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This is the first of a 3-part article excerpted from the National Vaccine Information Center (NVIC) based in Vienna, Virginia. To read the other two parts of the article or see a great deal more information about vaccine safety, please see NVIC’s website,

Hepatitis B Vaccine: The Untold Story

Parents Question Forced Vaccination As Reports of Hepatitis B Vaccine Reactions Multiply

by Barbara Loe Fisher, author of DPT -- A Shot in the Dark

n 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." End of Part 1. Please see the next issue for the continuation, or visit