Highlights

• mRNA vaccines promote sustained synthesis of the SARS-CoV-2 spike protein.
• The spike protein is neurotoxic, and it impairs DNA repair mechanisms.
• Suppression of type I interferon responses results in impaired innate immunity.
• The mRNA vaccines potentially cause increased risk to infectious diseases and cancer.
• Codon optimization results in G-rich mRNA that has unpredictable complex effects.

Abstract

The mRNA SARS-CoV-2 vaccines were brought to market in response to the public health crises of Covid-19. The utilization of mRNA vaccines in the context of infectious disease has no precedent. The many alterations in the vaccine mRNA hide the mRNA from cellular defenses and promote a longer biological half-life and high production of spike protein. However, the immune response to the vaccine is very different from that to a SARS-CoV-2 infection. In this paper, we present evidence that vaccination induces a profound impairment in type I interferon signaling, which has diverse adverse consequences to human health. Immune cells that have taken up the vaccine nanoparticles release into circulation large numbers of exosomes containing spike protein along with critical microRNAs that induce a signaling response in recipient cells at distant sites. We also identify potential profound disturbances in regulatory control of protein synthesis and cancer surveillance. These disturbances potentially have a causal link to neurodegenerative disease, myocarditis, immune thrombocytopenia, Bell's palsy, liver disease, impaired adaptive immunity, impaired DNA damage response and tumorigenesis. We show evidence from the VAERS database supporting our hypothesis. We believe a comprehensive risk/benefit assessment of the mRNA vaccines questions them as positive contributors to public health.

Graphical abstract

Peter McCullough speaks at the 78th Annual Meeting of the Association of American Physicians and Surgeons on October 2, 2021.

1. COVID-19 vaccination is voluntary research. The COVID-19 public vaccination program operated by the CDC and the FDA is a clinical investigation and under no circumstance can any person receive pressure, coercion, or threat of reprisal on their free choice of participation. Violation of this principle of autonomy by any entity constitutes reckless endangerment with a reasonable expectation of causing personal injury resulting in damages.

   2. COVID-19 vaccines do not work well enough. The current COVID-19 vaccines are not sufficiently protective against contracting COVID-19 to support its use beyond the current voluntary participation in the CDC sponsored program. A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported from 46 U.S. states and territories as of April 30, 2021. Among these cases, 6,446 (63%) occurred in females, and the median patient age was 58 years (interquartile range = 40–74 years). Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died. Among the 995 hospitalized patients, 289 (29%) were asymptomatic or hospitalized for a reason unrelated to COVID-19. The median age of patients who died was 82 years (interquartile range = 71–89 years); 28 (18%) decedents were asymptomatic or died from a cause unrelated to COVID-19. Sequence data were available from 555 (5%) reported cases, 356 (64%) of which were identified as SARS-CoV-2 variants of concern, including B.1.1.7 (199; 56%), B.1.429 (88; 25%), B.1.427 (28; 8%), P.1 (28; 8%), and B.1.351 (13; 4%). None of these variants are encoded in the RNA or DNA of the current COVID-19 vaccines. In response to these numerous reports, the CDC announced on May 1, 2021, that community breakthrough cases would no longer be reported to the public and only those vaccine failure cases requiring hospitalization will be reported, presumably on the CDC website (https://www.cdc.gov/mmwr/volumes/70/wr/mm7021e3.htm)

   3. COVID-19 vaccines have a dangerous mechanism of action. The Pfizer, Moderna, and JNJ vaccines are considered "genetic vaccines" or vaccines produced from gene therapy molecular platforms.[i] [ii] They have a injurious mechanism of action in that they all cause the body to make an uncontrolled quantity of the pathogenic spike protein from the SARS-CoV-2 virus. This is unlike all other vaccines where there is a set amount of antigen or live-attenuated virus. This means for the Pfizer, Moderna, and JNJ vaccines it is not predictable among patients who will produce more or less of the spike protein. The spike protein itself has been demonstrated to injure vital organs such as the brain, heart, lungs, as well as damage blood vessels and directly cause blood clots. Additionally, because these vaccines infect cells within these organs, the generation of spike protein within heart and brain cells in particular, causes the body's own immune system to attack these organs.

   4. There is a burgeoning number of cases of myocarditis or heart inflammation among individuals below age 30 years.[iii] The Centers for Disease Control has held emergency meetings on this issue and the medical community is responding to the crisis and the US FDA has issued a warning on the Pfizer and Moderna vaccines for myocarditis.[iv] It is known that myocarditis causes injury to heart muscle cells and may result in permanent heart damage leading to heart failure, arrhythmias, and cardiac death. Because this risk is not predictable and the early reports may represent just the tip of the iceberg, no individual under age 30 under any set of circumstances should feel any obliged to take this risk with the current genetic vaccines particular the Pfizer and Moderna products.

   5. The US FDA has given an update on the JNJ vaccine concerning the risk of cerebral venous sinus thrombosis in women ages 18-48 associated with low platelet counts.[v] Because this risk is not predictable no woman under age 48 under any set of circumstances should feel any obliged to take this risk with the JNJ vaccine.

   6. COVID-19 vaccines are generating record safety reports. In 1990, the Vaccine Adverse Event Reporting Systems (“VAERS”) was established as a national early warning system to detect possible safety problems in U.S. licensed vaccines.[vi] VAERS is a passive reporting system, meaning it relies on individuals to voluntarily send in reports of their experiences to CDC and FDA. VAERS is useful in detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. The total safety reports in VAERS all vaccines per year up to 2019 was 16,320. The total safety reports in VAERS for COVID Vaccines alone through June 25, 2021 is 411,931.[vii]

   7. People are dying and being hospitalized in record numbers in the days after COVID-19 vaccination. Based on VAERS as of June 25, 2021, there were 6,985 COVID-19 vaccine deaths reported and over 23,257 hospitalizations reported for the COVID-19 vaccines (Pfizer, Moderna, JNJ). By comparison, from 1999, until December 31, 2019, VAERS received 3167 death reports (158 per year) adult death reports for all vaccines combined. Thus, the COVID-19 mass vaccination is associated with at least 39-fold increase annualized vaccine deaths reported to VAERS. COVID-19 vaccine adverse events account for 98% of all vaccine-related AEs from Dec 2020 through present in VAERS.

   8. The safety profile is unknown and there is a reasonable expectation for harm for the following groups at all age ranges: COVID-19 recovered, suspected COVID-19 recovered, women of childbearing potential, children, persons with one or more chronic diseases.

   9. Any personal choice or protected health information concerning the COVID-19 vaccine and its complications is confidential and anonymous according to federal law, otherwise, you will be subject to additional federal fines and penalties for violation of protected health information laws and statutes.

   In conclusion, the investigational, genetic COVID-19 vaccines are not safe for general use and cannot be deployed indiscriminately unless proven otherwise. Please cease and desist pressure/harassment/mandates for COVID-19 vaccination.

Dr. Peter McCullough has been the world's most prominent and vocal advocate for early outpatient treatment of SARS-CoV-2 (COVID-19) Infection in order to prevent hospitalization and death. On May 19, 2021, I interviewed him about his efforts as a treating physician and researcher. From his unique vantage point, he has observed and documented a PROFOUNDLY DISTURBING POLICY RESPONSE to the pandemic -- a policy response that may prove to be the greatest malpractice and malfeasance in the history of medicine and public health.

Dr. McCullough is an internist, cardiologist, epidemiologist, and Professor of Medicine at Texas A & M College of Medicine, 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 40 peer-reviewed publications on the infection and has commented extensively on the medical response to the COVID-19 crisis in TheHill and on FOX NEWS Channel. 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, and New Hampshire Senate concerning many aspects of the pandemic response.

Peter A. McCullough, MD, MPH, FACP, FACC, FAHA, FCRSA, FCCP, FNKF, FNLA
Professor of Medicine, Texas A & M College of Medicine
Board Certified Internist and Cardiologist
President Cardiorenal Society of America
Editor-in-Chief, Reviews in Cardiovascular Medicine
Editor-in-Chief, Cardiorenal Medicine
Senior Associate Editor, American Journal of Cardiology
For more information about Dr. McCullough, please visit: https://heartplace.com/dr-peter-a-mccullough