The Saga of Pediatric Hepatitis B Vaccination

From the Pink Sheets to the VAERS Reports

by F. Edward Yazbak, MD, FAAP

The pink sheets are the minutes of meetings between the vaccine manufacturers and the vaccine authorities and their committees.

VAERS reports are reports of side effects of vaccines made to the Vaccine Adverse Events Reporting System.

On March 27, 2001, Judy Converse, testifying before the Massachusetts House of Representatives Committee on Education, Arts and Humanities (1), stated the following:

1. • Hepatitis B virus (HBV) infection is not a childhood disease.
2. • No agency, the CDC included, lists children or infants among individuals at risk.
3. • Hepatitis B. (Hep.B) is an adult lifestyle disease spread in the United States primarily by sexua| contact and sharing of needles.
4. • Adults age 20-40 are typically affected and over 90% recover with no permanent effects.
5. • Even for adults, hepatitis B virus incidence is almost a non-issue in the US. Incidence is so low in fact that the Centers for Disease Control and Prevention (CDC) stated in 1997: “State level incidence rates of hepatitis B are deemed unreliable. This item is not amenable to survey data collection due to low incidence. National estimates of hepatitis B incidence are corrected for underreporting by using an algorithm that adjusts reported incidence upward by approximately 6-fold“.
6. • In 2000, there were only 19 cases of HBV infections reported for all age groups in Massachusetts or about 2-3 cases per million MA residents.
7. • HBV infections have steadily declined (10% per year) since 1986, before universal pediatric vaccination was introduced because of safe sex and needle precautions.
8. • A large market had to be created for the new vaccine and the group of infants and children, not at risk of the disease, was targeted.
9. • Administration of the Hepatitis B vaccine to a newborn who is not at risk to prevent an adult lifestyle disease makes as much sense as taking an aspirin on Monday to prevent a hangover on Friday.

Ms. Converse was right on every point.

1. Hepatitis B is a reportable disease. The incidence rate of Hepatitis B in the United States has always been very low, 0.1 to 0.5% compared to 5 to 20% in the Far East and Africa. In 1991, there were 18,003 cases of hepatitis b viral illness in the US with an estimated population of 248 million.

According to the Guide to Clinical Preventive Services,“The number of cases [in the U.S.] peaked in 1985 and has shown a continuous decline since that time”

In 1986, only 279 cases of HBV infections in children under 14 were reported nationwide.

“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,” according to the CDC (1996). (2)

Interestingly, after the Hepatitis B vaccine was recommended for general pediatric use, the CDC released new statistics on the “estimated incidence” of hepatitis B in the US. Now some 1_ million Americans had chronic Hepatitis B, 5000 died annually from liver failure and many others developed carcinoma of the liver. The CDC also added that in the 80s, some 200,000 to 300,000 cases of Hepatitis B occurred annually.

A special committee of the Institute of Medicine (IOM) was convened recently to do “a comprehensive assessment of evidence pertaining to the theory that the hepatitis B vaccine caused what are known as demyelinating neurological disorders, including multiple sclerosis and Guillain-Barré syndrome.” In a press release on May 30, 2002 the committee stated that Hepatitis B vaccination did not cause or trigger neurological illnesses. The committee then took the risk of HBV infections in the unvaccinated to a new high: “In the United States, one out of 20 people will contract the hepatitis B virus through direct contact with the blood or body fluids of an infected person. The younger people are when they become infected, the more likely they will develop the chronic form of the disease. For example, chronic infection is likely to occur in 90 percent of infected newborns and 6 percent of infected adults. They face serious health consequences and no cure. A quarter of those with chronic hepatitis B will die from cirrhosis or liver cancer, including children who will not reach young adulthood. These chronic carriers can infect others. Sometimes a person with the infection has no symptoms at all, and only a blood test can reveal it� Looking at people born in 1998, the Centers for Disease Control and Prevention estimated that about 6,800 perinatal infections and 18,700 infections of infants and children up to the age of 9 would have occurred without immunization. About 12,100 of these children would have developed the chronic form of the disease, and about 3,000 would have eventually died from cirrhosis or liver cancer.” .

Neither the IOM Committee nor the CDC can support such claims.

In May 1999, at a Congressional Hearing on “Hepatitis B Vaccine: Helping or Hurting the Public Health,” Dr. Harold Margolis, Head of the Hepatitis Division of the CDC, was asked about the success of the pediatric Hepatitis B vaccination program. He answered, under oath, that the program was successful and that the number of HBV infections in children under age two had declined from 266 in 1990 to 95 cases in 1997. Statistically those numbers and the difference between them are so small, relative to the total number of toddlers under two, that they are insignificant. Nevertheless Margolis’ own figures are absolute proof that the above statistics from the IOM Committee are wrong.

Hepatitis B: Control measures

Pediatric HBV infections almost always occur by vertical transmission from infected mother to newborn infant.

In many states all expectant mothers are tested for Hepatitis B infection and carrier state. If the mother is positive, Hepatitis B Immune Globulin is administered to the newborn immediately after birth and promptly followed by the first dose of Hepatitis B vaccine. A second dose of the vaccine is administered at age 1 month and a third at age 6 months. It is imperative to identify all affected mothers and to immunize their newborns in order to prevent the development of acute and chronic Hepatitis B infections. The argument raised by the CDC that universal newborn vaccination is advisable because infants who need the vaccine do not sometimes receive it, is not a valid one. Exposing all newborns in the United States to a vaccine with potential side effects, in order to protect very few infants who would have been missed otherwise, is not reasonable. Obstetricians who do not test expectant mothers and pediatricians, who do not follow the recommended protocol, when caring for infants whose mothers are hepatitis b surface antigen positive, are negligent. If the State Boards of Medical Review fail to deal with such poor quality of care, malpractice attorneys will not.

Vaccination of a newborn, whose mother’s immune status is not known, is a sensible precaution.

In addition, there are well-identified pediatric high-risk groups in whom the hepatitis B vaccination is recommended. Among them are children whose parents were born in Alaska, Asia, Africa, the Amazon basin, the Pacific Islands, Eastern Europe and the Middle East; also children potentially exposed to abusive and aggressive infected classmates and those living in the same household with infected adults.

Except for the above listed groups, the risk of hepatitis B in healthy children seems negligible, and the side effects of the vaccine (including death) outweigh its benefits.

In 1997 as an example, Illinois, Massachusetts, New Jersey and Pennsylvania reported NO hepatitis B infections in children under 5; New Hampshire reported 1 case, Washington state reported 2, Michigan 9, and Texas 13 cases. It is not known how many, if any, of those children were vaccinated. In the same year, there were 106 reports to VAERS of serious adverse events in children under five in those same eight states. Of these, ten children died. Thirteen of the serious adverse events and two deaths occurred in children who had received the Hepatitis B vaccine alone.

The “New” Hepatitis B Recombinant vaccine

A common reason often mentioned for mandating Hepatitis B vaccine for general pediatric use is that the infants are “available” while teenagers and young adults who are contemplating risky behavior are not. “Complete control of [hepatitis B virus] infection in high-risk populations probably will continue to be impeded, regardless of the source of the vaccine, by the difficulties inherent in getting vaccine to those who need it most (e.g. health care workers entering the workforce and young newly active homosexual men)” the committee on Hepatitis B contended. “Thus the long-term goal for control of hepatitis B in the U.S, as in the highly endemic areas of the world, is the development of a vaccine that can be used universally in childhood.”(3)

To lump The United States with “the highly endemic areas of the world” to promote the universal use of a vaccine in vulnerable infants is unjustified, unethical and reckless.

The “recombinant” Hepatitis B vaccine is the first recombinant vaccine ever marketed.

One would have expected that both safety and efficacy would have been major priorities with a new concept vaccine. Sadly, they were not.

Efficacy of the Hepatitis B vaccine

Clinical efficacy of the vaccine was never proved prior to marketing.

“Recombinant Hepatitis B vaccine product license applications should not require efficacy studies, FDA’s Vaccines and Related Biological Products Advisory Committee recommended July 28. In a unanimous vote, the committee agreed that FDA should approve recombinant hepatitis B product license applications based on serum antibody tests, instead of requiring clinical trials to demonstrate efficacy in human populations”. (4)

To think and to state, that a vaccine that will be forced on every newborn and on every child in this Country does not need clinical trials and absolute proof of efficacy is preposterous. Thirteen years later, the vaccine manufacturer was still unable to guarantee efficacy: “As with other hepatitis B vaccines, the duration of the protective effect of Recombivax HB in healthy vaccinees is unknown at present, and the need for boosters doses is not yet defined.” (5)

It is presently presumed that the Recombinant Hepatitis B vaccine is effective for 5-9 years and NO MORE than 11 years. It is well known that the incidence of the disease peaks between ages 25 and 35 [20 to 40]. Vaccinating an infant or child, who is not at risk, will not provide immunity years later, when protection is really needed and when risk-taking behavior usually starts. In fact, it can be argued that early childhood vaccination may increase the risk of infection by giving the young adult a false sense of security later in life, when immunity no longer exists, and when avoiding risky behavior is most important.

Safety of the Hepatitis B vaccine

Because of lack of adequate testing before licensure, the safety of the presently used Recombinant Hepatitis B vaccine will always be in question

An article in the June 1, 1984 Journal of the American Medical Association stated:

1. “The result of this study indicates the vaccine � is safe and immunogenic for man.”

The following was the comment by a Merck researcher in relation to that particular study: “The study was conducted among 37 healthy, low risk adult Merck employees who were vaccinated�” (6)

Such a small sample was clearly insufficient, but even when larger groups were later observed, the duration of the follow-up was unacceptably short:

1. “Among 1,252 healthy adults, who were administered the new vaccine and then monitored for five days after each dose, the most frequent complaints were local reactions at the injection site�”(7)

Similar information was still being reported in 2001: “Among 147 healthy infants and children who were monitored for 5 days �”(8)

One has to wonder how the manufacturer actually released the very first recombinant vaccine after only a five-day clinical follow-up period and how the vaccine authorities recommended it for newborns and infants with immature immune systems.

No other new drug or biological has ever been released after such a short clinical observation. It is no wonder that long-term problems and serious immune complications are occurring at alarming rates.

FDA Approval

Just as concerning is the fact that the FDA (Federal Drug Administration) approved and licensed the Recombinant Hepatitis B vaccine in RECORD TIME: within 5 months of the submission of the license application.(9)

This appears to be the shortest approval time ever recorded.

It is well known that the FDA has held up the approval of several valuable drugs and medications for months and years. In fact, it took the FDA 13 months to approve NIX, a shampoo used to treat head lice infestation. (10)

The results of the premature release and the wide use of the Recombinant Hepatitis B vaccine seem to be evident in the number of reports filed with VAERS (Vaccine Adverse Events Reporting System).

VAERS Reports

From 1990 to the end of 2002, there were 9,520 reports to VAERS of children under one year of age who had adverse events shortly after receiving a dose of Hepatitis B vaccine, either alone or with other vaccines. The first report was filed on 10/9/90 and the last on 12/31/02. There were 627 reports of death. In 401 of these, SIDS (Sudden Infant Death Syndrome) was listed as the cause of death. The complications in 284 other infants were felt to be life threatening. There were 4,227 Emergency Room visits and 1,591 infants were hospitalized.

In all, there were 38,600 reports to VAERS concerning adverse events and 753 reports of death, occurring at all ages, shortly after the administration of Hepatitis B vaccine alone or with other vaccines. The complications in 745 survivors were considered life threatening at sometime. There were 14,476 Emergency Room visits, and 3,115 patients were hospitalized. 914 patients became disabled and 224 developed jaundice.

Clearly, there were proportionately more infants’ deaths – under the age of 1 – than there were deaths among individuals older than 12 months of age: 627 deaths in 9,520 reports compared to 126 deaths in 29,080 reports. Deaths among infants less than 1 after Hepatitis B vaccination, alone or with other vaccines were therefore statistically significantly higher than those in adults and children older than 1 year. (X-squared=1,420, P‹0.001).

The proportion of deaths reports among children aged 1 to 5 was about the same as that of adults and children over 5. There were 28 deaths among the 3,752 cases reported in the younger age group compared to 101 deaths among the 15,808 cases over age 5.

As concerning as the clear vulnerability of infants is the fact that in 64% [401/627] of the deaths under 1, the cause of death was listed as SIDS. This finding, never previously reported, deserves attention for two reasons:

1. Hepatitis B vaccination starting in the nursery appears to be a factor in Sudden Infant Death Syndrome
2. The actual problem may be much more serious than even this study reveals. Parents and physicians who believe that the infant’s sudden death is unexplained (or due to the mother’s smoking, the baby’s sleeping position, over bundling etc) are less likely to report the death as a vaccine reaction. Many cases are therefore, in all probability, never reported and the actual incidence of SIDS following Hepatitis B vaccination may be even higher in the first year of life. (11, 12)

The following are the number of reports to VAERS of demyelinating conditions and neurological symptoms occurring shortly after Hepatitis B vaccination: Multiple Sclerosis 50, Guillain Barre’ Syndrome 113, Myelitis/Encephalomyelitis 108, Optic Neuritis 67, Paralysis 342, Ataxia 129, Confusion 51 and Hearing loss 32. Some of these conditions were the subject of the IOM study discussed earlier.

There were 121 reports of autism to VAERS shortly after Hepatitis B vaccination. (1)

HBHEPB is a combination of Hemphilus Influenzae B and Hepatitis B vaccines. The product, which was released in late 1996, is only recommended for infants aged 6 weeks to 15 months and only if their mothers do not have Hepatitis B nor are chronic carriers.

There were 2,863 reports to VAERS where the patient had received HBHEPB either alone or with other vaccines. The first report was filed on 5/22/97 and the last was filed on 12/20/02. During those 5 years, 123 infants died and 71 others were thought to have been in life threatening situations. There were 1,380 patients seen in Emergency Rooms and 405 of them were hospitalized.

It is important to mention that the majority of adverse events are not reported to VAERS and that the report of an adverse event is not documentation that a vaccine caused the event.

The manufacturer of one of the many brands of Hepatitis B vaccine on the market lists multiple side effects occurring in less than one percent of patients receiving that particular product. When one considers the millions of doses used in the United States, this amounts to many cases indeed.

Although the pediatric Hepatitis B vaccine has been available in single unit doses, Thimerosal was always added as a preservative from the time the vaccine was licensed until the middle of 1999. Thimerosal is a mercury derivative, which has been used since the 1930s to assure sterility of multiple dose vaccine vials. Although this discussion is not about mercury toxicity, it must be noted that in the United States mothers have been advised to properly discard mercury thermometers and to limit their intake of tuna and other game fish during pregnancy.

When it comes to the Sad Saga of the mandated Pediatric Hepatitis B Vaccination Program, there are still, twelve years later, more questions than answers. Probably the most baffling question is: why was a new vaccine recommended for a vulnerable infant without risk/benefit analysis and in order to prevent a disease that was not an immediate threat and that had a decreasing incidence?

http://vran.org/vaccines/hepatitis/pediatric-hepb.htm
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