As public concern grows over the large and growing number of shots on the Centers for Disease Control and Prevention (CDC) childhood immunization schedule, several critics are sounding the alarm about one shot in particular — the hepatitis B (Hep B) vaccine.
Among the 76 vaccine doses on the schedule, the CDC recommends that every infant born in the U.S. get their first dose of the Hep B vaccine on the day they are born. Studies show that more than 90% of infants typically do so.
By age 24 months, most of those infants have received the recommended three doses of the vaccine.
Hepatitis B is a liver disease caused by the hepatitis B virus (HBV), which can range from a mild, short-term, acute illness lasting a few weeks to a serious, long-term, chronic infection.
The virus is transmitted through bodily fluids, most often via intimate contact such as sex or sharing intravenous (IV) drug equipment. Being an IV drug user is the most common risk factor for the disease.
Infected pregnant mothers can also pass the disease to their infants, but relatively few do — about 25,000 pregnant women per year, or 0.69%, have Hep B, and about 1,000 of them pass it to their babies, according to the U.S. Department of Health and Human Services.
The CDC says, “almost all children and older adults infected with acute HBV recover completely with no lasting liver damage.”
Women can be tested for the disease to see if their babies would benefit from vaccination, but that’s not what the CDC recommends.
Instead, today the Hep B vaccine is required for children to attend either childcare, school, or both, in every state except Alabama.
School-age children don’t fit the profile of those at risk for contracting Hepatitis B. Also, the CDC has no evidence that Hepatitis B has ever been transmitted in a school setting, according to a records search posted on Substack by attorney Aaron Siri, who made the request.
Siri argues the Hep B mandate is about profit, not about protecting children from a contagious disease.
“The Hepatitis B vaccine is a case study in agency capture,” Siri wrote. All children would not be required to take the shot, he said “if pharma didn’t stand to earn billions through a wider mandate of this product.”
The Hep B vaccine market, valued at more than $8 billion in 2023, is projected to grow to over $13 billion by 2032, with the U.S. making up the largest market for the vaccine, Fortune Business Insights reported.
Why did the Hep B vaccine get added to the childhood schedule?
In a Yale Journal of Health Policy, Law and Ethics article, Children’s Health Defense (CHD) CEO Mary Holland questioned the constitutionality of mandating the Hep B vaccine for children to access education, especially given that CDC data show that transmission is unlikely through routine contact among children.
She said the CDC’s position on mass vaccination for children changed after the pharmaceutical companies got legal protection from liability.
When the CDC vaccine advisory committee made its first Hep B vaccine recommendation in 1982, the agency observed that the U.S. was a place of “low HBV prevalence.” CDC officials recommended the shot only for people at higher risk, including healthcare workers, people likely to be in sexual or “needle stick” contact with an infected person and infants born to mothers infected with the virus.
In 1988, the committee called for all pregnant mothers to be screened to determine if vaccination would be necessary. At that time, it was estimated that 16,500 mothers per year were infected and that without vaccination, an estimated 3,500 infants would become chronic carriers.
Later that year, the National Vaccine Injury Compensation Program (VICP), created by the 1986 Childhood Vaccine Injury Act, was established. The law protects vaccine makers from liability for injuries related to vaccines on the CDC’s childhood schedule, and the VICP is meant to provide an alternative means of compensating people who suffer “accidental injury or death” from taking those vaccines.
By 1991, the CDC had begun describing HBV risks differently, stating that the consequences of infection were “major health problems” in the U.S. — even though rates had not changed and the number of children infected with HBV was just a few hundred.
The CDC’s advisory committee concluded that because it was challenging to vaccinate those at risk for HBV, mass immunization against the virus was “the most effective means of preventing HBV infection and its consequences.”
The committee recommended all infants be vaccinated, regardless of their mothers’ hepatitis B status, and the Hep B vaccine was added to the childhood immunization schedule.
Dangers of the Hep B vaccine
Then and now, there are two Hep B vaccines licensed for infants at birth: Merck’s Recombivax HB and GSK’s Engerix-B. Both are made using a genetic engineering technology that was new when the vaccines were developed.
The clinical trials for both brands included only a small number of children, and researchers followed up on safety monitoring with infants for only four or five days in the different trials.
No medium or long-term studies were done, no comparisons were made between vaccinated and unvaccinated subjects, and the vaccines were administered only to healthy babies.
According to the Recombivax HB label, during clinical trials, 434 doses of the drug were administered to 147 healthy infants and children up to age 10, who were each monitored for five days after each dose. During those five days, 10% of infants experienced systemic reactions, including “irritability, fever (≥101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.”
Among the much larger group of 1,252 healthy adults, reactions were wide-ranging and sometimes serious. They included injection site issues and fevers, upper respiratory infections, influenza, body pain, insomnia and hypotension.
The Engerix-B package insert doesn’t specify how many babies were included in its clinical trials. However, it does indicate the trial subjects were monitored for only four days. The insert lists similar adverse events to those of Recombivax HB.
Post-marketing studies, which collect voluntary reports of adverse effects registered in places like the Vaccine Adverse Events Reporting System (VAERS), the Vaccine Safety Datalink, or with the vaccine makers, showed many more serious side effects reported for both versions of the Hep B vaccine.
Examples include immune system disorders like systemic lupus erythematosus, thrombocytopenia, Guillain-barré syndrome, multiple sclerosis, transverse myelitis, febrile seizure, Bell’s Palsy, herpes zoster, encephalitis, and many more.
Premature infants who take either Hep B vaccine have also experienced sleep apnea, which the labels warn about.
The inserts indicate it is impossible to determine whether the vaccine caused any of the reported events. Heritage Foundation Policy Analyst Catherine Pakaluk, Ph.D., criticized this approach to identifying adverse effects.
She wrote:
“To the extent that clinical trial data are insufficient to draw robust safety conclusions, patients are effectively used as test subjects post-licensure, but without knowledge that they are part of the test and without hope that their own adverse experiences will be scientifically useful as they would be in the case of a controlled trial. Voluntary adverse event data are suitable for identifying safety signals, but not for drawing conclusions about real risks.
The available data comes mostly from clinical trials that had small sample sizes, no control groups, and only a few days of follow-up, she added. The only other data source is post-licensure data, “which suffer from a lack of statistical usefulness.”
Peer-reviewed research also links the Engerix B vaccine to CNS inflammatory demyelination — a group of diseases in which the immune system attacks and damages the myelin sheath that protects the brain and spinal cord — namely multiple sclerosis in children.
Studies of children in the U.S. also linked the Hep B vaccine to arthritis, acute ear infections and sore throats. And a 2008 study associated Hep B vaccination of male newborns with autism diagnoses at three times the normal rate.
In a recent presentation about the Hep B vaccine, CHD science team member Heather Ray highlighted other safety concerns. For example, Ray noted that vaccine dosage is the same for newborn infants as it is for adults. Vaccine dosage doesn’t vary for a 7-pound infant or a 210-pound linebacker, she said.
The dose exposes babies to both the genetically engineered antigen and the aluminum adjuvant.
“Aluminum is a heavy metal that’s a proven neurotoxin and can cross the blood-brain barrier,” Ray said. “It has scientifically been shown to cause autism, asthma, autoimmune diseases and other horrendous neurological diseases and chronic illnesses.”
Infants’ organ membrane barriers are more permeable than those of adults, making them more susceptible to aluminum.
Until 2001, the Hep B vaccines also contained 25 micrograms of the mercury-containing preservative thimerosal.
Since the VAERS was established in 1990, there have been 18,950 adverse events reported in children under age 2 following Hep B vaccination, and 31,082 reports in children under age 17.
VAERS has been estimated to contain approximately 1% of adverse events, according to David Kessler, former head of the U.S. Food and Drug Administration (FDA).
Critics say Hep B vaccine poses many risks and no benefits for most babies
In terms of efficacy, the Hep B vaccine package inserts say the vaccine has been shown to produce antibodies to hepatitis B, and “appears to have protected infants whose mothers tested positive for hepatitis B antigens.”
Pakaluk wrote, “Therefore, we can conclude that the vaccine provides a robust antibody response to a disease to which they are not regularly exposed, and how long that antibody response lasts is unknown. In other words, for children not exposed to hepatitis B, there is no known benefit (italics original).”
Substack writer J.B. Handley, who has called for the elimination of the vaccine from the childhood schedule, wrote, “It’s a nearly useless vaccine, unless you are in the tiny minority of babies who have a mother with Hepatitis B.”
The Informed Consent Action Network, in 2020, filed a petition with the FDA demanding that the licensure of the Hep B vaccines be revoked or suspended until their safety was determined in a properly designed clinical trial.
CHD Senior Research Scientist Karl Jablonowski said,
“The CDC immunization schedule was simply not written for most people. The childhood Hep B recommendation is a prominent example. It is a pathogen that is primarily transmitted between humans through dirty needles and unprotected sex.
“In rare circumstances, it may be transmitted between people who live together — if one of them has an active infection — by things like shaving razors. Most children have zero risk factors and zero exposure. Most children should not be vaccinated against hepatitis B.”