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The Childhood Vaccination Schedule – Part One: The First Vaccine – Hepatitis B


Michael Bryant

21st Century Wire

Introduction

As more vaccines are added to the US childhood immunization schedule it’s imperative that there be a broader public discussion about the prominence of vaccines in public health policy, what benefits they convey and a forthright assessment of the risks involved. 

Though vital to both the short and long term health of children, exploratory questions, in-depth rational discussion and comprehensive analysis about vaccines are considered off-limits for the mainstream medical establishment.

In the conventional narrative it is accepted as an article of faith that vaccines are miraculous discoveries responsible for global disease eradication and are the most important medical product for disease prevention.

For today’s pediatricians promoting and implementing the childhood immunization program has become their primary duty.

It is widely believed that if we stopped, or even reduced vaccinations, we would be going back to the dark ages. Any individual that challenges this vaccine orthodoxy is seen as a heretic.

Despite the deeply ingrained belief system of the vaccine ideology a growing number of parents and health advocates are beginning to ask many of the questions which have been swept under the rug for years.

Are all of these vaccines necessary? Are they safe? Are the diseases they are supposed to prevent truly diseases of concern?

Does the claim that vaccines are responsible for reductions in disease, disability, and death from a variety of infectious diseases fit with the facts when scrutinized?

Why such an increase in the number of vaccinations through the years? Has this escalating vaccine program produced an accompanying improvement in health outcomes?

What happens if I don’t give my child all of these vaccines? What happens if I don’t give my child any of these vaccines? What happens to children who don’t get vaccinated?

These are some of the questions parents are not supposed to ask and precisely the questions that need to be addressed.

While the information presented in this series is publicly available it is denied admittance into the public discourse by means of systematic indoctrination by a compromised media apparatus and a medical establishment which has created a mystique around vaccines while persuading the public they are the holiest of all medicinal products.

As an antidote to this institutional programming we embark upon a series of articles which take a close look at each of the vaccines on the childhood schedule and the diseases they are designed to prevent.

Our series begins with an overview of the US Childhood Immunization Schedule and a detailed look at the initial shot given to infants on the first day of life- the Hepatitis B vaccine.

The United States Childhood Immunization Schedule – An Overview

In the past few decades the childhood vaccine schedule in the United States has exploded into what is now the most aggressive childhood vaccination schedule in the world. It wasn’t always this way. Most baby boomers likely had only 2 or 3 vaccinations- polio, smallpox and DTP with never more than one shot given per visit.

With the recent addition of the COVID-19 vaccines to the childhood schedule the number of recommended injections ballooned to a regimen of 72 injections of 90 antigens by age eighteen for any child that undergoes the full immunization schedule circa 2023.

To understand how this came to pass we need to understand the history of how we got here.

The first vaccine mandate in the United States was enacted in Massachusetts in 1810 and was centered on smallpox. The legislation was essentially an ad hoc law which gave local health boards the authority to require vaccination.

The first public school mandate was issued in Massachusett in the 1850’s. At that time the only vaccine of interest was for smallpox. By the end of the 1800s most states in New England had smallpox vaccine requirements for children attending public schools.

The next significant stride in vaccine recommendations and requirements for children would arrive a century later in 1954, focusing on the polio vaccine developed by Jonas Salk.

By 1955, the polio vaccine was fully licensed and through the Polio Vaccine Assistance Act Congress appropriated funds to provide federal grants for states to purchase the vaccine and for the costs of planning and conducting vaccination programs.

This Act would become the template for the utilization of federal funds to cover various costs of vaccine programs and would  provide the impetus for a mass inoculation campaign for polio.

At this time there were no codified mechanisms to mandate vaccine uptake, doctors recommendations were considered just that- guidance with no strict obligation or enforcement for adherence.

In 1962 the Vaccine Assistance Act would establish a permanent mechanism to provide ongoing financial support to state and local health departments. This Act would allow the CDC to appropriate federal funds for the provision of vaccines and establish an advisory group to assist in managing vaccination programs.

To this day the 1962 Act remains one of the most important mechanisms for aligning local and state health department immunization activities with federal funds to deliver vaccines to children.

In 1964 the Advisory Committee on Immunization Practices (ACIP) was created under the US Public Health Service. Its mission was to review the science and evidence of vaccines given to children and to make recommendations on when those vaccines should be given and at what age.

The 1960s and 1970s saw a wave of new vaccines hit the market. A second type of polio vaccine was developed along with the first Hepatitis B vaccine. Measles vaccines were developed as a single vaccine and then combined with the mumps and rubella vaccines to create the “MMR” vaccine.

Paralleling the increase in the volume of vaccines came the creation of global immunization programs. In 1974 the World Health Organization established the Expanded Programme on Immunization which was designed to ”strengthen vaccine programmes, supply, and delivery, and ensure universal access to all relevant vaccines for all populations across the life course.”

These changes radically altered the business landscape of vaccine manufacturing. What was once a cottage industry of small pharmaceutical companies, individual investigators and physician scientists evolved into the mega corporations that exist today.

By 1977, the U.S. federal government had set up the Childhood Immunization Initiative which sought to increase vaccination rates in children against seven diseases (diphtheria, measles, mumps, pertussis, poliomyelitis, rubella, tetanus) for which vaccines had been developed. This began the process by which all 50 states would adopt mandatory school vaccinations.

In the 1980s, vaccines against Hepatitis B, Haemophilus influenzae type b, and pneumococcal disease were recommended for children at different ages. By 1983 the number of recommended injections had increased to 23 doses of 7 vaccines by age six.

In 1986, the National Childhood Vaccine Injury Act created a system of passive and active surveillance for cases of adverse reactions to vaccines as well as a mechanism to compensate any persons injured by vaccines.

With the passage of the 1986 Act and its implementation in 1988, a liability shield for pharmaceutical companies was created. On the heels of the 1986 Act the number of vaccines placed on the CDC schedule would escalate.

Even as the list of available vaccines was growing local and state health boards had differing opinions on when to give vaccines, which children should get them and how many should be given.

In order to standardize vaccine uptake, the first “harmonized” childhood immunization schedule  was issued in 1995 by the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). combining recommendations of all three national groups.

This initial schedule included diphtheria, tetanus, pertussis, measles, mumps, rubella, polio (oral), Haemophilus influenzae type b, and Hepatitis B vaccines. (The DTP and MMR vaccines were combination vaccines for diphtheria, tetanus, pertussis; and measles, mumps, rubella.)

Since then, the schedule has been adjusted as new vaccines have been developed, taken off the market or the risk profile for children changed.

Today, according to the National Conference of State Legislatures (NCSL), all 50 states have legislation requiring specific vaccines for students with exemptions varying from state to state.

These laws apply not only to children attending public schools but also to those attending private schools and day care facilities.

There are 45 states and Washington D.C. that grant religious exemptions for people who have religious objections to immunizations and 15 states which allow for philosophical exemptions.

All school immunization laws grant exemptions for medical reasons.

Six states (California, Connecticut, Maine, Mississippi, New York, and West Virginia) do not allow religious or philosophical exemptions from vaccination requirements as of 2021.

NCSL also states that the laws and regulations on vaccine requirements in all 50 states and DC follow the vaccine schedule set forth by CDC.

The trajectory of this vaccine program would result in 54 injections of 72 antigens by 2019 for  US children by age eighteen who adhered to the full CDC schedule- with even more shots added as the Covid vaccines were placed on the child immunization schedule.

This dizzying array of injections in the childhood immunization schedule begins on a child’s first day of life with the Hepatitis B vaccine.

Hepatitis B – The Disease: A Case Study In Manufacturing Public Perception 

The first question every parent should ask when considering the Hepatitis B vaccine is, “Does my child need a vaccine for Hepatitis B on the first day of life?”

Given the low risk of newborns acquiring the HepB infection and the ease with which pregnant mothers can be screened it’s fair to ask why a newborn would need the HepB vaccine?

Before arriving at that answer we look back at how Hepatitis B, the disease, was transformed from a relatively obscure disease which impacted a limited population into a widespread public health predicament.

The conventional characterization of Hepatitis B is as a type of viral hepatitis which causes acute and chronic liver infection. It is generally accepted that in order to contract HepB direct contact with infected blood or other body fluids is required. Transmission routes that by any standards pose little or no risk to infants.

This is in fact how public health officials characterized the disease back in 1981 when the Hepatitis B vaccine  initially gained approval. The CDC’s own Fact Sheet on HepB the disease does not include newborn babies as a risk group for that disease.

The risk groups listed are, “injection drug users, homosexual men, sexually active heterosexuals, infant/children of immigrants from disease-endemic areas, sexual/household contacts of infected persons, infants born to infected mothers, health care workers and hemodialysis patients.”

What was it that changed the CDC’s earlier 1982 recommendation, which targeted only a small “at-risk” population, into a set of more aggressive policies that would result in the 1991 recommendation that all infants get three doses of HBV by 18 months of age?

And how did the HepB vaccine become compulsory for all schoolchildren in 47 states by the year 2000 even as the CDC admits that they lack proof of HepB being transmitted in a school setting?

In large part the answer to these questions lies in how the public’s perception of HepB was radically altered through orchestrated media messaging and deliberately provocative depictions of the disease by industry and public health officials. Notably the change in HepB’s image came immediately following the vaccine’s development, licensure and introduction.

In the late 1970s and early 1980s, prior to the approval of the vaccine, HepB was a disease which had little to no relevance to most Americans and nowhere to be found on the media radar. Before the Hepatitis B vaccine was developed and marketed most Americans had little reason to view the disease as a threat to their health.

New cases of HepB were quite low in the 1970’s, began to rise in the 1980’s, concurrent with the AIDS crisis, and then began to fall again in the 1990’s.

By its own admission the CDC attributed this decline to, “reduction of transmission among men who have sex with men and injection-drug users, as a result of HIV prevention efforts.”

As scientific discoveries leading to the vaccine moved forward HepB acquired a more public image.

The advent of the AIDS crisis in the early 1980s, the development of genetically-engineered pharmaceuticals in the late 1980s, and the political push for health reform in the early 1990s all led to changes in how HepB was presented to Americans.

The media, medical and scientific community would all contribute in altering the image of HepB through the 1980s and 1990s. Media outlets would often conflate HepB with HIV/AIDS in order to arouse public attention and induce fear towards this obscure disease.

Provocative headlines and stories began to surface with claims that Hepatitis B was similar to HIV and possibly worse.

The historical medical view that HepB was a disease which only impacted a narrow subset of the population was replaced by hysterical media representations that anyone could be at risk of Hepatitis B.

In her article, “Do We Really Need Hepatitis B on the Second Day of Life?”, Vaccination Mandates and Shifting Representations of Hepatitis B, history of health sciences professor Elena Conis chronicles some of this history:

“Outlets from the Philadelphia Tribune to Good Housekeeping reported that a third of people with the disease were not in any of the known risk groups. Redbook warned readers that hepatitis was “spreading fast,” and the Boston Globe noted that hepatitis was spread by sharing gum, food, toothbrushes, and razors and by body piercing. New York magazine, in a feature titled, “The Other Plague,” recounted the stories of a young woman who contracted a fatal case by getting her ears pierced, a young man who was infected when mugged at knife-point, and a woman infected at a nail salon. Frequent mention of the prevalence of asymptomatic carriers heightened the sense of an immediate health threat: in the words of the New York magazine reporter, anyone could be one of the U.S.’s 1.5 million “Typhoid Marys,” unwittingly transmitting hepatitis B to people unaware of their risk.”

Such media reports citing HepB disease statistics would normally originate with statements generated by officials at the CDC.

Most of the inflated disease statistics found in the media reports were generated in the very same  ACIP Morbidity and Mortality Weekly Report (MMWR) which called for mass vaccination with hepatitis B vaccine.

In that report the CDC stated that there are an “estimated 1 million-1.25 million persons with chronic hepatitis B infection in the United States” and that, “each year approximately 4,000-5,000 of these persons die from chronic liver disease” and that, “an estimated 200,000-300,000 new [Hepatitis B] infections occurred annually during the period 1980-1991.”

To generate those statistics the CDC, in what at best would be considered duplicitous, circled back to itself citing an MMWR 1990 report as the basis for their claims. Nowhere in either report were scientific references used to support those claims.

Despite the media campaign, vaccine uptake for HepB was not rising to desired levels as vaccinating high-risk adults was proving to be difficult. This would result in a more systematic strategy at the national level.

In September of 1991 the Immunization Practices Advisory Committee (ACIP) would develop and codify a national program for the HepB vaccine- Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination.

In 1992 the World Health Organization (WHO) would follow suit recommending that “all infants should receive their first dose of hepatitis B vaccine as soon as possible after birth, preferably within 24 hours, even in countries where Hepatitis B virus is of low endemicity.”

Acknowledging children were not in the at-risk group for HepB the ACIP committee lamented that “HBV transmission cannot be prevented through vaccinating only the groups at high risk of infection.”

Using this rationale they declared a blanket vaccination policy for all newborns- “a comprehensive strategy to prevent HBV infection, acute hepatitis B, and the sequelae of HBV infection in the United States.”

Earlier that year, June 11,1991 in a Boston Globe article titled, “U.S. To Urge All Children Be Vaccinated for Hepatitis B,” an official from the CDC admitted, “We do not feel that targeting adults for vaccination has worked. This will be the first time that a vaccine is recommended for children to prevent a disease that primarily occurs in adults.”

In testimony before Congress Michael Belkin summed it up neatly, “So in the CDC and ACIP’s own words, almost every newborn US baby is now greeted on its entry into the world by a vaccine injection against a sexually transmitted disease for which the baby is not at risk -because they couldn’t get the junkies, prostitutes, homosexuals and promiscuous heterosexuals to take the vaccine.”

Not to be swayed by logic, the CDC would effectuate a comprehensive HepB vaccine program and a medical product with an initial target population of drug addicts and homosexuals would become compulsory for every child in the country.

The Hepatitis B Vaccine Clinical Trials- The Devil’s In the Details

It is a near certainty that few physicians will study the details of a vaccine clinical trial found in the package inserts of each vaccine. Rarely will a pediatrician or physician initiate a conversation with a patient or parent about what those trials entailed and what else the package insert reveals.

Yet that is exactly the first place one should go to get a clear picture of the safety profile for any vaccine.

In 2017 the Informed Consent Action Network (ICAN) received a tip from a supporter that the clinical trials used by the FDA to license the two children’s HepB vaccines, Engerix-B and Recombivax HB, only reviewed safety data for a few days after injection.

ICAN was so stunned by this revelation that they assumed the supporter was making false claims. Upon reviewing the package inserts for both vaccines ICAN found the claims to be true.

The package insert for GlaxoSmithKline’s Energix-B vaccine, approved in 1989, acknowledges  that the subjects were monitored for only 4 days after administration of the vaccine. By any standards 4 days of post-injection data is inadequate to assure a product’s safety. As noted by ICAN, “the review period for a vaccine given to infants and young children should be longer as neurological and developmental disorders are often discovered until the child is a few years old.”

A 2019 study authored by researchers at the FDA and Duke University confirmed ICAN’s position, stating that compared to licensing time period for adults, “data on drug efficacy and safety in children may require an additional 6 years.”

Another troubling facet of GSK’s pre-licensure clinical trials is that ENGERIX-B was administered to 5,071 healthy adults and children. Of the 13,495 doses administered in 36 clinical trials nowhere is it listed how many of those subjects were adults, how many were children and how many were infants.

As there were no specifics on how many individuals from each age group were involved the results of these trials are uninterpretable with respect to the risks of vaccinating infants.

While the trials for Energix-B were certainly less than rigorous the pre-licensure trials for Merck’s Recombivax HB vaccine might hold the dubious distinction for being the most unscrupulous and underpowered trials in the annals of the Pharmaceutical Industry.

In only three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to a whopping 147 healthy infants and children (up to 10 years of age) who were monitored for a mere 5 days after each dose.

Along with the fact that 147 subjects is a grossly insufficient number upon which to base any determination on vaccine safety, the ages of the trial participants are not even listed. How many infants were in the study? Was there even a single newborn in the study?

Additionally, as is the case with virtually all vaccine clinical trials, neither of these two HepB trials used a proper randomized placebo-controlled clinical trial.

Beyond the untrustworthy nature of the composition and execution of these trials there is also the nagging problem with the difference between the noted outcomes of the clinical trials versus the post marketing experience.

In the clinical trials, effects are only studied for a few days immediately following vaccination, (with no true placebo), and only minor adverse reactions such as irritability, fever, diarrhea, fatigue/weakness and injection site pain are mentioned.

But in the “post marketing data”, which means post-approval injections in the general population,  a laundry list of more serious adverse reactions such as Guillain-Barré syndrome, multiple sclerosis, encephalitis, thrombocytopenia, meningitis, Stevens-Johnson syndrome, tachycardia and many more are reported.

This is one of the elemental tricks the Pharmaceutical Industry uses to conceal the nature and extent of injuries which may be attributable to the shots.

More serious adverse reactions are swept under the rug by asserting that “no causal link has been established” between the injection and these reactions.

In the trials subjects are observed for only a few days and nothing is found to cause concern.

But when the general public starts reporting real world serious adverse events, these are dismissed as no long term studies are done which could establish causal relations.

ICAN’s lawyer Aaron Siri in a 9 hour deposition brought these many problems to the attention of Stanley Plotkin, the ‘Godfather of Vaccines’, who authored what is considered the bible on vaccines,

In the deposition Siri gets Plotkin to admit that the Hepatitis B vaccine (given to babies on their first day of life), has not had an adequate safety study:

Siri asked, “How long does it say that safety was monitored after each dose?”

Dr. Plotkin responded, “Five days.”

Siri responded, “Is that long enough to detect an autoimmune issue that arises after five days?”

Dr. Plotkin stated, “No.”

Siri then asked, “Was there any control group in this trial?”

Dr. Plotkin, who had just argued how important control groups are to cause and effect, answered, “It does not mention any control group, no.”

Based on the weight of the evidence ICAN is currently petitioning the FDA to withdraw the licensure of these Hepatitis B vaccines and asserts that these vaccines should never have been approved.

Given that the utility of the Hep B vaccine for toddlers is unsubstantiated and the clinical trials are at best problematic it would seem incumbent upon the manufacturers to at least provide ironclad evidence for the safety of these products.

Is this the case?

The data tell a different story.

Dangers of the HepB Vaccine- An Open Secret

In the first months of life a child’s brain and biological systems are at critical stages of development. Throughout pregnancy parents are bombarded with directives from their physician telling them a multitude of vaccinations will be essential to protect their child from the pending torrent of infectious diseases.

In addition to the medical stipulations given by their pediatrician, parents understand that they will be faced with mandates for day care and schooling as well as ever-present societal pressures. The combination of these forces create a climate of fear and coercion intended to bring about automatic compliance.

Little to no information about vaccines are volunteered at most pediatric visits. Parents are expected to obediently trust their physician and place their faith in a medical system that assiduously claims vaccinations are necessary, safe and effective. Questions challenging the utility and safety of a vaccine are typically discouraged and dismissed.

In the United States the journey into this world of mass vaccination begins on the day of birth with the Hepatitis B vaccine.

To the extent that Hepatitis B is a danger to anyone, that risk is understood to be through sexual contact or sharing needles. A sexually transmitted risk or a needle exchange risk means there is little to no chance of Hepatitis B infection for infants calling into question the fundamental rationale for this vaccine.

Less than one percent of all HepB cases occur in children under 15 years old. In North America, Europe and Australia a mere one-tenth of one percent are said to be carriers of HepB. Of adults infected, 90-95% clear the virus on their own, without intervention.

While it is thought that infants born to mothers who are infected with HepB carry a greater risk of contracting the disease, pregnant women can easily be screened for this disease if there is a concern.

Given this risk profile, as infants and young children receiving this vaccine face little to no chance of hepatitis B infection, we have to ask, Is this vaccine worth the  potential risk of neurodevelopmental disorders or other adverse impacts associated with this vaccine?

The answer to those questions can be found in answering the most important question for any medical product, “Is it safe?”

From the earliest days of development and production safety concerns have dogged the various iterations of the Hepatitis B vaccine.

The original HepB vaccine, Heptavax B, manufactured by Merck Sharp & Dolme and approved by the FDA in 1981, was unlike previous vaccines in that it contained inactivated virus collected from plasma of HepB-infected donors rather than live, weakened virus or killed, denatured virus.

Maurice Hilleman hypothesized that he could make a HepB vaccine by injecting patients with Hepatitis B surface protein using three treatments of blood serum together with rigorous filtration. To obtain the necessary plasma Hilleman collected blood from gay men and intravenous drug users—groups said to be at risk for viral hepatitis.

Hilleman believed the immune system would recognize the surface proteins as foreign, and manufacture specific antibodies which would destroy these proteins. His theory went that if the patient were infected with HepB in the future the immune system would produce protective antibodies which would destroy the viruses.

On November 16, 1981, CBS Evening News reporter Dan Rather touted Hilleman’s vaccine as the “first completely new viral vaccine in 10 years,” and hailed it as, “the first vaccine ever licensed in the United States that is made directly from human blood.”

Though lauded as a revolutionary medical achievement at the time, the original plasma derived HepB vaccine was not intended for widespread use in the US due to the fact that liver cancer was relatively uncommon in the US at the time and the cost of the vaccine was seen as prohibitive.

Excitement surrounding this novel plasma vaccine soon dissipated due to a public relations problem. It came to light that the clinical trials which tested the vaccine in the 1970s had included only gay men who had been identified as being at high risk of the infection.

The approval of the serum derived vaccine had the added misfortune of coinciding with the AIDS crisis which heightened concerns over the safety of using potentially contaminated human serum in vaccines due to fears of transmission of live HepB or other blood-borne pathogens.

As gay men and injection drug users were frequent blood donors for the vaccine this brought about fears that blood plasma could be infected and the vaccine itself could become a carrier for HIV/AIDS.

These concerns of potential contamination with human viruses led to the 1986 introduction of a second hepatitis B vaccine, Recombivax-HB. This new type of vaccine, known as a recombinant vaccine, manufactured by Merck Sharp & Dolme, was the first vaccine produced using recombinant DNA technology.

The creation of this new type of vaccine entailed inserting the gene of the HepB virus protein envelope  into yeast cells, eliminating the risk of viral contamination from using human serum to produce the vaccine.

Frank E. Young, FDA Commissioner at the time, heralded this development as yet another medical marvel declaring, “This vaccine opens up a whole new era of vaccine production. These techniques should be able to be extended to any virus or parasite to produce other vaccines that normally cannot be propagated in the laboratory.”

Noting that the plasma-derived vaccine had annual sales of only $45 million, Edward E. Penhoet, president of Merck’s collaborator Chiron Corp., suggested that the new recombinant HepB vaccine would be more profitable for Merck as genetically engineered vaccines are “cheaper to produce” than those derived from human blood.

By 1989, a second recombinant hepatitis B vaccine, Engerix-B manufactured by The SmithKline Beecham Company, was approved for use in the U.S.

While the new HepB vaccines tempered anxieties surrounding the previous plasma-based vaccines a different set of problems materialized in the manufacturing processes and with certain ingredients in the HepB recombinant vaccines.

A 2005 French study, Multiple sclerosis and hepatitis B vaccination: Adding the credibility of molecular biology to an unusual level of clinical and epidemiological evidence, highlighted issues with HepB virus polymerase contamination asserting, “We reviewed evidence showing that hepatitis B vaccine HBV has a marked potential to induce auto-immune hazards, neurological as well as non-neurological. We emphasized that for a drug used as a prevention, HBV was remarkable by the unusual frequency, severity and variety of its hazards.”

The authors came to the stark conclusion that, ‘‘the principle of precaution’’ should urgently be applied [with] regard to the tiny benefit (if any) of large HepB vaccination in low-endemic countries. In addition, the benefit/ratio of this costly prophylaxis should be seriously re-assessed even in countries where the frequency of HepB is higher.”

Soon issues surrounding genetically modified yeast proteins used in the HepB vaccines cropped up.

Links to yeast-containing vaccinese and autoimmune disease were observed, creating concerns that the genetically engineered yeast in the HepB vaccines may cause children with an allergy to yeast to react severely to the vaccine.

Bioinformatics and epidemiological evidence link the yeast protein found in the Hepatitis B vaccines to numerous autoimmune disorders. Part of the study’s stark conclusion was, “Vaccine makers have refused to perform such checks, resulting in devastating consequences.”

The Hepatitis B Foundation warned, “The vaccine may not be recommended for those with documented yeast allergies or a history of an adverse reaction to the vaccine.”

The CDC’s Pinkbook on Hepatitis B identified another potential problem with latex packaging in the vaccines observing, “Some presentations of HepB vaccines contain latex, which may cause allergic reactions.”

As the first dose of the HepB vaccine is recommended and usually given on the day of birth this presents a conspicuous problem. How is it possible to know if a newborn has an allergy to yeast or latex or any of the other vaccine ingredients?

While certainly not insignificant, even more alarming safety concerns than yeast and latex allergies have been identified with certain ingredients found in the HepB vaccine.

Until the early 2000s the original gene based HepB vaccines, Recombivax and Engerix, contained the mercury preservative thimerosal, a mercury- and thiosalicylate-containing organic compound with antiseptic, bactericidal, and fungicidal properties. Certain exposures to thimerosal are known to be toxic to the central nervous system, kidneys, liver, spleen, and bone marrow. Some believe that even the tiniest amounts of methylmercury, found in thimerosal, carry a risk of adverse neuropsychological outcomes.

A 2016 longitudinal study of the relationship between Thimerosal-containing hepatitis B vaccination and developmental delays made an assessment that, “During the decade in which Thimerosal-HepB Vaccines (T-HBVs) were routinely recommended and administered to US infants (1991–2001), an estimated 0.5–1 million additional US children were diagnosed with specific delays in development as a consequence of 25 μg or 37.5 μg organic Hg from T-HBVs administered within the first 6 months of life.”

The study added, “[This] study provides compelling new evidence to confirm and extend previous epidemiological studies finding a significant relationship between organic Hg exposure from Thimerosal-containing childhood vaccines and the subsequent increased risk of a diagnosis for specific delays in development.”

A 2018 cross-sectional study published in the International Journal of Environmental Research and Public Health strongly suggested that the 1990s-era thimerosal-containing HepB vaccine caused considerable harm to children concluding, “This cross-sectional study provides new evidence consistent with and extends the results from previous epidemiological and biological studies on the adverse effects of Hg exposure from Thimerosal-containing childhood vaccines. This study supports a significant about nine-fold increase in the risk of adverse effects as measured by receipt of special education services among boys receiving infant Thimerosal-containing hepatitis B vaccination.”

The study added to the chorus of voices demanding thimerosal be removed from all vaccines given to pregnant women and children.

The Food and Drug Administration (FDA) Modernization Act of 1997 called for the FDA to review and assess the risk of all mercury-containing food and drugs.

In 1999 the FDA determined that, “under the recommended childhood immunization schedule, infants might be exposed to cumulative doses of ethylmercury that exceed some federal safety guidelines established for ingestion of methylmercury, another form of organic mercury (Ball et al., 2001). In July 1999, the American Academy of Pediatrics (AAP) and the U.S. Public Health Service (PHS) issued a joint statement recommending the removal of thimerosal from vaccines as soon as possible.”

The statement also recommended, “a temporary suspension of the birth dose of hepatitis B vaccine for children born to low-risk mothers until a thimerosal-free alternative became available.”

Merck responded by making a new vaccine available immediately, gaining FDA approval for its  thimerosal-free Recombivax HB vaccine on August 27, 1999 with distribution beginning in September.

SmithKline Beecham reformulated its thimerosal-free Engerix-B which the FDA approved in 2000.

Neal Halsey, M.D., director of the Institute for Vaccine Safety, assured the public the new Engerix-B contained only trace amounts of thimerosal (<1 mcg), which will “have no clinically relevant effects making it equivalent to a thimerosal-free product.”

While recommending newborns and infants up to the age of six months avoid vaccinations with thimerosal the CDC still allowed those over the age of six months to receive the thimerosal-containing HepB vaccines.

Even as thimerosal was being phased out of children’s vaccines, safety concerns surrounding ingredients in the Hepatitis B vaccine persisted. Disturbing reports relating to aluminum adjuvants found in the vaccines emerged and continue to this day.

In a 2008 article in Mothering magazine pediatrician Robert Sears sounded alarm bells about the dangers of vaccinations which contained aluminum adjuvants.

While embarking upon an inquiry to see if anyone had actually tested and scientifically assessed “safe” levels of injected aluminum he discovered an FDA document on aluminum toxicity which warned:

“Aluminum may reach toxic levels with prolonged parenteral administration [i.e., injected into the body] if kidney function is impaired. Research indicates that patients with impaired kidney function, including premature neonates [i.e., babies], who received parenteral levels of aluminum at greater than 4 to 5 micrograms per kilogram of body weight per day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading [i.e., toxic buildup in certain body tissues] may occur at even lower rates of administration.”

A second document produced by the American Society for Parenteral and Enteral Nutrition (ASPEN) also emphasized a daily limit of 4 to 5 mcg of aluminum per kilogram (2.2 lbs) of body weight for babies being fed an IV solution containing aluminum.

While neither of these documents mentioned vaccines specifically, both the ASPEN group and the FDA agreed that all injectable solutions for children should be limited to a maximum amount of 25 mcg of aluminum within a 24-hour period.

The FDA’s Code of Federal Regulations explicitly states, “The aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed 25 micrograms per liter ([micro]g/L).”

The unsettling fact regarding the HepB vaccine in regards to aluminum is that each dose, given at birth, 2 months and 6 months, is laced with 250 mcg of aluminum– far exceeding the recommended safe levels for large volume parenteral (LVP) drug products.

In a 2011 study Canadian scientists Professor Christopher Shaw and Dr. Lucija Tomljenovic asked the question, Aluminum Vaccine Adjuvants: Are they Safe?

The answers they discovered are worth quoting at length:

“Aluminum is an experimentally demonstrated neurotoxin and the most commonly used vaccine adjuvant. Despite almost 90 years of widespread use of aluminum adjuvants, medical science’s understanding about their mechanisms of action is still remarkably poor.

Experimental research, however, clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans. In particular, aluminum in adjuvant form carries a risk for autoimmunity, long-term brain inflammation and associated neurological complications and may thus have profound and widespread adverse health consequences.” [Bold added]

“Given that multiple aluminum-adjuvanted vaccines are often given to very young children (i.e., 2 to 6 months of age), in a single day at individual vaccination sessions, concerns for potential impacts of total adjuvant-derived aluminum body burden may be significant. These issues warrant serious consideration since, to the best of our knowledge, no adequate studies have been conducted to assess the safety of simultaneous administration of different vaccines to young children.” [Bold Added]

In a 2013 study, Aluminum in the Central Nervous System: Toxicity in Humans and Animals, Vaccine Adjuvants, and Autoimmunity, Shaw and Tomljenovic concluded, “In young children, a highly significant correlation exists between the number of pediatric aluminum-adjuvanted vaccines administered and the rate of autism spectrum disorders. Many of the features of aluminum-induced neurotoxicity may arise, in part, from autoimmune reactions, as part of the autoimmune/inflammatory induced by adjuvants (ASIA) syndrome.

UK Professor Christopher Exley, known as Mr. Aluminum, has devoted much of his life to studying the dangers of aluminum, with a particular focus on the use of aluminum adjuvants in childhood vaccines.

With numerous studies and papers to his credit Exley is particularly recognized for his discovery which proved that cells known to populate a vaccine injection site actually take up aluminum adjuvant into their cell bodies.

Accompanying this finding was his pioneering revelation that antigens and adjuvants are taken up as separate particles. Both discoveries have implications for the possible role of aluminum adjuvants in instigating serious adverse events distant from the vaccine injection site.

Multiple studies have aligned with Exley’s findings that the intramuscularly injected aluminum vaccine adjuvant is absorbed into the systemic circulation and travels to different sites in the body such as the brain, joints and the spleen where it accumulates and is retained for years post-vaccination.

Cui Bono?

According to statistics, Hepatitis B causes death in fewer than one quarter of one percent of those infected. It is a near certainty that even that rate is an overestimate since deaths of hepatitis B infected drug addicts and alcoholics is more likely due to their habits which destroy their liver and other vital organs and not the disease.

In 1986, five years before the CDC began pushing for vaccination of all newborns, the US had documented fewer than 280 cases of hepatitis B infection in children under age 14. Newborns are probably the least likely human beings on the planet at risk of actually getting hepatitis B.

Given that most infants are not at risk for Hepatitis B in the United States and given the copious documentation linking the Hepatitis B vaccine to various pathologies (here, here and here) we return to the question: Why the fanatical push for universal HepB vaccination for children?

If we look at the HepB childhood vaccination program from a perspective of health and “saving lives” we are confronted with a world of contradictions and manipulations- none of it makes sense.

If looked at it through the lens of power, money and control everything makes perfect sense.

A 2005 letter written by Dr. Marc Girard to the Director General of the World Health Organization referenced a correspondence he had with an Indian colleague, Dr J. Puliyel, on the false data being disseminated by the WHO about the epidemiology of hepatitis B in India. 

This exchange gives us insight into the processes by which a once non-existent threat is turned into a public health crisis and the motives behind this.

Girard noted that, “the mechanisms of the deception described by Dr Puliyel were exactly comparable to those I observed in my own country — and of course with the same results: a plea of “experts” to include hepatitis B vaccination in the national vaccination program, in spite of its costs and, its unprecedented toxicity.” [Emphasis added]

Dr. Girard went on to state: “It is blatant that in the promotion of the hepatitis B vaccination, the WHO has never been more than a screen for an undue commercial promotion, in particular via the Viral Hepatitis Prevention Board (VHPB), created, sponsored and infiltrated by the manufacturers.

In Sept 1998, while the dreadful hazards of the campaign had been given media coverage in France, the VHPB met a panel of “experts”, the reassuring conclusions of which were extensively announced as reflecting the WHO’s position: yet some of the participants in this panel had no more “expertise” than that of being employees of the manufacturers.” [Emphasis added]

Girard also drew attention  to a 1997 interview published in the French journal Sciences et Avenir in which GlaxoSmith Beecham’s business manager admitted, “We started increasing the awareness of the European Experts of the World Health Organization (WHO) about Hepatitis B in 1988. From then to 1991, we financed epidemiological studies on the subject to create a scientific consensus about hepatitis being a major public health problem. We were successful because in 1991, WHO published new recommendations about hepatitis B vaccination.”

This cynical admission by one of the primary manufacturers of the Hepatitis B vaccine offers a glimpse into how the time honored strategy of problem-reaction-solution is applied in the Pharmaceutical Industry

The disease itself is seen as superfluous, all that is necessary is to create the perception that there is a widespread public health crisis which requires a heroic and international medical intervention in the form of a vaccine which, curiously, was already in production leading into the “crisis.”

Such a frank admission reinforces the facts surrounding the history of Hepatitis B, there was little to no problem with this disease until after the vaccine became available and for marketing reasons they had to change the image of the disease.

Tracing the breadcrumbs of the entire production of the Hepatitis B vaccine campaign a pattern emerges which appears to be a non-medical agenda that leads to the reliable predictor-follow the money.

For years vast amounts of financial and political capital were invested in the Hepatitis B vaccine as well as enormous amounts of resources allocated towards research and development. Each new HepB vaccine was hailed as a medical wonder.

Despite these efforts the medical industry couldn’t get people to take the vaccine which meant meager returns on these enormous investments.

To solve this dilemma, and address the sunk costs, the pharmaceutical industry, through its cadre of captured policy makers, invented regulations fashioned to make the vaccines compulsory thusly creating a captured customer base and guaranteeing revenue.

The “at-birth” vaccines have the added benefit, from the manufacturers perspective, of providing “vaccine training wheels” for new parents, conditioning them for a steady routine of immunization appointments.

The 12 million doses of Hepatitis B vaccine administered to children each year in the US alone represents a substantial annual income stream for vaccine manufacturers.

The NY Times reported that the average cost to fully vaccinate a child to the age of 18 in a private doctor’s office soared from $100 in 1986 to $2,192 by 2014.

To get every dose of every recommended vaccine in a private pediatricians office circa 2023 that cost now exceeds a staggering $3,000.

Heading into the 21st century the commercialization of vaccines has expanded into a colossal and profitable global enterprise, and according to International Monetary Fund chief Kristalina Georgieva, vaccine policy is now one of the most important drivers of global economic policy.

A Final Word

In two separate hearings in 1999 Michael Belkin, whose daughter died of Sudden Infant Death Syndrome (SIDS) immediately after receiving a Hepatits B vaccine dosage, called the HepB vaccine policy a ”bureaucratic vaccination program that is on auto-pilot flying into a mountain” and accused CDC bureaucrats of “hav[ing] a vested interest in the status quo.”

Mr. Belkin’s conclusions merit reciting in full:

  • Newborn babies are not at risk of contracting the hepatitis B disease unless their mother is infected.

  • Hepatitis B is primarily a disease of junkies, gays, and promiscuous heterosexuals.

  • The vaccine is given to babies because health authorities couldn’t get those risk groups to take the vaccine.

  • Adverse reactions out-number cases of the disease in government statistics.

  • Nothing is being done to investigate those adverse reactions.

  • Those adverse reactions include numerous deaths, convulsions and arthritic conditions that occur within days after

  • Hepatitis B vaccination. The CDC is misrepresenting hypothetical, estimated disease statistics as real cases of the disease.

  • The ACIP is recommending new vaccines for premature infants without having scientific studies proving they are safe.

  • The U.S. vaccine recommendation process is hopelessly compromised by conflicts of interest with vaccine manufacturers, the American Academy of Pediatrics and the CDC.

While Mr. Belkin was addressing the Hepatitis B vaccination specifically as an injection which may present risks for health complications, the risks of toxicity and adverse reactions for all vaccines is a question that demands far more rigorous scrutiny than has been provided to date.

We hope that this series will provide a framework for a long overdue assessment of this highly contentious medical issue.

Our next installment takes a look at the Rotavirus vaccine.

***
READ MORE VACCINE NEWS AT: 21st Century Wire Vaccine Files

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