The Hepatitis B Vaccine
Examining Safety and Unveiling Concerns
The safety of vaccines is a crucial aspect of public health, and understanding the details of clinical trials is essential for informed decision-making. Unfortunately, many people blindly follow the “Safe and Effective” statement given by their doctors or public health officials.
We are told that vaccines undergo rigorous safety studies and that they have saved the world. But is that really true? Is there something more, like financial incentives for doctors and pharmaceutical companies? Do the people doing the studies have a vested interest?
These are fair questions that require reflection.
Enter the Hep B Vaccine
One doesn’t have to look very far when starting to investigate. We can start with the very first vaccine given to infants on day 1 of their lives and that is the Hepatitis B vaccine.
Before we look into the clinical trials and safety profiles of these vaccines, please consider the following points and dangers when it comes to vaccinating a newborn for Hepatitis B.
Points for Consideration:
Lack of Justification:
The Hepatitis B vaccine is administered to newborns in the United States despite the low risk of hepatitis B infection for infants. The primary modes of transmission for the disease are through sexual contact or sharing needles, presenting virtually no chance of infection for infants.
Correct me if I’m wrong, but I’m fairly certain no parents are throwing their children into some promiscuous sex ring followed up or combined with intravenous drug use. Forgive me for the sarcasm, but it’s a very valid and logical point.
Issues with Recombinant Vaccines:
The introduction of recombinant vaccines like Recombivax-HB aimed to address safety concerns but raised new issues. Concerns include HepB virus polymerase contamination and the use of genetically modified yeast proteins, potentially leading to autoimmune disorders.
Think of all the children that get put on some type of medication for some chronic illness (allergies, autoimmune issues, etc.) and parents think nothing of it. What’s the one thing they have in common? Vaccines.
Thimerosal Controversy:
Thimerosal, a mercury-based preservative, was initially included in HepB vaccines until concerns about mercury toxicity led to its phase-out in the early 2000s. Thimerosal has been linked to developmental delays and adverse neuropsychological outcomes in children. While the CDC recommends that newborns and infants up to the age of six months avoid vaccinations with thimerosal, it still allows infants over the age of six months to receive the thimerosal-containing HepB vaccines.
Aluminum Adjuvants:
The Hepatitis B vaccine contains aluminum adjuvants in amounts exceeding recommended safe levels. Aluminum is considered a neurotoxin and has been associated with immunological disorders, autoimmunity, and long-term brain inflammation, raising concerns about its impact on young children.
Consider the following:
The FDA’s Code of Federal Regulations explicity 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 about the HepB vaccine with regard to aluminum is that each dose—given at birth, at 2 months, and at 6 months—is laced with 250 mcg of aluminum, an amount far exceeding the recommended safe levels for large volume parenteral (LVP) drug products.
In a 2011 study, two Canadian scientists, Professor Christopher Shaw and Dr. Lucija Tomljenovic, asked a serious question in the title of an article they co-wrote, “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. [Emphasis 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.” [Emphasis added.]
Two years later, in 2013, the same scientists produced another study—this one with a statement of fact rather than a question in its title: “Aluminum in the Central Nervous System: Toxicity in Humans and Animals, Vaccine Adjuvants, and Autoimmunity.“
In this study, 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.
No article on aluminum in vaccines is complete unless it mentions UK chemist Christopher Exley, who is a professor of bioinorganic chemistry and group leader of the Bioinorganic Chemistry Laboratory at Keele University. Known as “Mr. Aluminum,” Dr. Exley has devoted much of his life to studying the dangers of aluminum. His particular focus is on the use of aluminum adjuvants in childhood vaccines.
Credited with conducting numerous studies on the subject, Exley is particularly recognized for his discovery that cells known to populate a vaccine injection site actually take up the aluminum adjuvant from the vaccine into their cell bodies.
Accompanying this finding was his pioneering revelation that antigens and adjuvants are taken up as separate particles.
Both of Exley’s 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.
Lack of Comprehensive Safety Studies:
Despite the identified safety concerns, there is a lack of comprehensive studies assessing the safety of the simultaneous administration of different vaccines to young children. The absence of such studies raises questions about the overall safety of vaccination practices.
The United States has the highest first day infant mortality rate out of all of the industrialized countries in the world. What is it that we give on day 1 that most other countries don’t? The Hepatitis B vaccine.
In this post, we will look into the clinical trials of two widely used hepatitis B vaccines – Engerix-B and Recombivax HB – and expose the glaring concerns about their safety profiles.
Engerix-B Clinical Trials:
In 2017, the Informed Consent Action Network (ICAN) uncovered a startling revelation about the clinical trials for Engerix-B. The package insert (see Section 6.1) revealed that safety data was reviewed for only four days after vaccine administration, a period deemed insufficient for assessing long-term effects, especially in babies and toddlers. The inadequacy of this safety review period raises questions about the reliability of the vaccine's safety profile.
Lack of Age-specific Data:
One notable flaw in GlaxoSmithKline’s pre-licensure trials for Engerix-B is the absence of age-specific data. With 13,495 doses administered in 36 trials, the distribution among adults, children, and infants remains undisclosed. Without this information, the risks associated with vaccinating infants with Engerix-B remain unclear, undermining the reliability of the trial results.
Recombinant Vaccines and Underpowered Trials:
The clinical trials for Merck’s Recombivax HB vaccine also present concerns. Administered to only 147 healthy infants and children in three studies, the trial's small sample size raises questions about the vaccine's safety. Moreover, the short monitoring period of five days after each dose further adds to the skepticism regarding the vaccine's comprehensive safety assessment.
Placebo-controlled Trials and Post-marketing Discrepancies:
Both Engerix-B and Recombivax HB trials lacked proper randomized placebo-controlled designs, a standard in clinical trials. Post-marketing data reveals a stark contrast between clinical trial outcomes and real-world experiences, with more serious adverse reactions reported in the general population. This raises concerns about the adequacy of clinical trials in predicting real-world vaccine safety.
Simply put, there was no saline placebo group in the study, the gold standard when it comes to clinical trials, but magically missing from vaccine trials. It’s tobacco science at it’s best.
ICAN's Legal Challenge:
ICAN, through a nine-hour deposition, highlighted these concerns to Dr. Stanley Plotkin, a prominent figure in vaccine development. The deposition revealed that the hepatitis B vaccine lacked an adequate safety study, with safety monitored for only five days after each dose.
In the deposition, Siri got Plotkin to admit that the hepatitis B vaccine (given to babies on their first day of life) has not had an adequate safety study:
Aaron Siri: “How long does it say that safety was monitored after each dose?”
Dr. Stanley Plotkin: “Five days.”
Siri: “Is that long enough to detect an autoimmune issue that arises after five days?”
Plotkin: “No.”
Siri: “Was there any control group in this trial?”
Dr. Plotkin, who had just argued that control groups are essential to gauge cause and effect, answered, “It does not mention any control group, no.”
ICAN is currently petitioning the FDA to withdraw the licensure of hepatitis B vaccines based on these substantial concerns.
Be Informed and Choose Wisely
The discrepancies between clinical trial outcomes and post-marketing experiences, coupled with the inadequacies in safety monitoring periods, underscore the need for a more thorough examination of hepatitis B vaccine safety.
Informed discussions between healthcare professionals and patients should include a critical analysis of clinical trial details to ensure transparency and foster public trust in vaccination programs.
Unfortunately, this doesn’t happen. Parents are bombarded with scare tactics and promised that vaccines are “safe and effective”. Yet as anyone with logic can see just from the Hepatitis B vaccine, that is far from the truth.
Inform yourself, question everything, and have open discussions with your primary care providers. If they get defensive, belittle you, or have no answer, it’s time to find a new doctor. Simple as that.