Thank you for reading and sharing Bailiwick News by email and social media. To support Bailiwick with a paid subscription: 1986 National Childhood Vaccine Injury Act, National Vaccine Program, and National Vaccine Injury Compensation Program.Summaries of key provisions, brief analysis.
JMJ Note: A version of the information about the National Childhood Vaccine Injury Act published below will be incorporated into Part 2 (in-progress) of a two-part series. Part 1 published May 9, 2025 - Are vaccines biological and chemical weapons? By physical composition and physiological effects, yes. Under deceitful American and international law, no. A. Introduction Headwaters of the scientific and legal deception system set up to authorize intentional, knowing torture, mutilation and murder of babies, children and adults through vaccine production and vaccination programs are to be found in the 19th century, in microbiology and epidemiology research, and in centralization of publishing on disease causation, case diagnosis, classification of diseases and classification of cause-of-death. Centralization facilitated falsification and mischaracterization of evidence and mis-attribution of causation, while also reducing the probability of exposure for deceivers and their deceptions. Legal records — especially American statutes and regulations — help expose how accurate information about microbiology and disease causation has been successfully obscured and suppressed throughout the intervening decades, to maintain the plausibility and flood-momentum of the headwater lies. It's important to understand as many as possible of the legal-mechanistic details about how biological product and vaccination laws veil and obscure truth, because the scientific, medical and statistical lies are so large, so long-standing, and still so widely believed. To see clearly underneath, viewers must peel back layers or pull out threads of sub-component deceptions and understand how they work. Over time, pulling out threads creates larger threadbare sections in the legal veils for more light to shine through, so that more people can see more truth, stop taking vaccines, stop vaccinating babies and children and bring about full abolition of vaccine production and vaccination programs. Below is an effort to pull out some of the threads woven into US federal law in 1986 when Congress and President Ronald Reagan established the National Vaccine Program, National Vaccine Injury Compensation Program (NVICP or VICP), Vaccine Injury Table (VIT) and Vaccine Injury Trust Fund (VITF); revised biological product manufacturing establishment licensing law; and authorized the US-HHS Secretary to apply the laws, publish and revise agency regulations and run the programs.
Some of the ostensible, false purposes cited in 1986 to support enactment of the VIT table and the VICP process were to (1) lower the barriers for a small subset of injured petitioners to demonstrate general causation, by providing that identified injuries or deaths occurring after administration of listed vaccines whose onset fell within the required time frame, would be — in most cases — presumptively considered as vaccine-caused and therefore compensable and; (2) relieve manufacturers of the fear of product liability litigation, and thereby maintain and expand vaccine supply and use. The VIT table and VICP process also serve several deceptive functions. The VIT table and VICP process help induce public perception that there exist scientific, medical and statistical foundations for claims that vaccines prevent disease and only "rarely" cause injury and death. To the extent people believe unfounded claims that vaccines prevent disease and that adverse reactions are rare and only take the form of severe, rapid-onset symptoms (such as seizures) and death within hours or days of administration, people remain ignorant of the falsehoods embedded in "vaccine-preventable disease" classifications, and ignorant of the causation, by vaccination, of a wide variety of injury, chronic disease, and death processes that develop and become observable in signs and symptoms weeks, months and years afterward. The VIT table and VICP process also help induce public perception that there exist credible scientific, medical, manufacturing and legal procedures for identifying vaccine-preventable diseases; diagnosing cases; making vaccines whose contents correspond to one or more preventable diseases; identifying vaccine-caused injuries; and financially compensating injured people, their caregivers and the survivors of the dead. To the extent people believe the sequence of disease-causation and disease-prevention lies, and believe that the VICP compensation process is legitimate, it is more difficult for people to recognize that they have been deceived for a very long time, are being deceived in the present, and are justified in developing hostility to the always-harmful, never-beneficial character of vaccine container contents, all vaccination acts and all acts recommending vaccination. The VIT table and VICP process block or prevent public, adversarial fact-finding, product component identification and characterization, and causation assessments, because if conducted, those fact-finding acts would expose long-known, highly-plausible mechanisms of action through which vaccines cause injury and disease by introducing foreign biological matter into the blood and organs of living animals and humans. See Charles Richet, (Nobel Prize lecture, 1913¹); Coombs and Gell, 1968, cited in Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Casuality (NASEM, 1994²); Coombs and Gell, 1975, cited in Biologic Markers in Immunotoxicology (NASEM, 1992³); Tracey Northern, ‘Contagion, Fact-Checked’ (2021⁴) Preventing fact-finding in the vaccine injury context also prevents public understanding that there is no theoretical or practical way to apply traditional tort liability principles to products that are not designed to any quality standards, and therefore cannot be subject to design defect claims, and are not manufactured to any quality standards and therefore cannot be subject to manufacturing defect claims. Through the VIT/VICP system set up in 1986, the US government has paid out some compensation to a small pool of injured victims who have suffered narrowly-limited forms of rapid-symptom-onset injuries and deaths; shielded the acts and omissions of DoD scientists, vaccine bottlers, FDA regulators, pediatricians and other vaccinators from scrutiny and liability attribution; and blocked victims of vaccine-caused delayed-symptom-onset and chronic injuries from compensation, thus preserving the overall vaccination system from public outrage and abolition. The tradeoff has been well worthwhile. It bought the US government, vaccine bottlers and pediatricians 40 more years and hundreds of millions more doses delivered to millions more targets. Under the VICP framework, the HHS Secretary occupies several roles. He is the respondent, similar to the defendant in a civil tort case or a criminal prosecution. By Congressional statute, he stands as the respondent alone, unaccompanied by his collaborators among epidemiologists, military researchers, drug company executives and employees, FDA regulators, doctors, nurses, and pharmacists. The HHS Secretary selects vaccines, vaccine-caused injuries, and time periods during which signs and symptoms of injury must occur, for inclusion in the VIT table, for a claim to be deemed compensable. His VIT decisions create two broad categories of injury: "on-table" and "off-table." The HHS Secretary also determines "qualifications and aids to interpretation" by which signs and symptoms documented in a medical file are to be assessed as to whether they meet the conditions described in the VIT table. These decisions are, like many other determinations in the communicable disease/biodefense/biological product context, made unilaterally by the HHS Secretary alone, without any requirement for production of physical evidence, without standards of evidence against which claims can be tested, and without evidentiary review procedures through which judges or legislators can hear and rule on challenges to HHS determinations. In the VICP process, the special masters (attorneys appointed by federal court to act as administrative law judges) and the supervising judges serve only ministerial functions. They ensure that medical evidence is submitted in proper formats, and they apply the conditions for eligibility previously established by the HHS Secretary through the VIT table. For each case, the HHS Secretary is authorized to accept a finding that the petitioner's injuries fall within the narrow terms of the VIT table conditions, or — at his discretion — challenge the presumption of injury causation by alleging that "factors" other than administration of a vaccine caused the injuries. As summarized below, the list of ‘unexplained’ or ‘hypothetical’ causes that Congress barred the HHS Secretary from using by the first part of the "factors unrelated" definition, remain available for his use under the list in the second part, of non-specific conditions and agents listed as "infection, toxins, trauma...or metabolic disturbances." Those four terms — infection, toxins, trauma, metabolic disturbances — denote agents and injurious effects of blood poisoning, by foreign biological matter, of a living animal or human: the act known as vaccination or immunization. An analogous situation would be a criminal prosecution process in which a criminal defendant is authorized to make general rules about evidence admissibility; make decisions during his trial about whether proffered evidence is admissible; and revise the admissibility rules over time. B. 1986 NCVIA In 1986, Congress and President Ronald Reagan enacted PL 99-660: the State Comprehensive Mental Health Services Plan Act of 1986. Through PL 99-660, Congress (1) established the National Vaccine Program and National Vaccine Injury Compensation Program/VICP (National Childhood Vaccine Injury Act/NCVIA); (2) amended biological product manufacturing regulation law (42 USC 262) to authorize exports of "partially processed biological products" and set up an ostensible recall system for biological products presenting "an imminent or substantial hazard to public health;" and (3) established a National Commission to Prevent Infant Mortality whose tasks included assessing "adequacy of biostatistics registration systems for collecting and reporting on infant health statistics." C. 42 USC 300aa-1 to 300aa-33 (Vaccines) The NCVIA passed by Congress had two main parts, establishing the National Vaccine Program and the National Vaccine Injury Compensation Program. i. National Vaccine Program - 42 USC 300aa-1 to 300aa-6 The first part set up the National Vaccine Program under the Public Health Service Act, and was codified at 42 USC 300aa-1 to 300aa-6. Congress directed the Secretary of health and Human Services to establish a National Vaccine Program "to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines" (42 USC 300aa-1) and appoint a Director to coordinate nine program areas including
Federal agencies to be coordinated by the Director to carry out these nine program areas included NIH, CDC, FDA-Office of Biologics Research and Review (OBRR), Department of Defense, US-Agency for International Development, National Center for Health Statistics, National Center for Health Services Research and Health Care Technology Assessment, and the Health Care Financing Administration, along with non-governmental organizations "engaged in the development and production of vaccines." Congress directed the Director of the National Vaccine Program to draft an implementation plan and set priorities for research, development, testing, licensing, production, procurement, distribution and use of vaccines (42 USC 300aa-3) and to submit annual reports about the implementation of the National Vaccine Program to Congressional committees (42 USC 300aa-4). Congress established a National Vaccine Advisory Committee (NVAC) of vaccine researchers, vaccine manufacturers, doctors, parents, and State and local health officials, tasked with "recommending ways to encourage the availability of an adequate supply of safe and effective vaccination products and recommend research priorities." (42 USC 300aa-5). [Note on vaccine committees: Congress and federal executive officers have set up several vaccine-related committees since the 1960s, including NVAC established in 1986 through 42 USC 300aa-5; Immunization Practices Advisory Commission (IPAC) established by the PHS Surgeon General in 1964 and renamed the Advisory Commission for Immunization Practices (ACIP) in 1965; and the Advisory Commission on Childhood Vaccines (ACCV), established by Congress in 1986 through 42 USC 300aa-19 and tasked with advising the HHS Secretary on implementation of the National Vaccine Injury Compensation Program (VICP or NVICP).] To fund the first eight tasks National Vaccine Program, Congress appropriated $15 million for 1987-1991. To fund the ninth task — implementation of the National Vaccine Program — Congress appropriated $125 million for 1987-1991. (42 USC 300aa-6) ii. National Vaccine Injury Compensation Program The second part of the NCVIA passed by Congress in 1986 established the National Vaccine Injury Compensation Program, or VICP, codified at 42 USC 300aa-10 to 300aa-33. Through the VICP program, Congress set up an alternative compensation system for people injured by vaccines, their caretakers, and survivors of those killed by vaccines, to divert petitioners out of civil courts typically involved in adjudicating product liability claims. At that time, available products used on babies and children were alleged to prevent seven named, allegedly uniquely-diagnosable, alleged disease-states allegedly caused by specific, isolatable, identifiable pathogens allegedly contained, in whole or in part, in vaccine containers: polio, diphtheria, tetanus, pertussis, measles, mumps and rubella. Although they are also important to understand, this report does not lay out VICP procedural steps in detail; relationships between special masters, Court of Federal Claims, district court judges; attorney fee payment rules; funding of the compensation trust fund (VITF) through excise taxes levied on vaccine bottlers and investment of proceeds; or relationships between VICP procedures and standard tort litigation. This report focuses on VIT table components and some of the evidentiary elements of the VICP procedure. a. Types of claims authorized for compensation - 42 USC 300aa-11 Congress authorized petitioners to use the VICP program to seek eligibility review and compensation for three basic types of claims. The first, and most likely to be deemed eligible, became known as "on-table" injuries, and included any "illness, disability, injury, or condition" including death set forth in the Vaccine Injury Table as caused by one of the seven vaccines generally required for school attendance as of 1986 (diphtheria, tetanus, pertussis, polio, measles, mumps and rubella) if the "first symptom or manifestation" of the injury, significant aggravation or death occurred within the time period after administration identified in the VIT table: generally 24 hours to 3 days or 15 days. 42 USC 300aa-11(c)(1)(C)(i) The second and third categories, less likely to be deemed eligible, became known as "off-table" injuries. The second category included injuries not identified in the VIT table, but allegedly caused by a vaccine listed on the VIT table. 42 USC 300aa-11(c)(1)(C)(ii)(I). The third category included injuries caused by a vaccine identified in the VIT table but whose symptom onset occurred outside the time period after administration identified in the table. 42 USC 300aa-11(c)(1)(C)(ii)(II) b. Parties; HHS Secretary to be named as respondent; limits on discovery - 42 USC 300aa-12 Congress directed petitioners to name the Secretary of Health and Human Services as the respondent in their petitions. 42 USC 300aa-12(b)(1) Congress did not authorize petitioners to name vaccine developers, manufacturers, regulators, or administrators (doctors, nurses) as parties. Congress directed petitioners to collect and submit medical and financial information to support the injury claims and compensation amounts. Congress prohibited discovery (collection and disclosure of evidence) apart from medical reports about injuries and financial reports about caregiving expenses and lost income. 42 USC 300aa-12(c). Congress, in other words, barred the collection and exchange of information about product design, testing, manufacturing, identification, misbranding, mislabeling, quality standards, adulteration or contamination during processing, storage and use, and all other product-related factors. c. Determination of eligibility and compensation - 42 USC 300aa-13 Congress assigned the initial burden of proof for "on-table" injuries to the petitioner, to demonstrate by a preponderance-of-the-evidence standard, that the injured party "sustained, or had significantly aggravated, any illness, disability, injury or condition [set forth in the VIT] or died from the administration of such vaccine, and the first symptom or manifestation of the onset or...significant aggravation...or the death occurred within the time period after vaccine administration" set forth in the VIT. 42 USC 300aa-13(a)(1)(A) Congress directed that, if the petitioner provided medical reports supporting the claim that the injured person sustained a VIT-listed injury, from a VIT-listed vaccine, within the VIT-listed time period, the HHS Secretary as respondent would have an opportunity to rebut the conclusion, if he could demonstrate by a preponderance-of-the-evidence that "the illness, disability, injury, condition, or death...is due to factors unrelated to the administration of the vaccine." 42 USC 300aa-13(a)(1)(B) Congress provided that the term 'factors unrelated to the administration' "does not include any idiopathic, unexplained, unknown, hypothetical or undocumentable cause, factor, injury, illness or condition," but that the term may include "infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner's illness, disability, injury or death." 42 USC 300aa-13(a)(2)(A) and (B) d. Vaccine Injury Table (VIT) and Qualifications and Aids to Interpretation - 42 USC 300aa-14 Through the NCVIA, Congress established an initial Vaccine Injury Table; an initial set of "Qualifications and Aids to Interpretation;" and authorized the HHS Secretary to revise, by Federal Register rulemaking, the VIT table and the interpretive provisions. 42 USC 300aa-14(a), (b) and (c) The VIT table and "qualifications and aids to interpretation" are codified at 42 CFR 100. Compensable injuries listed in the first, 1986 VIT table included anaphylaxis occurring within 24 hours of administration of a listed vaccine; encephalitis (brain damage) symptoms occurring within 3 days (for diphtheria, tetanus, pertussis and polio vaccines) and 15 days (for measles, mumps and rubella vaccines); shock-collapse or hypotonic-hyporesponsive collapse symptoms occurring within 3 days (DTP, polio) or 15 days (MMR); residual seizure disorder occurring within 3 days (DTP, polio) or 15 days (MMR); or any acute complication of any of the above injuries that had occurred within the time period. For polio vaccines other than Inactivated Polio Vaccine, compensable injuries also included paralytic polio occurring within 30 days to six months depending on the "immunodeficient" status of the injured person. Qualifications and aids to interpretation listed by Congress in the first interpretation guidelines, and subject to unilateral revision by the HHS Secretary thereafter, provided for a few forms of medical evidence to be deemed relevant and admissible. Shock collapse or hypotonic-hyporesponsive collapse claims could be supported by symptoms such as "decrease of decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning pale white or blue, unresponsiveness to environmental stimuli, depression of consciousness, loss of consciousness, prolonged sleeping with difficulty arousing, or cardiovascular or respiratory arrest." To make a claim for residual seizure disorder, the injured person was required to have not suffered a seizure or convulsion without fever or with a fever of less than 102 degrees Fahrenheit before the first seizure or convulsion after the administration of the vaccine, and -- for MMR vaccines -- to have endured the first seizure (without fever or with fever less than 102) within 15 days after administration and 2 or more seizures (without fever or with fever less than 102) within 1 year after the administration. For all other vaccines, the petitioner had to demonstrate that the first seizure (without fever or with fever less than 102) occurred within 3 days, and 2 or more seizures occurred within 1 year. To make a claim for encephalopathy (brain damage), the injured person was required to demonstrate manifestations such as "focal and diffuse neurologic signs, increased intracranial pressure, or changes lasting at least 6 hours in level of consciousness, with or without convulsions." Congress noted that neurological signs and symptoms might be temporary or might result in permanent impairment, might include "high pitched and unusual screaming, persistent unconsolable crying, and bulging fontanel" which would be compatible with encephalopathy but would not, alone, be considered "conclusive evidence." Congress added that encephalopathy "usually can be documented with slow wave activity on an electroencephalogram." Congress did not provide a definition for anaphylaxis or anaphylactic shock in the first interpretation guidelines enacted in 1986. HHS secretaries have since added and revised a definition for anaphylaxis at 42 CFR 100.3(c)(1), narrowly limiting diagnosis of anaphylaxis to “an acute, severe, and potentially lethal systemic reaction that occurs as a single discrete event with simultaneous involvement of two or more organ systems” (as of 82 FR 6301, Jan. 19, 2017) thus excluding and suppressing scientific and medical knowledge that anaphylaxis also denotes injuries to organ systems that become observable weeks, months or years after the initial injury in the form of chronic disease or multiple, non-discrete events. To repeat a key point: Congress provided grounds for the HHS Secretary, as respondent, to rebut the presumption that a vaccine had caused brain damage and thereby render it an "off-table" injury, by attributing the damage causation to unspecified "infection, toxins, trauma, or metabolic disturbances" that are known to be injurious agents or observable effects of injurious, foreign biological matter delivered into the blood of living animals and humans through accidental wounds or through intentional wounds caused by vaccine needles and syringes. And Congress authorized the HHS Secretary to revise, at will, the “qualifications and aids to interpretation” by which vaccines and patient symptoms (medical files) are assessed for the purposes of finding injuries to be, or to not be, vaccine-caused. Synopsis from Innovation and Challenge: the First Year of the National Vaccine Injury Compensation Program (1991, Wendy K. Mariner)
Synopsis from Vaccine Injury Compensation: Program Challenged to Settle Claims Quickly and Easily (1999, General Accounting Office/GAO):
Synopsis from Bruesewitz v. Wyeth (2011, SCOTUS):
Synopsis, Recalibrating Vaccination Laws (2017, Efthimios Parasidis)
e. Definitions - 42 USC 300aa-33 Congress defined the term "vaccine-related injury or death" to mean "an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine." 42 USC 300aa-33(5) Congress did not define the terms 'vaccine,' 'adulterant,' or 'contaminant' in the definitions section of the NCVIA in 1986, or direct the HHS Secretary to define the terms by agency regulations. Congress did not identify analytical methods by which a petitioner, manufacturer, regulator or VICP claim reviewer could identify or distinguish among vaccine components to determine whether an isolatable substance could be classified or categorized as a vaccine, adulterant or contaminant; how a substance could be classified or excluded from the category of "intentionally added;" or how a substance or mixture of substances could be identified or excluded as an injury-causative agent. In November 2002 (PL 107-296), Congress added a definition for vaccine at 42 USC 300aa-33(7) which read: "The term 'vaccine' means any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit thereof or toxin, developed or administered to produce or enhance the body's immune response to a disease or diseases and includes all components and ingredients listed in the vaccine's product license application and product label." Congress also made conforming amendments at 42 USC 300aa-33(3) and at the definition of "vaccine-related injury or death" at 42 USC 300aa-33(5), excluding from being classified as an adulterant and contaminant "any component or ingredient listed on a product's license application or label." The sentence added to 300aa-33(5) read: "For purposes of the preceding sentence, an adulterant or contaminant shall not include any component or ingredient listed in a vaccine's product license application or product label." In February 2003 (PL 108-7), Congress repealed the provisions enacted in November 2002, including the definition for 'vaccine,' noting that the biological product law should be applied as if the November 2002 amendments had never been enacted. The November 2002 to February 2003 maneuvers were related to an autism case then moving through the VICP process (Leroy v. Secretary of HHS), in which petitioner parents of a brain-damaged child attempted to classify the additive thimerosal as an adulterant or contaminant, whose inclusion in vaccines would place their case outside the jurisdiction of the court reviewing their VICP eligibility and compensation claims. The court ruled against the parents, finding that thimerosal could not be classified as an adulterant or contaminant, because it was intentionally added to vaccines to ostensibly serve as a preservative. f. Advisory Commission on Childhood Vaccines; adverse event reporting by health care providers; record-keeping and reporting by manufacturers - 42 USC 300aa-19; 42 USC 300aa-25 to 300aa-28 Through the NCVIA, Congress established an Advisory Commission on Childhood Vaccines (ACCV), and assigned the ACCV duties to advise the HHS Secretary on implementation of the NVICP; recommend changes to the Vaccine Injury Table (VIT); provide advice "regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions;" survey Federal, state and local programs relating to the "gathering of information on injuries associated with the administration of childhood vaccinations;" advise the HHS Secretary on "means to obtain, compile, publish and use credible data related to the frequency and severity of adverse reactions associated with childhood vaccines;" and recommend to the National Vaccine Program Director, "research related to vaccine injuries which should be carried out." 42 USC 300aa-19 Through the NCVIA, Congress directed health care providers who administer vaccines to report "specified adverse experiences, occurring within specified time intervals" to a database to be set up and administered by FDA and CDC, launched in November 1990 as VAERS [Vaccine Adverse Event Recording System]. 42 USC 300aa-25 Congress directed the HHS Secretary to develop information materials for health care providers to distribute to legal representatives of children receiving vaccines listed in the Vaccine Injury Table. Information sheets were to contain information about "the frequency, severity and potential long-term effects of the [alleged] disease to be [allegedly] prevented by the vaccine;" vaccinations required for school attendance and under recommended immunization schedules; warning signs and symptoms of adverse reactions to look for and report to the vaccinator; how and to whom to report "any major adverse reactions;" contraindications and identification of characteristics of potential recipients who might be at higher risk of a "major adverse reaction" and the availability of the VICP compensation program. 42 USC 300aa-26 Through the NCVIA, Congress established a so-called "mandate for safer vaccines," ostensibly directing the HHS Secretary to "promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on December 22, 1987, and...make or assure improvements in...the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines." Congress directed the HHS Secretary to set up a task force, comprised of NIH Director, FDA Commissioner and CDC Director, to consult with the Advisory Commission on Childhood Vaccines, and to submit reports every two years to Congressional committees describing actions taken to improve the safety of vaccines. 42 USC 300aa-27. By stipulation signed in July 2018 in a case brought by Informed Consent Action Network (ICAN), HHS provided corroborating evidence supporting the conclusion or negative inference that "mandate for safer vaccines" studies have not been conducted; reports have not been compiled (because studies were not conducted) and reports have not been provided to Congress (because reports were not compiled). Through the 1986 NCVIA, Congress required vaccine manufacturers to “(1) prepare and maintain records documenting the history of the manufacturing, processing, testing, repooling, and reworking of each batch, lot, or other quantity of such vaccine, including the identification of any significant problems encountered in the production, testing, or handling of such batch, lot, or other quantity" and "(2) if a safety test on such batch, lot, or other quantity indicates a potential imminent or substantial public health hazard is presented, report to the Secretary within 24 hours of such safety test which the manufacturer (or manufacturer's representative) conducted…” 42 USC 300aa-28. Congress did not define the term vaccine by physical composition. Congress did not direct the HHS Secretary to define the term vaccine by physical composition. Congress did not enact provisions designating analytical tests that could be used to identify vaccines by physical components or assess quality or safety characteristics, did not designate any third party (such as the USP-NF) to designate such analytical tests, and did not direct the HHS Secretary or FDA Commissioner to designate such analytical tests. Congress also did not require vaccine-bottlers to collect or report information about adverse effects experienced by living recipients of the products after the containers leave the bottling facilities. Congress did not define the term "imminent or substantial public health hazard" or any of its constituent words, and did not direct the HHS Secretary or FDA Commissioner to define them. Because the contents of vaccine containers are unstable mixtures of biological matter (living and dead, bacteria, fungi, plant, insect, animal, human), chemicals and nutrient solutions, any process or batch testing that a vaccine-bottler or regulator conducts cannot fully identify the biological and chemical matter contained in any “batch, lot or other quantity,” and cannot meaningfully characterize any product in terms of purity, potency, safety or “potential imminent or substantial public health hazard.” Thus, there is no way for vaccine manufacturers to collect or report meaningful product identity or product quality information to support any finding that any product presents or does not present an “imminent or substantial public health hazard.” D. 42 USC 262 - Regulation of biological products; recall authority; export of partially processed biological products In 1986, through the same NCVIA, Congress revised two sections of 42 USC 262. i. 42 USC 262(d)(2) One change, codified at 42 USC 262(d)(2)(A) and (B), authorized the HHS Secretary to "issue an order immediately ordering the recall of such batch, lot or other quantity" of biological product “upon a determination that a batch, lot or other quantity of a product licensed under this section presents an imminent or substantial hazard to the public health.” Congress provided for application of 5 USC 554 (agency hearings with opportunities for manufacturers to challenge recall orders), and civil penalties up to $100,000 per day to be assessed against violators. Congress did not define "imminent or substantial hazard to the public health," and did not direct the HHS Secretary to define the terms or to prescribe agency regulations governing the recall process. See FDA Regulatory Procedures Manual, Ch. 7 (Recall Procedures, Version 10, July 2021), which mentions “imminent or substantial hazard” but under Implementing Regulations, Procedures and Industry Guidance [Guidance for Industry], at p. 16/153, notes “N/A” for “not applicable.” ii. 42 USC 262(h) and 21 USC 382 A second change in 1986, codified at 42 USC 262(h) and 21 USC 382, authorized export of "partially processed biological products" to listed countries including Australia, Austria, Belgium, Canada, Denmark, Federal Republic of Germany, Finland, France, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Portugal, Spain, Sweden, Switzerland and the United Kingdom. The provision authorized biological products to be exported "not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man...[and] intended for further manufacture into final dosage form outside the United States in a country listed" upon approval of an application submitted to the HHS Secretary. Congress provided that the HHS Secretary "may not approve an application" unless he determines that the product is "manufactured, processed, packaged, and held in conformity with current good manufacturing practice and the outside of the shipping package is labeled with the following statement: 'This product may be sold or offered for sale only in the following countries: ___ '," filling in the space with the list of importing countries. 42 USC 262(h)(1)(A) Applications were to "describe the partially processed biological product to be exported," list the countries to which the product is to be exported; certify that the product would not be exported to any other country, identify the manufacturing establishments, and certify that the final product to be developed was approved in the importing country, or approval was being sought. 42 USC 262(h)(1)(B) Congress provided that partially processed biological products intended for export were not subject to the other licensing provisions of 42 USC 262. 42 USC 262(h)(2) Congress authorized the HHS Secretary to determine that prohibition of export of partially processed biological products is necessary for "protection of the public health in the United States or the country to which it is to be exported" and not approve an application on that basis. 42 USC 262(h)(3). Congress did not identify the party or parties authorized to submit applications. Congress did not define physical standards, or direct the HHS Secretary to define physical standards, for the HHS Secretary to use in determining whether a product was or was not a "partially processed" biological product, nor how any partially processed biological product related to "protection of the public health." E. 1986 - National Commission to Prevent Infant Mortality In 1986, through a different section of PL 99-660, Congress established a National Commission to Prevent Infant Mortality, codified as statutory notes under 42 USC 289g and 42 USC 285g. Congress defined "infant mortality" as referring to "the number of infants born alive but who die before their first birthday." The commission was set up under the National Institute of Child Health and Human Development, which had been established by Congress in 1985. The infant mortality commission was tasked with assessing Federal, State, local and private resources which "impact infant mortality" including the effectiveness of supplemental feeding programs, policies to ensure access to prenatal and post-natal care for low-income pregnant women, mothers and infants up to age one, and "adequacy of the national biostatistics registration system with respect to the collection and reporting of infant health statistics." The commission was also tasked with identifying barriers to health care needed to prevent high infant mortality, hold hearings, and make recommendations for national policies. This program provided a useful way to collect information about the effectiveness of vaccination for harming infant health and inducing infant mortality, especially among low-income pregnant women and infants born to low-income women. Related:
1 "...Anaphylactic symptoms also vary to a great extent, although the differences are marked rather according to the nature of the experimental animal than according to the nature of the poison used. It is indeed worthy of note to find that the phenomena are constant, whatever the poison used. I have made especial study of anaphylaxis in dogs, which permits of greater accuracy in specifying symptoms than in experiments with the guinea-pig. In the dog, four degrees of anaphylaxis may be distinguished, according to intensity...[description of symptoms including "prurience or itching...rapid breathing, lowered arterial pressure, faster heart-beat, vomiting, blood diarrhoea and rectal tenesmus...depression of the nervous system...ataxia [lack of muscle coordination]...pupils are dilated, the eyes haggard and after heart-rending cries, the animal falls to the ground, urinating and defecating underneath himself, unconscious...breathing is laboured and agonized...heart beats are so faint as to be barely perceptible: blood pressure hardly reaches the one or two centimetre mercury level...all the symptoms point to the central nervous system being the seat of severe and sudden intoxication. This brutal assault of the poison on the nervous system has been called anaphylactic shock..." Richet further described work by Milton J. Rosenau and John Anderson of the US-Public Health Service and other researchers who induced similar effects, by injection of foreign biological matter, in rabbits, guinea pigs… Richet: "Anaphylaxis has been observed in all animals: the horse, the goat, the ox, the rat, the pigeon, the duck and even recently in frogs. Anaphylaxis takes place also in human subjects and has caused death in certain instances..." Charles Richet (Nobel Lecture, 1913) 2 "...A classification of immunologic reactions that can cause disease has been proposed by Coombs and Gell (1968). Four reactions make up the classification: type I, immediate hypersensitivity, the most serious clinical manifestation of which is anaphylaxis; type II, reaction of antibody with tissue antigens; type III, Arthus-type reaction, caused by deposition of antigen-antibody complexes in tissues, leading to the tissue-damaging effects of complement and leukocytes; and type IV, delayed-type hypersensitivity, which is mediated largely by T lymphocytes and macrophages. In clinical reactions to foreign antigens, these categories frequently overlap. These reactions are a by-product of the body's capacity to reject foreign invasion, particularly by microorganisms..." Coombs and Gell, 1968, cited in Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Casuality (NASEM, 1994, p. 59) 3 "... Mechanisms of Chemically Induced Immune Disease. Exposure to immunotoxicants can cause immunologic suppression, resulting in altered host resistance. The outcome of immune suppression is influenced by the dose and mechanism of action of the immunotoxicant along with concomitant exposure to other agents, such as bacteria, viruses, parasites, or chemicals at levels so low they might normally be innocuous... Xenobiotics also can act as sensitizers to stimulate the immune system as antigens by provoking a substantial immune response that leads to hypersensitivity...Diseases that are immune-reaction mediated include rheumatoid arthritis, some types of diabetes, and myasthenia gravis... An older classification of immune reactions, developed by Gell and Coombs (Gell et al., 1975), is noted in Table 2-1 for comparison..." Coombs and Gell, 1975, cited in Biologic Markers in Immunotoxicology (NASEM, 1992, pp. 26-27) 4 "There are only three diseases: toxemia, malnutrition and injury …toxemia is poisoning of any kind, it can be from pollution in the air and the water, even your food. It is drugs and especially vaccines..malnutrition [is]...being severely depleted in certain nutrients and remember all drugs (and poisons) deplete the body of nutrients as they get used up to deal with toxins…injury, physical or mental...physical injury can be obvious, a cut or stab or a broken bone even bruises. It can also be hidden as in internal injuries which could be caused by number 1 again (toxemia)..." Tracey Northern, ‘Contagion, Fact-Checked’ (2021)
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