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You are here: Home / Specific Vaccines / Hepatitis-B Vaccine / Hepatitis-B Disease and Its Vaccine

Hepatitis-B Disease and Its Vaccine

October 2, 2008 By Vaccine Choice Canada

According to the 2008 Merck Frosst RECOMBIVAX HB® Product Monograph: “The incubation period for type B hepatitis is relatively long: six weeks to six months may elapse between exposure and the onset of clinical symptoms. The prognosis following infection with hepatitis B virus is variable and dependent on at least three factors: (1) Age – infants and younger children usually experience milder initial disease than older persons; (2) Dose of Virus – The higher the dose, the more likely acute icteric [pertaining to jaundice] hepatitis B will result; and, (3) Severity of associated underlying disease – Underlying malignancy or pre-existing hepatic disease predisposes to increased morbidity and mortality.” (emphasis ours)

Regarding possible sources, the 2006 Canadian Immunization Guide states: “HBV [hepatitis B virus] is found mainly in the blood, vaginal secretions, semen and serous fluids of an infected person. It is present in the saliva at concentrations 1,000-10,000 times less than in blood.” The Merck Manual states: “Maternal acute Type B hepatitis during the 3rd trimester of pregnancy or within 2 mo of delivery is associated with a 70% risk of maternal-infant transmission of HBV.” It notes that, “Only 5% of infants born to mothers with acute Type B hepatitis during the 1st or 2nd trimester will develop the disease.” Mothers who are chronic carriers of HBsAg are likely to transmit the disease only if they also carry HbeAg. (see below for explanation of abbreviations)

Regarding possible routes of perinatal transmission, The Merck Manual explains: “Maternal-infant transmission of HBV occurs primarily at the time of delivery through the ingestion of contaminated vaginal contents and through maternal-fetal transfusion. Transplacental transmission is rare. Postpartum transmission may occur through neonatal exposure to infectious maternal blood, saliva, stool, urine, or breast milk.”

The Merck Manual notes that symptoms of hepatitis can range from minor flu-like symptoms to liver failure. Hives and arthralgias may occur as well as jaundice, the latter peaking within 1-2 weeks, then fading during a 2-4 week recovery.

Explaining the intricacies of the hepatitis B virus and their highly variable occurrence, the 2006 ‘Canadian Immunization Guide’ states: “Hepatitis B virus (HBV) is one of several viruses that cause hepatitis. HBV is a double-stranded DNA virus with three major antigens, known as hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg) and hepatitis B core antigen (HBcAg). HBsAg can be detected in serum 30 to 60 days after exposure and persists until the infection resolves. Any person positive for HBsAg is considered infectious. In most cases, anti-HBs appears after HBsAg has disappeared and the infection has resolved. In severe acute HBV infections, anti-HBs may be present simultaneously with HBsAg. In a proportion that varies inversely with age [ie, the older the patient, the greater the effect], infection persists. Anti-HBs confers long-term immunity.

“HBcAg never appears in serum. Anti-HBc develops in all HBV infections, is not protective and persists indefinitely as a serologic marker, both in chronic active infection and in resolved infection after clearance of HBsAg. Anti-HBc IgM is a marker of recent HBV infection. It appears during the first week of acute hepatitis illness and is usually present for 6-12 months. It can be used to diagnose recent acute hepatitis B. In 10%-15% of cases of chronic hepatitis B infection, IgM anti-HBc may also be detected, particularly when a replication HBV is present. HBeAg is associated with viral replication and high infectiousness. Anti-HBe usually indicates a reduction in replicating virus and lower infectiousness. Methods of quantification of HBV DNA in serum are available to assist in determining both infectiousness and prognosis.”

The RECOMBIVAX HB® monograph states: “Persistence of viral infection (the chronic hepatitis B virus carrier state) occurs in 5-10% of persons following acute hepatitis B”. And, Canada, USA and Western Europe have an extremely low prevalence of hepatitis B surface antigen in each of their populations as a whole: “less than 0.5%”. (emphasis ours) The 2006 Canadian Immunization Guide completes the picture of minimal presence in Canada by saying, “Although there are no national data on the prevalence of chronic HBV infection for the whole Canadian population, Canada is considered an area of low endemicity. It is estimated that < 5% of residents have markers of past infection, and < 1% are HBsAg carriers.” (emphasis ours)

Numerous epidemiological studies suggest that antibodies produced during symptomatic hepatitis B infection confer natural immunity to the virus on subsequent exposure. However, concerning long-term immunity from the vaccine, the monograph states: “the duration of protective effect of RECOMBIVAX HB® is unknown at present, and the need for booster doses not defined.” But it also maintains that, “Routine booster vaccinations in immunocompetent persons are not recommended since protection has been shown to last for at least 15 years. Studies of long-term protective efficacy, however, will determine whether booster doses of vaccine are ever needed.” Inscrutably, the monograph adds, “It is important to recognize that absence of detectable anti-HBs in a person who has been previously demonstrated to have anti-HBs does not mean lack of protection, because immune memory persists. Booster doses in this situation are not indicated.”

The only evidence of safety provided by the RECOMBIVAX HB® monograph is data from a group of studies in which a total of only 1252 healthy adults were given up to the recommended three doses of the vaccine and monitored for only five days following vaccination. As usual, the greatest proportion of reactions was of those at the injection site. Post-marketing adverse event reports included serious reactions such as anaphylaxis, other hypersensitivity reactions with onset days to weeks following vaccination, encephalitis, Guillain-Barré syndrome, multiple sclerosis, arthritis, eczema, etc.

The monograph describes the vaccine as “a non-infectious subunit viral vaccine consisting of surface antigen (HBsAg or Australia antigen) of hepatitis B virus produced in yeast cells.” It explains, “A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain [Saccharomyces cerevisiae]…The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The currently produced vaccine contains no detectable yeast DNA but may contain <1% yeast protein.” The monograph is non-committal regarding mercury in the RECOMBIVAX HB® used in Canadian vaccination programs; all it admits to is that the mercury-containing preservative, Thimerosal, “has been added only to the preservative-containing formulations.” The 2006 Canadian Immunization Guide states: “In some preparations thimerosal is used as preservative. Thimerosal has been shown not to be associated with chronic neurological disease despite theoretical concerns raised a few years ago that resulted in the marketing of thimerosal-free HBV vaccines. It is to be emphasized strongly that post-exposure immunoprophylaxis for infants born to infected mothers must be undertaken without delay, regardless of the type of vaccine available, because of the high risk of long-term complications if infection occurs.” This statement is a prime example of Public Health’s arrogant unconcern for the well-being of children and their families. Please see the articles listed under ‘Mercury’ in the VRAN website ‘Vaccine Ingredients’ section. Also present in the vaccine and not to be dismissed, are aluminum hydroxyphosphate and formaldehyde.

References:

RECOMBIVAX HB® Product Monograph; Merck Frosst Canada Ltd; Feb 14, 2008.

Canadian Immunization Guide, Seventh Edition – 2006; Public Health Agency of Canada.

The Merck Manual, Fourteenth Edition; 1982.

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Filed Under: Hepatitis-B Vaccine, Specific Vaccines Tagged With: Hepatitis-B Vaccine

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