March 27, 2001

Testimony before Massachusetts House of Representatives Committee on Education, Arts and Humanities
Room 234, Massachusetts State House,
Boston, Massachusetts 02133

PLEASE SUPPORT HB 1936

I am a board-certified pediatrician trained in infectious diseases and a fellow of the American Academy of Pediatrics. I was the Assistant Clinical Director of the Charles V. Chapin Hospital in Providence, RI, and the Deputy Director for Pediatrics of the Child Development Study at Brown University.

Since 1998, I have devoted my time to autism research, specifically the epidemic increase in autism and the autism-vaccine connection. Prior to that I practiced Pediatrics in Cumberland and North Smithfield, RI for 34 years and was President of the Medical Staff and Director of Pediatrics at Woonsocket Hospital. I was also the School Physician in both Woonsocket and North Smithfield, and my responsibilities included the implementation of all vaccine mandates and all school department health regulations.

The Massachusetts Department of Education is responsible to provide to the children of the State the best possible education in the safest possible environment. It is not and should not be responsible for implementing vaccination mandates except in those situations where the student body is in real danger and at imminent risk.

Hepatitis B does not pose such a risk.

The Hepatitis B vaccine is NOT compulsory for teachers, coaches and janitors (who are at higher risk of exposure to blood).

Hepatitis B Infection: Facts.

“The incidence rate of Hepatitis B in the US has always been very low (0.1-0.5%), even before the vaccine was recommended for general pediatric use in 1991.To quote 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”.

There were 18,003 cases of Hepatitis B reported in 1991, in a total US population of 248 millions. According to the CDC Morbidity and Mortality Weekly Report (October 31, 1997) there were only 10,637 cases of Hepatitis B reported nationwide in 1996, with only 279 cases in children under the age of 14; "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 1997 CDC Prevention Guidelines: A Guide to Action “ 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%)”.

Hepatitis B: Control measures

In Massachusetts all expectant mothers are tested for Hepatitis B. If the mother is positive, the newborns are given Hepatitis B Immune Globulin immediately after birth and started on the Hepatitis B vaccine series. It is imperative to identify all affected mothers and to immunize their newborns in order to prevent them from developing acute and chronic Hepatitis B infections.

Other well-identified pediatric high-risk groups are:

A. Children whose parents were born in Alaska, Asia, Africa, the Amazon basin, the Pacific Islands, Eastern Europe and the Middle East.

B. Children potentially exposed to abusive and aggressive infected class-mates

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.

The Hepatitis B Recombinant vaccine

The reason for mandating Hepatitis B vaccine for general pediatric use is illogical. It is universally accepted that such mandate was forced upon our children only because they were “available” while efforts to vaccinate high-risk adults had repeatedly failed. “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.” (Pink sheet, January 14, 1985 p.167)

To lump The United States with “the highly endemic areas of the world” to promote universal use and increased sales of a vaccine is unjustified and reckless.

Efficacy of the Hepatitis B vaccine

When it comes to proving efficacy prior to vaccine licensing, the evidence is scarce.

“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” (Pink Sheet 50 (31): T&G-4-T&G-5, August 1, 1988 p 133 To think (and to state) that a vaccine that will be forced on every child in this Country does not need clinical trials and absolute proof of efficacy is preposterous.

In fact to this day, SIXTEEN YEARS later, the vaccine manufacturer still does not 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”. (2001 Physicians Desk Reference (PDR), p 2016)

It is presently presumed that the Recombinant Hepatitis B vaccine is effective for 5-9 years and NO MORE than 11 years. It is known that the incidence of the disease peaks between ages 25 and 35. Vaccinating a child who is not at risk will not protect him or her years later when protection is really needed and risk-taking behavior usually starts. In fact, early childhood vaccination may increase the risk of infection by giving a false sense of security in adulthood, when immunity no longer exists, and when avoiding risky behavior is most important.

Safety of the Hepatitis B vaccine

The safety of the presently used Hepatitis B vaccine was questioned earlier because of the lack of adequate testing prior to licensing.

An article in the June 1, 1984 Journal of the American Medical Association reported that “The result of this study indicates the vaccine … is safe and immunogenic for man” “The study was conducted among 37 healthy, low risk adult Merck employees who were vaccinated…” according to the Merck researchers (The pink sheet 46(23): T&G-3, June 4, 1984)

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

“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…” (The pink sheet 48 (30): 3-4, July 28, 1986, p 47). “Among 147 healthy infants and children who were monitored for 5 days ” (2001 PDR p 2017)

One has to wonder how the manufacturer and the vaccine authorities recommended and actually released the very first recombinant vaccine (a totally new vaccine concept) after only a five-day follow-up period and then went on to mandate it for all children. It has become evident now that long-term problems and serious immune complications are occurring at alarming rates.

No other drug or biological has ever been released after such short clinical observations.

FDA Approval

Most surprising also is the fact that the FDA approved and licensed the Recombinant Hepatitis B vaccine in RECORD TIME: within 5 months of the submission of the license application. (The pink sheet, 48 (30): 3-4, July 28, 1986, p 46). This appears to be the shortest approval time ever recorded.

In fact, in the same pink sheet, on page 48, there is a statement to the effect that it took the FDA 13 months to approve the NIX shampoo for lice.

It is well known that the approval of several good medications was held up for months and years by the FDA. In fact, approved pharmaceutical products are listed in the official records as: Licensed after 48 months, Licensed after 72 months etc.

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

As of 5/31/00, there were 18,525 events reported. 6,900 cases required ER visits, 1,606 were hospitalized, and 344 were listed as life threatening. There were 387 deaths related to the vaccine. Other listed outcomes were 332 disabled, 4,782 unknown recovery and 1,395 recovered. Many more events have been reported in the last twelve months. When one considers the statement of the former head of the FDA that at most 10% of adverse events are actually reported to VAERS, the picture becomes immensely more alarming. The vaccine manufacturer lists in the PDR multiple side effects occurring in less than one percent of cases. This is also just as alarming because it represents an impressive number when more than 60-70 million American children are to be immunized and BY FAR exceeds the number of cases of childhood Hepatitis B infections.

In conclusion, I respectfully request that the Joint Committee on Health Care reconsider the Hepatitis B vaccine policy in our Massachusetts schools. The risks of this particular vaccine far outweigh any possible benefit for our children.

The continued mandate of this vaccine with all its problems may result in parents losing faith in vaccine programs in general, and opposing all vaccinations, many of which we know are necessary and effective.

Respectfully submitted,

___________________ F. Edward Yazbak, MD

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