Covid-19 Vaccine Mandates Fail the Jacobson Test

T. Belman. Everyone should watch the Rogan interview with McCullough. I watched it and was blown away.

20 MILLION VIEWERS SO FAR.

What he had to say was definitive.

The Dark Horse interview is also well worth viewing, also.

By    NOVEMBER 30, 2021

Americans are a freedom-loving lot. It is our founding ethos and we have defended it across the world on numerous occasions. At the same time, we have a strong tradition of social altruism and dedication to the common good, especially in times of crisis.

Now that the Covid-19 pandemic has been with us for close to two years and vaccines for almost one, we have learned that the vaccines work to a degree and that they have both known serious risks and theorized potential risks.

Over the last few months, Americans have been increasingly facing demands that they be vaccinated or revaccinated—from governments, schools, employers, shopkeepers, even relatives.

These demands include legally enforceable “mandates” that coerce Americans to choose between compliance with vaccination demands and their livelihoods, attending school, travel, and partaking in manifold occasions of civic and religious celebration. Some Americans feel that these demands are appropriate, whereas others see them as classic examples of government overreach—as infringements of their constitutional and natural rights.

We are facing, in other words, questions about how best to integrate our perennial commitment to freedom with our equally long-standing concern for public health, in this time of crisis.

Anti-mandate contentions based on rights-claims pure and simple do not engage the most important issues presented by government vaccine mandates. Nor do they deal with the tension between freedom and civic responsibility. Based on the scientific knowledge and medical experience acquired over the last two years, it is time for a significant reconsideration of how best to integrate freedom with the genuine requirements of public health in service of the common good.

During the pandemic, the courts have rightly relied upon a century-old precedent of the Supreme Court in mandate cases, but they have gravely misunderstood and misapplied that precedent to uphold draconian and unjustified Covid-19 vaccine mandates.

Much that we have to say about these courts was presaged by three U.S. Supreme Court Justices on October 29, 2021. Arguing (unsuccessfully; they were in the minority) that the high Court should take up the case of a mandate challenge from Maine, Justices Gorsuch, Thomas, and Alito maintained that, although eleven months earlier the Court said that “stemming the spread of Covid-19” qualified as a “compelling interest,” “this interest cannot qualify as such forever.”

Why not? Precisely because (these Justices wrote) there are now three “widely distributed vaccines.” Eleven months earlier there were none. “At that time, the country had comparably few treatments for those suffering with the disease. Today we have additional treatments and more appear near.”

We would add especially that it has now become obvious that “eliminationist” strategies, in which the overriding public health goal is zero infections, are neither possible nor constructive. We must learn to live with Covid-19 as we have learned to live with other ineradicable, perennial airborne respiratory germs, such as those which cause the common cold and the flu.

Justices Gorsuch, Thomas and Alito wrote: “If human nature and history teach us anything, it is that civil liberties face grave risks when governments proclaim indefinite states of emergency.” They said: “At some great height, after all, almost any state action might be said to touch on ‘… public health and safety’…and measuring a highly particularized and individual interest“ in the exercise of a civil right “’directly against these rarified values inevitably makes the individual interest appear less significant’.”

It is time to bring our legal thinking about Covid-19 vaccine mandates down to earth.

At times of national emergency, government’s overriding goal must be to protect the population while removing the cause of the state of emergency. This means that certain laws, regulations, and policies may be temporarily suspended to accomplish these tasks. For example, if the army needs your car to transport soldiers to the front line, so be it. In particular, during the 1902 smallpox epidemic, the U.S. Supreme Court in Jacobson v. Massachusetts, 197 U.S. 11 (1905) ruled that the State of Massachusetts could compel residents to obtain free vaccination or revaccination against the infection, or suffer a penalty of $5 (about $150 today) for noncompliance.

In authoring the majority opinion in Jacobson, Justice John Marshall Harlan argued (1) that individual liberty does not allow people to act regardless of harm that could be caused to others; (2) that the vaccination mandate was not shown to be arbitrary or oppressive; (3) that vaccination was reasonably required for public safety; and (4) that the defendant’s view that the smallpox vaccine was not safe or effective constituted a tiny minority medical opinion.

By 1905, smallpox vaccination had been in common use for almost a century, and populations, legislatures and courts had been essentially unanimous in accepting it as appropriate and effective to prevent smallpox both in individuals and in outbreaks. In the Cleveland smallpox epidemic of 1902-4, there were 1,394 recorded cases and 252 deaths, a case fatality risk of 18%; thus a clear public safety rationale for preventing the infection.

The Court in Jacobson used a host of expressions to describe its four-part scrutiny of the Cambridge, Massachusetts vaccine mandate in that case. Among these expressions are: whether the requirement was “arbitrary and not justified by the necessity of the case”; whether the mandate went “far beyond what was reasonable required for the safety of public”; whether it was a ”reasonable regulation, as the safety of the general public may demand;” and whether it has a “real and substantial relation” to the public health.

The Jacobson Court never said that it used a “rational basis” test; indeed, that lowest-level of judicial scrutiny was not then a term of art that courts used. And that test surely does not describe in substance what the Court in 1905 did.

Courts during the Covid-19 pandemic have nonetheless regularly applied “rational basis” review to vaccine mandates, citing Jacobson as authority for doing so! To cite just one of several possible examples, Judge Frank Easterbrook, writing for the Seventh Circuit Court of Appeals in throwing out a lawsuit by Indiana University students against that institution’s vaccine mandate, said: “[g]iven Jacobson v. Massachusetts,… there can’t be a constitutional problem with vaccination against SARS-CoV-2.”

The main reason for that conclusion was his claim that the Jacobson court used the weakest standard of judicial analysis of government action. Easterbrook invoked the “rational-basis standard used in Jacobson. But the Jacobson Court carefully scrutinized the medico-scientific understanding of the smallpox epidemic and the vaccines then in use, much more so than has occurred in Covid-19 vaccine mandate litigation today.

The Supreme Court in Jacobson repeatedly invoked the “common good” of the polity as the principle of sound constitutional thinking about the public health emergency of the day. Just so—then and now. The Court did not, however, equate the “common good” with a reflexive preference for some collective interest over each person’s rights, or with automatic deference to the latest asserted findings of “the science.”

Likewise, it is imperative that courts today follow Jacobson and critically examine and weigh the asserted scientific bases for vaccine mandates. Over the last year, much of the public discourse about vaccines, their efficacy and their hazards of adverse reactions has revolved around statements made by the CDC, FDA and other governmental agencies and personnel. These agencies are tasked with studying, reporting on and approving drugs, medical devices, and vaccines in the context of various diseases and conditions, including population outbreaks in the US and elsewhere in the world.

During the Covid-19 pandemic, it has become evident that these agencies have not uniformly reflected objective verifiable science but have had repeated instances of numerous conflicts of interest in review panel members having explicit or hidden ties to pharma and vaccine companies. These problems and other apparently illogical or contradictory public statements made by these government agencies have eroded public trust in the agencies substantially.

In this context, for the government to assert that its constitutional obligations (as described in Jacobson, for example) are satisfied only “because a government agency says so” would be self-serving and wholly inadequate. Such reasoning would not satisfy the burden of proof; rather, the government would need to demonstrate the relevant, full, non-cherry-picked scientific evidence to make the case.

Now let’s consider the four criteria upon which Jacobson relied in deciding that the smallpox vaccine mandate in 1905 passed constitutional muster, and use them to evaluate today’s Covid-19 vaccine mandates.

(1) Individual liberty does not allow people to act regardless of harm that could be caused to others. Of course. But this criterion as stated is vague in the range of its possible implications. For example, people are naturally professionally and economically competitive. One person succeeds at another’s failure. Such harms can be serious, but this cannot possibly be a type of harm envisioned by Justice Harlan.

What seems apparent is that this criterion is addressing the compelling interest in limiting people from acting to spread the infection. In Constitutional law a “compelling interest” is a necessary or crucial action rather than a preferential one; for example, saving the lives of large numbers of people at risk.

In fact, the federal government has already set a de facto threshold for this level. Annually, approximately 500,000 Americans die from tobacco-related diseases. Yet, the federal government has never acted to curtail tobacco use in any meaningful way. This implies that 500,000 deaths per year is not large enough to trigger a compelling government interest.

At the beginning of the Covid-19 pandemic, which classes of people would be at high mortality risk from the infection was uncertain. After six months, it was well-established that there is a huge Covid-19 mortality difference between people over age 70 and people under age 30.

Thus, it seems that any truly “compelling” interest can only apply to high-risk individuals, who are definable and comprise a small minority of the general population. Furthermore, the lives of such individuals can often be protected by known existing and available pharmacologic and monoclonal antibody interventions (see criterion (3) below), which means that there may be a less-than-compelling interest for universal vaccination even among them.

Finally, the required government interest is required to be shown to support a vaccine mandate, not the free availability of vaccines. Since most individuals at high risk of bad Covid-19 outcomes presumably would rationally choose to obtain vaccinations, the additional numbers of saved lives attributable to the mandate, over and above the lives saved under general vaccine availability in the same population, is very likely not large enough to satisfy the large numbers needed to show that an indiscriminate mandate serves a “compelling” interest in public health.

Additionally, we know now, and both Drs. Anthony Fauci and Rochelle Walensky have stated publicly, that fully vaccinated individuals can become infected and transmit the virus to others. A number of such outbreaks have occurred in diverse locales. Thus, there is no apparent compelling interest in mandating vaccination for low-risk individuals specifically in an attempt to reduce infection transmission to high-risk people—just as there is no compelling interest in mandating vaccination to reduce infection transmission to low-risk people.

Just to be clear, government compelling interest inheres in prevention of serious outcomes such as hospitalization and mortality. But we assert that that there is no such compelling interest in Covid-19 case occurrence. The overwhelming majority of cases recover. Prevention of Covid-19 cases is at most a desirable policy goal and not a compelling interest.

As has become increasingly apparent, natural immunity following Covid-19 infection is stronger in repelling subsequent viral outbreaks than vaccine-based immunity. (Thus, prevention of Covid-19 case occurrence per se is actually counterproductive in ending the pandemic.) While the Supreme Court has opined that “[s]temming the spread of Covid-19 is unquestionably a compelling interest” in Roman Catholic Diocese v. Cuomo, that decision was rendered early in the pandemic, before the long-term weakness of vaccine-based immunity was understood. With what is known now, reasoning about compelling Interest for vaccine mandates no longer applies.

(2) The vaccination mandate is not shown to be arbitrary or oppressive. Covid-19 vaccine mandates imposed by the federal government and some state governments require vaccination by all adults except those requesting medical exemptions or religious exemptions. Criteria promulgated by the CDC for medical exemptions however are extremely limited, essentially involving only severe life-threatening allergic reactions as demonstrated from taking the first vaccination of the two-dose mRNA series. Religious exemption requests appear to have met variously capricious responses by vaccine mandate reviewers, and some states have prohibited religious exemptions altogether, in violation of (as Justices Gorsuch, Thomas, and Alito argued and as we would maintain) constitutional guarantees of religious liberty.

The one quite irrational consideration of all vaccination mandates to date is that the mandates ignore people who have had Covid-19 and thus have natural immunity. There are now more than 130 studies demonstrating the strength, durability and wide spectrum of natural immunity particularly versus vaccine immunity.

Whether people with natural immunity would have even stronger immunity if they also undergo vaccination is irrelevant, because their natural immunity is more than sufficient and long-lasting to satisfy the goal of vaccine mandates.

Some arguments have been put forward asserting that antibody levels may be higher in vaccinated people than people recovered from Covid-19, but antibody levels per se do not translate into degree of immunity. Antibody levels in vaccinated people decline appreciably starting at four months post-vaccination, whereas antibody levels in Covid-19 recovered stay roughly constant during those months. Other assertions have been that asymptomatic or mild Covid-19 infections may not produce strong natural immunity; however, these claims have been shown to be scientifically unfounded. Empirical population studies on reinfection/breakthrough infection demonstrate that natural immunity is as strong or stronger than vaccine immunity.

Finally, natural immunity can be documented by having ever had a positive Covid-19 PCR, antibody or T cell test, regardless of current status of those tests.

Similarly, Covid-19 vaccine mandates for children are unwarranted because children almost entirely get infected from their parents or other adults in the household, and infrequently transmit the infection to their classmates, teachers or uninfected household adults.

Normal healthy children do not die from Covid-19, and the 33 children aged 5-11 years estimated by the CDC to have died from Covid-19 between October 3, 2020 and October 2, 2021 all had chronic conditions like diabetes, obesity, being immunocompromised (e.g., after cancer treatment) that put them at high risk, and even these numbers are much lower than childhood deaths from traffic and pedestrian accidents, or even being hit by lightning. Covid-19 in children is almost entirely an asymptomatic or mild disease typified by fever and tiredness and resolves on its own in 2-3 days of rest. Thus, vaccine mandates for children are unwarranted.

In sum, a policy requiring vaccination of people who are either already immune or of no consequence either for their own health or for spreading the infection is arbitrary. It is oppressive in inflicting a medical procedure on people who do not need it for themselves or for others. Such a policy would even fail the “rational basis” test which so many courts have applied perfunctorily.

(3) Vaccination is reasonably required for public safety. Vaccination in theory prevents personal infection and disease, as well as transmission of infection to others. The government’s interest is almost entirely in the latter. We now know that the Covid-19 vaccines in the real world don’t prevent transmission all that well.

Further, public safety is enhanced by use of medications for early outpatient treatment that safely allow increase in population natural immunity. An extensive body of studies has accumulated over the last 18 months showing that various approved but off-label medications dramatically reduce risks of Covid-19 hospitalization and mortality when started in ambulatory patients within the first five days or so of symptom onset.

Meta-analyses of hospitalization and mortality risks calculated by the first author are shown in the figures on the next page for two drugs, hydroxychloroquine and ivermectin. Additional thorough discussion of standards of evidence of randomized and nonrandomized drug trials, as well as on a number of small trials that failed in the adequacy of their study designs and executions, is posted here. These analyses show that numerous drugs and monoclonal antibodies are available to treat ambulatory patients with Covid-19 successfully, making vaccination a choice for dealing with the pandemic, but not a necessity.

As stated earlier, sole reliance on FDA or CDC opinions on these medications, without demonstration of full, objective, and unbiased data underlying those opinions, would be inadequate for standards of proof. The evidence however is overwhelming that treatment recipes used by doctors actually treating Covid-19 outpatients work very well and thus provide alternatives to vaccination for preventing hospitalization and mortality.

(4) The vaccine has a long popular, medical, and legal history of being regarded as safe and effective. This criterion decisively distinguishes Jacobson and the smallpox vaccine mandate from what is happening today. Jacobson did not accept dissenting testimony about vaccine safety or efficacy because the vaccine at that time had been a staple in society for almost 100 years.

The genetic Covid-19 vaccines have no such information, have every indication that they are orders of magnitude more harmful, and even the FDA still classifies all three in use in the US as experimental, which means that their EUA designations have only required showing that they may convey some benefit and need not be harm-free, i.e., have not been established as safe and effective, let alone known as such for decades or longer.

Jacobson established criteria of Safety and Efficacy that must be shown beyond all doubt, that embody the provably safe and effective use of the vaccine for decades. The Covid-19 vaccines come nowhere near close to that standard.

The mandatory smallpox vaccine of 1902-4 had been in use for nearly a century and a gigantic amount of information was available and known about its short- and long-term safety and efficacy, and it was widely accepted across all segments of society based on that body of information.

In contrast, the Covid-19 genetic vaccines included in the proposed federal mandate have essentially zero long-term history and the slimmest of information about safety and efficacy.

According to the VAERS database, to date some 19,000 deaths have been associated with the Covid-19 vaccines, of which more than one-third occurred within three days of vaccination. In this one year of Covid-19 vaccination, this number is more than double the number of deaths from all other vaccines over more than 30 years combined in the VAERS data. It is also more than 150 times the mortality risk of smallpox vaccination, 0.8 per million vaccines (Aragón et al., 2003).

The VAERS database also identifies more than 200,000 serious or life-threatening non-death events to date, and this number is almost certainly at least 10-fold undercounted because of the work, difficulty, impediments and lack of general knowledge involved in filing adverse event reports in the VAERS system. Many of these adverse events portend lifelong serious disabilities. But two million serious or life-threatening events is well more than the damage that would have been caused by even untreated Covid-19 occurrence in the same 200 million vaccinated Americans, especially given that two-thirds of them have strong natural immunity from having had asymptomatic or symptomatic Covid-19.

These numbers indicate that these severe events caused by the vaccines very likely outnumber serious Covid-19 outcomes that would have occurred in the same individuals had they not been vaccinated. As well, those numbers would be dramatically lower with general availability of the suppressed but effective treatment medications for early ambulatory patient use.

With regard to efficacy, the three US Covid-19 vaccines showed great promise in their original randomized trials results. However, as these vaccines have been rolled out in hundreds of millions of doses to the general public in the “real world,” their performance has differed from what was originally described.

Over time, vaccine efficacies in reducing risks of Covid-19 infection and mortality have declined appreciably, over 4-6 months for infection and 6-8 months for mortality. Many jurisdictions have begun to consider requirements for periodic booster doses, which is a frank admission that the touted original vaccination programs have not been sufficiently effective.

At a population level, large-scale vaccination rollout has reduced waves of infection. Over time though, as the vaccines have lost effectiveness, the waves have begun to recur. This has been seen dramatically in the U.K. and Netherlands over the last five months. In an analysis of Covid-19 case data from 68 countries and 2,947 U.S. counties, it was observed that the magnitude of case occurrence is unrelated to the level of population vaccination (Subramanian and Kumar, 2021).

Thus, if vaccination were to be the only method of combating the pandemic, it appears that vaccinations repeated indefinitely at 6-month intervals would be required, and even that may not be all that successful in reducing spread substantially. There are no vaccination programs for other general diseases in the US that require such a high frequency of compliance. Even influenza, which has a substantial annual mortality, has an annual revaccination frequency, is only perhaps 50% effective over the flu season, is not mandated.

The Jacobson case set a model of how the U.S. government and its subdivisions would be empowered to protect the public while at the same time minimizing limitations of activities and infringements of rights. Further, it relied solely on a moderate economic penalty for noncompliance. The smallpox pandemic in 1902-4 had an estimated case fatality risk of 18%, whereas the case fatality risk of Covid-19 is less than 1%. This massive difference should have given hesitancy to the draconian purported control measures that have been instituted across the country.

A careful reading of Jacobson shows that it is not just an automatic consideration allowing the government to do what it wants when a pandemic emergency has been officially declared. In a pandemic, courts look to Jacobson for precedent as an apparent direct fit, but even so must evaluate the evidence for satisfying all of the Jacobson criteria. As we have shown, Covid-19 vaccine mandates do not satisfy any of the required criteria in Jacobson, let alone all of them.

The question to be addressed then is why a pandemic infection with approximately 1/20th the natural mortality risk of the previous smallpox pandemic would be subject to the grievous penalties of loss of employment, loss of medical care, loss of necessary activities of daily life, and mandate of vaccines that unlike in the previous pandemic have no long-term safety data. Given that none of the Jacobson criteria have been met, the infringements and demands of the government and its public health agencies have not been justified according to law. This is the argument that must be made as to why the proposed vaccine mandate is an unwarranted overreach inconsistent with established public health policy and law.

  • Harvey Risch is Professor of Epidemiology in the Department of Epidemiology and Public Health at the Yale School of Public Health and Yale School of Medicine. Dr. Risch received his MD degree from the University of California San Diego and PhD from the University of Chicago. After serving as a postdoctoral fellow in epidemiology at the University of Washington, Dr. Risch was a faculty member in epidemiology and biostatistics at the University of Toronto before coming to Yale.

  • Gerard V. Bradley is professor of law at the University of Notre Dame, where he teaches Legal Ethics and Constitutional Law. At Notre Dame he directs (with John Finnis) the Natural Law Institute and co-edits The American Journal of Jurisprudence, an international forum for legal philosophy. Bradley has been a visiting fellow at the Hoover Institution of Stanford University, and a senior fellow of the Witherspoon Institute, in Princeton, N.J. He served for many years as president of the Fellowship of Catholic Scholars.
December 16, 2021 | 9 Comments »

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  1. This has the potential of an enormous shift in momentum:

    In rebuke to Pentagon, Navy board finds 3-0 for vax objector amid questions of mandate’s lawfulness

    In a stinging rebuke to the Pentagon, a Navy administrative separation board voted unanimously to retain an officer who refused to comply with the military’s COVID-19 vaccine mandate.

    Navy Lt. Billy Moseley, who has been an officer for 22 years, could have chosen to retire from the military when he was ordered to receive the COVID vaccine. He also could have submitted a Religious Accommodation Request, since he objected to the vaccine for religious reasons.

    Risking his retirement, Moseley chose instead to take his case to the administrative separation board after learning “that the Navy and the other services intended to implement a blanket denial policy,” according to a press release from his attorney, R. Davis Younts.

    Moseley consulted with legal and medical experts and “became convinced that as an officer he had an obligation to take a stand against the unlawful order and be a voice for thousands of enlisted Sailors,” the press release continued.

    Younts told Just the News Moseley is one of the first Navy service members — maybe even the first officer — to go to the board over the COVID vaccine mandate.

    Any service member who has been in the military for more than six years is entitled to the board for due process. In the Navy, the board’s recommendation on whether to retain or separate (another term for firing) a member of the service is binding.

    Younts argued at the board hearing that the mandate for the experimental COVID vaccines was not a lawful order since the military has not made fully FDA-approved versions of the vaccines available to military members.

    The military defense attorney told Just the News that the attorneys for the Navy agreed with him that there are no FDA-approved vaccines available, only interchangeable vaccines. Younts added that if there are no FDA-approved vaccines available, then the president would have to authorize the experimental shots that are currently available, which hasn’t happened.

    On Friday, the board voted 3-0 that Moseley’s failure to follow the COVID vaccine order did not count as misconduct and that he should remain in the Navy. Younts said that the board members weren’t convinced that the vaccine order was lawful.

    He added that this precedent “puts the Navy in an interesting position” regarding the other service members who have also refused the COVID vaccine.

    While this is “only one case of thousands and we have many more clients facing prosecution by the military, we are encouraged that the truth was revealed in this Board, and we hope this ground-breaking case sends a strong message to the Department of Defense,” Younts’ press release concluded.

    No unlawful order should ever be followed. Not by anyone, not by the military, not by the police, and not by the public. Legitimizing illegality to the point that such behavior is mandatory is the ultimate example of tyranny. Oppose it, always oppose it, as if your life depends upon it, because sooner or later, it may well be the case.

  2. @Adam

    But this is an outright lie.

    The biggest lies are often the most successful, and the reality of these facts was never really in question as VAERS told a tale of unimaginable concern and it represents only some fraction of the truth in the US alone. Among these innumerable lines of data and the daunting lists of variable harms including the major categories of immunolgical, cardiovascular and neurological symptoms, lies the following paragraph which strongly speaks as a summary of this terrible tragedy:

    Within Pfizer’s self-generated document, a serious red flag surfaces: 1228 people were recorded to have died within three months after taking the vaccine, while no record accounts for the gender of the study participants who died. This data, which has significant safety implications, was known to Pfizer by end of February, yet on April 12, Dr Mace Rothenberg former Pfizer Chief Medical Officer, when talking to the Washington Journal about the development of the Pfizer vaccine said “I can tell you that no corners were cut” and “there have been no deaths that have occurred directly as a result of the vaccine alone.”

    As Dr. Malone has spoken of many times, “Pfizer is a known criminal enterprise, why does anyone believe them?” or something to this effect. If this was ever in doubt by any, which of course it was, this should no longer be the case, which, unfortunately, it is. The reality is that as a third and fourth round of these highly toxic compounds, both the mRNA/lipidnanoparticle and Spike protein, are being applied to tens of thousands of people on a daily basis around the world. We would of course expect these revelations to give pause to those who are so enchanted by this talisman of safety, but in doing so we would also be incorrect.

    In addition to the multitudes of people eagerly standing for their chance in this lottery of death/injury, we should take a moment to consider how this information is affecting both the company responsible for producing this product as well as the agencies afforded the responsibility for certifying it as safe, while both have been fully cognizant of the contents of 100% of documents to which we know have access to only 1% or less. Well, in spite of these recently revealed facts being unveiled to the public and the shocking realities of the multitudes of lies used by the company and their captured overseers to hide these details from the public, Pfizer has been authorized to proceed with the use of a booster, 3rd shot, to children ages 16 and 17 years of age. This may be surprising, or the surprises may, by now, appear to be taking on a jaded effect, but the full reality will serve to recharge this aspect of the situation. In spite of what is known of the vaccines, the deaths, neurological, immunological and cardiovascular injuries, Pfizer’s request for EUA has no research to base their request upon and the US agencies have had no requirement for them to do so, and yet the authorization has been granted. Let me repeat this. The Booster for children is being granted with no data to support their use or predict their harms, none. Not one case.

    It should be recalled that myocarditis has now struck 19,039 children according to the under-reported Red Box VAERS report, over 4,200 in the US alone. The yearly total for this should be in the range of between 400 and 600 per year in the US. This is only the damage caused by myocarditis, and it has recently been established that the neurological injuries are, by far, the greater concern among children being injected with this vaccine-treatment. How dare they do this? How dare we allow them to do this. Do not comply.

  3. This is the report of a British journalist named Sonia Elijah analyzing the documents recently released under a Freedom of Information request of documentation of “adverse events” from Pfizer’s vaccine that it reluctantly provided to the FDA as a requirement for receiving authorization for the “general use” of the vaccine. Pfizer relunctantly provided some of its testing data to the FDA. Now the FDA has with even greater reluctance released about 1 percent of the documents provided to them by Pfizer. Even this tiny percentage of documents has been sufficent to show that there were numerous “adverse events” occurring to Pfizer test subjects during this two-month trial period–including some deaths. Both Pfizer and the FDA have claimed there have been no adverse reactions attributable to the Pfizer vaccine in their publications and press releases. But this is an outright lie.

    FDA’s forced hand drops Pfizer’s Bombshell Safety Document
    By Sonia Elijah

    The highly confidential Pfizer documents, which have been synonymous with the extreme lack of transparency revealed by the actions of pivotal governmental agencies, over the past 20 months, lead critics of the official narrative to demand “show us the data,” is finally being revealed–well sort of, the first few hundred redacted pages out of a trove of 451,000.

    What led to the disclosure?

    The crack in Pfizer and the Food and Drug Administration (FDA) iron dome-style data safeguarding, arrived in the form of a Freedom of Information Act (FOIA) release with the request filed on August 27, 2021, to access all the Pfizer documentation that the FDA had relied on to authorize the Pfizer-BioNTech Covid-19 vaccine for emergency use authorization. An agency that has received a FOIA request is required to ‘determine within 20 business days after the receipt of any such request whether to comply with such request,’ as set out by the 1967 FOIA law. It took the FDA though three months to release the first 91 redacted pages, on November 20.

    The FOIA request was issued by a group of over 30 scientists and academics who filed a civil action lawsuit against the agency because they failed to fully comply with the request, since less than 1% of the documentation was released and with the FDA taking the position that all the data would be shared by 2076. Subsequently, the governmental agency had the audacity to push the date back even further to 2096. This was due to their recent disclosure of the existence of thousands of additional pages, totaling 451,000 versus the originally stated 320,000 pages. However, the rate at which the FDA is willing to release the documentation has not changed and remains at 500 pages a month. It’s worth noting that it took the FDA only 108 days to review all of Pfizer’s documentation before authorizing the Pfizer BNT162B2 vaccine for emergency authorization use on December 1, 2020.

    The scientists, public health officials and academics, led by Dr Peter McCullough, formed the plaintiff group, PHMPT (Public Health and Medical Professionals for Transparency) and are being represented by the law firm of Aaron Siri, of Siri & Glimstad LLP.

    In an exclusive interview with Trial Site News, Aaron Siri, managing partner of the firm, who has extensive civil litigation experience, stated:

    “The court has not ordered a single page to be produced yet. For the most part, when our firm submits a FOIA request, they [the agency] will produce documents but the FDA wants to do it at a pace that’s incredibly slow, not commensurate with the needs of the request. The fight is not whether they’ll produce it-they’ll produce it. The fight is how long it will take and then the fight once we get it will be the redactions they put in.

    When I asked him whether FOIA requests will be made to obtain Moderna and Janssen’s (a subsidiary of Johnson and Johnson) documentation supplied to the FDA to secure emergency use authorisation, he responded:

    “You can’t make a request until a vaccine has been licensed. Authorization for emergency use is not the same as licensure or approval. The Pfizer vaccine is the only vaccine that’s been licensed/approved as “safe and effective” according to the FDA on August 23rd2021.”

    Details about the case and the relevant court documents can be found on Aaron Siri’s blog, Injecting Freedom.

    The first several hundred pages of the newly released Pfizer documents were shared on the PHMPT’s website.

    The focus of this investigative report centers on the 38-page document, entitled, “Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) received through 28 February 2021.” The report was prepared by Pfizer, between the time of December 1, 2020, through February 28, 2021. The adverse events reports originate in the United States, United Kingdom, Italy, Germany, France, Portugal, Spain and ‘56 other countries.

    It’s interesting to note that the artifact represents an amended analysis provided by Pfizer, a response to their failings associated with the incomplete submittal of a safety data package to the FDA, which the agency commented on. A reference is made to the FDA’s March 9th request to Pfizer ‘We are most interested in a cumulative analysis of post-authorization safety data to support your future BLA submission. Please submit an integrated analysis of your cumulative post-authorization safety data, including U.S. and foreign post-authorization experience, in your upcoming BLA submission. Please include a cumulative analysis of the Important Identified Risks, Important Potential Risks, and areas of Important Missing Information identified in your Pharmacovigilance Plan, as well as adverse events of special interest and vaccine administration errors (whether or not associated with an adverse event). Please also include distribution data and an analysis of the most common adverse events. In addition, please submit your updated Pharmacovigilance Plan with your BLA submission.’

    The many unknowns

    In the short three-month period in which the data was ‘reported spontaneously to Pfizer,’ 42,086 cases were recorded with 158,893 events. According to the data, one can interpret that the average person (case) would have suffered from just under four symptoms (events). Particularly troubling, the FDA opted to protect Pfizer’s interests by redacting the total number of doses to (b) (4), hindering the ability to calculate the incidence rates and provide a meaningful analysis of the data. Another deeply concerning fact centres on important limitations cited by Pfizer: ‘the magnitude of underreporting is unknown.’ In relation to this topic, investigators leading a prominent Harvard study conducted from 2007-2010, discovered that ‘less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the FDA.’ Assuming this math is correct, we can conclude that the 42,086 cases represent a staggeringly underreported amount.

    Other significant ‘unknowns’ peppered throughout Pfizer’s analysis are:

    2990 cases where the gender is unknown
    6876 cases where the age is unknown
    9440 cases where the outcomes are unknown
    Another anomaly that stands out is that for case outcomes, Pfizer has chosen to include those recovering from adverse events in the same category with those recovered, under the label, ‘Recovered/Recovering’. This move alone seems questionable.

    The large numbers of spontaneous adverse event reports

    Alarmingly, the analysis makes note of the fact that there has been such a large volume of adverse events, classified as ‘serious cases’ in that short period of time, that Pfizer has had to take on more full-time employees and make significant technology changes to cope with the processing of the voluminous reports while also meeting regulatory reporting timelines. As recorded in the document:

    ‘Due to the large numbers of spontaneous adverse event reports received for the product, the MAH has prioritized the processing of serious cases, to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity.’ The report went on to state how Pfizer has dealt with these large numbers of adverse event reports. ‘Pfizer has also taken multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded additional b4 full-time employees (FTEs)..’

    (*b4 is a redacted term)

    The 1228 Deaths

    Within Pfizer’s self-generated document, a serious red flag surfaces: 1228 people were recorded to have died within three months after taking the vaccine, while no record accounts for the gender of the study participants who died. This data, which has significant safety implications, was known to Pfizer by end of February, yet on April 12, Dr Mace Rothenberg former Pfizer Chief Medical Officer, when talking to the Washington Journal about the development of the Pfizer vaccine said “I can tell you that no corners were cut” and “there have been no deaths that have occurred directly as a result of the vaccine alone.” Those defending the safety of the Pfizer vaccine have raised the argument that ‘correlation does not imply causation, in which two events occurring together does not establish a cause-and-effect relationship.

    Page 10 of the Pfizer analysis presents an important identified risk of anaphylaxis with nine reported fatalities. Four out of the nine occurred on the same day the individuals were vaccinated (see below).

    Pfizer emphasized that these individuals had underlying medical conditions but for all four of them to die on the same day that they were received the vaccine, suggests potential vaccinal death causality.

    In Table 7 of pages 16-17, 1403 cases of Cardiovascular AESIs (Adverse Event of Specific Interest) were reported and segmented by the following: Arrhythmia; Cardiac Failure; Cardiac failure acute; Cardiogenic shock; Coronary artery disease; Myocardial infarction; Postural orthostatic tachycardia syndrome; Stress cardiomyopathy; Tachycardia.

    The relevant event onset latency ranged from less than 24 hours to 21 days. This means that relevant events occurred from any time less than 24 hours up to 21 days of receiving the vaccine, with a median of less than 24 hours. 136 relevant event outcomes were fatal. Therefore, 50% of these relevant outcomes (including deaths) occurred less than 24 hours of receiving the vaccine. This points again to vaccine death causality.

    Yet, Pfizer somehow concludes: ‘This cumulative case review does not raise any new safety issues. Surveillance will continue.’

    When looking at the category ‘Immune-mediated/Autoimmune AESIs’, 1050 cases were reported, with just over three times more females affected than males- there were 12 fatal outcomes. The median of the relevant event onset latency was less than 24 hours, which again suggests vaccine death causality.

    The seriousness of the cases

    Looking at the graph below, a significant portion of cases are reported as serious compared to non-serious with the highest number of serious cases in the ‘general disorders’ category. A serious case is one that is medically significant resulting in either hospitalization or that has a life-threatening consequence or death. It’s interesting to note that for cardiac, immune, vascular, and infections, serious cases dominate and for immune cases, all are classified as serious.

    Women were x3 times more affected by adverse events from the vaccine.

    Across the board, in every category of AESI (adverse events of special interest), women were generally three times more adversely affected than men. However, nowhere was this as pronounced as in the case of anaphylaxis (a potentially life-threatening allergic reaction), where women were over eight times more affected. Out of the 1002 anaphylaxis cases reported meeting the Brighton Collaboration level of 1-4 (level 1 being the highest level of diagnostic certainty of anaphylaxis) 876 females were affected compared to 106 males. Women were also significantly more affected by cardiovascular events; 1076 females were reported as cases compared to 291 males. The statistically significant data reveals the real possibility of gender-specific vaccine safety risks.

    Yet nowhere in Pfizer’s analysis does the company comment on this data, but instead confidently reasserts, ‘the cumulative case review does not raise any new safety issues.’

    The missing information

    Also noteworthy, the data associated with the ‘Use in pregnancy and lactation’ were somehow excluded in the original analysis submitted to the FDA. In the amended version, 413 adverse cases are reported with 84 classified as serious.

    Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion (23), outcome pending (5), premature birth with neonatal death, spontaneous abortion with intrauterine death (2 each), spontaneous abortion with neonatal death, and normal outcome (1 each).

    It’s alarming that Pfizer makes the assertion that ‘there were no safety signals that emerged from the review of these cases of use in pregnancy and while breastfeeding.’ The data contained in the heavily redacted document appears to contradict this upbeat assessment.

    In pediatric individuals < 12 years of age, which was originally missing from Pfizer’s analysis, 34 cases were reported with 24 categorized as serious. The fact young children were administered the Pfizer vaccine raises concern since emergency use authorization was not awarded to the company to administer to the pediatric population at that time. Moreover, the age range raised considerable alarm given its ‘from 2 months to 9 years.’ The report lacks data on how many children in total were administered the vaccine, hence, there is no way of calculating incidence rates to extrapolate a meaningful analysis.

    A sample list of the known AESIs in Pfizer’s cumulative analysis.

    Blood and lymphatic system disorders: Lymphadenopathy

    Cardiovascular events: acute myocardial infarction; Arrhythmia; Cardiac failure; Cardiac failure acute; Cardiogenic shock; Coronary artery disease; Myocardial infarction; Postural orthostatic tachycardia syndrome; Stress cardiomyopathy; Tachycardia

    Gastrointestinal disorders

    General disorders and administration site conditions

    Infection and infestations

    Musculoskeletal and connective tissue disorders: Arthralgia; Arthritis; Arthritis bacterial; Chronic fatigue syndrome; Polyarthritis; Polyneuropathy; Post viral fatigue syndrome; Rheumatoid arthritis

    Nervous system disorders

    Respiratory, thoracic, and mediastinal disorders: Lower respiratory tract infections; respiratory failures, Viral lower respiratory tract infections; acute respiratory distress syndrome; Endotracheal intubation; Hypoxia; Pulmonary hemorrhage; Respiratory disorder; Severe acute respiratory syndrome

    Skin and subcutaneous tissue disorders

    Anaphylaxis

    Vaccine-Associated enhanced Disease (VAED) including Vaccine-associated enhanced respiratory disease (VAERD).

    COVID-19

    Facial paralysis

    Immune-Mediated/Autoimmune disorders

    Neurological (including demyelination): Convulsions; Ataxia; Cataplexy; Encephalopathy; Fibromyalgia; Intracranial pressure increased; Meningitis; Meningitis aseptic; Narcolepsy

    Pregnancy-Related: Amniotic cavity infection; Caesarean section; Congenital anomaly; Death neonatal; Eclampsia; Foetal distress syndrome; Low birth weight baby; Maternal exposure during pregnancy; Placenta praevia; Pre-eclampsia; Premature labor; Stillbirth; Uterine rupture; Vasa praevia

    Renal: Acute kidney injury, renal failure

    Thromboembolic events: Embolism and thrombosis; Stroke AESIs, Deep vein thrombosis; Disseminated intravascular coagulation; Embolism; Embolism venous; Pulmonary embolism

    It’s worth comparing the list above with the list below accessed via the FDA’s website under the document ‘Pfizer-BioNTech fact sheet for recipients and caregivers’, revised as of Dec 9, 2021. It’s evident to see that many of the serious and life-threatening side effects have not been included, even though Pfizer’s cumulative analysis of post-authorization adverse event reports was produced for the FDA on April 30, 2021.

    Conclusion

    While this author strives to remain as objective and unbiased as humanly possible, a thorough review of this one report suggests that the FDA and Pfizer have appeared to conceal the full extent of the Pfizer-BioNTech vaccine side effects from the public. If this assumption is in fact true, then the ‘Gold Standard’ regulatory agency and the prestigious multinational pharmaceutical company have thrown the entire concept of informed consent out the window.

    It’s also a travesty that months later, the FDA dragged its feet and released this important safety document based on adverse event case reports under FOIA law. Case reports play an important role in pharmacovigilance. The recognition of the link between thalidomide given to mothers and malformations in their babies was triggered by a case report.

    Perhaps even more devastating—and a mockery of the whole point of advanced regulatory systems meant to ensure public safety–would be if the FDA wins the ongoing dispute to delay information release, then the public must wait another 75 years to access all the data, which by then will be far too late.

  4. What about the fact that long established medications such as hydroxychloroquin and ivermectin have proven effective when taken early on and have been banned by those making billions in profit from the shots being forced upon the populations, under the guise of “emergency” use???

  5. my two cents
    must must must view Rogan interview with McCullough linked in this article.
    also if co commentator Peloni posts links in his comments ….review those as well.

  6. This is a “must see” video about Anthony Fauci, and the disaster he has wreaked on American health sinc he began heading the NIAID in 1984:

    https://rumble.com/vqu2pe-robert-f.-kennedy-jr-discusses-covid-and-the-vaccination-of-children.html

    The statistics are incredible: The generation raised before Fauci began pushing unregulated vaccinations has an autism rate of about 1 in 1000. In the “vax generation”, it has become 1 in 34. Also, the severe reactions to the COVID 1984 jab are 100 times as many as the 30,000 or so reported in VAERS. That means something on the order of 3 million Americans have had severe reactions to the shots. All this is being covered up by Fauci, the NIH, the media and, incrediby, VAERS itself — which claims that their own data are too unrealiable to believe!

    Fauci is probably the most dangerous man in the world.

  7. Dr. McCullough sent Dr. James Lyons-Weiler a copy of his slide-deck from the Joe Rogan show and he attached a source link for each of the slides. The slides and the associated sourcing is in the link here:
    https://popularrationalism.substack.com/p/dr-peter-mccullough-on-the-joe-rogan
    The interview between McCullough and Rogan is really very much worth watching. As McCullough noted about half way thru the interview, “its like Grand Rounds”. Very potent explanations and expanded discussions on many topics.