Hepatitis B (HBV) Vaccines

//Hepatitis B (HBV) Vaccines
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Hepatitis B Vaccine Licensed By FDA Without Adequate Proof of Long Term Safety

In 1986, the FDA gave Merck & Co. a license to market the first recombinant DNA hepatitis B vaccine, which replaced the old hepatitis B vaccines made from blood taken from human chronic hepatitis B virus carriers. In awarding Merck & Co. and, later, SmithKline BeechamPharmaceuticals, licenses to market their genetically engineered hepatitis B vaccines in the U.S., the FDA allowed both drug companies to use “safety” studies which only included a few thousand children monitored for only four or five days after vaccination to check for reactions. As “proof” their hepatitis B vaccine is safe to be used in children, Merck & Co. stated in their 1993 product insert that “In a group of studies, 1636 doses of RECOMBIVAX HB were administered to 653 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose.”

Hepatitis Vaccines Cause Autoimmune and Demyelinating Diseases

Montinari et al published a study in Italy evaluating 30 children and adults, the majority aged 3 to 9 months, who suffered central nervous system disorders, such as seizures and autism, following hepatitis B vaccination. The purpose of the study was to investigate whether there is an immunogenetic basis (autoimmune type) responsible for the demyelination process in the brain that can occur following recombinant hepatitis B vaccination. The authors concluded “autoimmune diseases are more frequent in nations where vaccines are widely used, the so called “clear” communities” and they identified several potential genetic markers that “may visualize risk patients for autoimmune diseases following hepatitis B vaccination.

In 1996, Burton A. Waisbren, M.D., a cell biologist and infectious disease specialist, who is a founding member of the Infectious Disease Society of America and past President of the Infectious Disease Society of Milwaukee, pointed out in the Wisconsin Medical Journal that “there is an increasing number of reports in the refereed medical literature about demyelinizing diseases occurring after an individual has received the hepatitis B vaccination…since the hepatitis B virus itself has been reported to cause autoimmune problems, should we not be wary of giving antigens that seem to have triggered these problems?” Waisbren, in a presentation before a 1996 Institute of Medicine Vaccine Safety Forum, warned that genetically engineered hepatitis B vaccines contain polypeptide sequences that are present in human neurologic tissues such as myelin and that, by a mechanism called molecular mimicry, these polypeptides can act as autoantigens which can induce autoimmune demyelinating diseases of the brain such as multiple sclerosis.

Hepatitis B is Rare

According to Guide to Clinical Preventive Services, in the U.S. “the greatest reported incidence [of hepatitis B] occurs in adults aged 20-39” and “the number of cases peaked in 1985 and has shown a continuous gradual decline since that time.” According to Harrison’sPrinciples of Internal Medicine (1994), mother to child transmission of hepatitis B “is uncommon in North America and western Europe.”

The U.S. and western Europe have always had among the lowest rates of hepatitis B disease in the world (0.1% to 0.5% of the general population). In 1991, there were 18,003 cases of hepatitis B reported in the U.S. out of a total U.S. population of 248 million.

Hepatitis B is Benign For Most

According to Harrison’s, in cases of acute hepatitis B “most patients do not require hospital care” and “95 percent of patients have a favorable course and recover completely” with the case-fatality ratio being “very low (approximately 0.1 percent).”

Hepatitis B is Not Highly Contagious

Hepatitis B is primarily an adult disease transmitted through infected body fluids in high risk populations such as needle using drug addicts; sexually promiscuous heterosexual and homosexual adults. To inoculate small children with this vaccine is extremely inappropriate.

The Wrong People

According to CDC Prevention Guidelines: A Guide to Action (1997), a book written by federal public health officials at the U.S. government Centers for Disease Control (CDC), “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 (HBV) Vaccines by Brand

Bio-Hep-B Hepatitis B Vaccine (Recombinant)
Manufacturer Bio-Technology General (Israel) Ltd.
Microorganism Hepatitis B Virus
Licensed 03/28/2000
Recommendations All ages; differing formulations recommended for adults and children, three i.m. injections, 0, 1, and 6 months.
Ingredients Aluminum hydroxide, Virus: Hepatitis B, Chinese hamster ovary cells, Protein contaminants
Product Descriptions Package insert

Energix-B Recombinant  Hepatitis B Vaccine (Recombinant)
Manufacturer GlaxoSmithKline
Microorganism Hepatitis B Virus
Licensed 03/28/2000
Recommendations Three doses administered 0, 1, and 6 months.
Ingredients Aluminum hydroxide, Thimerosal, Yeast, Sodium chloride, Virus: Hepatitis B, Disodium phosphate dehydrate, Sodium dihydrogen phosphate dehydrate
Product Descriptions Prescribing Information

Enivac-HB
Manufacturer Centro de Ingenieria Genetica Y Biotecnologia (Cuba); Panacea Biotec LTD (New Delhi, India)
Microorganism Hepatitis B Virus
Licensed
Recommendations There are two different schedules; (i) – Three i.m. injections at 0,1, 6 months and (ii) Four i.m. injections at 0,1,2 months + 1yr (high risk of infection).
Ingredients Aluminum hydroxide, Thimerosal, Virus: Hepatitis B
Product Descriptions

Euvax-B HEPATITIS B VACCINE, RECOMBINANT
Manufacturer LG Chemical (South Korea)
Microorganism Hepatitis B Virus
Licensed 1996
Recommendations Three injections at 0, 1, 6 months. Pediatric; neonates, infants, and children aged up to and including 15 years of age. Adults; from 16 years.
Ingredients Aluminum hydroxide, Thimerosal, Yeast, Sodium chloride, Sodium phosphate-monobasic, Virus: Hepatitis B, Potassium phosphate
Product Descriptions Package insert

Fendrix Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Manufacturer GlaxoSmithKline
Microorganism Hepatitis B Virus
Licensed 2005
Recommendations Four injections administered at 0, 1, 2, 6 months.
Ingredients Yeast, Sodium chloride, Aluminum phosphate, Virus: Hepatitis B, AS04C containing 3-O-desacyl-4- monophosphoryl lipid A
Product Descriptions Package insert

H-B Vax II Hepatitis B vaccine (recombinant)
Manufacturer Merck
Microorganism Hepatitis B Virus
Licensed 01/2006
Recommendations Adults (greater than or equal to 20 years): 3 x 1 mL i.m. injections in deltoid muscle; 1st dose at elected date, 2nd dose 1 month later, 3rd dose 6 months after 1st dose.
Ingredients Aluminum hydroxide, Thimerosal, Virus: Hepatitis B
Product Descriptions http://www.whale.to/m/hbvax.html

Hepacare Hepatitis B Vaccine (recombinant)
Manufacturer Medeva
Microorganism Hepatitis B Virus
Licensed Withdrawn 2002
Recommendations 3 doses at monthly intervals (6, 10 and 14 weeks).
Ingredients Thimerosal, Sodium chloride, Aluminum phosphate
Product Descriptions

Hepaccine-B HEPATITIS-B VACCINE
Manufacturer Chiel Jedang (South Korea)
Microorganism Hepatitis B Virus
Licensed 09/23/1999
Recommendations 3 doses at monthly intervals (6, 10 and 14 weeks).
Ingredients Thimerosal, Sodium chloride, Aluminum phosphate
Product Descriptions

Recombivax HB® Hepatitis B Vaccine (RECOMBINANT)
Manufacturer Merck & Co.
Microorganism Hepatitis B Virus
Licensed 09/23/1999
Recommendations Single i.m. injections administered at 0, 1 month, 6 months.
Ingredients Aluminum hydroxide, Virus: Hepatitis B
Product Descriptions Package insert

Shanvac-B Hepatitis-B Vaccine IP (r-DNA)
Manufacturer Shantha Biotechnics Pvt. Ltd.
Microorganism Hepatitis B
Licensed
Recommendations 3 doses (0, 1, 2 months) plus booster at 12 months.
Ingredients Aluminum hydroxide, Thimerosal, Virus: Hepatitis B
Product Descriptions Package insert

Twinrix (adult) Combined hepatitis A and hepatitis B vaccine
Manufacturer GlaxoSmithKline
Microorganism Hepatitis A (strain HM175) & B virus (rDNA)
Licensed 05/11/2001
Recommendations Single i.m. injections at 0, 1, and 6 months for those 16 years of age and older.
Ingredients Aluminum hydroxide, Formaldehyde, Latex, Human Diploid cells: MRC5 proteins, 2 – Phenoxyethanol, Thimerosal, Yeast, Sodium chloride, Aluminum phosphate, Polysorbate 20, Virus: Hepatitis A, Amino acids, Dextrose, Neomycin sulphate, Formalin, Recombinant HBsAg protein, Aminoglycoside (antibiotic)
Product Descriptions

TwinrixJunior Combined hepatitis A and hepatitis B vaccine
Manufacturer GlaxoSmithKline
Microorganism Hepatitis A & B
Licensed 01/19/2007
Recommendations 3 i.m. injections at 0, 7, 21-30 days, and 12 months.
Ingredients Formaldehyde, Latex, 2 – Phenoxyethanol, Thimerosal, Sodium chloride, Virus: Hepatitis B, Polysorbate 20, Virus: Hepatitis A, Amino acids, Neomycin sulphate
Product Descriptions

Procomvax Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
Manufacturer Sanofi Pasteur
Microorganism Haemophilus b and Hepatitus B
Licensed 07/05/1999
Recommendations Single i.m. injections administered at 2, 4, and 12-15 months.
Ingredients Yeast, Sodium chloride, Virus: Hepatitis B, Haemophilus influenzae B, Sodium Borate, Neisseria meningitides OMPC, Aluminum hydroxyphosphate sulfate
Product Descriptions Package Insert

Comvax® HBV and Hib conjugate vaccine
Manufacturer Merck
Microorganism The Hib virus and Hepatitis B virus
Licensed 10/02/1996
Recommendations 3 injections at 2, 4, 6 and months and a booster at 12 to 15 months of age.
Ingredients Aluminum hydroxide, Formaldehyde, Yeast, Virus: Hepatitis B, Haemophilus influenzae B, Sodium Borate, Amino acids, Dextrose, Neisseria meningitides OMPC, Mineral salts, Nicotinamide adenine dinucleotide, Hemin chloride, Soy peptone
Product Descriptions Package Insert

Tritanrix HepB (DTPw+HBV) Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine
Manufacturer GlaxoSmithKline
Microorganism C. diphtheriae, C. tetani, B. pertussis and hepatitis B virus
Licensed 07/19/1996 (E.U.)
Recommendations Three injections with an interval of at least one month between each.
Ingredients Thimerosal, Yeast, Sodium chloride, Aluminum phosphate, Diphtheria toxoid, Tetanus toxoid, Virus: Hepatitis B, Aluminum oxide
Product Descriptions

Tritanrix HB-HIB (DtwP, HBV, HiB) Diphtheria, tetanus, pertussis and hepatitis B
Manufacturer GlaxoSmithKline
Microorganism C. diphtheriae, C. tetani, B. pertussis and hepatitis B virus
Licensed 07/19/1996
Recommendations Single injection as early as 6 weeks of life.
Ingredients Aluminum hydroxide, Yeast, Sodium chloride, Aluminum phosphate, Diphtheria toxoid, Tetanus toxoid, Virus: Hepatitis B
Product Descriptions

Primavax (DT, HBV) Diphteria, tetanus and hepatitis B
Manufacturer Pasteur Merieux (Italy), Aventis Pasteur MSD
Microorganism C. diphtheriae, C. tetani, B. pertussis, hepatitis B virus
Licensed Withdrawn March 8, 2000
Recommendations
Ingredients Diphtheria toxoid, Tetanus toxoid, Virus: Hepatitis B
Product Descriptions

Pediarix™ (HBV, DTaP, IPV) and inactivated Polio
Manufacturer GlaxoSmithKline
Microorganism C. diphtheriae, C. tetani and B. pertussis, H. influenzae virus type b and the polio virus
Licensed 12/13/2002
Recommendations 3 i.m. injections in infants as early as 6 weeks of age, to 7 years of age.
Ingredients Aluminum hydroxide, Formaldehyde, Neomycin, Polymyxin B, Polysorbate 80, Thimerosal, Yeast, Pertussis toxin, Filamentous hemagglutinin (FHA), Pertactin, Stopper vial may contain dry latex rubber, Tetanus, Sodium chloride, Virus: polio
Product Descriptions Package insert

Infanrix® (DTaP) Diphtheria and tetanus toxoids, acellular pertussis
Manufacturer GlaxoSmithKline
Microorganism The bacteria C. diphtheriae, C. tetani, B. pertussis
Licensed 01/29/1997
Recommendations For use as the initial four doses of the recommended diphtheria, tetanus, and pertussis vaccination series among children aged 6 weeks-6 years. Infanrix is also licensed for all remaining doses in the schedule for children who have received one or more doses of whole-cell DTP vaccine. Each dose of Infanrix contains 24 µg PT, 25µg FHA, 8µg Pn, 25 Lf of diphtheria toxoid, and 10 Lf of tetanus toxoid (Table 1).
Ingredients Aluminum hydroxide, Formaldehyde, Latex, 2 – Phenoxyethanol, Polysorbate 80, Pertussis toxin, Filamentous hemagglutinin (FHA), Pertactin, Sodium chloride, Diphtheria toxoid, Tetanus toxoid
Product Descriptions University: http://www.vaccinesafety.edu/components-DTaP.htm

Infanrix Penta (DTaP, HBV, IPV) Diphtheria, tetanus, acellular, hepatitis B, inactivated polio
Manufacturer GlaxoSmithKline
Microorganism C. diphtheria and C. tetani toxoid, B. pertussis, Hepatitus B, Polio virus Type 1 (Mahoney strain) Type 2 (MEF-1 strain), Type 3 (Saukett strain), adsorbed
Licensed 10/23/2000
Recommendations 4 injections at 2, 3, 4, and 11 or 12 months, interval of at leasts 1 month between doses. Not intended for children over 3 years of age.
Ingredients Aluminum hydroxide, 2 – Phenoxyethanol, Pertussis toxin, Filamentous hemagglutinin (FHA), Pertactin, Aluminum phosphate, Diphtheria toxoid, Tetanus toxoid, Virus: Hepatitis B, Medium 199, Virus: polio
Product Descriptions EMEA Document

Infanrix Hexa (DTaP, IPV, Hib, HBV) Diptheria, tetanus, pertussis, H. influenzae B, Hepatitis B and inactivated polio virus
Manufacturer GlaxoSmithKline (France)
Microorganism Diphtheria, tetanus, and pertussis toxoids, hepatitis B, Poliovirus Type 1 (Mahoney strain), Type 2 (MEF-1 strain), Type 3 (Saukett strain)
Licensed 10/26/2000
Recommendations Three i.m. injections at 2, 3, 4 months.
Ingredients Aluminum hydroxide, 2 – Phenoxyethanol, Pertussis toxin, Filamentous hemagglutinin (FHA), Pertactin, Sodium chloride, Aluminum phosphate, Diphtheria toxoid, Tetanus toxoid, Virus: Hepatitis B, Medium 199, Virus: polio, Haemophilus influenzae B, Lactose
Product Descriptions EMEA Document

Hexavac (DTaP, IPV, HBV, Hib) Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted
Manufacturer Aventis Pasteur MSD
Microorganism C. Diphtheriae, C. tetani, B. pertussis, polio virus, hepatitis B and Haemophilus influenzae type b
Licensed 10/26/2000
Recommendations One i.m. injection for infants (from 2 to 12 months of age) with booster vaccination in toddlers (from 12 to 18 months of age).
Ingredients Aluminum hydroxide, Formaldehyde, Sucrose, Pertussis toxin, Filamentous hemagglutinin (FHA), Diphtheria toxoid, Tetanus toxoid, Bovine (cow) serum, Sodium hydroxide, Virus: Hepatitis B, Medium 199, Haemophilus influenzae B, Acetic acid, Trometamol, Sodium hydrogen carbonate, Potassium dihydrogen phosphate, Disodium phosphate dehydrate
Product Descriptions Suspension Press Release