October 09, 2009
By J.B. Handley
Hepatitis B Vaccine: An Unmitigated Disaster
As most readers of AoA know, the Hep B vaccine was added to the CDC’s
childhood immunization schedule in the early 1990s, requires four doses before a
child is eighteen months old, and is the only vaccine on the CDC’s schedule that
is recommended to be given on an infant’s first day of life.
What else do we know about this vaccine? Quite a bit, actually. In no particular
1) A recent study published in the journal Neurotoxicology called “Delayed
Acquisition of Neonatal Reflexes in Newborn Primates Receiving a
Thimerosal-containing Hepatitis B Vaccine: Influence of Gestational Age and
Birth Weight” found that monkeys who received a Hepatitis B vaccine on the first
day of life experienced a significant delay in survival reflexes versus monkeys
who received a placebo.
2) A recent study published in the journal the Annals of Epidemiology titled
“Hepatitis B Vaccination of Male Neonates and Autism” found that “Boys who
received the hepatitis B vaccine during the first month of life had 2.94 greater
odds for ASD [autism] compared to later- or unvaccinated boys.”
3) A recent study published in the journal Neurology called “Hepatitis B vaccine
and the risk of CNS inflammatory demyelination in childhood” found that the
Engerix B vaccine for Hep B (the one my son received) appears to increase the
risk of central nervous system inflammatory demyelination.
4) A recent study published in Toxicological and Environmental Chemistry titled
“Hepatitis B triple series vaccine and developmental disability in US children
aged 1-9 years” stated "the odds of receiving EIS [special education services]
were approximately nine times as great for vaccinated boys as for unvaccinated
boys after adjustment for confounders. This study found statistically
significant evidence to suggest that boys in United States who were vaccinated
with the triple series Hepatitis B vaccine, during the time period in which
vaccines were manufactured with thimerosal, were more susceptible to
developmental disability than were unvaccinated boys."
5) In 2002, the Institute of Medicine (which I personally believe is a corrupt
agent of the vaccine industry but many believe is the final word on medical
issues) published a study titled, “Immunization Safety Review: Hepatitis B
Vaccine and Demyelinating Neurological Disorders” in which they reached the
following non-conclusion: “Additionally, the committee found that the
epidemiological evidence favors rejection of a causal relationship between the
hepatitis B vaccine in adults and multiple sclerosis. However, the evidence was
inadequate to accept or reject a causal relationship between the hepatitis B
vaccine and all other demyelinating conditions.” (Author’s note: If you’re a
vaccine, and you can’t get an “all clear” from the vaccine-loving IOM, you’re in
6) Generation Rescue analyzed the vaccine schedules of 30 first-world countries.
60%, or 18 countries, have Hep B vaccine on their schedule. That means 12
countries, or 40% of the countries, DO NOT require the Hep B vaccine, despite
the fact that it has been readily available for 19 years. Of countries that do
require Hep B vaccine, we could only find a few Eastern European countries like
Bulgaria and Latvia who also give the shot to babies on the first day of life.
Many other countries appear to pursue a more balanced approach to Hep B vaccine,
here are some direct quotes from country vaccination schedules.
The Hepatitis B vaccine addition to the U.S. vaccination schedule for children
is a wildly destructive disaster for seemingly little benefit to public health.
The science proving what a disaster it is will keep coming.
- Italy: “Hepatitis B vaccine is administered at birth only to children
born to HBsAg + mothers. Otherwise immunisation starts at 3 months of age.”
- Finland: “Hepatitis B vaccine is given only to infants of HbsAg
- carrier mothers or fathers at the age of 0, 1, 2 and 12 months.”
- Denmark: “Vaccination against hepatitis B is recommended to children of
HBsAg-positive mothers starting at birth with both hepatitis B
immunoglobulin and one dose of HepB.”
- Norway: “HepB is recommended for risk groups only.”
- Sweden: “HepB is only recommended to children considered high-risk
groups. Vaccination is given at birth to infants of mothers positive for
- The Netherlands: “Only for children born to HBsAg positive mothers.”
I’d like to wrap this piece up with two remarkable statements from a very
courageous father, Michael Belkin, who
lost his infant daughter to a Hepatitis B vaccine. And, it’s not only this dad’s
command of the facts that makes his statements remarkable, it’s also because
these statements were delivered in public, to both the Advisory Committee on
Immunization Practices, the very group that added Hep B to our schedule, and the
U.S. Congress, TEN YEARS AGO:
TESTIMONY OF MICHAEL BELKIN BEFORE THE ADVISORY COMMITTEE ON IMMUNIZATION
PRACTICES -- CENTERS FOR DISEASE CONTROL AND PREVENTION (February 17, 1999) --
My name is Michael Belkin. I am a father, businessman, former quantitative
strategist at Salomon Brothers, and Director of the Hepatitis B Vaccine Project
of the National Vaccine Information Center (NVIC).
The NVIC has studied Vaccine Adverse Event Reporting System (VAERS) data
obtained under the Freedom of Information Act covering the last nine years on
hepatitis B vaccine adverse events -- and in 1996 there were more than three
times as many reported serious adverse reactions as reported cases of the
disease in the 0 to 14 age group. Of the total 2,424 adverse event reports made
between 1990 and October 1998 in children under age 14 who only received
hepatitis B vaccine, there were 1,209 serious events and 73 deaths. Thus, one
half of the reports for children under age 14 who received only hepatitis B
vaccine were for serious events that required an emergency room visit,
hospitalization, or caused life-threatening health problems or permanent
As a UC Berkeley graduate and advisor to some of the largest financial
institutions in the world, I am qualified to analyze and make conclusions about
statistics. Based on that experience, I am astonished that the scientists on
this Committee would disregard or cover up data showing the number and severity
of adverse reactions to this vaccine. Science is observing and learning from
what is observed. The assertions of the CDC that the many reported adverse
reactions to this vaccine do not exist or are a coincidence violates the basic
principle of science, which is rooted in the observation and analysis of data.
A benefit/risk analysis of the hepatitis B vaccine for the average infant in
America, not born to infected parents, must conclude that the VAERS data on
adverse reactions shows the real-world risk of a newborn infant dying or being
injured by the hepatitis B vaccine is a greater threat than the remote chance of
contracting the primarily blood-transmitted disease.
My 5-week old daughter, Lyla Rose, died within 16 hours of her hepatitisB
vaccination, which she received because of the universal vaccination policy this
Committee instituted in 1991. At her death, Lyla had four of the eight
highest-reported symptoms in the VAERS hepatitis B vaccine adverse reaction
data. The NY Medical Examiner observed brain swelling at the autopsy but refused
to record that or mention the hepatitis B vaccine Lyla received in the autopsy
I hold each one of you who participated in the promulgation or perpetuation of
that mandated newborn vaccination policy personally responsible for my
daughter's death and the deaths and injuries of all the other beautiful, healthy
infants who are victims of the hepatitis B vaccine. Your negligence is the
proximate cause of my daughter's death and you have failed to exercise
At the NVIC, we are overwhelmed following up constant new reports of deaths,
seizures and autoimmune reactions following hepatitis B vaccination. Because the
CDC refuses to acknowledge this large number of serious adverse reactions,
hospitals and doctors who have been misled about the risks continue to
administer the vaccine and then deny any vaccine connection when children die,
get ill or have seizures within hours or days. CDC officials tell parents they
have never heard of hepatitis B vaccine reactions.
That is a lie. For this government to continue to insist that hepatitis B
vaccine adverse reaction reports do not exist is negligent, unethical -- and is
a crime against the children of America.
It is a sad day for the U.S. when the nation's children need protection from the
official medical authorities who are charged with protecting them from disease.
MICHAEL BELKIN TESTIMONY TO U.S. CONGRESS (Tuesday May 18, 1999)
My daughter Lyla Rose Belkin died on September 16, 1998 at the age of five
weeks, about 15 hours after receiving her second Hepatitis B vaccine booster
shot. Lyla was a lively, alert five-week-old baby when I last held her in my
arms. Little did I imagine as she gazed intently into my eyes with all the
innocence and wonder of a newborn child that she would die that night. She was
never ill before receiving the Hepatitis B shot that afternoon. At her final
feeding that night, she was extremely agitated, noisy and feisty -- and then she
fell asleep suddenly and stopped breathing. The autopsy ruled out choking. The
NY Medical Examiner ruled her death Sudden Infant Death Syndrome (SIDS).
But the NY Medical Examiner (Dr. Persechino) neglected to mention Lyla's swollen
brain or the hepatitis B vaccine in the autopsy report. The coroner spoke to my
wife and I and our pediatrician (Dr. Zullo) the day of the autopsy and clearly
stated that her brain was swollen. The pediatrician Dr. Zullo's notes of that
conversation are "brain swollen ... not sure cause yet ... could not see how
recombinant vaccine could cause problem."
SIDS is a diagnosis of exclusion ..it wasn't this, it wasn't that, everything
has been ruled out and we don't know what it was. A swollen brain is not SIDS.
Through conversations with other experienced pathologists, I subsequently
discovered that brain inflammation is a classic adverse reaction to vaccination
(with any vaccine) in the medical literature.
I set out to do an investigation of the Hepatitis B vaccine and attended a
workshop at the National Academy of Sciences, Institute of Medicine on
"Neo-Natal Death and the Hepatitis B Vaccine," the Advisory Committee on
Immunization Practices (ACIP) February meeting, and a debate in New Hampshire
between the Chairman of the ACIP, Dr. Modlin, and Dr. Waisbren about the safety
of the Hepatitis B vaccine. I also obtained the entire Vaccine Adverse Events
Reporting System (VAERS) database on Hepatitis B vaccine adverse reactions and
have investigated it thoroughly.
These are my conclusions, supported by the following pages of text and analysis
that are too lengthy to present in entirety in the time allotted for this
appearance. Please read the results of my investigation, as it will help you
understand the magnitude of the hepatitis B vaccine issue.
* 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
* 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
* 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
Conclusion: If (as with the recently-recommended rotavirus vaccine) Hepatitis B
vaccine was recommended in 1991 without scientific proof that it was safe in a
broad sample of racially and genetically diverse babies less than 48 hours old
before they established that recommendation, then the CDC has been experimenting
on babies like guinea pigs and this Committee should suspend that universal
The Hepatitis B vaccine was effectively mandated in 1991 for universal
immunization of newborn babies by the Advisory Committee on Immunization
Practices (ACIP) -- an adjunct of the Centers for Disease Control and Prevention
(CDC). Paradoxically, the CDC's own Fact Sheet on the Hepatitis B disease does
not include newborn babies as a risk group for that disease. That Fact Sheet
lists the risk groups as injection drug users, homosexual men, sexually active
heterosexuals, infants/children of immigrants from disease-endemic areas, low
socio-economic level, sexual/household contacts of infected persons, infants
born to infected mothers, health care workers and hemodialysis patients NOT
Question: Why then, did the ACIP establish a policy mandating that
newborn babies not at risk of the disease be automatically administered the
3-shot Hepatitis B vaccine as their first involuntary indoctrination into the
pediatric care of America?
Answer: Here is that rationale from the original ACIP 1991 statement
establishing the official vaccination policy "Hepatitis B Virus: A Comprehensive
Strategy for Eliminating Transmission in the United States Through Universal
Childhood Vaccination ..." "In the United States, most infections occur among
adults and adolescents ... The recommended strategy for preventing these
infections has been the selective vaccination of persons with identified risk
factors ... However, this strategy has not lowered the incidence of Hepatitis B,
primarily because vaccinating persons engaged in high-risk behaviors,
life-styles, or occupations before they become infected generally has not been
feasible ... Efforts to vaccinate persons in the major risk groups have had
limited success. For example, programs directed at injecting drug users failed
to motivate them to receive three doses of vaccine ... In the United States it
has become evident that HBV transmission cannot be prevented through vaccinating
only the groups at high risk of infection ... In the long term, universal infant
vaccination would eliminate the need for vaccinating adolescents and high-risk
adults ... Hepatitis B vaccination is recommended for all infants, regardless of
the HBsAg status of the mother ... The first dose can be administered during the
newborn period, preferably before the infant is discharged from the hospital,
but no later than when the infant is 2 months of age ..." (emphasis added).
So in the CDC and ACIP's own words, almost every newborn U.S. 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. That is the essence of the Hepatitis B universal vaccination
Question: What are the risks and benefits for administering this vaccine
Answer: Hepatitis B is a rare, mainly blood-transmitted disease. In 1996,
only 54 cases of the disease were reported to the CDC in the 0-1 age group.
There were 3.9 million births that year, so the observed incidence of hepatitis
B in the 0-1 age group was just 0.001%. In the Vaccine Adverse Event Reporting
System (VAERS), there were 1,080 total reports of adverse reactions from
Hepatitis B vaccine in 1996 in the 0-1 age group, with 47 deaths reported. Total
VAERS Hepatitis B reports for the 0-1 age group outnumber reported cases of the
disease 20 to 1.
Question: Why don't they just screen the mother to see if she is infected
with Hepatitis B (since that's about the only way a baby is likely to get the
disease), instead of vaccinating all infants?
Answer: Selling vaccines is extremely profitable and the process of
mandating vaccines is fraught with conflicts of interest between vaccine
manufacturers, the ACIP and the American Academy of Pediatrics. The business
model of having the government mandate everyone must buy your product is a
Question: What studies are being done on the data from the FDA's Vaccine
Adverse Event Reporting System (VAERS)?
Answer: Absolutely nothing. The 25,000 reports are going into a drawer
and being forgotten.
How many reports are enough to show a drug or vaccine is dangerous -- 2,500?
25,000? 250,000? Chen of the CDC and Ellenberg of the FDA monitor this data,
write reports and deliver speeches about how VAERS Hepatitis B adverse reaction
reports show nothing out of the ordinary and show "the relative safety of HB
vaccine when given to neonates and infants." VAERS shows nothing of the kind.
TAKE A LOOK AT THE VAERS DATA YOURSELF.
The health authorities continue to negligently downplay the steady stream of
serious adverse reactions to this vaccine and more infants and adults continue
to die and suffer central nervous system and liver damage after HB vaccination.
Question: Why do the CDC, ACIP and Merck say that there are
140,000-320,000 new infections/yr (70,000-160,000 symptomatic infections/yr)
when their own CDC data shows only 10,000 reported cases year?
Answer: They are passing off estimated, hypothetical numbers as actual
cases. This is statistical fraud. In the financial world such mis-representation
would lead to criminal charges. If a company inflated its earnings or revenues
by 300% (as the CDC does hepatitis B disease statistics) and foisted those
figures off as official data (and not some back-of-the-envelope guess-timate) --
that company would be investigated by the SEC and sued by shareholders. Why
doesn't that happen in the medical world? There's no regulator to keep the CDC
honest. They do not say those figures are hypothetical estimates, they
misrepresent the data. Go try to audit those 320,000 supposed new infections/yr.
You will not find them. The whole exercise is designed to increase public
hysteria about the risk of a low-risk disease so the CDC can extend it's
pervasive influence and Merck can increase it's $900 million/year vaccine
Question: What process does the Center for Disease Control employ to make
a vaccine recommendation?
I attended the February Advisory Committee on Immunization Practices (ACIP)
meeting in Atlanta and was absolutely appalled. Every vote by the Committee on
new vaccine mandates was unanimous (except for one dissenting vote on Rotavirus
vaccine for premature infants). There was hardly any discussion of adverse
reactions, the ACIP simply rubber-stamped every proposal on the agenda. I call
it Vaccination Without Representation. In one instance, the ACIP passed a
recommendation for Rotavirus vaccine for premature infants even though no
scientific studies had been done showing it was medically safe. Dr. Modlin,
(Chairman of the ACIP), said in a pro-Hepatitis B vaccine debate in New
Hampshire "How do we determine whether something is scientifically valid or not?
... 1) Is the theory biologically plausible? 2) Has it been tested by
appropriate methods? 3) Is the study well concluded? 4) Are the results
statistically sound?" But at the February ACIP meeting, when it came time for
the ACIP to rubber-stamp approval of Rotavirus vaccine for premature infants,
here are Modlin's quotes from the official transcript: "... available data are
insufficient to fully establish the safety and efficacy of rotavirus vaccine in
premature infants ... there is a section under Adverse Events that details what
little information there actually are with respect to premature infants ... To
my knowledge we don't have data from a clinical trial specifically ... Some bit
of information from Seattle, as I recall, that had suggested there was a slight
increase in relative risk for hospitalization for premature infants ...
Obviously a situation where we have to make a judgment in the absence of data,
and with a vaccine that has not yet been tested in the group ..." (ACIP
transcript, pages 102-112) Modlin then held a vote and the recommendation for
premature infants passed nine to one -- Modlin voted yes, Dr. Glode against.
This is a clear example of how the medical bureaucracy (led by the CDC and
ACIP), is recommending vaccines without scientific evidence that those vaccines
are safe in a broad sample of racially and genetically diverse infants.
What Should Be Done? This Committee should investigate the 1991 ACIP
recommendation establishing universal hepatitis B vaccination of newborn babies
in the hospital -- and if (as with the Rotavirus vaccine example above) no
studies were done to prove this was safe in a broad sample of racially and
genetically diverse babies less than 48 hours old before they established that
recommendation, then the CDC has been experimenting on babies like guinea pigs
and this Committee should suspend that universal immunization policy.
VAERS ANALYSIS (Vaccine Adverse Event Reporting System)
I studied statistics at the University Of California at Berkeley and went on to
develop sophisticated proprietary risk/reward statistical models at Salomon
Brothers from 1986-91 -- and in my subsequent, ongoing business provide
statistical economic and financial forecasts to mutual funds, investment banks,
pension funds and hedge funds.
I studied VAERS Hepatitis B vaccine data obtained by the National Vaccine
Information Center (NVIC) under the Freedom of Information Act. The data has
some flaws (incomplete fields, some multiple reports) but any qualified,
impartial quantitative analyst or statistician not affiliated with Merck,
Smithkline, the CDC, the FDA or the AAP who examines these reports will find a
clear and undeniable pattern of central nervous system (CNS) and liver disease
striking thousands of people within 0-4 days after vaccination with Hepatitis B
vaccine. These reports have been ignored, explained away, or considered
"acceptable" by the FDA, CDC and drug companies. This Committee should launch an
investigation of the VAERS Hepatitis B data by a team of independent scientists
not beholden to vaccine manufacturers or the FDA/CDC bureaucracy. The following
is intended to be a starting point for such an investigation. This does not
profess to be a complete, exhaustive analysis -- simply an overview,
highlighting aspects of the data that may not previously have been brought to
The total 24,775 VAERS Hepatitis B reports from July 1990 to October 31, 1998
show 439 deaths and 9673 serious reactions involving emergency room visits,
hospitalization, disablement or death. Therefore, more than one third of total
reports were serious events. 17,497 of those total reports were for Hepatitis B
vaccine only, the remainder were vaccine cocktails where hepatitis B was
administered along with DPT, HIB, IPV, OPV, etc.
The Hepatitis-B-vaccine-only reports show a shocking cluster of reactions in
females starting in their teenage years (the male/female reporting ratio is
balanced before age 16). For ages 16-55, 77% of VAERS reports are women -- more
than three times as many women as men are reporting adverse reactions to
Hepatitis B vaccine. The median onset of adverse event after vaccination is one
day, 70% of reactions happen within four days of vaccination. Independent
scientists should investigate why females are more disposed to have adverse
reactions to Hepatitis B vaccine and/or report them to VAERS. One possible
explanation is that nurses have to take this vaccine for their jobs and are thus
more exposed than most adults to Hepatitis B vaccine adverse reactions. Rather
than dismiss that factor as an "over-reporting bias" as Dr. Chen of the CDC did
at the February ACIP meeting, perhaps investigators might consider that nurses
are alert health care workers and ought to be listened to with regard to the
dangers of adverse events with any vaccine (rather than ignored). Personal case
studies reported to the author have showed many teenage girls getting severe,
debilitating adverse reactions to Hepatitis B vaccine, having nothing to do with
nursing. Do women have a greater vulnerability to auto-immune reactions to
Hepatitis B vaccine? Is the government discriminating against women by
administering this vaccine without regard for genetic risk of CNS and liver
disease? Those are questions that independent scientists should investigate.
A second area of concern is the VAERS reports involving Hepatitis B vaccine
administered with other vaccines (vaccine cocktails). Health officials are fond
of dismissing those reports as being attributable to Hepatitis B vaccine,
because of the multiple other antigens present (almost as if they wanted to
cloak Hepatitis B vaccine reactions from scrutiny). Let's avoid that controversy
and focus on the extremely disturbing VAERS data of Hepatitis B vaccine with
other vaccines. These reports amount to only one third of total reports (7,275),
but account for two thirds of total deaths (291). The median onset of those
deaths was 2 days after vaccination -- displaying a clear temporal association.
The median age of death was 0.5 years in this group. 50% of all
Hepatitis-B-vaccine-cocktail reports were serious (died, emergency room,
hospitalized, disabled). I grouped convulsive reactions together from the
Hep-B-vaccine-cocktail data and found a deeply disturbing pattern. These were
anything labeled convulsions, seizures or tremors in the VAERS Hep-B-cocktail
data. Of the 1189 such reports, fully 80% (950) were serious (died, ER,
hospitalized, disabled) median age 0.5 years, median onset after vaccination 0
days (less than one day). Someone should do follow-up and find out what happened
to those poor infants who suffered severe convulsions after a Hepatitis
B-multi-vaccine cocktail. In the personal reports I've taken of similar adverse
reactions, the children were left brain-damaged and developmentally disabled.
Looking beyond the debate over whether VAERS reports of vaccine cocktails can be
attributed to Hepatitis B, the data strongly suggests combining multiple
vaccines may be convenient and profitable for pediatricians -- but fatal or
debilitating for infants. Where are the scientific studies showing Hepatitis B
vaccine is safe to administer with DPT, HIB, IPV, OPV, etc.? Did anyone doing
cost/benefit analysis for those studies include data showing the higher
mortality and serious reactions present in the VAERS data? Why not? Is there an
identifiable genetic marker in those who suffered convulsive reactions to screen
out those vulnerable in the future? These are all matters for independent
scientists to audit.
Another area that leaps out of the VAERS database is something I dubbed
arthritic reactions. These are joint pains, tingling, numbness, aching, fatigue,
etc. I found 2,400 of those reports in just a quick survey of the first
reporting column of VAERS (Hepatitis B vaccine only). Almost one half of those
are serious, involving an ER visit, hospitalization, death or disablement. These
are the type of adverse reactions reported by many adults who are forced to take
the Hepatitis B vaccine for their jobs. In the reports of such adverse reactions
I've taken, the symptoms do not go away, most patients complain it gets worse
over time. Scientists not corrupted by drug company or CDC/FDA institutional
bias should examine the thousands of VAERS Hepatitis B arthritic reaction
reports and develop a diagnosis of their Hepatitis B vaccine-related illness.
Anyone who doubts if Hepatitis B vaccine adverse reactions exist should sit down
and read the symptoms and text comments of a random selection of VAERS reports.
When one does so, they will find a similar but wide-ranging list of CNS and
liver reactions that occur within days of vaccination. The Merck package insert
claims "Injection site reactions and systemic complaints were reported following
17% and 15% on the injections, respectively." The standard rule of thumb is only
about 10% of reactions are reported to VAERS. So the actual number and full
horror of the Hepatitis B vaccine reaction story is potentially much larger than
even VAERS suggests.
J.B. Handley is co-founder of