Ingredients in Childhood Vaccines in Canada

While health officials recommend an ever increasing quantity of vaccines for babies and young children, they are less than forthcoming with the ingredients list of vaccine additives and the potential for reactions. Today’s parents are concerned about the health impact of multiple vaccines & additives on their children’s health. Vaccine product monographs listing ingredients can be located in the CPS index (Compendium of Pharmaceuticals and Specialties) obtainable through any pharmacy in Canada. Some vaccine product monographs can be accessed on line at the manufacturers’ websites.

Starting at two months of age, most babies are injected with the following vaccines: Diphtheria, Tetanus, acellular Pertussis, Polio, Act-HIB (haemophilus influenza B), Hepatitis B, 7 valent Pneumococcal vaccine, Meningococcal C vaccine. Babies may be injected with as many as 8 vaccines concurrently. See the Canadian Immunization Guide (in English or French) for details of the vaccine schedule and number of doses given of each vaccine.

In the northern territories, babies are also routinely injected within hours of birth with BCG (tuberculosis vaccine) & hepatitis B vaccine. The province of New Brunswick vaccinates newborns with hepatitis B vaccine within hours of birth.

A two dose schedule of MMR (measles, mumps, rubella) vaccine is generally started at 12 months and given again at 18 months or 4-6 years. Varicella (chickenpox) vaccine is also injected at 12 months of age. Additionally, Influenza vaccine is now recommended for all children starting at 6 months of age. Babies and young children are injected with two doses of flu vaccine 30 days apart.

Health officials keep vaccine reaction reports under wraps. Unlike the U.S. where the VAERS (Vaccine Adverse Events Reporting System) is accessible on line and can be searched by anyone for vaccine reactions, Canadians do not have access to the vaccine reaction data base held by Health Canada. Only by filing an Access to Information request with the specific lot number of a vaccine, is it possible to obtain limited vaccine reaction information.

People should also know that the manufacturers do not disclose all the ingredients nor full details of the manufacturing process. Health Canada protects the “proprietary rights” of these companies and upholds their right to secrecy – something the greater Canadian public should be up in arms about. That parents are expected to submit their children for injection with multiple vaccines without first having full disclosure of all known ingredients is a disturbing statement on the control exerted by monopoly medicine and corporate and government allies.

Thimerosal (a preservative comprising 50% ethyl mercury) was phased out of early infant shots in Canada when polio vaccine was combined with DPT. Mercury is a potent neurotoxin. Apparently inactivated, injectable polio vaccine is degraded by thimerosal, hence vaccine combinations that contain polio vaccine do not contain thimerosal. Thimerosal may, however still be used in the manufacturing process, then filtered out. The question remains however, whether trace amounts of thimerosal still persist in the final product. Thimerosal was replaced by 2-phenoxyethanol, another toxic substance used in antifreeze and is contained in Pentacel, the DTPaP+Hib vaccine injected into most Canadian babies starting at 2 months of age.

Currently the two vaccines given to Canadian babies that may still contain thimerosal are influenza vaccine and hepatitis B. Both vaccines are available in single dose vials without thimerosal. Parents who choose to inject their babies with these vaccines should know they do have a choice to choose thimerosal free vaccines.

Your Baby’s First Shot – Five Vaccines in One:

Pentacel – combines Act-HIB and Quadracel vaccines(4 vaccines)

Produced by Sanofi Pasteur

Description:

Act-HIB ® Reconstituted with QUADRACEL ®Haemophilus b Conjugate Vaccine (Tetanus Protein – Conjugate) Reconstituted with Component Pertussis Vaccine and Diphtheria and Tetanus Toxoids Adsorbed Combined with Inactivated Poliomyelitis Vaccine.

Each single dose (approximately 0.5 mL) after reconstitution contains:

  • purified polyribose ribitol phosphate capsular
  • polysaccharide (PRP) of Haemophilus influenzae type b
  • covalently bound to 20 µg of tetanus protein 10 µg
  • pertussis toxoid (PT) 20 µg
  • filamentous haemaglutinin (FHA) 20 µg
  • fimbrial agglutinogens 2 + 3 (FIM) 5 µg
  • pertactin (PRN) 3 µg
  • diphtheria toxoid 15 Lf
  • tetanus toxoid 5 Lf
  • poliovirus type 1 (Mahoney) 40 D-antigen units
  • poliovirus type 2 (MEF1) 8 D-antigen units
  • poliovirus type 3 (Saukett) 32 D-antigen units
  • aluminum phosphate 1.5 mg
  • 2-phenoxyethanol (not as a preservative) 0.6% v/v
  • polysorbate 80 10 ppm (by calculation)
  • bovine serum ≤50 ng
  • trace amounts of formaldehyde
  • trace amounts of polymyxin B and neomycin may be present from the cell growth medium

For information on precautions and adverse events, see the manufacturer’s monograph.

Hepatitis B vaccines marketed in Canada are produced by Merck Frosst & GlaxoSmithKline

Recombivax HB

Produced by Merck Frosst

Description:

RECOMBIVAX HB ® [hepatitis B vaccine (recombinant)] is a non-infectious subunit viral vaccine consisting of surface antigen (HBsAg or Australia antigen) of hepatitis B virus produced in yeast cells. 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 according to methods developed in the Merck Research Laboratories.

Two formulations are available:

  • 10 µg/1.0 mL formulation: each 1.0 mL dose contains 10 µg of hepatitis B surface antigen adsorbed onto approximately 0.5 mg of amorphous aluminum hydroxyphosphate;
  • 40 µg/1.0 mL formulation: each 1.0 mL dose contains 40 µg of hepatitis B surface antigen adsorbed onto approximately 0.5 mg of amorphous aluminum hydroxyphosphate;

Thimerosal (mercury derivative) 1:20,000 (50 µg/mL) has been added only to the preservative-containing formulations. All preparations have been treated with formaldehyde prior to adsorption onto amorphous aluminum hydroxyphosphate. The vaccine is of the adw subtype.

For information on precautions and adverse events, go to: manufacturer’s monograph.

ENGERIX ® -B

Produced by GlaxoSmithKline

Hepatitis B Vaccine (Recombinant)

Composition:

The vaccine is a slightly opaque, white, sterile suspension. A slow settling of the white aluminum hydroxide may occur during storage leaving a clear colourless supernatant liquid. Each 1 mL adolescent/adult dose of vaccine contains 20 µg of hepatitis B surface antigen adsorbed onto 0.5 mg of Al +++ as aluminum hydroxide. Each 0.5 mL pediatric dose contains 10 µg of hepatitis B surface antigen adsorbed onto 0.25 mg of Al +++ as aluminum hydroxide. Multi-dose presentations contain 5.0 mg of 2-phenoxyethanol per mL as preservative.

The ENGERIX ® -B formulation contains a trace amount of thimerosal (‹0.5 µg mercury in the 0.5 mL pediatric dose and ‹1.0 µg mercury in the 1.0 mL adolescent/adult dose) from the manufacturing.

For information on precautions and adverse events see the manufacturer’s monograph.

Prevnar – 7-valent conjugate pneumococcal vaccine

Produced by Wyeth Lederle

The manufacturer’s website does not allow consumers to view a product monograph. Ingredients list is taken from CPS 2004 edition, product monograph page 1587:

Prevnar is a sterile solution of saccharides of the capsular antigen of S.pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F and diphtheria CRM197 protein. Individual polysaccharides are prepared from purification of the culture broth of each serotype. The saccharides are directly conjugated to the protein carrier CRM197 protein by reductive animation. CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of C. diphtheriae strain C7(B197) and/or C.diphtheriae strain C7 (B197) pPx350 grown in a casamino acids and yeast extract-based medium. CRM197 is purified through ultrafiltration, ammonium sulfate precipitation, and iron-exchange chromatography to high purity. Each serotype is conjugated as a monovalent preparation prior to compounding as a multivalent vaccine. Individual glycoconjugates are analyzed for saccharide to protein ratios, for molecular size, free saccharide and free protein.

Each dose (0.5ml) contains:

  • 2ug of each saccharide for serotypes 4, 9V, 14, 18C, 19F and 23F,
  • and 4 ug of serotype 6B (16 ug total saccharides);
  • and approximately

  • 20ug of CRM197 carrier protein.

Nonmedicinal ingredients:

  • aluminum phosphate adjuvant
  • sodium chloride
  • and water for injection

For information on precautions and adverse reactions, see the CPS Index available at any pharmacy or medical library in Canada.

MENJUGATE® – Meningococcal Group C–CRM197 Conjugate Vaccine

Produced by Merck Frosst

Description:

Menjugate ® (Meningococcal Group C–CRM197 Conjugate Vaccine) is intended for the prevention of meningitis and/or septicemia caused by Neisseria meningitidis group C in infants and older age groups. Menjugate ® is composed of meningococcal group C oligosaccharides conjugated to a protein carrier, a non-toxic mutant of diphtheria toxin, CRM197. In the final vaccine, aluminum hydroxide is used as an adjuvant.

Composition:

Menjugate ® (Meningococcal Group C–CRM197 Conjugate Vaccine) is formulated as a powder for suspension with each 0.5 mL dose containing 10 micrograms of meningococcal C oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein (12.5 to 25.0 micrograms).13 Mannitol, sodium phosphate monobasic monohydrate, and sodium phosphate dibasic heptahydrate are present as excipients in the final lyophilized formulation. The lyophilized product is to be reconstituted with an adjuvant diluent containing aluminum hydroxide (1.0 mg per 0.5 mL dose) and sodium chloride in sterile water for injection. Menjugate ® contains no preservative.

For information about precautions and adverse effects, see the manufacturer’s monograph.

M-M-R ® II Measles, Mumps and Rubella Virus Vaccine, Live, Attenuated, MSD Std.

Produced by Merck Frosst

Composition:

M-M-R ® II (Measles, Mumps and Rubella virus vaccine, live, attenuated, MSD Std.) is a sterile lyophilized preparation of (1) ATTENUVAX ® (Measles virus vaccine, live, attenuated, MSD Std.), a more attenuated line of measles virus, derived from Enders’ attenuated Edmonston strain and propagated in chick embryo cell culture; (2) MUMPSVAX ® (Mumps virus vaccine, live, attenuated, MSD Std.), the Jeryl Lynn ® (B level) strain of mumps virus propagated in chick embryo cell cultures; and (3) MERUVAX ® II (Rubella virus vaccine, live, attenuated, MSD Std.), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in human diploid lung fibroblasts.

The reconstituted vaccine is for subcutaneous administration. When reconstituted as directed, the dose for injection is 0.5 mL and contains not less than the equivalent of 1,000 CCID50 (50% cell culture infective dose) of measles virus 5,000 CCID50 of mumps virus; and 1,000 CCID50 of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), fetal bovine serum (‹1 ppm), other buffer and media ingredients and approximately 25 µg of neomycin. The product contains no preservative.

The growth medium for measles and mumps is Medium 199 (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and human albumin) as stabilizer and neomycin.

The growth medium for rubella is Minimum Essential Medium (MEM) (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing human serum albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.

The cells, virus pools, fetal bovine serum, and human albumin are all screened for the absence of adventitious agents. Human albumin is processed using the Cohn cold ethanol fractionation procedure.

For information about precautions and adverse events, see the manufacturer’s monograph.

VARIVAX® III varicella virus vaccine, live, attenuated (Oka/Merck) is a live, attenuated virus vaccine (a lyophilized preparation of the Oka/Merck strain of varicella).

COMPOSITION- Active Ingredients:

VARIVAX ® III [varicella virus vaccine, live, attenuated (Oka/Merck)], when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.5 mL dose contains a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted and stored at room temperature for 30 minutes.

Non-Medicinal Ingredients:

Each 0.5 mL dose contains approximately 18 mg of sucrose, 8.9 mg hydrolyzed gelatin, 3.6 mg of urea, 2.3 mg sodium chloride, 0.36 mg monosodium L glutamate, 0.33 mg of sodium phosphate dibasic, 57 µg of potassium phosphate monobasic, 57 µg of potassium chloride. The product also contains residual components of MRC-5 cells including DNA and protein; and trace quantities of neomycin, and fetal bovine serum from MRC-5 culture media. The product contains no preservative.

For information about precautions and adverse events, ese the manufacturer’s monograph.

Influenza Vaccines

In Canada, Vaxigrip and Fluviral are the two vaccines most widely used and are produced by pharmaceutical companies Sanofi Pasteur and ID Biomedical respectively. Product information for Vaxigrip is available on the Sanofi Pasteur website. Fluviral product details are not available on the ID Biomedical website but are copied below from the CPS index – 2004 edition.

A recent meta analysis conducted by international researchers at the Cochrane Vaccines Field, looked at the results of 64 international flu vaccine studies. They concluded that there is no scientific ground on which influenza vaccines should be recommended for babies. Despite this, the Canadian Paediatric Society promotes flu shots for all children 6 months and older, including those with immune dysfunction and other chronic diseases. Infants and young children are injected with two doses of the vaccine 30 days apart. See article by Dr. F. Edward Yazbak, “Nothing New about Lack of Effectiveness of Influenza Vaccination in Babies“ (5. Notes)

VAXIGRIP® – Produced by Sanofi Pasteur

Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)

DESCRIPTION: – from CPS index, 2004 edition, page 2149

VAXIGRIP ® [Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)] for intramuscular use, is a sterile suspension prepared from influenza viruses propagated in chicken embryos. The virus-containing fluids are harvested and the virus inactivated with formaldehyde and purified by zonal centrifugation. The virus is then chemically disrupted using polyethylene glycol p-isooctylphenyl ether (Triton ® X-100) producing a “split-antigen”. The split antigen is suspended in sodium phosphate-buffered, isotonic sodium chloride solution. The type and amount of viral antigens contained in VAXIGRIP® conform to the current requirements of the World Health Organization (WHO).

And from the VAXIGRIP ® web page: [Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)] also contains Triton ® X-100 and trace amounts of sucrose and neomycin. Thimerosal (added as a preservative in multidose presentation only).

For information on precautions and adverse events, see the manufacturer’s monograph.

Fluviral S/F – Produced by ID Biomedical (previously Shire Bilogics)

Split-Virion Influenza Virus Vaccine, Inactivated

DESCRIPTION: – from CPS index – 2004 edition page 793

Fluviral S/F for i.m. injection is a trivalent, split-virion influenza vaccine prepared from virus grown in the allantoic cavity of embryonated hens’ eggs. The virus is inactivated with formaldehyde, purified by centrifugation and disrupted with sodium deoxycholate and/or polyethylene glycol p-isooctylphenyl ether (TritonX-100).

The composition of Fluviral S/F is established in agreement with the recommendations of the Canadian National Advisory Committee on Immunization (NACI). The split-virion vaccine contains 0.01% thimerosal as a preservative, and trace residual amounts of egg proteins, sodium deoxycholate and/or polyethylene glycol p-isooctylphenyl ether (Triton X-100). Antibiotics are not used in the manufacture of this vaccine.

The product monograph also contains the specific antigens designated for the 2003-04 influenza season.

Notes & Sources for more information:

  1. VRAN publishes a comprehensive 32 page newsletter 3X a year with reports on vaccine awareness issues from around the world & alternatives to vaccination. Please contact VRAN.
  2. Numerous other vaccines may be offered your children that are not listed above. These may include DPT vaccines such as Adacel recommended for teens and young adults, Hepatitis A vaccines, 4-valent meningococcal vaccines, and DT (diphtheria & tetanus) as single tetanus vaccine is no longer available in Canada. Product monographs for these vaccines can be found at the Sanofi Pasteur website and VaccineShoppeCanada, and Merck Frosst.
  3. Critical Decisions Count: Medical and Articles on Immunizations.
  4. VRAN Links to associated vaccine awareness websites around the world.
  5. Vaccination Not Mandatory in Canada – Health Canada Statement
  6. F. Edward Yazbak, MD, Nothing New about Lack of Effectiveness of Influenza Vaccination in Babies
  7. Meningitis C vaccine: A Look at the Disease & The Jab, by Dr. Jayne Donegan
  8. Additional articles on Meningitis C
  9. Prevnar: Articles & critiques http://www.whale.to/v/prevnar.htm