By F. Edward Yazbak MD
The hepatitis B vaccine was hailed as the first “Cancer Vaccine”.
It was probably the least tested vaccine ever marketed and it has resulted in a multitude of reports to the Vaccine Adverse Event Reporting System.
Recommending hepatitis B vaccination for all infants in 1991 was a huge mistake. It still is.
The thimerosal in the single-dose vials of the vaccine may have been responsible, in part, for the sudden increase in autism in the nineties.
It now appears that the wide use of the vaccine in endemic areas was associated with an increase in hepatocellular carcinoma, now due to the much more serious hepatitis C virus infection.
According to the Hepatitis B vaccine Fact Sheet (1) of the Centers for Disease Control and Prevention (CDC):
|•||Hepatitis B vaccine prevents hepatitis B disease and its serious consequences like hepatocellular carcinoma (liver cancer). Therefore, this is the first anti-cancer vaccine.|
|•||Medical, scientific and public health communities strongly endorse using hepatitis B vaccine as a safe and effective way to prevent disease and death.|
This report will partially review some of the politics and shenanigans related to the mandated pediatric hepatitis B vaccination program, probably the most ill-advised vaccine program ever instituted in the United States.
Some of the information that will be presented is from the “Pink Sheets” (PS), the official records of the minutes of meetings between the vaccine manufacturers and the vaccine authorities and their committees. All pink sheets quoted in this report are available for review.
A VAP report devoted to “Pink Sheets” is planned.
Evaluation and licensing
The authors of a report about the hepatitis B vaccine published on June 1, 1984, in the Journal of the American Medical Association (JAMA) stated with assurance that “The result of this study indicates the vaccine … is safe and immunogenic for man.”
The following statements from “Pink Sheets” contradict such a statement.
“The study was conducted among 37 healthy, low risk adult Merck employees who were vaccinated…at 0, 1 and 6 months” [PS 6/4/1984: (p. 37)]
“Merck’s Recombivax HB was approved by the Food and Drug Administration (FDA) on July 23, 1986 within five months of the submission of a license application.” [PS 7/28/1986 (p. 44)]
Note: Of about 50 listed new drugs approved in 1985-1986, no other product was approved in less than 12 months. Licensing NIX, a shampoo for lice, took 13 months. Most other drugs took over 2 years. [PS 2/23/1987 (p. 49, 50, 51)]
“RECOMBINANT HEPATITIS B VACCINE PLAs 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 (PLAs) based on serum antibody tests, instead of requiring clinical trials to demonstrate efficacy in human populations” [PS 8/1/1988 (p. 133)]
Note: Capitalized words reproduced as they appeared on the document.
“Merck reported that 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…” [PS 7/28/1986 (p. 45)]
Sixteen years later, the 5 day rule was still evidently in effect. Regarding the safety of the vaccine in children, the PDR (Physicians Desk Reference) was still stating in 2001 that, “Among 147 healthy infants and children who were monitored for 5 days…”
A second recombinant hepatitis B vaccine was licensed in 1989.
The Hilleman Memo
Maurice R. Hilleman Ph.D., a leading expert on immunization, developed over 40 vaccines and published more than 480 original articles on virology, epidemiology, immunology, and infectious diseases.
Two years ago, a 1991 confidential memo from Dr. Hilleman to the head of Merck’s vaccine division was made public.(2) In the memo, Dr. Hilleman wrote “The regulatory control agencies in some countries, particularly Scandinavia (especially Sweden) but also UK, Japan, and Switzerland have expressed concern for thimerosal, a mercury preservative, in vaccines. Some countries require absence of thimerosal from single-dose package. This trend will probably spread… Sweden is requiring thimerosal free single-dose packaging of all products as soon as can be reasonably achieved. The deadline for DT is January, 1992… “The focal point for present concern is in Scandinavia… The immediate Merck concern is to be able to qualify for sale of single-dose products in Sweden and in Norway and Denmark… The public awareness has been raised by the sequential wave of experiences in Sweden including mercury exposure from additives, fish, contaminated air, bird death from eating mercury-treated seed grains, dental amalgam leakage, mercury allergy, etc… In some instances, public immunization programs may be endangered by public refusal to accept vaccines with thimerosal.”
Dr. Hilleman went on, “For babies: The 25 µg of mercury in a single 0.5 ml dose and extrapolated to a 6 lb baby would be 25X the adjusted Swedish daily allowance of 1.0 µg for a baby of that size… If 8 doses of thimerosal-containing vaccine were given in the first 6 months of life (3 DPT, 2 HIB and 3 Hepatitis B) the 200 µg of mercury given, say an average size of 12 lbs would be about 87X the Swedish daily allowance of 2.3 µg of mercury for a baby of that size.”
To put all this into perspective: In 1991, we have an international expert (and the # 1 US vaccine expert) on vaccines telling the chief of the vaccine division of the largest US vaccine manufacturer that it is imperative to immediately produce mercury-free vaccines for Scandinavian children in order to avoid exposing them to unacceptable levels of mercury and to guarantee a market share.
All this while the CDC and the FDA were introducing a new mercury-containing vaccine and no one, including members of the medical profession, was uttering not a word and doing absolutely nothing, about the copious amounts of mercury that were being injected in American infants.
This sad state of affairs lasted until 1999.
Vaccinate every infant in the United States
In November 1991, the Advisory Committee on Immunization Practices (ACIP) of the CDC recommended that the hepatitis B vaccine be integrated in the pediatric vaccination schedules. Three doses of vaccine were supposedly needed and were originally recommended: the first shortly after birth, the second a month later and the third at six months of age.
In 1996, Comvax was licensed by the FDA and recommended for use at 2, 4 and 6 months of age. Comvax contained HIB and Hepatitis B vaccine. The wide use of Comvax meant that small infants received not only the recommended 3 but actually FOUR doses of hepatitis B vaccine, counting the nursery dose. The same unfortunate situation has been present since 2002 when Pediarix, the 5 in 1 vaccine containing the hepatitis B vaccine was licensed.
There is no possible scientific justification for this situation to continue. Making money for the vaccine companies’ stockholders is not a required function of ACIP members. The neonatal dose of hepatitis B vaccine for infants at no risk should be discontinued. It should have been when combination vaccines containing the vaccine were mandated.
Everyone agrees that it is imperative to identify hepatitis B-infected mothers and to administer hepatitis B immune globulin and the first dose of vaccine to their infants shortly after birth. Obstetricians who fail to identify mothers who are hepatitis B surface antigen positive and pediatricians who fail to treat their infants according to protocol should be exposed and punished. Using the argument that we must vaccinate every healthy American infant because some doctors are careless and irresponsible is ludicrous.
So why did we ever start vaccinating no-risk infants?
According to the investigations editor of United Press International (UPI) the chairman of the vaccine advisory committee (in 1991) said that 30% of children who develop hepatitis B do so because of unknown cases, possibly because of exposure in day care.
It is hard for me to believe that this doctor, who I will not name, really said that. If he did, I challenge him to reveal where he obtained this information.
This same doctor was also quoted as saying that universal hepatitis B vaccination of infants was instituted because the CDC tried to give the shots to teens, but it was hard to get them to show up for all three doses. “So they said, 'Well, we've got a captive audience and we want to give it to the newborns anyways’.” (3) Years later, this statement attempting to blame the CDC for the decision, when he and his committee approved the vaccination program, is still not a sensible excuse.
The fact is that indeed, this wild reasoning had prevailed for years before the recombinant vaccine was licensed: “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)… “Thus the long-term goal for control of hepatitis B in the US, as in the highly endemic areas of the world, is the development of a vaccine that can be used universally in childhood.” [PS 1/14/1985 p. 167]
It should be mentioned that the incidence rate of Hepatitis B virus (HBV) infection 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. When it comes to HBV infection, mentioning the US with these areas is nonsense.
Fifteen years later, there is still no good reason to vaccinate ALL babies born in the United States. On March 14, 2007, the following was still listed among the “CDC’s Hepatitis B Frequently Asked Questions”. (4)
What are the risk factors for hepatitis B?
You are at increased risk of HBV infection if you:
|•||have sex with someone infected with HBV|
|•||have sex with more than one partner|
|•||are a man and have sex with a man|
|•||live in the same house with someone who has chronic (long-term) HBV infection|
|•||have a job that involves contact with human blood|
|•||are a client in a home for the developmentally disabled|
|•||travel to areas where hepatitis B is common|
Who should get vaccinated?
|•||All babies, at birth|
|•||All children 0-18 years of age who have not been vaccinated|
|•||People of any age whose behavior or job puts them at high risk for HBV infection (see risk factors under general information)|
It is now very evident that in 1991, a leading US vaccine manufacturer was rushing to produce Thimerosal-free vaccines for Scandinavian infants while starting to mass produce a new pediatric vaccine containing Thimerosal for use in the United States …for the next eight years.
Thimerosal has been added to vaccines as a “preservative” since the 1930s supposedly to prevent contamination of multiple dose vials. Very strangely and for unknown reasons, much of the recombinant hepatitis B vaccine administered to US newborns and infants from 1991 to 1999 was available in single dose vials containing 12.5 µg of mercury per dose.
The potential mercury load for US infants was 187.5 µg by the age of six months- substantially more than what Scandinavian infants received before 1991. One must keep in mind, that the 187.5 µg of mercury were not evenly distributed over the first 180 days of the baby’s life. Mercury was in fact injected in our infants in relatively large amounts in a very few seconds shortly after birth and at the 2, 4 or 6 month visits for almost eight years.
According to the CDC, individuals chronically infected with the hepatitis B virus are at increased risk for cirrhosis and hepatocellular carcinoma (HCC). To date, the CDC and the vaccine lobby still claim, that hepatitis B vaccination of infants and children in the US is needed because it will ultimately decrease the incidence of hepatocellular cancer.
Until a few months ago, the hepatitis B vaccine was the only cancer vaccine we had in the United States.
A study by El-Serag and Mason, published in the New England Journal of Medicine (NEJM) in 1999, revealed that the incidence of histologically confirmed hepatocellular carcinoma (HCC) had increased from 1.4 per 100,000 population (1976-1980) to 2.4 per 100,000 (1991-1995) with black males being twice as affected as white males. There was also a 41% increase in the mortality rate from primary liver cancer, a 46% increase in related hospitalizations and with time, a significant increase in the incidence of HCC among younger individuals. (5)
Such unexpected findings should have alarmed people in high places. If they did, no one told the rest of us.
Because hepatitis B virus infection is so common in Taiwan, a serious vaccination program has been implemented since the mid 1980s.
Chang et al reported in the NEJM in 1997 that the incidence of pediatric liver cancer had decreased since the vaccination program had been initiated. “The average annual incidence of hepatocellular carcinoma in children 6 to 14 years of age declined from 0.70 per 100,000 children between 1981 and 1986 to 0.57 between 1986 and 1990, and to 0.36 between 1990 and 1994 (P<0.01). The corresponding rates of mortality from hepatocellular carcinoma also decreased. The incidence of hepatocellular carcinoma in children 6 to 9 years of age declined from 0.52 for those born between 1974 and 1984 to 0.13 for those born between 1984 and 1986 (P<0.001).” (6)
Just three years later, when the same team re-evaluated the situation and paid special attention to the sex distribution, disturbing findings emerged. The follow-up study extended from 1981 to 1996 and included all children aged 6 to 14 years who had been diagnosed with HCC: 201 boys and 70 girls in all.
According to the investigators, “The boy-girl incidence ratio decreased steadily from 4.5 in 1981-1984 (before the program's introduction) to 1.9 in 1990-1996 (six to 12 years after the vaccination program was launched). The incidence of HCC in boys born after 1984 was significantly reduced in comparison with those born before 1978 (relative risk [RR], 0.72; P = .002). No significant decrease in HCC incidence was observed in girls born in the same periods (RR, 0.77; P = .20). The incidence of HCC in boys remained stable with increasing age, while an increase of HCC incidence with age in girls was observed. These age and sex effects remained the same regardless of birth before or after the vaccination program.” (7)
The authors concluded: “Our results suggest that boys may benefit more from HBV vaccination than girls in the prevention of HCC.”
Because “No significant decrease in HCC incidence was observed in girls born in the same periods” the girls did not appear to have benefited from the vaccination. In fact, because the “incidence of HCC in boys remained stable with increasing age, while an increase of HCC incidence with age in girls was observed” then the incidence of hepatocellular carcinoma seems to have actually increased among vaccinated girls as they got older – not exactly what the hepatitis B vaccination program was supposed to do.
Because vaccines have risks, administering a vaccine that is ineffective is never justified. Exposing girls to a vaccine that may increase their risk of developing cancer is inexcusable.
B & C
Hepatitis B virus (HBV) infection
According to the CDC, “approximately 10% of all acute HBV infections progress to chronic infection, with the risk of chronic HBV infection decreasing with age… Persons with chronic infection are often asymptomatic and may not be aware that they are infected, yet are capable of infecting others. Chronic infection is responsible for most HBV-related morbidity and mortality, including chronic hepatitis, cirrhosis, liver failure, and hepatocellular carcinoma.
Chronic active hepatitis
develops in over 25% of carriers, and often results in cirrhosis. An estimated
3,000 to 4,000 persons die of hepatitis B-related cirrhosis each year in the
United States. Persons with chronic HBV infection are at 12 to 300 times higher
risk of hepatocellular carcinoma than non-carriers. An estimated 1,000 to 1,500
die each year in the United States of hepatitis B-related liver cancer”. (8)
So, at least 9 out of 10 individuals with acute hepatitis B virus infection get better and have no complications.
Hepatitis C virus (HCV) infection
According to the World Health Organization (WHO): “Hepatitis C has been compared to a “viral time bomb”… about 180 million people, some three percent of the world's population, are infected with hepatitis C virus, 130 million of whom are chronic HCV carriers at risk of developing liver cirrhosis and/or liver cancer. It is estimated that three to four million persons are newly infected each year, 70 percent of whom will develop chronic hepatitis. HCV is responsible for 50-76 percent of all liver cancer cases, and two thirds of all liver transplants in the developed world.
Current estimates are that 3.9 million Americans are chronically infected with HCV, with prevalence rates as high as 8-10 percent in African Americans. Injectable drug use remains the main route of transmission, accounting for nearly 90 percent of new HCV infections. Sexual transmission is thought to be relatively infrequent.
Mother-to-child HCV transmission has been widely documented. The risk of perinatal infection ranges from 3-15 percent in different populations. Transmission is believed to occur in utero, as a consequence of a high viral load in the mother.” (9)
So 7 out of 10 people with HCV infection will develop chronic liver disease or worse problems.
If one could choose between the two illnesses, there would be NO CHOICE.
A study from Taiwan published in the International Journal of Cancer in October 2006 alarmed most medical experts in the Far East. (10)
The investigators who reviewed a total of 18,423 cases of hepatocellular carcinoma over 20 years (1981-2001) concluded:
“Our study demonstrates that the percentage of HBV-related HCC has progressively decreased over the last 20 years. The relative decrease in HBV-related HCC was not due to a decrease in HBV-related HCC death. Instead, it was caused by an increase in HCV-related HCC. Prevention of new HCV infection and the treatment of chronic hepatitis C should be the primary goals, which will result in better control of HCC in the future, even in an HBV-endemic area like Taiwan.”
In other words, even in Taiwan where hepatitis B virus infection is rampant, three teams of experts have concluded that the best way to control hepatocellular carcinoma is to prevent hepatitis C virus infection.
Undoubtedly, the CDC and assorted experts will keep proclaiming that administering the hepatitis B vaccine to an infant at no risk will still prevent hepatocellular carcinoma in the United States.
The “experts” are not likely to mention that there may be 5 million cases of HCV infections in the United States, that the majority of cases is yet to be diagnosed, that 75-85% of affected individuals have chronic disease, that hepatitis C is the leading cause of liver cancer and that it will continue to be - as infected citizens get older. (11, 12)
According to the CDC “at the end of 2003, approximately 1,039,000--1,185,000 persons in the United States were living with HIV/AIDS.” (13)
When evaluating data from VAERS, it is important to note that for any reported event no cause and effect relationship has been established. VAERS is interested in all potential associations between vaccines and adverse events. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.
Related to Hepatitis B vaccine
1990 through January 31, 2007
The fact that the overwhelming majority of neonatal deaths occurred on the day of vaccination or in the next 72 hours, does not seem to have been noticed by anyone at the CDC or the FDA. Interestingly, in 1999, after only 15 reports of intestinal obstruction to VAERS, the CDC recommended that vaccination with Rotashield® be stopped (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4843a5.htm).
|•||The recombinant hepatitis B vaccine was the first cancer vaccine.|
|•||Parents in the United States were told that vaccination of infants starting in the nursery would prevent liver cancer by preventing hepatitis B virus infection.|
|•||While rushing to produce mercury-free pediatric vaccines for Scandinavia in 1991, a vaccine manufacturer introduced a new pediatric hepatitis B vaccine with thimerosal in the United States.|
|•||According to a committee of the IOM, pediatric hepatitis B vaccination and the sharp rise in autism in the 90’s were unrelated.|
|•||The CDC maintains that SIDS deaths occurring 6-72 hours after hepatitis B vaccination are due to the infants sleeping on the belly and to other assorted mysterious causes.|
|•||Presently, the rising incidence of liver cancer is mostly due to hepatitis C infection, a much more serious viral infection for which there is no vaccine. Even in the Far East, where HBV infection is rampant, leading experts are insisting that the best way to control hepatocellular carcinoma is to prevent HCV infection.|
|•||There is already ample evidence that the Human Papilloma Virus (HPV) vaccine, the second cancer vaccine, will create its own set of problems.|
|•||Whether cervical cancer increases or decreases in the next few years remains to be seen.|
|•||As of March 16, 2007, a dose of hepatitis B vaccine costs the CDC $9.00 and the private sector $23.20. A dose of the available HPV vaccine costs the CDC $96.75 and the public sector $ 119.75. Three doses of HPV vaccine are recommended.|
|•||What are we doing?|
For more on the subject: E.E. Mast, H.S. Margolis et al. “A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part 1: Immunization of Infants, Children, and Adolescents.” Dec. 23, 2005 / 54(RR16); 1-23. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5416a1.htm
|3.||UPI investigates: The vaccine conflict by Mark Benjamin, Investigations Editor-7/21/2003. http://www.generationrescue.org/pdf/upi.pdf|
|5.||H.B. El-Serag, A.C. Mason. “Rising incidence of hepatocellular carcinoma in the United States.” N Engl J Med. 1997 Jun 26; 336(26): 1855-9.|
|6.||M.H. Chang, C.J. Chen, M.S. Lai, H.M. Hsu, T.C. Wu, M.S. Kong, D.C. Liang, W.Y. Shau, D.S. Chen.“Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Hepatoma Study Group.” N Engl J Med. 1997 Jun 26; 336(26): 1906-7.|
|7.||M.H. Chang, W.Y. Shau, C.J. Chen, T.C. Wu, M.S. Kong, D.C. Liang, H.M. Hsu, H.L. Chen, H.Y. Hsu, D.S. Chen. “Hepatitis B Vaccination and Hepatocellular Carcinoma Rates in Boys and Girls.” JAMA. 2000; 284: 3040-3042.|
|8.||Epidemiology and Prevention of Vaccine-Preventable Diseases, CDC (Centers for Disease Controls and Prevention), 5th Editon, January, 1999. Hepatitis B - page 225-226.|
|9.||World Health Organization, Hepatitis C, Initiative for Vaccine Research (IVR). Available at http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html|
|10.||Lu SN, Su WW, Yang SS, Chang TT, Cheng KS, Wu JC,Lin HH, Wu SS, Lee CM, Changchien CS, Chen CJ, Sheu JC, Chen DS, Chen CH. Secular trends and geographic variations of hepatitis B virus and hepatitis C virus-associated hepatocellular carcinoma in Taiwan. Int J Cancer. 2006 Oct 15;119(8):1946-52.|
|11.||US Department of Health & Human Services. Viral hepatitis C fact sheet. December 8, 2006. Available at: http://www.cdc.gov/ncidod/diseases/hepatitis/c/fact.htm Accessed February 13, 2007.|
|12.||Edlin BR. Five million Americans infected with the hepatitis C virus: a corrected estimate. Hepatology. 2005;42(suppl1):213A.|
|13.||CDC-MMWR June 2, 2006 / 55(21);589-592 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5521a2.htm|
F. Edward Yazbak, MD, FAAP