Hepatitis B Vaccines

Hepatitis B Vaccines:

·         Engerix B

·         Recombivax HB

·         Twinrix (Hep A and B)

·         Pediarix (DTaP, IPV and Hep B)

·         Comvax (Hep B and HIB)

·         Nabi-HB = Immune Globulin

 ·         Bay Hep B = Immune Globulin (human)

 ·         HB-vax II

·         PTY LTD

 ·          Hexa (DTaP, Hep B, HIB, IPV)

Contains Thimerosal (mercury): Engerix B and Twinrix

Contains Aluminum: Pediarix, Recombivax, Comvax

Contains Fetal Cell lines: Twinrix (MRC-5)Hexa (MRC-5)

Energix B (Hep B) Glaxo:  

The CONTROL GROUP received plasma-derived vaccines. The vaccines administered to the CONTROL GROUP are not revealed.

Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasma-derived vaccines.
In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration.

 

 
Recombivax HB (Hep B) Merck:

 

This vaccine was not evaluated for safety using a control group.

In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose.
In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.
In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose.

 

     

    • At no point was Hepatitis B evaluated at birth, to see what effect it would have on either liver enzymes, or immune system parameters.

    In 1982, the C.D.C., the F.D.A., and the manufacturer created a surveillance system to monitor spontaneous reports of adverse events occurring after inoculation with the new-plasma derived hepatitis B vaccine (Heptavax-B, Merck Sharp and Dohme, West Point, PA). In the three years between June 1, 1982 and May 31, 1985, an estimated 850,000 persons received the vaccine. During that period, a total of 41 reports were received for one of the following neurologic adverse events: convulsions (5 cases), Bell’s palsy (10 cases), Guillain-Barre syndrome (9 cases), lumbar radiculopathy (5 cases), brachial plexus neuropathy (3 cases), optic neuritis (5 cases), and transverse myelitis (4 cases).  Half of these occurred after the first of three required vaccine doses. In some analyses, Gullain-Barre syndrome was reported significantly more often that expected (p=<0.05). Shaw FE, Jr., Graham DJ, Guess HA, Milstien JB et. al.   Postmarketing surveillance for neurologic adverse events reported after hepatitis B vaccination. Experience of the first three years   Am J Epidemiol 1988 (Feb);   127 (2):   337-352

     When Evidence Based Medicine (EBM) Fuels Confusion: Multiple Sclerosis after Hepatitis B Vaccine as a Case in Point.M. Girard/Medical Veritas 4 (2007) 1436-1451.

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        One of the major side effects of the Hepatitis B vaccine in the kids ‘catch-up campaign’ is “bronchospasm” and kids who have asthma are nearly always guaranteed to have a serious asthma attack on the day of their shot.  

      RHEUMATIC DISORDERS DEVELOPED AFTER HEPATITIS B VACCINATION
      Aim
      : to obtain an overview of rheumatic disorders occurring after hepatitis B vaccination.

      Conclusion: hepatitis B vaccination might be followed by various rheumatic conditions, and might trigger the onset of underlying inflammatory and/or auto-immune rheumatic diseases. However, a causal relation between hepatitis B vaccination and the observed rheumatic manifestations cannot be easily established. Further epidemiological works are needed to establish whether hepatitis B vaccination is associated or not with an incidence of rheumatic disorders higher than normal.

      Other Studies:

      Several papers have been published linking immunization to lupus and other rheumatoid diseases. A study of lupus patients receiving polio vaccines showed 5% had a flare following immunization (Schattner et al., 1992). Several papers have reported patients with lupus developing deterioration in kidney function following immunization (Ristow et al., 1978); (Louie et al., 1978). Lupus has been reported to occur following immunization with the Hepatitis B (Tudela et al., 1992), and pneumococcal (Ries & Shemonsky, 1981) vaccines. Immunization with the influenza vaccine has been associated with a rise in anti-double stranded DNA antibodies, an marker for lupus (Huang et al., 1992). Rheumatoid arthritis has been observed to occur following immunization with Hepatitis B vaccine (Vautier & Carty, 1994). Rheumatoid factor, auto antibodies that bind other antibodies, have been reported to develop following vaccination (Aho et al., 1962); (Aho et al., 1967); (Palit et al., 1977); (Welch et al., 1982).

       The Genetic Centers of America, MedCon, Inc., Silver Spring, Maryland 20905, USA.

       OBJECTIVES: Adverse events and positive re-challenge of symptoms reported in the scientific literature and to the Vaccine Adverse Event Reporting System (VAERS) following hepatitis B vaccination (HBV) were examined.

       

       

       

      METHODS: The VAERS and PubMed (1966-2003) were searched for autoimmune conditions including arthritis, rheumatoid arthritis, myelitis, optic neuritis, multiple sclerosis (MS), Guillain Barre Syndrome (GBS), glomerulonephritis, pancytopenia/thrombocytopenia, fatigue, and chronic fatigue, and Systemic Lupus Erythematous (SLE) following HBV.  

       

      RESULTS: HBV was associated with a number of serious conditions and positive re-challenge or significant exacerbation of symptoms following immunization. There were 415 arthritis, 166 rheumatoid arthritis, 130 myelitis, 4 SLE, 100 optic neuritis, 101 GBS,
      29 glomerulonephritis, 283 pancytopenia/thrombocytopenia, and 183 MS events reported following HBV A total of 465 positive re-challenge adverse events were observed following adult
      HBV that occurred sooner and with more severity than initial adverse event reports. A case-report of arthritis occurring in identical twins was also identified.

      CONCLUSIONS: Evidence from biological plausibility, case-reports, case-series, epidemiological, and now for positive re-challenge and exacerbation of symptoms, and events in identical twins was presented. One would have to consider that there is causal relationship between HBV and serious autoimmune disorders among certain susceptible vaccine recipients in a defined temporal period following immunization. In immunizing adults, the patient, with the help of their physician, should make an informed consent decision as to whether to be immunized or not, weighing the small risks of the adverse effects of HBV with the risk of exposure to deadly hepatitis B virus. (NEUROLOGY 2004; 63:838-842 American Academy of Neurology,   Miguel A. Hernán, MD et al)

      • Recombinant hepatitis B vaccine and the risk of multiple sclerosis-A prospective study.
        Miguel A. Hernán, MD et al.

         

        • Conclusions: These findings are consistent with the hypothesis that immunization with the recombinant hepatitis B vaccine is associated with an increased risk of MS, and challenge the idea that the relation between hepatitis B vaccination and risk of MS is well understood.
         

         

         

      Celiacs less likely to gain immunity from Hep B:  

      A total of 23 subjects were reviewed. All had a clinical and pathological diagnosis of celiac disease. All subjects reported receiving the full series of hepatitis B vaccinations. Of the subjects, 19 had testing for hepatitis B vaccine response. Of these 19 subjects, 13 did not achieve long-term immunity as seen by the negative qualitative or quantitative anti-HBs antibody titer.

      Hepatitis B Study:

      Conclusions: Anti-HBs disappeared by 5 years of age in most children who were vaccinated with hepatitis B vaccine from birth. Although most children showed immunologic memory, one-third failed to demonstrate an anamnestic response to a booster dose. Additional long term studies of low risk infants are needed to determine duration of protection and the necessity for or timing of booster doses.

      HEPATITIS B VACCINE: The first hepatitis B virus vaccines developed in the 1970s were made using virus isolated from the blood of human chronic hepatitis B carriers. A plasma-derived hepatitis B vaccine was licensed by the U.S. in 1981 and used in high-risk populations in the 1980s until a genetically engineered, recombinant hepatitis B vaccine was developed. Today, hepatitis B recombinant vaccine used in the U.S. is derived from hepatitis B surface antigens produced in yeast cells. A portion of the hepatitis B virus gene is cloned into the yeast (a common baker’s yeast) and the vaccine is produced from cultures of this recombinant yeast strain. The vaccine is treated with formaldehyde and contains 95 percent hepatitis B virus surface antigen, 4 percent yeast protein, aluminum hydroxide and thimerosal added as a preservative.” (source: The Consumer’s Guide to Childhood Vaccines by Barbara Loe Fisher).

       

       

       

       

       

       

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