Table of Contents
Introduction - Vaccines for Newborns, Infants, and Children.
A Child is Born, and the Injections Begin
The Liver and Its Vulnerabilities
Hepatitis B: The Birth of a New Viral Disease and the Illusion of
Knowledge
What’s in the Syringe?
The Dance of the Epidemiologists
Testing and Crunching the Number
The Subterranean Story
From Science to Policy
“Foreign Aid”
Big Vats, Tainted Blood, and a Nobel Prize Winner Ignored
Anatomy of a Panic
Introduction
Vaccines for Newborns, Infants, and Children
At the time this chapter was being written, the CDC recommended more than 70 vaccine doses for children aged 18 and under. The total reflects the number of individual doses recommended in the CDC childhood immunization schedule from birth through age 18, including booster doses and multi-dose vaccine series.
Before the National Childhood Vaccine Injury Act of 1986, which shielded vaccine manufacturers from civil product-liability claims, the routine childhood immunization schedule in the United States was relatively small and focused primarily on diphtheria, tetanus, pertussis, polio, and measles-mumps-rubella.
In the years that followed, vaccines were gradually added to the childhood schedule for hepatitis B (recommended for infants beginning in 1991), Haemophilus influenzae type b (Hib) (late 1980s–early 1990s), varicella (chickenpox) (1995), pneumococcal disease (2000), meningococcal disease (2005), rotavirus (2006), hepatitis A (mid-1990s, expanded nationally in 2006), and human papillomavirus (HPV) (2006).
Each of these additions expanded the number of doses recommended for children and, correspondingly, the size of the pediatric vaccine market. The shielding of the industry from civil product-liability claims not only removed financial liabil ity from these companies for their products but also removed all practical incentives to make them safe and effective. The number of vaccine doses recommended for children in the United States is substantially higher than in many other developed countries, including nations with child health outcomes comparable to or better than those of the United States, such as Germany, Denmark, Sweden, and Japan.
In the course of writing this chapter, following a Presidential directive to review international vaccination practices, acting CDC Director Jim O’Neill, under HHS Secretary Robert F. Kennedy Jr., ordered that the U.S. childhood vaccination schedule be brought more closely into line with those of other developed countries. Shortly thereafter, the attorneys general of fourteen states, including California, New Jersey, and Michigan, sued the agency, demanding that the previous schedule be fully restored.
One of the vaccinations removed from the childhood schedule is the hepatitis B injection for infants. However, it remains on the schedule for children and adolescents up to age 18 who have not previously received the vaccine.
The procedure for how vaccines are added to the childhood schedule is covered at some length in Chapter X. Briefly: the FDA approves a vaccine for use; the CDC’s Advisory Committee on Immunization Practices (ACIP) then votes on whether to recommend it; the CDC director formally adopts the recommendation; and individual states, which generally follow the federal recommendation, make accepting the vaccine a condition of enrolling in school. This is the path by which local states made more than 70 vaccine doses for children aged 18 and under, a legal requirement for children to receive an education.
“The safety and effectiveness of vaccines—pediatric and otherwise—has been established beyond any doubt”. This is the often-repeated claim made by the CDC and echoed emphatically by the news media, public health officials, and many—though not all—physicians. Yet an obvious logical question arises. If vaccines have been proven safe and effec tive, why did vaccine manufacturers seek liability protection in the first place? And why did the U.S. government grant it? No other industry enjoys this kind of government protection for the products it manufactures and distributes. An industry that produces safe and effective products should not require extraordinary government protection in order to remain in business.
A natural question follows: If vaccines are safe and effective, where is the proof? Simply claiming that something is so does not make it so. One might expect to find an organized and publicly available body of documentation systematically explaining each vaccine on the childhood schedule—how it came to be judged safe and effective, and why it was recommended for routine use in children.
Such a body of documentation would be useful to several groups: pediatricians who oversee the administration of vaccines, media figures who press the public to get vaccinated, state legislators who vote on which vaccines to make mandatory, public school officials who enforce vaccine mandates, and parents and other caregivers who want to make an informed decision regarding an invasive medical procedure required by school authorities. If one sincerely wanted to combat “vaccine hesitancy”, it would be hard to imagine a more useful set of documents.
Instead, if any of the parties listed above wish to obtain a straightforward and comprehensive answer to how a particular vaccine came to be declared safe, effective, and necessary, they must start their quest by piecing together information from a wide array of technical reports, regulatory filings, committee transcripts, and journal articles. The process requires locating documents across multiple government websites and scientific databases and reconstructing the reasoning behind each recommendation from materials that no government agency or medical association has ever assembled into a single, systematic explanation of the schedule as a whole.
In other words, there is no single place where an ordinary citizen—or even a physician—can go to see the complete case for the childhood vaccine schedule laid out in one coherent form. Given the absence of such documentation, it’s reasonable to ask how those who speak with such certainty about the safety and effectiveness of vaccines arrived at their conclusions.
Tracing the science and rationale behind every vaccine on the schedule is beyond the scope of this book. However, in the spirit of helping to “prime the pump”, what follows is the story of how one vaccine—the hepatitis B shot—found its way onto the childhood vaccination schedule, in this case, a vaccine given at birth so far to an estimated 115 million-plus newborns in the US.
Chapter 1
A Child is Born, and the Injections Begin
A child is born.
In hospitals where it is encouraged, and not all encourage it, the newborn is given to its mother to rest on her chest for skin-on-skin contact and a first attempt at breastfeeding for an “undisturbed first hour”.
Roughly 20% of U.S. hospitals advertise this as their ideal and have paid for a specific Baby-Friendly USA certification.1 The remaining 80% may or may not follow this practice.
Where the “undisturbed first hour” ideal is not practiced or upheld, the sequence of events is as follows. The cord is cut within seconds of birth, and the baby is immediately taken from the mother to a radiant warmer across the room or down the hall. There in a heated bassinet under a heat lamp, the baby is dried, suctioned if needed, scored, measured, given a vita min K injection, erythromycin eye ointment, ID bands, and a hepatitis B vaccine injection.
Whether given an undisturbed first hour with their mother or not after the momentous occasion of being born, all babies are eventually removed from their mother’s care for the procedures listed above. In the U.S., universal vitamin K injections at birth started in 1961. Universal hepatitis B vaccine injections started in the U.S. 30 years later, in 1991.
On the surface, the rationale for injecting newborns with vitamin K appears to be very straightforward. It’s stated that all newborns are born with a vitamin K deficiency, and since vitamin K is essential to clotting, insufficient vitamin K can lead to uncontrolled bleeding of the gastrointestinal system, the umbilical stump, or blood vessels in or around the brain. The latter case, a serious one that really causes grave harm, is said to occur in 1 in 14,000 and 1 in 25,000 births.
Missing from the official rationale are three well-established medical facts:
First, the vitamin K deficiency is measured against adult levels. By that standard, infants are “deficient” in numerous substances, including the liver enzymes needed to neutralize substances injected into them.
Second, serious vitamin K deficiencies that have an elevated bleeding risk do not appear out of the blue. Women with epilepsy, clotting disorders, heart conditions, and tuberculosis have their conditions managed by a variety of medications that cross the placenta and actively deplete fetal vitamin K during pregnancy.
Third, if there is a serious bleeding issue, a vitamin K injection after birth is too little too late. The treatment for intracranial bleeding is a full IV of vitamin K. A newborn-sized injection carries only a small fraction of what is needed in an emergency situation.
Without getting too detailed about the content of these injections, there are two brands used in the U.S. – preservative-free Amphastar from International Medication Systems and AquaMEPHYTON from Pfizer.
The primary difference between the two brands is that the one from Pfizer contains benzyl alcohol as a preservative. Pfizer’s FDA-approved product clearly states in its FDA mandated package insert that benzyl alcohol can cause gasping syndrome, neurological deterioration, seizures, intracranial hemorrhage, and death in premature and low birth weight infants. It then goes on to say: “Use benzyl alcohol-free phytonadione formulations in neonates and infants, if available,” and “Whenever possible, use preservative-free phytonadione (vitamin K) formulations in neonates (newborns).”
Given the choice between a product known to have serious side effects – and one that the manufacturer’s own warning label counsels against using – and using one that does not contain harmful preservatives, which brand do most hospitals choose? Getting a precise answer is not easy. It’s up to whoever occupies the hospital’s purchasing offices, but this we do know. A look at International Medication System’s SEC filings reveals that their vitamin K sales are in decline, which they attribute to “increased competition”. Given that they only have one FDA authorized competitor, that means Pfizer’s product is gaining market share.
What is the special virtue of the Pfizer product that makes it increasingly more attractive to hospitals?
The preservative-free International Medication System product comes in single-dose vials. Open it, use it, discard it. Every infant gets a fresh vial. Given that packaging and shipping a vial costs at least as much, maybe more, than what’s in it, this safer approach is more expensive than the Pfizer approach.
Pfizer puts ten doses in a single vial. This means that once opened for an injection, a single vial can be closed and put back on the shelf and drawn from again later up to nine more times. During this period, the vial is not refrigerated. According to United States Pharmacopeia standards, once opened, the vial that contains 10 doses is “good” for 28 days.
How is this 28-day standard enforced and by whom? The pharmacy department delivers the vials to the labor and delivery unit. According to The Joint Commission on Accreditation of Healthcare Organizations, the nurses who open the vials are supposed to note their open date and expiration date on the vial and dispose of any vial past its expiration date. It’s an honor system, and hospitals receive outside audits on this and other medication management practices every three years by the Joint Commission. Dates of when inspections are most likely to occur are predictable (they take place as part of the regular accreditation cycle). Despite this advanced notice and the well-documented phenomenon of hospitals tightening compliance in the period when a survey is expected, between 2020 and 2021, up to 13% of hospitals received Joint Commission citations specifically related to general medication storage violations.
The vitamin K injection, like the hepatitis B vaccine injection, which we will discuss at length in the coming chapters, is made in the following way.
The nurse loads the syringe from the vial and then, holding the newborn’s leg steady with one arm, makes the injections with the other. A newborn will pull away from pain, so the leg has to be held firmly.
The injection is made in the part of the newborn’s thigh that faces outward, midway between the ankle and knee (anterolateral thigh). Newborns have very little muscle. For example, at birth, the deltoid is quite undeveloped, but there is muscular development of the thigh. The reason this part of the thigh is injected is that there are no major blood vessels in it, unlike the inner thighs, which have the femoral artery and vein running through them.
There are some settings in which two practitioners are involved in the process, one to steady the newborn’s leg and one to make the injection, but this is not mandated in U.S. medical practice, where the procedure is usually carried out by a single practitioner. When done according to plan, the needle goes in at a 90-degree angle and is inserted to its full length, 5/8 of an inch, through the skin, through the layer of fat underneath the skin, and directly into the muscle.
There are no large blood vessels on the outer part of the thigh, but that doesn’t mean there are no blood vessels. It’s an anatomical fact that all muscle tissue is infused with blood vessels.
If the goal is to avoid injecting into a blood vessel (and it is in this case), there is a method to ensure that the needle has not inadvertently punctured a blood vessel. It’s called aspiration. In aspiration, the needle is inserted, and the plunger is pulled back. If blood appears in the plunger, that indicates that the needle has punctured a blood vessel, and the practitioner tries in another spot.
For reasons not clear, this traditional common-sense safety protocol has been officially removed from U.S. medical practice when it comes to vaccinations, and no guidance whatsoever has been given regarding the vitamin K injection. In any event, the CDC’s General Best Practice Guidelines for Immunization from the Advisory Committee on Immunization Practices are crystal clear:
“Aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion but before injection) is not necessary because no large blood vessels are present at the recommended injection sites, and a process that includes aspiration might be more painful for infants.”
In his book The Needle’s Secret, researcher Marc Girardot relays a report he received from an expert familiar with the practices of bodybuilders who frequently self-inject steroids. Despite taking great care with the process, including aspirating the needle before the ultimate injection, they report accidentally injecting directly into a blood vessel, and thus the bloodstream itself, on average, 1 to 3 times per 100 injections. The result of this is the carrier oil going directly to the lung, a painful condition called “tren cough” which is accompanied by violent coughing, tightness in the chest, shortness of breath, dizziness, and, subjectively, a feeling of impending doom.
Steroid users are motivated by instant, painful consequences to avoid hitting blood vessels, and yet they do often. Readers will have to speculate on how often a system that injects newborns, without bothering with even the basic precaution of aspiration, routinely creates injection-related adverse reactions in its patients. The reason speculation is needed is that the question had never been researched because the assumption is that it does’t happen because “no large blood vessels are present”. When an intact reacts to an injection with crying, color change, and breathing irregularity, is it a reaction to the pain of the injection or something else?
Roughly thirty years after the introduction of routine vitamin K injections for newborns, the United States adopted a policy of universal hepatitis B vaccination for infants. Current guidelines recommend that the first dose be given within 24 hours of birth.
In practice, the injection is usually administered during the newborn’s first round of processing. Shortly after birth, the infant receives a vitamin K injection, and erythromycin ointment is applied to its eyes (a nineteenth-century German innovation beyond the scope of this book). Basic measurements such as weight and length are recorded, and an identification bracelet is affixed. The hepatitis B vaccine is given either during this first round of processing or at some point within the first 24 hours of life, almost always before the mother leaves the hospital with her baby.
Since 1991, when this procedure was initiated, over 100 million newborns in America have received the Hep B injection at birth. Among developed nations, the U.S. is an outlier. Germany, France, Italy, Spain, the United Kingdom, Sweden, Denmark, Norway, Finland, the Netherlands, and Japan, all countries with measurably better health outcomes for their infants and children, do not recommend the hepatitis B vaccine at birth unless there is a specific medical justification relevant to the child. In contrast, the World Health Organization (WHO) has aggressively and successfully promoted Hep B vaccines at birth in over 110 nations, mostly low- or middle-income countries, particularly in Asia and Africa.
In the chapters that follow, we’ll trace why the U.S. is alone among developed nations in requiring Hep B vaccines at birth, specifically how the idea was sold to the federal government and by whom.
Get a DRAFT of the Book at: https://www.brasscheckbooks.com/hepbbook/
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