should be reported.

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