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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Click here to view References: 1 National Academies Committee to Review Relevant Literature Regarding Adverse Events Associated with Vaccines. Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intra bvcxzmuscular Vaccine Administration, National Academies Press 2024.2 National Academies of Sciences, Engineering and Medicine. New Comprehensive Review Examines Potential Harms of COVID-19 Vaccination and Intramuscular Vaccination. Press Release Apr. 16, 2024.
3 FDA. Emergency Use Authorization for Vaccines Explained. Nov. 20, 2020.
4 FDA. Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry. Revised October 2023.
5 Taneer S, Rowhani-Farid A, Hong K et al. Transparency of COVID-19 vaccine trials: decisions without data. BMJ Evidence-Based Medicine Aug. 8, 2021.
6 FDA. Fact Sheet for Recipients and Caregivers About Pfizer-BioNTech COVID-19 Vaccine (2023-2-24 Formula) which has Emergency Use Authorization (EUA) to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 6 Months through 11 Years of Age. Sept. 11, 2023.
7 CDC. Updated (2023-2024 Formula) COVID-19 Vaccine: Interim 2023-2024 COVID-19 Immunization Schedule for Persons 6 Months of Age and Older.
8 Tricare Newsroom. Secretary of Defense Mandates COVID-19 Vaccinations for Service Members. Aug. 25, 2021.
9 The White House. Fact Sheet: Biden Administration Announces Detail of Two Major Vaccination Policies. Nov. 4, 2021.
10 MedAlerts. Search Vaccine Type (Diseases): COVID19/COVID19-2. Number of COVID Shot adverse events reported to VAERS as of Apr. 26, 2024 is 1,637.441.
11 Health Resources Services Administration (HRSA). National Vaccine Injury Compensation Program (VICP). And Vaccine Injury Compensation Program Data & Statistics. May 1, 2024.
12 DHHS. Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Final Rule. Federal Register Oct. 7, 2011.
13 Meissner C. A Viral Pandemic, Vaccine Safety, and Compensation for Adverse Events. JAMA Network Feb. 5, 2021.
14 Fragkou PC, Dimopoulou D. Serious complications of COVID-19 vaccines: A mini-review. Metabolism Open 2021; 12: 100145.
15 Couzin-Frankel J, Vogel G. In rare cases, coronavirus vaccines may cause Long Covid-like symptoms. Science Jan. 20, 2022.
16 Gao JJ, Tseng HP, Lin CL et al. Acute encephalitis after COVID-19 vaccination: A case report and literature review. Hum Vaccin Immunother 2022; 18(5).
17 Fan Ht, Lin YY, Chiang WF et al. COVID-19 vaccine-induced encephalitis and status epilepticus. QJM: An International Journal of Medicine 2022; 115(2): 91-93.
18 Huq MR, Kawnayn G, Kabir H et al. Acute Vaccine-Related Encephalopathy and Acute Disseminated Encephalomyelitis (ADEM) After COVID-19 Vaccination: A Case Series from Bangladesh. Cureus 2023; 15(5).
19 Mastropaolo M, Hasbani MJ. Small Fiber Neuropathy Triggered by COVID-19 Vaccination: Association with FGFR3 Autoantibodies and Improvement during Intravenous Immunoglobulin Treatment. Case Rep Neurol 2023; 15(1): 6-10.
20 Khat-Khoel M, Bhattacharyya S, Katz J et al. COVID-19 mRNA vaccination leading to CNS inflammation: A case series. J Neurol 2022; 269(3): 1093-1106.
21 Mahroum N, Lavine N, Ohayon A et al. COVID-19 Vaccination and the Rate of Immune and Autoimmune Adverse Events Following Immunization: Insights From a Narrative Literature Review. Front Immunol 2022; 13.
22 Finsterer J. Neurological side effects of SARS-CoV-2 vaccinations. Acta Neurol Scand 2022; 145(1): 509.
23 Chatterjee A, Chakravarly A. Neurological Complications Following COVID-19 Vaccinations. Curr Neurol Neurosci Rep 2023; 23(1): 1-14.
24 Willison AG, Pawlitski M, Lunn MP et al. SARS-CoV-2 Vaccination and Neuroimmunological Disease. JAMA Neurol 2024; 81(2): 179-186.
25 Nakamura F, Awaya T, Ohura M et al. Graves Disease After mRNA COVID-19 Vaccination, with the Presence of Autoimmune Antibodies Even One Year Later. Vaccines (Basel) 2023; 11(5): 934.
26 Mung SM, Goh L, Hughes M, Jude EB. Inflammatory Arthritis Associated with COVID-19 Vaccination. Cureus 2023; 15(3).
27 Angeli F, Reboldi G, Trapasso M et al. Blood Pressure Increase Following COVID-19 Vaccination: A Systematic Overview and Meta-Analysis. J Cardivasc Dev Dis 2022; 9(5): 150.
28 Genco L, Canntelli M, Noto M et al. Alopecia Areata after COVID-19 Vaccines. Skin Appendage Disord 2023; 9(2): 141-143.
29 Balasubramanian I, Faheem A, Padhy SK, Menon V. Psychiatric adverse reactions to COVID-19 vaccines: A rapid review of published case reports. Asian J Psychiatry 2022; 71.
30 George J. Rare Syndrome After COVID Vaccines Described – “Long vax” events often include neurologic symptoms. MedPage Today Dc. 1, 2023.
31 Dolgopol VB, Greenberg M, Aronoff R. Encephalitis Following Smallpox Vaccination. AMA Arch NeurPsych 1955; 73(1): 216-223.
32 Byers RK, Moll FC. Encephalopathies Following Prophylactic Pertussis Vaccine. Pediatrics 1948; 1(4): 437-457.
33 Institute of Medicine. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. National Academy Press 1994.
34 Weiber RE, Caserta V, Benor DE, Evans G. Acute encephalopathy followed by permanent brain injury or death associated with further attenuated measles vaccines: a review of claims submitted to the National Vaccine Injury Compensation Program. Pediatrics 1998; 101(3 Pt 1): 383-387.
35 HRSA. Vaccine Injury Table: Encephalopathy and Encephalitis. In:Vaccine Injury Compensation Program (VICP) under the 1986 National Childhood Vaccine Injury Act. Jan. 3, 2022.
36 Institute of Medicine Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. Afterword on Research Needs. In: Adverse Effects of Pertussis and Rubella Vaccines (pg. 206). National Academy Press 1991.
37 Institute of Medicine Vaccine Safety Committee. Need for Research and Surveillance and Research Needs. In: Adverse Effects Associated with Childhood Vaccines: Evidence Bearing on Causality (pgs. 305 & 317). National Academy Press 1994.
38 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Preface (pgs. ix-xi). The National Academies Press 2012.
39 Fisher BL. Oral presentation on Public Perspective on Assessment of Health Outcomes Related to the Recommended Childhood Immunization Schedule. Institute of Medicine Public Workshop Feb. 9, 2012.
40 Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. Conclusions. In:The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press 2013.
41 CDC. Child and Adolescent Immunization Schedule by Age: Recommendations for Ages 18 Years or Younger, United States, 2024. Nov. 16, 2023.
42 National Academies Committee to Review Relevant Literature Regarding Adverse Events Associated with Vaccines. Consensus Study Review Highlights of Evidence Review of the Adverse Effect of COVID-19 Vaccination and Intramuscular Vaccine Administration. National Academy of Sciences April 2024.
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6 Responses
Thank you for your report. Give us ideas of how to agitate for serious and thorough studies, What reports are coming from Japan, Israel, Europe???
Also if you keep all your footnotes but have a summarized version for the unconvinced I’d be interested.
You’re do the RIGHT THINGS!! Again Thankyou!
Quote: 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. / end.
They’ll never successfully investigate themselves for their long standing history of criminal behavior that has maimed killed or somehow harmed over half of the worlds population over a lifetime of this vaccination program. We have all the data we need to prove this, and the institutional people invested in these programs will simply never acknowledge such. It’s time to give credit where credit is due; Vaccines harm people. No doubt about it. Those whom refuse to acknowledge this are not to be trusted. Asking the institutions whom pushed this lie and denied all evidence for this long to come clean and acknowledge their consciously and purposefully applied lies and deceptions is like asking a robber in the middle of the night to please return peoples belongings they stole. Or asking a serial killer to kindly bring his victims back to life. Never going to happen. There is no more tests that need be ran. The results are clear; Populations whom do not take vaccines have far better health outcomes and far fewer cases of disease and chronic illness. You can’t study what you refuse to look at, which is why they have never and will never acknowledge the studies already completed outside of the official institutional realms on these matters. We the peoples only remedy is to take ourselves out of their false narratives and allow ourselves to believe the simple truth; We can not trust those institutions because they destroyed their own credibility.
We’ve all seen this movie before. I wonder what the next big “scare” after “bird flu”will be? Hopefully the sick and the healthy will learn to stay away from the carcinogens. There are safer and better medicines available to fight against diseases. Even Vitamin C is a safer than most meds and vaccines I hear about these days.
since taking the pfizer covid shot, both my daughter and granddaughter have developed exercise induced asthma. no family history of asthma of any kind. thanks cdc, thanks pfizer. they also get a rapid succession of respiratory infections, which was not the case before getting the shots and getting covid. regardless of the cause-vaccine, disease, or both, i hold those at the nih responsible for funding dangerous research that no one should be doing, and for green lighting a defective technology
My husband had a pulmonary embolism and blood clots in his calfs. He also had pain in his calfs after the first shot. He was experiencing breathlessness after about 10 steps. After imaging, he was told to get to emergency room right away. He was in the hospital for 4 days. He was admitted immediately while other people were waiting.
When he saw his doctor after that, his doctor said “I’m so glad you’re alive!” This was during the pandemic.
I’m so glad he’s alive too!!!!
My husband had a pulmonary embolism and blood clots in his calfs. He also had pain in his calfs after the first shot. He was experiencing breathlessness after about 10 steps. After imaging, he was told to get to emergency room right away. He was in the hospital for 4 days. He was admitted immediately while other people were waiting.
When he saw his doctor after that, his doctor said “I’m so glad you’re alive!” This was during the pandemic.
I’m so glad he’s alive too!!!!