Mandating COVID-19 Vaccinations for Everyone is Unethical and Not Scientifically Justified

Sanjay Verma, MD FACC
20 min readJan 16, 2022

--

Risks and Complications associated with COVID-19 Vaccines

SARS-CoV2, the virus that causes the disease COVID-19, has indubitably caused tremendous disease burden worldwide. SARS-CoV2 is perhaps the greatest public health crisis in one hundred years. As of the time of this writing, CDC’s officially confirmed COVID-19 numbers indicate 50 million ‘cases’ and about 820,000 deaths in the US alone. Furthermore, an estimated 100M-150M people have been infected with SARS-CoV2 (about two to four times the officially confirmed PCR numbers in the general population). Hard metrics such as hospitalizations and deaths are easier to track and report to inform public health policy. While difficult to define and quantify, SARS-CoV2 has also caused long term symptoms in countless survivors (“long COVID” or Post Acute COVID Syndrome, PACS). PACS ought to be part of our assessment of disease burden and we are only now beginning to better quantify the disease burden across age groups.

Early in 2020, as we were just learning about the disease, it’s full clinical manifestations and impact, due to limited testing capacity and under recognition of mild and moderate illness, many people with COVID-like illness were not tested. The initial focus of our testing, diagnostic, and therapeutic modalities were almost exclusively on hospitalized patients, based upon the concerns of inadequate ICU capacity, ventilator supply, limited supply of personal protective equipment (PPE). Much of the initial projections and extrapolations were based upon critically and severely ill hospitalized patients. We now have amassed vast data enabling a more comprehensive and representative description of clinical spectrum of clinical disease, contextualizing organ specific disease burden, and irrefutable evidence of clearly defined risk stratification. Thus, it behooves us to also reassess our approach(es) to pandemic control. Most notably, government, educational, and private business COVID-19 vaccine mandates are at the forefront of policy debate and legal challenges.

Summary of CDC Data on COVID-19 Deaths and COVID-19 Hospitalizations by Age group
CDC Data on COVID-19 Hospitalizations by Age

COVID-19 vaccines have had tremendous benefit in reducing COVID-19 hospitalizations and deaths in certain high-risk populations. They have been readily available for over one year for adults, with teens and children having access in the past few months also. Almost anyone who wishes to be vaccinated most certainly has had the opportunity to do so. However, they are not without complications and side effects. While these complications and severe adverse reactions are relatively rare, the risk is not the same across all age groups and risk profiles. For many high-risk individuals (e.g., age >65 years-old, Body Mass Index, or BMI, ≥30, medical conditions such as diabetes mellitus, high blood pressure, coronary artery disease, congestive heart failure, immune compromised, cancer chemotherapy, congenital circulatory conditions, etc.) the benefits of COVID-19 vaccines probably far outweigh the risks. However, for other individuals (especially younger individuals with normal BMI and no underlying medical conditions) the benefits may not always outweigh the risks of severe adverse reactions. In fact, for some subgroups, the risk of harm may exceed any potential benefit since these younger, healthier individuals are at very low risk of severe COVID-19 complications themselves.

COVID-19 VACCINES AND MYOCARDITIS

COVID-19 vaccines are associated with a known increased risk of myocarditis (inflammation of the heart). The FDA Fact Sheet for Moderna and the FDA Fact Sheet for Pfizer have been updated after Emergency Use Authorization (EUA) to reflect that risk. Sweden, Finland and Denmark have halted the use of Moderna’s mRNA vaccine in people under 30 years old because of these concerns. The FDA Summary Basis of Regulatory Action also discusses this risk of myocarditis. Their model “predicted excess cases of vaccine-associated myocarditis/pericarditis would exceed COVID-19 hospitalizations and deaths under the “worst case” scenario”.

Earlier in 2021 during the time when COVID vaccines were granted EUA, a study evaluating the risk of myocarditis, concluded that the risk of myocarditis after COVID-19 infection was greater than the risk after COVID-19 vaccination. This contribute to the ongoing stance by the government that the COVID vaccines’ “benefits are greater than the risks”. However, this analysis was imperfect because it combined all age groups in its analysis. It is well established that COVID-19 hospitalizations are predominantly comprised of those older than 65 years (this cohort outnumbers all other age groups combined for COVID hospitalizations). CDC’s own analysis reveals that 91% of all COVID-19 hospitalizations occurred in people with underlying medical conditions and most recently CDC Director Rochelle Walensky has stated that 75% of COVID deaths were in people with at least 4 underlying medical conditions. Therefore, the myocarditis cases after COVID infection likely occur in older people with underlying medical conditions. In contrast, preliminary review of unverified reports in VAERS reveals the post vaccine myocarditis occurs more in younger people without underlying medical conditions. Thus, many physicians have suggested that formal subgroup analysis by age and gender might corroborate the findings in VAERS and early Israeli data which suggest increased risk of myocarditis after vaccination amongst younger males. Initial analysis based upon VAERS data did suggest increased risk based upon younger age and male sex.

This was confirmed in a more recent study that demonstrated for those less than 40 years-old, the risk of myocarditis after COVID-vaccination is far greater than after COVID-19 infection.. The study found that compared to background rate in general population there was a 3.4x increased risk for Pfizer COVID vaccine and 20.71x increased risk after Moderna vaccine whereas the risk after COVID infection was 4.06x the background rate in the general population. When this group is further risk stratified, the 16–29 year old group had an even greater risk of myocarditis after vaccination, especially for Moderna mRNA vaccine (COVID infection yielded 2.83x increased risk, Moderna vaccine yielded 74.39x increased risk, and Pfizer vaccine yielded 2.88x increased rick compared to background rate in general population). The authors of this study recently performed an urgent updated analysis to include the effect of boosters. Their analysis found that the risk of myocarditis was further exacerbated after boosters, especially for the Pfizer mRNA vaccine. In another recent study on myocarditis after vaccination, the authors found only 17% of cases had any underlying medical conditions (in contrast to the 91% of COVID hospitalizations having underlying medical conditions). This group of young healthy people is at very low risk of severe COVID complications themselves.

Risk of myocarditis, pericarditis and cardiac arrhythmias
Risk of myocarditis by age after COVID-19 vaccination (16–29 age has the highest risk). From Table 3B in Supplementary Appendix
Risk of myocarditis after sequential COVID-19 vaccination and after infection, increasing after booster

CDC’s analysis of myocarditis after COVID-19 vaccination underestimates the risk by relying upon passive surveillance in VAERS which is dependent upon self-reporting. One study demonstrated that active surveillance for myocarditis after vaccination found the risk to be 2–4 times greater than the CDC estimates based only upon VAERS. This underestimation may not be an outlier of just one study. Another more recent preprint study of 12 to 39 year-old patients, insured by Kaiser Permanente Northwest, concluded, “The true incidence of myopericarditis is markedly higher than the incidence reported to US advisory committees.” The authors added, “Our estimate of the incidence of myopericarditis following COVID-19 mRNA vaccine is similar in magnitude to that reported from two studies from Israelbut higher than that reported in the US studies and at VBRPAC and ACIP meetings. Complete case estimates are essential when modeling risk and benefit for wide-scale vaccine implementation and booster doses in younger age groups.” The risk of anaphylaxis is also underestimated by 22 times according to this study using active surveillance after COVID vaccination. Previous research also confirmed that active surveillance better estimates the risk of myocarditis after small pox and influenza vaccines compared to reliance on VAERS data alone. Thus far, the government has not published any formal analyses based upon active surveillance of all those vaccinated. The models used in FDA Summary Basis for Regulatory Action did employ data from Optum’s health database: the worst-case scenario from this database analysis suggested the risks of myocarditis might be greater than the benefits (preventing COVID hospitalizations and deaths) for younger patients. Additional anecdotal evidence suggests many health care professionals are under reporting the vaccine injury cases they do encounter. Anecdotal evidence is indeed subject to recall, selection, and confirmation biases and thus cannot be accepted prima facie without further corroboration and investigation. It can, however, serve as a safety signal to warrant more formal investigation. Despite all this, all the available CDC, ACIP, and VRBA committee meetings on the topic are primarily based upon data from VAERS.

CDC’s analysis of the risks and benefits of myocarditis is further limited by their strict case definition of myocarditis, requiring diagnosis by cardiac MRI. Cardiac MRI is not available in many community hospitals. Previous research has demonstrated that a probable diagnosis myocarditis based upon clinical criteria using either echocardiographic or cardiac MRI findings carries the same prognosis as those made by definitive diagnosis with the gold standard myocardial biopsy. Thus, insistence on cardiac MRI for their risk-benefit analysis inappropriately underestimates the extent of the risk.

CDC continues to state that myocarditis cases after COVID-19 vaccination “were generally mild”. However, their own analysis reveals that about 20% were not mild, some of the patients being admitted into the intensive care unit and on medications to support their blood pressure (on inotropic medications for cardiogenic shock). Subsequent published research confirmed that about 20% of the cases were more severe than just mild (also confirmed in this research letter). This correlates with the recent comprehensive analyses from Israel which analyzed health care database systems finding about 20% of the cases are not just mild.

According to current practice guidelines, a diagnosis of acute myocarditis necessitates activity restriction for three to six months due to the increased risk of sudden cardiac death with aerobic activity. For those who develop cardiac dysfunction (left ventricular systolic dysfunction) known as dilated cardiomyopathy, the 5-year transplant free survival is 73% (27% mortality). In the aforementioned study from Israel, of the 54 cases of myocarditis, 14 had cardiac dysfunction. 10 of these 14 (71%) with cardiac dysfunction at time of diagnosis had persistent cardiac dysfunction at time of discharge (i.e., the heart function did not improve). Therefore, it is disingenuous to summarily conclude these myocarditis cases after vaccination are “generally mild”.

In professional sports, there has been a three hundred percent increase in cardiovascular deaths amongst soccer players. In the absence of any formal and methodical analysis, including autopsies and biopsies, we cannot scientifically infer any causation with COVID-19 vaccination. However, such a dramatic rise ought to trigger a safety signal for formal investigation. Pending such investigation, continued mandated vaccination policies risks irreparable catastrophic harm.

Annual cardiovascular deaths amongst FIFA players

In addition to myocarditis, other cardiovascular risks after COVID vaccination include potentially increased 5-year risk of acute coronary syndrome, more than doubling the 5-year risk after vaccination based upon inflammatory biomarkers.

To better contextualize the COVID-19 disease burden for younger people, we can compare to all-cause mortality and other causes of mortlaity. One assessment of disease burden is excess mortality (number of deaths above the baseline expected deaths). CDC’s analysis of excess deaths reveals almost no excess deaths in those younger than 25 years-old, during 2020 and 2021 compared to 2019. Clearly, this age group is at very low risk of severe COVID complications. They are more likely to suffer harm from vaccine associated myocarditis than from severe COVID complications. Additionally, 2020 witnessed a thirteen percent increase in suicides amongst male teenagers 10–14 years old. While there were 47 more deaths from suicide for 5–14 year old males in 2020 (396) compared to 2019 (349), there were 38 total deaths from COVID-19 in the same cohort. Fentanyl is now the leading cause of death amongst 18–45 year-olds (78,795 in 2020 and 2021 combined), far eclipsing the total COVID-19 deaths (52,638 in 2020 and 2021 combined) in the same age group.

Current vaccine mandate do not provide for exemptions based upon individual risk stratification (those < 40 years-old are at greater risk of vaccine associated myocarditis than of myocarditis after COVID-19 infection, especially those who are 16–29 years old). Even when such relatively uncommon severe adverse events do occur, OSHA brazenly stipulates that any potential vaccine associated injuries not be reported (“OSHA will not enforce 29 CFR 1904’s recording requirements to require any employers to record worker side effects from COVID-19 vaccination at least through May 2022”).

CDC Data on Weekly Deaths (0–24 yo age group): No Excess deaths
Percent change in deaths from suicide, year of year, by age group

COVID-19 VACCINATIONS ASSOCIATED WITH NEUROLOGICAL AND HEMATOLOGICAL COMPLICATIONS

Johnson and Johnson’s COVID vaccine (Janssen) is known to be associated with bleeding and clotting disorders: Vaccine Immune Thrombotic Thrombocytopenia (VITT), and Cerebral Venous Sinus Thrombosis (CVST). Some of the patients who have suffered from these serious adverse reactions after COVID-19 vaccination have died. Most of those suffering from these side effects were women of child bearing age, many of whom did not have any underlying medical problems. CDC subsequently issued a preference for mRNA vaccines (Pfizer and Moderna) over Janssen COVID-19 vaccination. More recently, FDA updated its fact sheet to include rare bleeding risk. However, by this time many organizations had already implemented vaccine mandates and numerous people had already suffered.

Janssen COVID vaccination is also associated with increased, albeit rare, risk of the severely disabling neurological disorder called Guillain-Barre Syndrome (BGS). GBS causes ascending paralysis and has a mortality rate of 3–13%. This severe neurologic complication can be severely disabling and “Estimates indicate that 15–20% of patients have moderate residual deficits from GBS and that 1–10% are left severely disabled.”

These hematological and neurological complications are not unique to Janssen’s COVID-19 vaccination. Cursory review of data available in VAERS demonstrates such severe adverse reactions have also been reported with mRNA vaccinations (Pfizer and Moderna). Additionally, a related phenomenon, transverse myelitis after COVID-19 vaccination, has also been published in scientific literature.

The mechanism for neurological injury after COVID vaccination is not fully elucidated yet. However, what is clear is that the spike protein has been found in circulation beyond the intramuscular injection site from four weeks to four months. The spike protein has also been found to cross the blood brain barrier. Most recently, there are now also reports of newly diagnosed intracerebral brain masses after COVID vaccination perhaps in reaction to post-vaccination inflammation (exact mechanism not yet known).

POTENTIAL ADVERSE EFFECTS ON THE IMMUNE SYSTEM

The aim of vaccination is to stimulate the adaptative immune system to develop neutralizing antibodies as well as memory B and T cells to better attack a pathogen. Ideally, vaccines would prevent disease, but at the very least offer benefit in reducing disease severity. COVID-19 vaccines have not been under evaluation long enough to have thorough evaluation of long-term adverse effects. In one molecular biology study, the authors note that “Together, these data suggested that after vaccination, at least by day 28, other than generation of neutralizing antibodies, people’s immune systems, including those of lymphocytes and monocytes, were perhaps in a more vulnerable state. The authors therefore conclude, “Altogether, our study recommends additional caution when vaccinating people with pre-existing clinical conditions, including diabetes, electrolyte imbalances, renal dysfunction, and coagulation disorders.” Another study suggested that COVID-19 vaccination “may contribute to a diminished innate immune response towards the virus.”

In addition to potential immune dysregulation in certain medical conditions, there has been concern about autoimmunity after vaccination due to antigen mimicry. We are already witnessing new autoimmune phenomena after vaccination.Additionally, after COVID-19 infection a study found that the majority of SARS-CoV2 antibodies are autoantibodies, and not neutralizing. The authors raise the concern that “similar autoimmune antibodies may also be secreted following COVID-19 vaccination.” This has not yet been formally evaluated or proven, but certainly warrants pause before any mandates render such caution moot.

IMMUNITY FROM PRIOR INFECTION

Numerous studies have been published demonstrating the people previously infected by SARS-CoV2 have sustained and highly effective immunity. Reinfections are not common, and when they do occur the vast majority of infections are spared form hospitalization and death. Children even seem to have cross reactive immunity to SARS-CoV2 from exposure to benign common cold corona viruses. However, public health officials repeatedly state that we do not yet know how long immunity from prior infection lasts. The same argument could be made for immunity after COVID-19 vaccination. In fact , we have increasing evidence immunity after vaccination wanes after six months, especially for higher risk groups. Immunity after booster seems to wane after ten weeks. For almost every other infectious disease, existence of immunity precludes health care workers from needing subsequent vaccination or boosters. Public Health officials and hospitals have broken from well established standard of care by requiring COVID-19 vaccination and boosters despite presence of immunity from prior infection. Therefore, institutional and government vaccination mandates that do not exempt those with immunity from prior infection are not only unscientific, they are an eggregious violation of a person’s bodily autonomy without any proven incremental benefit to the interest of the State or the institution by whom they are mandated.

AUTOPSY METHODOLOGY

While CDC claims that all deaths after vaccination are adjudicated, there does not seem to be a methodical and standardized approach to evaluating for potential vaccine mediated injuries. CDC’s assessment seems to be based upon review of the medical chart and reliance on coroner’s reports. Board certified cardiologists and pathologists do not seem to be involved. Dr. Burkhardt and colleagues performed a more thorough autopsy on seventeen people who had died soon after COVID vaccination. “Key observations were widespread vasculitis with microthrombi as well as intense lymphocytic infiltration of multiple organs.” These findings led Dr. Burkhardt to conclude the deaths were likely causally related to vaccination and not incidental temporal association. Thorough pathological analysis such as this does not seem to be part of CDC’s adjudication and chart review of deaths after vaccination.

SECONDARY PREVENTION (PREVENTING TRANSMISSION TO OTHERS)

During the oral arguments January 7, 2022 at the Supreme Court of the United States, attorneys and Supreme Court Justices repeatedly stated that these vaccines prevent transmission. That is the narrative coming from the White House and Public Health officials during the early rollout of the vaccines. However, published research has contradicted this narrative, demonstrating that the vaccines have minimal if any benefit in preventing transmission. CDC Director Rochelle Walensky declared “what they can’t do anymore is prevent transmission.” This is not new information as previous studies(even with Delta variant) had already concluded, “fully vaccinated individuals with breakthrough infections have peak viral load similar to unvaccinated cases and can efficiently transmit infection in household settings, including to fully vaccinated contacts. Host–virus interactions early in infection may shape the entire viral trajectory.“ Another study found that after vaccination, the “protective effect is relatively small, and dwindles alarmingly at three months after the receipt of the second shot.” This should have come to no surprise to any physician or scientist because vaccines generate protective IgG antibodies in blood circulation, but do not stimulate IgA antibodies for local immunity in the mucosa of nose, sinuses, and throat. Because Omicron variant replicates more actively in the upper airways than the lungs, it just magnified the lack of secondary prevention conferred by IgG dependent vaccine immunity.

OVERESTIMATING THE RISK OF COVID-19 HOSPITALIZATION

Most recently, Dr. Fauci and Dr. Paul Offit have both appeared on mainstream media, clarifying that many of the pediatric COVID-19 hospitalizations were not for COVID-19 itself. Every child admitted to the hospital receives routine surveillance with PCR testing. The COVID-19 hospitalization data thus combines those who were admitted for COVID-19 disease and those who were admitted for other causes (e.g., trauma, appendicitis). but had incidental PCR+ on routine surveillance. A study from 2021 performing a detailed hospital chart review found that there 40% of COVID-19 pediatric hospitalizations may be over counted when differentiating between children admitted with incidental PCR+ results and those admitted for COVID-19 disease. Another study performing a similar analysis of pediatric COVID-19 hospitalizations also found that 40% may have been over counted. NY Governor recently asked hospitals to make this distinction in their reporting. Preliminary results suggest that in NYC 49% of COVID-19 hospitalizations were “with COVID” and not “for COVID”. If COVID-19 hospitalization data includes both those hospitalized “for COVID-19” and those with incidental PCR+ (“with COVID-19) but hospitalized for other causes, then all the CDC analysis of the potential hospitalizations prevented with COVID-19 vaccination are also over estimated (i.e., fewer hospitalizations will be prevented than CDC models project). Furthermore, a recent study highlighted by CDC demonstrated significantly decreased risk of hospitalizations and deaths with Omicron. This only further reduces the benefit of COVID-19 vaccinations. This would suggest that rapid and pervasive spread of Omicron in the US population obviates and stultifies mandated COVID-19 vaccination policies.

GOVERNMENT CANNOT MANDATE EMERGENCY USE AUTHORIZATION (EUA) PRODUCTS

The Conditions of Emergency Use Authorization stipulate that people being offered EUA products “have the option to accept or refuse the EUA product and of any consequences of refusing administration of the product”. Therefore, government is prohibited from mandating EUA products. During the January 7 oral arguments before SCOTUS, it was mentioned numerous times by Justices and attorneys that the vaccines are FDA “approved”. However, this is not actually true. Janssen FDA Fact Sheet states, “Janssen COVID-19 Vaccine is available under EUA as a single primary vaccination dose for individuals 18 years of age and older and as a single booster dose for individuals 18 years of age and older at least two months after completing primary vaccination with the vaccine.” The Moderna FDA Fact sheet states, “The Moderna COVID-19 Vaccine has received EUA from FDA.” The apparent full BLA approval (i.e., ‘FDA approval’) for Pfizer COVID-19 vaccination is more complicated and nuanced. The Pfizer FDA Fact Sheet states “On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.” One might think that Pfizer-BioNTech and Comirnaty are interchangeable products with just a cosmetic name change. In Doe et al v. Austin a federal judge rejected Pfizer’s interchangeability. It is also noteworthy that “in the same footnote describing the EUA vaccine and Comirnaty as ‘interchangeabl[e],’ the FDA clarifies that the two products are ‘legally distinct.’ ”

GOVERNMENT CANNOT CAUSE HARM (1905 JACOBSON v. MASSACHUSETTS)

COVID-19 indubitably carries tremendous disease burden in risk of hospitalization and death. As noted above, about 820,000 people have died of COVID in US alone, and over 5 million worldwide. During regional surges, hospitals have been repeatedly overwhelmed. Understandably, government officials, schools, universities, and private institutions feel a moral, political, and public health imperative to mitigate harm to the extent possible. Difficult decisions need to be made balancing the health safety needs of all members of society. However, with the increased risks of myocarditis, 5-year risk of acute coronary syndrome, VITT, CVST, and GBS, and potential immune mediated injury, the role of government cannot be to cause potential vaccine mediated harm in low risk people while trying to prevent COVID-19 harm in high risk people, all the while completely neglecting immunity from prior infection. The oft cited 1905 Jacobson v. Massachusetts case is used by many to justify government mandated vaccines. A review of The Constitutional Right to Make Medical Treatment Decisions, notes that:

“The Court stated, in dicta, that in an “[e]xtreme case[],” such as an individual for whom vaccination would cause serious harm, the vaccination requirement should be waived. Either the vaccination law would have to be construed as not intended to reach such cases, “or, if it was so intended,” the Court could act to “protect the health and life of the individual concerned,” but the Court was:

not inclined to hold that the statute establishes the absolute rule that an adult must be vaccinated if it be apparent or can be shown with reasonable certainty that he is not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death.”

Furthermore, the Court was inclined to defer to governing bodies such as state legislatures for vaccine mandates, not federal government nor state governors issuing orders under a state of emergency (thereby bypassing state legislatures).

DEATHS AFTER COVID VACCINATION

There have been several news reports of sudden cardiac death after CVOID-19 vaccination. In one such case of a teen dying after COVID-19 vaccination, CDC stated, “This case is currently under investigation and until the investigation is complete, it is premature to assign a specific cause of death.” However, no formal report has been released on their findings even six months later. Another teen college student became very ill a few days after second dose of COVID vaccination and died soon after. The official cause of death is still unknown; however, based upon news reports the course of events seems to be consistent with acute fulminant myocarditis. Certainly, a formal investigation ought to have been conducted. In another example, VAERS ID 1764974 describes 15 year-old who died six days after receiving Pfizer COVID-19 vaccination (autopsy apparently revealed myocarditis). Another 26 year-old male died four days after receiving booster dose of Pfizer COVID vaccination. According to family, autopsy demonstrated biopsy proven myocarditis. CDC apparently did not contact the family or the pathologist. “CDC is leaving it up to state health departments to investigate deaths following COVID vaccines” In another case, “New Zealand links 26-year-old man’s death to Pfizer COVID-19 vaccine.” Five people in Vietnam have died due to adverse reactions following COVID-19 vaccination, the most recent one from anaphylactic shock. As mentioned above, there have also been documented deaths from CVST and VITT. Finally, even the elderly may have been subjected to premature death after COVID-19 vaccination. One study concludes, “Most nursing home patients have a short remaining life expectancy, but vaccination may, in a few cases, have accelerated a process of dying that had already begun. Nursing home patients should still be given priority for vaccination, but the benefits versus risk must be carefully weighed up for the frailest patients.” CDC continues to insist these events are rare and that the “benefits are greater than the risks” without regard to immunity from prior infection or risk stratification by age and sex. In total, there are about 21,700 deaths reported in VAERS. Many may in fact be temporal association without causation, as CDC repeatedly contends. In a recent Congressional hearing, CDC Director Rochelle Walensky stated “Everyone one of those [deaths] is being adjudicated.” Adjudicated by whom? How? Thus far no formal reports have been published by CDC detailing their process of adjudication. CDC’s approach seems to rely upon comparing to “background rate in general population” and chart review, without any cardiologist or pathologist evaluation, let alone standardized autopsy methodology. However, when there is a temporal cluster of such reports within 14 days after vaccination, it ought to warrant a more thorough, methodical investigation, including autopsies and biopsies with specific evaluation of immune and spike protein mediated pathology.

SUMMARY

COVID-19 has caused tremendous disease burden (both morbidity and mortality) in the USA and worldwide. COVID-19 vaccinations have dramatically reduced hospitalizations and deaths in many high-risk populations. The COVID-19 vaccines are readily available with over 90% voluntary uptake in many high-risk groups. All high-risk individuals should be encouraged to be vaccinated: for them the benefits probably far outweigh the risks. But for younger people with normal BMI and no underlying medical conditions, the risks may actually exceed the benefits. These risks, while rare, are sometimes severely disable and even fatal. As Justice Alito said in the January 7th oral arguments before SCOTUS, the risks may be rare but are nevertheless very real. For those people, ‘they want to balance the risks presented to their health differently, and [government] says no.”

Currently, almost none of the mandated vaccination policies (government, educational, or private business) accommodate individualized risk stratification or immunity from prior infection. Therefore, such polices may be causing unnecessary preventable minority harm in certain low-risk groups, which was prohibited in the 1905 Jacobson v Massachusetts dicta. It is very telling that none other than Dr. Paul Offit himself recommended that his son not receive the booster:

“Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told me that getting boosted would not be worth the risk for the average healthy 17-year-old boy. Offit advised his own son, who is in his 20s, not to get a third dose”

--

--

Sanjay Verma, MD FACC
Sanjay Verma, MD FACC

Written by Sanjay Verma, MD FACC

Interventional Cardiologist (California), Medical Ethics, Philosopher