DTaP: There are 7 different types of this vaccine, so we will look at each one . This presentation will include Daptacel, Infanrix, and Tripedia. This is a Recommended Vaccine. Which means it is a vaccine that is mandated for school and some workers, make sure to look at your state exemption laws. In Utah, we have Medical, Religious, and Philosophical.
If you follow the CDC present recommendation schedule Your Child will have: 6 Inoculations of 3 different diseases. Diphtheria, Tetanus, and Pertussis.
As of this year the CDC recommends that all adults get the TDaP vaccine every ten years. If you live to be 78 you will have a total of 12 inoculations for a total of 36 encounters.
The CDC Guide to Vaccine Contraindications and Precautions has many notes on TDaP inoculation, so we will have to do a separate presentation on that.
DTaP (Daptacel): Aluminum Phosphate, Ammonium Sulfate, Casamino Acid, Dimethyl-beta-cyclodextrin, Formaldehyde or Formalin, Glutaraldehyde, 2-Phenoxyethanol
DTaP (Infanrix): Aluminum Hydroxide, Bovine Extract, Formaldehyde or Formalin, Glutaraldyde, 2-Phenoxyethanol, Polysorbate 80
DTap (Tripedia): Aluminum Potassium Sulfate, Ammonium Sulfate, Bovine Extract, Formaldehyde or Formalin, Gelatin, Polysorbate 80, Sodium Phosphate, Trace Thimerosal
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*****I highly recommend that EVERYONE look at the Clinical Trials of each of these vaccines which are in the vaccine insert. Interesting Note in the Tripedia Vaccine Package Insert: IT IS EXTREMELY IMPORTANT WHEN A CHILD RETURNS FOR THE NEXT DOSE IN THE SERIES THAT THE PARENT SHOULD BE QUESTIONED CONCERNING OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER THE PREVIOUS DOSE OF THE SAME VACCINE (SEE CONTRAINDICATIONS AND ADVERSE REACTIONS SECTIONS). Adverse events following immunization should be reported by health-care providers to the Vaccine Adverse Events Reporting System (VAERS). (See ADVERSE REACTIONS section, Reporting of Adverse Events subsection.)
Daptacel Description: DAPTACEL vaccine is a sterile isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminum phosphate, for intramuscular injection. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid and acellular pertussis antigens [10 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin (FHA), 3 mcg 277 pertactin (PRN), and 5 mcg fimbriae types 2 and 3 (FIM)].
Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤5 mcg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% 280 v/v) 2-phenoxyethanol (not as a preservative). The acellular pertussis vaccine components are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (2) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. The FIM components are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. Corynebacterium diphtheriae is grown in modified Mueller’s growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection.
DTap Infanrix Description: INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile vaccine for intramuscular administration. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), and 8 mcg of pertactin (69 kiloDalton outer membrane protein). The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde.
Diphtheria and tetanus toxoids and pertussis antigens (PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice.
Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.625 mg aluminum by assay) and 4.5 mg of sodium chloride. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80).
DTaP Tripedia Description: Tripedia®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP), for intramuscular use, is a sterile preparation of diphtheria and tetanus toxoids adsorbed, with acellular pertussis vaccine in an isotonic sodium chloride solution containing sodium phosphate to control pH. After shaking, the vaccine is a homogeneous white suspension. Tripedia vaccine is distributed by Sanofi Pasteur Inc. Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium Clostridium tetani cultures are grown in a peptone-based medium containing a bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration. The acellular pertussis vaccine components are isolated from culture fluids of Phase 1 Bordetella pertussis grown in a modified Stainer-Scholte medium. After purification by salt precipitation, ultracentrifugation, and ultrafiltration, preparations containing varying amounts of both pertussis toxin (PT) and filamentous hemagglutin in (FHA) are combined to obtain a 1:1 ratio and treated with formaldehyde to inactivate PT. The diphtheria and tetanus toxoids are adsorbed using aluminum potassium sulfate (alum). The adsorbed toxoids are combined with acellular pertussis concentrate, and diluted to a final volume using sterile phosphate-buffered physiological saline. Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test), and 46.8 µg of pertussis antigens. This is represented in the final vaccine as approximately 23.4 µg of inactivated PT and 23.4 µg of FHA. The inactivated acellular pertussis component contributes not more than 50 endotoxin units to the endotoxin content of 1 mL of DTaP. The potency of the pertussis components is evaluated by measuring the antibody response to PT and FHA in immunized mice using an ELISA system.
The vaccine is formulated without preservatives, but contains a trace amount of thimerosal [(mercury derivative), (≤0.3 µg mercury/dose)] from the manufacturing process. Each 0.5 mL dose also contains, by assay, not more than 0.170 mg of aluminum and not more than 100 µg (0.02%) of residual formaldehyde. The vaccine contains gelatin and polysorbate 80 (Tween-80), which are used in the production of the pertussis concentrate
****Please see part one for Special Notes and Listed Side-effects in the Vaccine Inserts
Lf means: Lf dose: the limes flocculation dose of diphtheria toxin, the smallest amount of toxin that, when mixed with one unit of antitoxin, yields the most rapid flocculation in the Ramon test (in vitro); in general, the Lf dose is slightly less than the Lr dose.
Package Insert Link: Daptacel: http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm103037.pdf
Package Insert Link: Infanrix: https://www.gsksource.com/gskprm/htdocs/documents/INFANRIX.PDF
Package Insert Link: Tripedia: http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm101580.pdf
Other source information: http://www.drugs.com/mtm/potassium-phosphate-and-sodium-phosphate.html
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