Unknown Risks of COVID Shot Harm Revealed in New Report

• by Barbara Loe Fisher

• Published May 13, 2024
• Opinion

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At the request of the Health Resources Services Administration (HRSA), an agency in the U.S. Department of Health and Human Services (DHHS), the National Academies of Science, Engineering and Medicine assembled a committee of physicians and scientists to conduct a review of the evidence that COVID-19 shots can cause serious harm to health. The evidence review was recently published in a National Academies “consensus” report, Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. The National Academies committee conducting the review found there was “sufficient evidence to draw 20 conclusions about whether these vaccines could cause specific harms,” but that there was not enough evidence “to establish, accept, or reject a causal relationship” for 65 adverse events reportedly associated with the COVID vaccines.¹

Even though the National Academies committee concluded that, for example, “evidence establishes a causal relationship” between both the Pfizer/BioNTech and Moderna mRNA COVID shots and

myocarditis (heart inflammation), the main finding was that there is not enough available scientific evidence to make a causal relationship conclusion for more than 75 percent of the serious health problems associated with a biological product that has been approved and recommended by federal health officials and given to millions of Americans since December 2020.² The finding is yet another example of the failure of DHHS to come to grips with the lack of scientific evidence underpinning (1) U.S. Food and Drug Administration (FDA) safety and efficacy data requirements for pre-Emergency Use Authorization (EUA) and pre-licensure safety and efficacy standards for biological products like mRNA COVID shots;^{3 4 5} which children between six months and 11 years old are still being given under an EUA;⁶ (2) U.S. Centers for Disease Control and Prevention (CDC) universal use COVID vaccine recommendations;⁷ and (3) U.S. executive branch mandates implemented in 2021 that required Americans to be injected with COVID shots as a condition of employment.^{8 9}

Although one may disagree with the quality and quantity of the scientific evidence the National Academies committee relied upon to make causal relationship conclusions for 20 adverse events linked with COVID shots, the committee was transparent about the fact that there are significant scientific knowledge gaps about the biological mechanisms and individual risk factors potentially involved when COVID shots are followed by injury and death. The admission that “we don’t know” whether or not 75 percent of the adverse events reported following COVID shots are, in fact, causally related, should give people engaged in rational thinking about vaccine “benefits and risks” a pause—especially since HRSA asked the National Academies to only evaluate a portion of the numerous serious health problems reported after people receive COVID shots.¹⁰

Not All Evidence for COVID Shot-Related Adverse Events Was Evaluated

The National Academies committee was tasked to review COVID-19 shot adverse event evidence by HRSA officials, who administer the Vaccine Injury Compensation Program (VICP) created by Congress in 1986 under the National Childhood Vaccine Injury Act.¹¹ HRSA also administers the Countermeasures Injury Compensation Program (CICP) that was created by Congress in 2005 under the Public Emergency and Preparedness Act, which was finalized in 2011 and currently provides the agency with guidelines for awarding or denying COVID-19 shot injury and death claims under the Countermeasures Injury Compensation Program (CICP).^{12 13}

The National Academies committee was asked by HRSA officials to review the following “list of possible harms” linked to COVID-19 vaccines, including the following specific adverse events: Guillian-Barre syndrome (GBS); chronic inflammatory demyelinating polyneuropathy; Bell’s palsy; transverse myelitis; chronic headache; postural orthostatic tachycardia syndrome (POTS); sensorineural hearing loss; tinnitus; thrombosis with thrombocytopenia syndrome; immune thrombocytopenic purpura (ITP); capillary leak syndrome; myocardial infarction (heart attack); ischemic stroke; hemorrhagic stroke; deep vein thrombosis, pulmonary embolism, and venous thromboembolism; pericarditis without myocarditis; sudden death; and female infertility. The committee rejected a causal relationship between Pfizer and Moderna’s mRNA COVID shots and GBS; Bell’s Palsy; thrombosis with thrombocytopenia syndrome; myocardial infarction and infertility and between the Pfizer mRNA vaccine and ischemic stroke.

However, HRSA did not ask the National Academies to review the following types of brain and immune system dysfunction associated with COVID-19 shots in the medical literature, many of which have been reported after receipt of other vaccines: encephalitis; encephalopathy; acute disseminated encephalomyelitis (ADEM); seizures (convulsions) and epilepsy; small fiber neuropathy; multiple sclerosis; autoimmunity; thyroid disease; inflammatory arthritis; blood pressure disorders; hair loss; depression and other mental health disorders and debilitating poor health conditions.^{14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31}

Inflammation of the brain (encephalitis) and brain dysfunction (encephalopathy) have long been two of the most acknowledged serious complications of many different vaccines, including smallpox, pertussis and measles vaccines.^{32 33 34 35 36} Yet, HRSA did not task the National Academies with evaluating reports of encephalitis and encephalopathy following receipt of COVID shots, even though HRSA is the federal health agency responsible for processing COVID-19 vaccine injury and death claims.

Denying Vaccine Risks in a Vacuum of Science: An Old Story

I remember in 1991 and 1994, when The National Academies Institute of Medicine (IOM) published reports on Adverse Effects of Pertussis and Rubella Vaccines and Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Those reports were the first in a series of IOM vaccine safety reports spanning more than 20 years that were conducted in response to a vaccine safety research provision in the National Childhood Vaccine Injury Act of 1986, which parent co-founders of NVIC were responsible for securing in the Act. DHHS was mandated to engage an independent entity to review the evidence that federally recommended childhood vaccines could cause injury and death. At the time, there were nine federally recommended vaccines (diphtheria, tetanus, pertussis, polio, measles, mumps rubella, haemphilus influenza B and hepatitis B). One of the most eye-opening conclusions of the 1991 IOM committee conducting a review over 30 years ago was:³⁷

In the course of its review, the committee found many gaps and limitations in knowledge bearing directly or indirectly on the safety of vaccines. Such shortcomings related, for example to pathogenic mechanisms of specific infectious agents, the molecular basis of vaccine injury, and the natural history of conditions, such as encephalopathy, mental retardation and chronic arthritis…Although the committee was not charged with, and has not attempted, full consideration of the kinds of studies that would be both ethical and especially informative, either in the areas of vaccines that it has been charged to study or more generally, it recognizes nevertheless, that opportunities may exist for informative experiments in human populations that take advantage of the possibility of using alternative schedules for administration of vaccines.

A 1994 IOM committee conducting a review stated in its report, “The lack of adequate data regarding many of the adverse events under study was of major concern to the committee. Presentations at public meetings indicated that many parents and physicians share this concern.” The 1994 report reiterated and expanded on the vaccine safety science gaps identified in the 1991 IOM report:³⁸

In the course of its review, the committee encountered many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunization, insufficient or inconsistent information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiologic studies, and limited capacity of existing surveillance systems of vaccine injury to provide persuasive evidence of causation. The committee found few experimental studies published in relation to the number of epidemiological studies published. Clearly, if research capacity and accomplishment in these areas are not improved, future reviews of vaccine safety will be similarly handicapped.

2012 National Academies Committees Again Confirms Big Vaccine Science Knowledge Gaps

In 2012, an IOM committee reviewing vaccine evidence of harm in the report Adverse Effects of Vaccines: Evidence and Causality once again confirmed that there is “incomplete knowledge of the biologic mechanisms of vaccine-induced injury” and that “limitations of the currently available peer-reviewed data meant that, more often not [sic], we did not have sufficient specific scientific information to conclude whether a particular vaccine causes a specific adverse event.”³⁹ For 158 reported harms related to eight federally recommended vaccines (diphtheria, tetanus, pertussis (DTap/Tdap); measles, mumps rubella (MMR); hepatitis B; hepatitis A; varicella zoster (chickenpox); pneumococcal; influenza; meningococcal), there were too few scientifically sound biological mechanism and epidemiological studies published in the medical literature for 134 of the adverse events (85 percent), which prevented the IOM committee from determining whether more than 100 serious brain and immune system problems, such as multiple sclerosis, arthritis, lupus, stroke, SIDS, autism and asthma are or are not caused by the vaccines.

2013 IOM Report Concludes Safety of Early Childhood Vaccine Schedule Has Not Been Scientifically Established

In 2013, another IOM committee was engaged by DHHS to look at whether the CDC recommended childhood vaccine schedule for newborns to age six has been proven to be safe. IOM published The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies report and concluded the safety of the early childhood vaccine schedule has not been adequately scientifically established.⁴⁰ There was admission that there was not enough scientific evidence to determine if the CDC’’s recommended early childhood vaccine schedule is or is not associated with the development of asthma; atopy; allergy; autoimmunity; autism; learning disorders; communication disorders; developmental disorders; intellectual disability; attention deficit disorder (ADD); disruptive behavior disorder; tics and Tourette’s syndrome; and seizures, febrile seizures and epilepsy.

The 2013 IOM committee report stated:

The committee’s review confirmed that research on immunization safety has mostly developed around studies examining potential associations between individual vaccines and single outcomes. Few studies have attempted more global assessments of entire sequence of immunizations or variations in the overall immunization schedule and categories of health outcomes, and none has squarely examined the issue of health outcomes and stakeholder concerns in quite the way that the committee was asked to do in its statement of task. None has compared entirely unimmunized populations with those fully immunized for the health outcomes of concern to stakeholders.

Queries of experts who addressed the committee in open session did not point toward a body of evidence that had been overlooked but, rather, pointed toward the fact that the research conducted to date has generally not been conceived with the overall immunization schedule in mind.

Today CDC officials direct doctors to give children 52 doses of 15 vaccines, including COVID shots, plus an RSV monoclonal antibody shot between the day of birth and age six and doctors can give as many as 10 to 14 vaccines on the same day at age 15 months.⁴¹ By 18 years old, children are supposed to have received more than 70 doses of 17 vaccines according to CDC officials.

“Not Enough Information” for Most Conclusions About COVID-19 Shots Given to Children

In a press release issued by the National Academies on highlights of the Consensus Study Report on the Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration, there was acknowledgement that there was simply “not enough information in the literature” available to the committee to make conclusions about potential harms to children receiving COVID shots:⁴²

 As in adults, children 12-17 years old, particularly boys, had increased risk of myocarditis with both BNT162b2 (Pfizer/BioNTech} and mRNA-1273 (Moderna) vaccines. Because the vaccine was available to be administered to young children much later than to adults, there was not enough information in the literature for conclusions to be made about other potential harms to children, especially children under 11.

If Not Now, When?

The outstanding questions about how and why vaccines can cause harm and who is at highest risk for suffering harm will only be answered when pharmaceutical corporations, government health agencies and the doctors they fund at major academic institutions do the methodologically sound epidemiological and bench science that will answer those questions. The fact that National Academies committees have been hampered for more than 40 years by a vacuum in quality scientific evidence with which to make credible conclusions about the safety of government recommended and mandated vaccines is a medical scandal of historic proportions.

Parents have waited for nearly half a century for public health officials and their industry and academic partners to do their jobs and find out just how many children are being harmed by vaccines. Because they refused to do it, today many adults are also being swept into the vaccine adverse reaction net.

If not now, when?

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