NVIC Vaccine News

Hepatitis B Vaccine: The Untold Story

By Barbara Loe Fisher
Published September 22, 1998 in Infectious Diseases & Vaccines

Story Summary

    Reproduced from a 1998 NVIC Vaccine Reaction Edition
    Parents Question Forced Vaccination As Reports of Hepatitis B Vaccine Reactions Multiply


In increasing numbers, parents across the country are contacting the National Vaccine Information Center (NVIC) to report opposition to regulations being enacted by state health department officials that legally require children to be injected with three doses of hepatitis B vaccine before being allowed to attend daycare, kindergarten, elementary school, high school or college. Simultaneously, as more schools and employers bow to pressure from government health officials and require individuals to show proof they have been injected with hepatitis B vaccine before being allowed to get an education or a job, reports of serious health problems following hepatitis B vaccination among children and adults are multiplying.

The National Vaccine Information Center (NVIC) maintains that federal and state public health officials are promoting forced vaccination with hepatitis B vaccine without truthfully informing the public about the risks of hepatitis B disease in America or the known and unknown risks of hepatitis B vaccine. Without being provided with accurate and complete information about disease and vaccine risks, citizens cannot exercise informed consent, which becomes a human right when an individual considers undergoing a medical procedure that could cause injury or death.

Following is a general overview of what is and is not known about hepatitis B disease, the hepatitis B vaccine and the politics of hepatitis B vaccination.

Hepatitis B Not Highly Contagious

Unlike other infectious diseases for which vaccines have been developed and mandated in the U.S., hepatitis B is not common in childhood and is not highly contagious. Hepatitis B is primarily an adult disease transmitted through infected body fluids, most frequently infected blood, and is prevalent in high risk populations such as needle using drug addicts; sexually promiscuous heterosexual and homosexual adults; residents and staff of custodial institutions such as prisons; health care workers exposed to blood; persons who require repeated blood transfusions and babies born to infected mothers.

According to CDC Prevention Guidelines: A Guide to Action (1997), a book written by federal public health officials at the U.S. government Centers for Disease Control (CDC), "the sources of [hepatitis B] infection for most cases include intravenous drug use (28%), heterosexual contact with infected persons or multiple partners (22%) and homosexual activity (9%)." According to Harrison's Principles of Internal Medicine (1994), mother to child transmission of hepatitis B "is uncommon in North America and western Europe."

Although CDC officials have made statements that hepatitis B is easy to catch through sharing toothbrushes or razors, Eric Mast, M.D., Chief of the Surveillance Section, Hepatitis Branch of the CDC, stated in a 1997 public hearing that: " although [the hepatitis B virus] is present in moderate concentrations in saliva, it's not transmitted commonly by casual contact."

Hepatitis B Not A Killer Disease For Most

Symptoms of hepatitis B disease include nausea, vomiting, fatigue, low grade fever, pain and swelling in joints, headache and cough that may occur one to two weeks before the onset of jaundice (yellowing of the skin) and enlargement and tenderness of the liver, which can last for three to four weeks. Fatigue can last up to a year. According to Harrison's, in cases of acute hepatitis B "most patients do not require hospital care" and "95 percent of patients have a favorable course and recover completely" with the case-fatality ratio being "very low (approximately 0.1 percent)."

Those who recover completely from hepatitis B infection acquire life-long immunity. Of those who do not recover completely, fewer than 5 percent become chronic carriers of the virus with just one quarter of these in danger of developing life threatening liver disease later in life, according to Robbins Pathologic Basis of Disease (1994), a medical college textbook.

The Guide to Clinical Preventive Services (1996), written under the supervision of the U.S. Department of Health and Human Services (DHHS), states that the risk of developing a chronic hepatitis B infection is higher in infected infants than in infected older children and adults: "Infections during infancy, while estimated to represent only 1-3% of cases, account for 20-30% of chronic infections." Because infants born to infected mothers are at highest risk for developing chronic hepatitis B infections, routine screening of pregnant women for hepatitis B infection is one of the most important public health measures that can be taken to prevent chronic hepatitis B carriers. The Merck Manual (1992), a major medical reference used by physicians, notes that "postexposure vaccination is recommended for newborn infants of hepatitis B positive mothers."

Hepatitis B Low In U.S.

The U.S. and western Europe have always had among the lowest rates of hepatitis B disease in the world (0.1% to 0.5% of the general population) compared to countries in the Far East and Africa, where the disease affects 5-20% or more of the population. According to Guide to Clinical Preventive Services, in the U.S. "the greatest reported incidence [of hepatitis B] occurs in adults aged 20-39" and "the number of cases peaked in 1985 and has shown a continuous gradual decline since that time."

Even though hepatitis B disease is uncommon in the general population in the U.S., it continues to be high among those engaged in high-risk behaviors, especially IV drug use. Guide to Clinical Preventive Services states that "In recent years, a growing number of injection drug users have become infected; currently, between 60% and 80% of persons who use illicit drugs parenterally (through the skin such as with a needle stick) have serologic evidence of [hepatitis B] infection."

In 1991, there were 18,003 cases of hepatitis B reported in the U.S. out of a total U.S. population of 248 million. According to the October 31, 1997 Morbidity and Mortality Weekly Report published by the CDC, in 1996 there were 10,637 cases of hepatitis B reported in the U.S. with 279 cases reported in children under the age of 14 and the CDC stated that "Hepatitis B continues to decline in most states, primarily because of a decrease in the number of cases among injecting drug users and, to a lesser extent, among both homosexuals and heterosexuals of both sexes."

CDC Recommends All Infants Get Hep B Vaccine

Even though hepatitis B is an adult disease, is not highly contagious, is not deadly for most who contract it, and is not in epidemic form in the U.S. (except among high risk groups such as IV drug addicts), in 1991 the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) recommended that all infants be injected with the first dose of hepatitis B vaccine at birth before being discharged from the hospital newborn nursery. A similar recommendation was also made by the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP). This, despite the fact almost nothing is known about the health and integrity of an individual baby's immune and neurological systems at birth.

In 1991, media reports generated by the CDC used hepatitis B disease statistics that were not anchored in documented fact but are still used today to promote mass hepatitis B vaccination. Most of the inflated disease statistics originate with statements generated by the Centers for Disease Control. In the 1991 ACIP Recommendations calling for mass vaccination with hepatitis B vaccine published in the Morbidity and Mortality Weekly Report, the CDC states 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." The CDC gives no scientific reference for this data other than the CDC.

Just one year before the government's call for mass vaccination, hepatitis B vaccine maker SmithKline Beecham in their 1990 hepatitis B vaccine product insert stated, "The CDC estimates that there are approximately 0.5 to 1.0 million chronic carriers of hepatitis B virus in the U.S. and that this pool of carriers grows by 2% to 3% (12,000 to 20,000 individuals) annually."

Federal Recommendations Become State Laws

Because vaccination requirements are controlled by states and not the federal government, in order for federal health officials to achieve their goal of a 100 percent vaccination rate with new vaccines marketed by drug companies, they must persuade states to turn federal vaccine policies into state law. And, because during the past 50 years, most state legislatures have completely turned over the power to mandate vaccines to state health department officials, very infrequently do state legislators take a vote to approve the mandating of a new vaccine such as hepatitis B. So, while American children born in 1948 were only required by state health officials to show proof of smallpox vaccination to enter school, American children born in 1998 are required by most states to be injected with 33 or 34 doses of 9 or 10 different viral and bacterial vaccines to enter school, including three doses of hepatitis B vaccine.

Federal Health Officials Give State Health Officials Money To Force Hep B Vaccination

Following the 1991 CDC recommendation for universal use of hepatitis B vaccine by all children, state health department officials began issuing mandates requiring children to show proof they have been injected with three doses of hepatitis B vaccine in order to attend daycare or school. By the end of 1997, 35 states had regulations on the books requiring children to get 3 doses of hepatitis B vaccine and, yet, only 15 states had passed laws requiring prenatal screening of pregnant mothers for hepatitis B infection.

To encourage states to mandate use of hepatitis B vaccine by all children, federal health officials at the Centers for Disease Control give grants and other financial incentives to state health departments to reward them for promoting mass vaccination. Since 1965, the CDC has given state health departments hundreds of millions of dollars through categorical grant programs to promote mass use of federally recommended vaccines. At the same time, if state health officials do not show federal health officials proof they have attained a certain vaccination rate in their state, federal grants to state health departments can be withheld.

In 1993, the Comprehensive Childhood Immunization Act of 1993 was passed giving the Department of Health and Human Services (DHHS) the authority to award more than $400 million to states to set up state vaccine registries to tag and track children and enforce mandatory vaccination with federally recommended vaccines, including hepatitis B vaccine. The Performance Grant Program rewards a state with either $50, $75 or $100 per child who is fully vaccinated with all federally recommended vaccines, including hepatitis B vaccine and, in 1995, DHHS Secretary Donna Shalala gave the states the power to approve a newborn's social security number in order to set up vaccine tracking registries in more than half the states. The CDC plan is to hook up the state vaccine tracking registries in order to create a de facto centralized electronic database containing every child's medical records.

Pharmaceutical Industry Also Funds Forced Hep B Vaccination

In addition to federal grants, many states get money from the Robert Wood Johnson Foundation (Johnson & Johnson), which operates All Kids Count, to set up vaccine tracking systems to enforce state vaccination mandates. (In 1989, Merck & Co., the U.S. manufacturer of the measles, mumps, rubella (MMR), chicken pox and hepatitis B vaccines, joined with Johnson & Johnson to form Worldwide Consumer Pharmaceuticals Co. with the goal of becoming "one of the premier worldwide consumer products companies." Merck's 1997 vaccine sales reached 1 billion dollars.)

All Kids Count is a project of the Task Force for Child Survival and Development headquartered at The Carter Center (former President Jimmy Carter) in Atlanta, which is directed by former CDC director Dr. William Foege. The Task Force is supported by the World Health Organization, World Bank, Rockefeller Foundation, United Nation's Population Fund and vaccine manufacturers, entities which also sponsor the Children's Vaccine Initiative (CVI). The CVI, headquartered in Geneva, was launched in 1990 at the World Summit for Children and promotes "the development and utilization" of vaccines by all of the world's children.

Forced vaccination with hepatitis B vaccine is also promoted in states by non-profit organizations such as Every Child by Two, founded in 1991 by former First Lady Rosalyn Carter and Betty Bumpers, wife of Arkansas Senator Dale Bumpers. Every Child by Two is funded in part by grants from Merck, Lederle and Connaught, the three largest U.S. vaccine manufacturers.

The non-profit CDC Foundation, which began operation in 1995, has raised more than $15 million in the past four years to augment the CDC's campaign to enforce mass vaccination. The CDC Foundation, the Task Force for Child Survival & Development and vaccine manufacturers funded the recent National Immunization Conference held in Atlanta.

The five-year-old non-profit Immunization Action Coalition operates the Hepatitis B Coalition, which nationally promotes hepatitis B vaccination for all children. Funding comes from private donations, including a grant from SmithKline Beecham, manufacturer of the hepatitis B vaccine, and a new $750,000 grant from the Centers for Disease Control. A newsletter produced by this group contains the assurance that "Everything herein is reviewed by the Centers for Disease Control and Prevention for technical accuracy (unless it is an opinion piece written by a non-CDC author)."

Pharmacists Now Vaccinate

SmithKline Beecham, through the American Pharmaceutical Association, has also funded a nationwide campaign called "Pharmacy-Based Immunization Advocacy" which allows pharmacists to vaccinate children and adults. As of 1998, the Hepatitis B Coalition reports that 23 states have passed laws giving pharmacists the right to sell and administer hepatitis B and other vaccines.

Families Penalized For Refusing Hep B Vaccine

As state health departments accumulate power and money to force vaccination with all federally recommended vaccines, including hepatitis B vaccine, child and adult citizens are punished by both federal and state health officials with economic sanctions for refusing to comply. Refusal to be injected with hepatitis B vaccine can result in citizens being denied an education, including enrollment in daycare, elementary school, high school, college and graduate school; denial of health insurance; denial of employment; denial of federal entitlement benefits for poor children including food under the Women, Infants and Children (WIC) program and medical care under Medicaid. In some states, like Texas, a needy family loses $25 per month per child in state health benefits if all children have not received all federally recommended vaccines, including hepatitis B vaccine.

Hep B Vaccine Licensed By FDA Without Adequate Proof of Long Term Safety

In 1986, the FDA gave Merck & Co. a license to market the first recombinant DNA hepatitis B vaccine, which replaced the old hepatitis B vaccines made from blood taken from human chronic hepatitis B virus carriers. In awarding Merck & Co. and, later, SmithKline Beecham Pharmaceuticals, licenses to market their genetically engineered hepatitis B vaccines in the U.S., the FDA allowed both drug companies to use "safety" studies which only included a few thousand children monitored for only four or five days after vaccination to check for reactions. As "proof" their hepatitis B vaccine is safe to be used in children, Merck & Co. stated in their 1993 product insert that "In a group of studies, 1636 doses of RECOMBIVAX HB were administered to 653 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose."

Merck & Co. found that injection site and systemic complaints, such as fatigue and weakness, fever, headache and arthralgia (joint pain), were reported following up to 17 percent of all hepatitis B injections. Because the FDA did not require drug companies to provide scientific evidence that hepatitis B vaccine does not compromise the immune and neurological systems of children and adults over weeks, months or years post-vaccination, Merck & Co. warns in the 1996 product insert that "As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials" and SmithKline Beecham (1993) has a similar warning that "it is possible that expanded commercial use of the vaccine could reveal rare adverse reactions.

Another warning in the Merck 1996 product insert is "it is also not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity" and "it is not known whether the vaccine is excreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when the vaccine is administered to a nursing woman."

And, although doctors routinely inject hepatitis B vaccine into children along with many other vaccines such as DPT, HIB, MMR and chicken pox vaccine, Merck & Co. state in the 1996 product insert: "Specific data are not yet available for the simultaneous administration of RECOMBIVAX HB with other vaccines."

Hep B Vaccine Efficacy Also Questioned

All vaccines stimulate only an artificial, temporary immunity, and the length of immunity conferred by the hepatitis B vaccine and the future need for more "booster" doses later in life is still not clear. Merck & Co state in their 1996 hepatitis B vaccine product insert that "the duration of the protective effect of RECOMBIVAX HB in healthy vaccinees is unknown at present and the need for booster doses is not yet defined."

In the CDC Prevention Guidelines: A Guide to Action (1997), the CDC states "The duration of protection [of hepatitis B vaccine] and need for booster doses are not yet fully defined. Between 30% and 50% of persons who develop adequate antibody after three doses of vaccine will lose detectable antibody within 7 years but protection against viremic infection and clinical disease appears to persist." If immunity only lasts 7 years, babies vaccinated with hepatitis B vaccine may be candidates for more shots at age seven.

IOM Report Reveals Lack Of Adequate Scientific Studies

In Adverse Events Associated with Childhood Vaccines published in 1994 by the Institute of Medicine, National Academy of Sciences, observations about the limitations of hepatitis B vaccine studies included the statements that "it is important to note that individual trials usually involved a few hundred subjects for study...when larger vaccination programs were monitored, observations of adverse events were necessarily less detailed and less accurately reported" and "the studies were not designed to assess serious, rare adverse events; the total number of recipients is too small and the follow-up generally too short to detect rare or delayed serious adverse reactions."

The IOM report also noted that no controlled observational studies or controlled clinical trials have ever been held to evaluate repeated reports that hepatitis B vaccine can cause Guillain-Barre syndrome; arthritis; transverse myelitis, optic neuritis, multiple sclerosis and other central demyelinating diseases of the nervous system (degeneration of the myelin sheath of the brain that helps transmit nerve impulses); or sudden infant death syndrome (SIDS).

A major conclusion of the Institute of Medicine report was that almost no basic science research has been undertaken to define at the cellular and molecular level the biological mechanism of vaccine-induced injury and death. The report concluded that "The lack of adequate data regarding many of the adverse events under study was of major concern to the committee...the committee encountered many gaps and limitations in knowledge bearing directly or indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunization, insufficient or inconsistent information from case reports and case series...and inadequate size or length of follow-up of many population-based epidemiologic studies…."

Medical Literature Cites Immune System/Brain Damage

During the past decade, there have been many reports in the medical literature (primarily in international medical journals rather than U.S. medical journals) that hepatitis B vaccination is causing chronic immune and neurological disease in children and adults, including lupus: Tudela & Bonal (1992); Mamoux & Dumont (1994); Guiserix (1996); arthritis, including polyarthritis and rheumatoid arthritis: Christan & Helin (1987); Hachulla et al (1990); Rogerson & Nye (1990); Biasi et al (1993),(1994); Vautier & Carty (1994); Hassan & Oldham (1994); Rheumatic Review (1994); Gross et al (1995); Pope et al (1995); Cathebras et al (1996); Soubrier et al (1997); Guillain Barre Syndrome GBS): Shaw et al (1988), Tuohy (1989); demyelinating disorders such as optic neuritis, Bell's Palsy, demyelinating neuropathy, transverse myelitis and multiple sclerosis: Shaw et al (1988); WHO (1990); Reutens et al (1990); Herroelen et al (1991); Nadler (1993); Brezin et al (1993); Mahassin et al (1993); Kaplanski et al (1995); Baglivo et al (1996); Marsaudon & Barrault (1996); Berkman et al (1996); Waisbren (1997); diabetes mellitus: Poutasi (1996); Classen (1996); chronic fatigue: Salit (1993); Delage et al (1993); vascular disorders: Fried et al (1987); Goolsby (1989); Cockwell et al (1990); Poullin & Gabriel (1994); Mathieu et al (1996); Graniel et al (1997); and others.

In 1996, Burton A. Waisbren, M.D., a cell biologist and infectious disease specialist, who is a founding member of the Infectious Disease Society of America and past President of the Infectious Disease Society of Milwaukee, pointed out in the Wisconsin Medical Journal that "there is an increasing number of reports in the refereed medical literature about demyelinizing diseases occurring after an individual has received the hepatitis B vaccination...since the hepatitis B virus itself has been reported to cause autoimmune problems, should we not be wary of giving antigens that seem to have triggered these problems?" Waisbren, in a presentation before a 1996 Institute of Medicine Vaccine Safety Forum, warned that genetically engineered hepatitis B vaccines contain polypeptide sequences that are present in human neurologic tissues such as myelin and that, by a mechanism called molecular mimicry, these polypeptides can act as autoantigens which can induce autoimmune demyelinating diseases of the brain such as multiple sclerosis.

In that same year, Montinari et al published a study in Italy evaluating 30 children and adults, the majority aged 3 to 9 months, who suffered central nervous system disorders, such as seizures and autism, following hepatitis B vaccination. The purpose of the study was to investigate whether there is an immunogenetic basis (autoimmune type) responsible for the demyelination process in the brain that can occur following recombinant hepatitis B vaccination. The authors concluded "autoimmune diseases are more frequent in nations where vaccines are widely used, the so called "clear" communities" and they identified several potential genetic markers that "may visualize risk patients for autoimmune diseases following hepatitis B vaccination.

Montinari's work to identify genetic factors for predisposition to hepatitis B vaccine reactions is important in light of the study in 1989 by Alper et al to identify genetic factors for those who do not respond to hepatitis B vaccination. In that study, the authors concluded that there was genetic predisposition to failure to respond to the vaccine. They stated: "These results support our hypothesis that the production of anti-HBsAg [vaccine-induced antibodies] is a dominant trait and that the inability to produce high titers of anti-HBsAG after adequate immunization is a recessive trait..." The authors concluded that the genetic markers they identified are most prevalent in caucasians of European descent "and is associated with a wide variety of diseases with autoimmune features in this population, including Type 1 diabetes mellitus..."

In 1996, Barthelow Classen, M.D., CEO of Classen Immunotherapies Inc., published an epidemiologic study in the New Zealand Medical Journal and reported that there was a 60 percent increase in Type 1 diabetes (juvenile diabetes) following a massive campaign in New Zealand from 1988 to 1991 to vaccinate babies six weeks of age or older with hepatitis B vaccine. His analysis of a group of 100,000 New Zealand children prospectively followed since 1982 showed that the incidence of diabetes before the hepatitis B vaccination program began in 1988 was 11.2 cases per 100,000 children per year while the incidence of diabetes following the hepatitis B vaccination campaign was 18.2 cases per 100,000 children per year.

Vaccine Injuries Reported At NVIC Conference on Vaccination

At the First International Public Conference on Vaccination sponsored by the NVIC on September 13-15, 1997 in Alexandria, Virginia, physicians and scientists from around the world gathered to speak about vaccine-induced chronic illness. Canadian physician Byron Hyde, M.D., Chairman of the Nightingale Research Foundation, and an internationally recognized authority on myalgic encephalomyelitis (also known as chronic fatigue syndrome), spoke about the data he has accumulated on more than 200 cases of serious immune and neurological dysfunction following hepatitis B vaccination. Dr. Hyde said:

"There was a nurse in Wisconsin who had had two immunizations against hepatitis B. After the second, she started to complain. They insisted that she have three more [shots], full dosage. They gave her the first, she complained of headaches, pain, and they told her this was anxiety neurosis. They gave her the fourth and fifth and she lost I.Q., measurable loss of intelligence, measurable loss in stamina, all of the things you see in the worst cases of ME or chronic fatigue syndrome.....A lot of these cases that we've looked at suggest demyelinating disease, disseminated myelitis, localized injuries, three unexplained deaths...the problem with all of this is that nobody has ever seriously studied it...."

Dr. Hyde was particularly critical of the poor science and medicine that hurts patients. He concluded "Almost all of these people who had adverse reactions after the first immunization, after the second immunization were individuals who had immunological side effects and who told their physicians and the physicians did nothing about it but continued to proceed with immunization... I think part of the problem is the pharmaceutical companies and the governments themselves have attempted to say 'Here, take this sugar pill, it is danger-free, it is a wonderful thing, it has no risk, no problems' and doctors have become lazy and actually believed this dangerous philosophy put out by the pharmaceutical companies and the governments."

Hep B Vaccine Infant Deaths Reported In VAERS

Even though fewer than 10 percent of all doctors report health problems following vaccination, there are more than 16,000 reports of hospitalizations, injuries and deaths following hepatitis B vaccination that have been reported to the U.S. government Vaccine Adverse Event Reporting System (VAERS) since July 1990. There are reports of deaths in infants under one month of age following hepatitis B vaccination in VAERS, with most of the deaths being classified as sudden infant death syndrome (SIDS), even though SIDS is not historically recognized in the medical literature as occurring in babies under two months of age.

One of those death reports was made for a 15-day old baby boy who died within 48 hours of his first dose of hepatitis B vaccine. His father testified at a 1995 Institute of Medicine Vaccine Safety Forum workshop. He described what happened:

"For the first 13 days of his life, Nicholas was no different than any other baby. He ate well. When he slept, he slept well. He acted just like my first son acted when he came home from the hospital." Nicholas was given a hepatitis B shot at his regular check up at the pediatrician's office on the 13th day of his life. His father said:

"That night when I got home from work, I noticed that Nicholas was crying a lot more than usual. In fact, he was screaming some of the time. He was acting differently, but because we had just taken him to the doctor for a checkup and they told us he was a big healthy boy, we thought everything was OK. When he was just acting fussy, like babies sometimes do, we didn't know anything about vaccines or that they can cause problems for some babies."

"Nicholas cried on and off for most of the night. When I got up and went to work the next day, he was still crying on and off. He continued during most of the day and into the evening. The next morning, his mother found him dead in his crib. From the way he looked, he had been dead for several hours."

An autopsy was done the next day. A couple of weeks later, our pediatrician told us over the phone that the autopsy showed Nicholas had died of sudden infant death syndrome. He told us Nicholas was one of the healthiest babies he had ever seen…. What I didn't know then but I know now is that the pediatrician had made a report within 17 days of Nicholas' death to the government's Vaccine Adverse Event Reporting System, VAERS. In VAERS, Nicholas' death is listed as SIDS. Even though I didn't know anything about vaccines or SIDS, something told me that there was a reason why Nicholas died, and I had to find out why."

After seeing an article in the Washington Post about the Institute of Medicine report on adverse events associated with childhood vaccines, Nicholas's father called the National Vaccine Information Center and began talking to experts and researching infant death and vaccines. Eventually a clinical professor of pathology, who had reviewed Nicholas' medical records, autopsy and slides, stated in writing that Nicholas did not die of SIDS but died a cardiac death, caused by passive congestive changes with pulmonary edema and hemorrhage caused by the active immunization with hepatitis B vaccine. The pathologist stated "I do not believe this was a sudden infant death syndrome death. Sudden infant death syndrome is the most abused diagnosis in pediatric pathology. In this particular case, the infant was two weeks old. Sudden infant death at two weeks old is so rare as to be virtually unheard of."

The pathologist went on to say that Nicholas was at high risk for congestive heart failure because his mother had gestational diabetes, but that he would definitely have survived were it not for the stress induced by the hepatitis B vaccination.

Nicholas's father, in his testimony before the Institute of Medicine, asked "How many other newborn babies are dying from the effects of hepatitis B vaccine, but are being wrongly diagnosed as SIDS and no one ever knows the difference? I looked at the computer printouts of VAERS reports at the National Vaccine Information Center, and I saw there were other reports of babies just a few days or weeks old, who have died shortly after hepatitis B vaccination. Many are listed as SIDS deaths, but are they?"

Adults Report Hep B Vaccine Injury And Death To NVIC

As hepatitis B requirements force more adults to get vaccinated as a condition for getting a higher education or working in the health care field, NVIC is receiving more and more reaction reports like this one from a disabled nurse, who recently wrote in:

"24 hours after my first [hepatitis B] shot, I had muscle pain in legs and arms - was told this was 'normal.' Same thing after 2nd shot. Six weeks after 2nd shot I had my first episode of Raynauds [temporary loss of blood flow to fingers resulting in tingling, throbbing, swelling, intense pain] and also began having rashes on arms and neck. At this point it was minor and not constant. I asked if it had anything to do with the vaccine and was told no.

"Six months after the 1st shot, I received the booster. From then (1995) to today, I have constant daily fevers up to 100.5, tormenting rashes and prickling on arms, hands, neck and legs, muscle degeneration, joint pain with restricted movement, difficulty swallowing and Raynauds has become severe.

"I was perfectly healthy until the hepatitis B vaccinations and still all the doctors tell me it has nothing to do with my illness. I had reactions to two of the drugs they tried to treat me with. I am on total disability because of these symptoms. I am an RN but was taught that the vaccines were perfectly safe."

Parents Oppose Hepatitis B Vaccine Mandate In Illinois

In the spring of 1997, a suburban Chicago mother of two daughters, ages 9 and 11, became concerned when she received a notice from the school system stating that her older daughter had to be vaccinated with hepatitis B vaccine by September 1997 or she would be barred from attending school. Although both of Kathy Rothschild's daughters were fully vaccinated with all other childhood vaccines, she didn't know anyone with hepatitis B and couldn't understand why her daughter had to get the vaccine. Her research led her to a public library and then to NVIC.

With the help of Kathy Rothschild's State Senator, Kathy Parker, an agreement by the Illinois Department of Health to not voice opposition, and with support from NVIC members around the state, a bill passed the Illinois Senate 52-2 on March 20, 1997, allowing parents the right to philosophical exemption to vaccination. The bill also created a Task Force and required the Board of Health to hold public hearings to review how Illinois public health employees add new vaccines to state vaccination laws and how they implement those laws.

After the bill overwhelmingly passed the Senate, the Illinois Department of Health went back on its pledge not to oppose the bill and vigorously fought against the bill in the House, successfully killing it in committee before it had a chance to come to a floor vote. However, the health department did agree to roll back the hepatitis B mandate for one year (until September 1998) and to hold three public hearings, which resulted in testimony from physician expert witnesses and parents and reinforced the dangers of hepatitis B vaccine and the need for informed consent rights to be established within state vaccine requirements.

Doctor, Mothers Say Vaccine Safety Data Poor - In a December 1997 public hearing in Chicago before the Illinois Board of Health, Mayer Eisenstein, M.D., M.P.H., who is board certified in public health and preventive medicine, quality assurance utilization review, by the National Board of Medical Examiners and has recently completed a law degree, testified against the proposed hepatitis B mandate. He said: "The idea of giving this vaccine to a one-day old baby, a newborn, is preposterous. There is no scientific evidence for this. In fact, I called up the [hepatitis B vaccine] manufacturer and I had [a representative] come to St. Mary of Nazareth Hospital, where I am Chairman of the Department of Medicine, and I asked him: ‘Show me your evidence on one-day old infants as to side effects [from the hepatitis B vaccine]’ – we have none. Our studies were done on 5 and 10 year olds....As a father, grandfather, a physician, as a lawyer, I want the option of not giving it to my children unless I believe the scientific evidence is there."

Later during the public hearing, a mother whose child reacted to the hepatitis B vaccine testified that "We were told unless we had the shot our children were not getting into school. In the past, I got the shots for my children. So I went and got the [hepatitis B] shot. First shot, my daughter got slightly sick. We didn't associate it with the shot. We associated it with possible flu. Her legs hurt. Her back hurt...."

"The second shot, within two days of this shot, my daughter's symptoms went from mild to severe abdominal pain around the clock. She couldn't eat. She couldn't sleep. Her legs hurt. She broke out in a rash. She had eczema over most of her body. Going to the doctor, we were told it was in her head, that she needed a psychiatrist. Then we decided we would find out for ourselves.

"It was the people who gave me [information on the vaccine], the list that I should have gotten first that said what the reactions were, including severe abdominal pain, eczema, rash, hair loss. My doctor didn't tell me that. I was given a piece of paper that said reactions would be a minimum, maybe a small fever. She had a fever the whole time.

"I never knew any of this existed, and this is $18,000 later, a child who [had to be] out of school for the first three months and was tutored at home. I don't want to see other kids go through this. I think there should be more testing done. I think the parents should know that this shot isn't for something that's easily picked up. This is for sexual transmission or drug use. My child is ten years old. She plays with Barbie dolls and paints her fingernails. She doesn't know about this stuff. I don't want to give her a shot to protect her from something and someplace she's not at yet."

Citizens Make Plea for Informed Consent

Before testifying at a Board of Health public hearing held in Springfield on March 26, 1998, NVIC held a press conference in the State Capitol building. Then, along with scores of Illinois parents who traveled to Springfield to make public comment, NVIC President Barbara Loe Fisher Reverend Robert VandenBosch, President of the American Research Foundation, and Bonnie Dunbar, Ph.D., professor of cell biology at Baylor College of Medicine in Houston, presented formal testimony.

Fisher told the Board of Health "There is a six year old girl named Katherine lying in a bed in Skokie, Illinois unable to lift her head off her pillow or walk to the bathroom. Just 13 weeks ago, Katherine was an ice skater with boundless energy and a dream of going to the Olympics. Her mother didn't want her to get the hepatitis B shot but her pediatrician told her it was a political issue like AIDS and the American Academy of Pediatrics (AAP) was going to mandate the vaccine soon. Katherine got that hepatitis B shot and now she may never skate again. Where were her informed consent rights? And where will the doctors from the state health department and the CDC and the AAP be when her mother carries her up the stairs to the bathroom? And will the state of Illinois pay her medical bills when her insurance runs out after DHHS and the Justice Department oppose giving her federal compensation?"

During limited public comment time, all of the parents asked the Board of Health to allow citizens to follow the judgement of their conscience when making vaccination decisions for their children, including the right to exercise informed consent to vaccination without suffering harassment and punishment at the hands of state health and school officials. Some, like a young man who was kicked out of an Illinois college in the middle of the semester because of his sincere religious beliefs, asked for the right to follow his religious convictions without being punished by doctors employed by the state. He said:

"They have refused to give me credit for this semester and have told me not to attend class and have cancelled my appointment with my advisors. I applied for a religious exemption. Both my parents wrote letters identifying my objection. We were refused on the grounds that, in order for a religious exemption to occur, I must identify 'a recognized church or religious organization.' I don't believe that anyone has a right to judge my religion. How does recognition of my belief by another human being make it more or less? I am confused by the word 'organized.' How does the number of people or the structure under which they operate validate my beliefs? This is a violation of my Constitutional right to religious freedom."

Rev. Robert VandenBosch, an ethicist, warned that "The First Amendment [of the U.S. Constitution] clearly defines the free exercise of religious beliefs and the moral rights of individuals to obey the judgement of their conscience in matters of life and death. The Ninth Amendment of the Constitution guarantees that governmental authority cannot override individual rights of conscience. It states: 'The enumeration of the Constitution of certain rights shall not be construed to deny or disparage others retained by the people.' One of the rights retained by the people is the right of conscience."

Professor Of Cell Biology Investigates Hep B Vaccine Damage

Professor Bonnie Dunbar, Ph.D., who has a distinguished 25 year career in academic and laboratory science and has been honored by the U.S. National Institutes of Health (NIH) for her pioneering work in contraceptive vaccine development, presented at the March 26 Illinois Board of Health hearing and described disabling reactions to hepatitis B vaccine suffered by her brother and a research assistant.

"Three years ago my brother, who is a geologist Ph.D. agronomist with four college degrees, came to work with me at Baylor College of Medicine to work on a collaborative project in molecular genetic engineering of wheat proteins. He was required to take the hepatitis B vaccine. Within 24 hours to four days after the first injection, he had fever and severe fatigue for one week. Two to four weeks after that injection, he ended up with a whole series of symptoms that now 15 doctors have said are clearly symptoms of an adverse reaction to this vaccination. Even workman's compensation for the state of Texas is compensating him for over $300,000 worth of medical expenses."

"At about the same time, a 21-year old girl, a medical student, came to work in my lab for the summer, She, too, had to get the hepatitis B vaccine. After the first injection, she had fever and fatigue. Three weeks following her second injection, she lost vision in her one eye but, after 6 months, regained most of her sight. She was reluctant to get the third dose of vaccine, and talked with her doctor and he told her this [hepatitis B] vaccine is the safest, there's no problem. After the third injection, she ended up in the hospital for two months extremely ill and she has lost all of her eyesight in one eye."

Dr. Dunbar went on to explain to the Board of Health members that during the past three years of collecting data on the hepatitis B vaccine, she has been contacted by hundreds of doctors and patients around the world who have reported severe autoimmune and neurological complications to hepatitis B vaccination in previously healthy children and adults, including serious rashes, fever, joint pain, chronic fatigue, multiple sclerosis and lupus-like symptoms, rheumatoid arthritis and neurological dysfunction. As a basic science researcher with expertise in cell and molecular biology, she is investigating the possibility that molecular mimicry or other autoimmune mechanisms may be the reason why the genetically engineered hepatitis B vaccine "tricks" the immune systems of genetically susceptible individuals into attacking their own bodies, causing debilitating autoimmune disorders.

After analyzing the data she has accumulated, Dr. Dunbar, in collaboration with colleagues at other academic and medical institutions, applied for a NIH research grant to investigate the role that genetic factors may play in hepatitis B vaccine reactions and in vaccine failures. Their goal is to identify genetic markers so high risk children and adults could be screened out of the mass vaccination program and spared injury and death. The grant was turned down twice by the government in July 1997 and July 1998 but Dr. Dunbar and her colleagues are in the process of refiling the grant, along with additional data.

Hep B Vaccine Victims In France Sue

An article in the July 31, 1998 issue of Science, an American scientific journal, reports that French attorneys representing 15,000 French citizens filed a lawsuit against the French government "accusing it of understating the vaccine's risks and exaggerating the benefits for the average person." One French physician has reportedly collected data on more than 600 people suffering from serious immune and neurological dysfunction following hepatitis B vaccination, many with symptoms resembling multiple sclerosis. Science quotes a World Health Organization official as saying "These fears [of the hepatitis B vaccine] are quite unfounded" and reveals that CDC employee Robert Chen, who is responsible for monitoring vaccine safety for the U.S. government, has a simple explanation for the growing number of reports of hepatitis B vaccine associated injury and death in the U.S., Canada and Europe. His scientific analysis leads him to believe that "It's human nature to attribute cause to almost anything that precedes a tragedy."

Hep B Vaccination Can Mean A Positive Hep B Blood Test

A little known fact about hepatitis B vaccine is that those who are vaccinated can test positive for hepatitis B on some routine blood tests. NVIC has received calls from adults who report that, after getting hepatitis B vaccine, they are testing positive for hepatitis B when they undergo routine blood tests in doctor's offices. The Red Cross maintains that more sensitive lab tests used by blood banks can differentiate between hepatitis B antibodies produced by disease and those produced by the vaccine.

HIV vaccines now being tested in humans also produce positive tests for HIV. As noted in a September 1997 Washington Post article about HIV vaccine trials: "Foremost among the worries of many would-be volunteers is the problem of forever testing positive for AIDS antibodies...although sophisticated laboratory tests can usually tell the difference between AIDS antibodies caused by a vaccine and those that indicate a real HIV infection, few laboratories are equipped to make that distinction. Moreover, as vaccines get better by more closely mimicking the real infection, it will become more difficult to distinguish between the two."

Is Forced Hepatitis B Vaccination Paving Way For Forced Vaccination With AIDS Vaccine?

Hepatitis B is the first disease transmitted not by casual contact like smallpox or polio, but by high risk behavior such as IV drug use and sexual promiscuity, that has been mandated for use by all children. With the identical transmission routes as HIV, there are strong indications that forced vaccination of infants and children with hepatitis B is just a trial run for forced vaccination with an AIDS vaccine when it is put on the market in the next few years. AIDS vaccines are currently in human trials as a race to bring them to market intensified after a call last year by President Clinton to make the creation and use of an AIDS vaccine "a national mission."

CDC Plans For Mass Vaccination Of All Children With AIDS Vaccine

In a February 12, 1997 meeting of the CDC's Advisory Committee on Immunization Practices (ACIP), Neal Halsey, M.D., chairman of the American Academy of Pediatrics (AAP) Committee on Infectious Diseases, AAP liaison member of the ACIP and Director of the Institute of Vaccine Safety at John's Hopkins University, reminded HIV vaccine researchers and developers at the meeting that the CDC plans to target 11 to 12 year old children for "universal application" of an HIV vaccine. Halsey told them:

"One of the things that's happened in the past with vaccines is that sometimes the manufacturers have developed them and tested them primarily in an age group or a population which may not be the final target population that this committee has considered. Over the last few years we have developed a statement on adolescent immunization and it probably would be worth your reading that, and others, because we really see age 11 to 12 as the target age for introduction of vaccines for prevention of sexually transmitted diseases. And I know that, at this time, you are really studying adults and you're also some distance away from the actual - having a [HIV] vaccine in hand that might be licensed and approved - but at least it would be nice if there were studies that were planned in parallel when you move another step in the direction of actually having a candidate vaccine, realizing where WE think we would want to use universal application of such a vaccine. And so I think maybe [you should get] a copy of the adolescent immunization statement."

With the Children's Vaccine Initiative (CVI) and pharmaceutical industry setting up the mechanism for global mass vaccination of children and adults, including the creation of national and international vaccine tracking systems, countries with low HIV rates like the U.S. and Europe will be forced to use an HIV vaccine in order to pay for the vaccination of populations in Asia and Africa where HIV infection rates are skyrocketing. In 1996, HIV vaccine developer Stanley Plotkin, M.D., of Pasteur Merieux Pharmaceuticals (who developed the rubella vaccine and has been a vaccine policymaker member of the AAP Committee on Infectious Disease and AAP liaison member of the ACIP) explained why mandatory vaccination in rich countries like the U.S. help deliver vaccines to Third World markets:

"The keystone of the [global mass vaccination] system is that the research costs [of drug companies] are recouped in North America and Europe and the vaccines are sold in the developing world at much, much lower margins...the relatively high rate of childhood vaccination seen lately in most parts of the world is the result of that system," explained Plotkin.

CDC Tells Congress About Future Vaccines

In testimony before the U.S. Senate Committee on Labor and Human Resources in 1997, CDC official Walter Orenstein, M.D., made a bid to persuade Congress to reauthorize 288 million dollars for the CDC's Immunization Grant Program in the $427 million 1998 DHHS budget request for immunization activities. In a review of the history of vaccination, Dr. Orenstein recounted that, although almost a century passed between the development of the smallpox vaccine in 1796 and that of the rabies vaccine in the 1880's, by the middle of the 20th century there were nearly two dozen vaccines on the market.

Painting a picture of the future, Orenstein said: "On the horizon are vaccine technologies that would have been considered science fiction just a decade ago, but are now reported at scientific meetings. Snippets of synthetic DNA have worked as experimental vaccines in animals. Edible plants have been bioengineered to become vaccine factories....vaccines have been enclosed in microscopic capsules, permitting them to be released slowly over time..."

Orenstein reminded legislators that "Every day about 11,000 babies are born in this country. Each of these children starts with immunization coverage of zero. There is why our responsibility to our Nation's children never ends; it must be sustained every day of every year....completing state-based immunization registries is the cornerstone of assuring disease prevention."

Vaccine Registries To Tag, Track, Force Vaccination

Even though CDC officials admit that there is already a 96 percent vaccination rate in the U.S. with federally recommended vaccines, they are setting up state vaccine tracking registries and plan to link them together to create a de facto national electronic tracking system to ensure mass compliance with federal vaccine policies. Citizens will be tagged with a number at birth and tracked even when moving from state to state.

In 1995, DHHS Secretary Donna Shalala appropriated the social security numbers assigned to newborns to allow states to enter all babies in state vaccine tracking systems. In 1996, the Health Insurance Portability and Accountability Act (HIPAA), also known as the Kennedy-Kassebaum legislation, outlined plans for a "unique health care identifier" number, which is an alternative to the social security number, to be assigned to citizens at birth and electronically monitor their medical records, including vaccination records.

In a 1998 CDC publication entitled Initiative on Immunization Registries, the CDC states that "we see [vaccine] registries as a possible first step in the development of an electronic pediatric record" and "computerized registries will eventually be capable of capturing immunization for individuals of all ages" and "until a unique personal identifier can be established on a national basis, multiple means of identification must be used [in state vaccine registries]." Core data that is now collected in many state vaccine tracking systems include a citizen's name, address, phone number, social security number, birth date, sex, race, primary language, patient birth order, patient birth registration number, patient Medicaid number, mother's name (including maiden name) and social security number and father's name and social security number.

Most often state officials automatically enroll newborns into the vaccine registry without informing parents or giving them the right to "opt-out" of the registry. In the state of Texas, PROVE, a parent group led by Dawn Richardson, worked to get legislation passed in 1997 requiring the state health departments to obtain a parent’s prior written consent to enroll a child in a vaccine registry.

The CDC goes on to state that one of their main goals is "establishing a target date to achieve the goal of establishing immunization registries in every community in the Nation" and "promoting the inter-operability of registries with other developing medical information systems" and "promoting the automated exchange of immunization records between registries."

What You Can Do

If you want to make informed, voluntary decisions about hepatitis B vaccination, there are several actions you can take to educate your community and protect your informed consent and privacy rights. Circulate this newsletter in your community among your family, friends, and neighbors. Get reprints by sending in the enclosed reprint order card. Reprints are available for $1.25 each. Bulk pricing is available. Give copies to your doctors, lawyers, teachers, school principals, nurses and others. Send a copy to your favorite newspaper, radio and TV station. Send a copy to your state and federal legislators with a personal letter. Report vaccine reactions by calling NVIC at 1-800-909SHOT or accessing NVIC's website at www.nvic.org. If you are pregnant, get tested for hepatitis B disease. If you are infected, your baby is a candidate for vaccination. Stand up for your informed consent rights. If you do not test positive for hepatitis B; do not fall into one of the high risk categories described in this newsletter; and decide you do not want your newborn vaccinated before leaving the hospital newborn nursery, you can amend the "consent for medical treatment" forms you sign upon entering the hospital before giving birth by writing on the form that you do not give consent for hepatitis B vaccination of your baby in the hospital. Check to see if your state has a vaccine tracking system and, if you do not want your baby enrolled in a tracking system, find out how you can exercise your informed consent rights. Get more information, including checking your state vaccination laws for requirements and exemptions. Hepatitis B vaccine is required in 35 states. There are medical exemptions in all states, religious exemption in all but two states (West Virginia and Mississippi) and philosophical exemption in 16 states. Don't let anyone intimidate or coerce you into taking action before you have had the opportunity to become fully informed about all your options and are comfortable with your vaccination decision.

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