Disclaimer: This guide is for informational purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional. May contain affiliate links. Product photos/descriptions provided by company websites. This is not medical advice.
Pharmaceutical Name
Trade (marketing or proprietary) name: Adacel, BOOSTRIX
Generic (nonproprietary or active ingredient) name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Suspension for Intramuscular Injection, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed injectable suspension for intramuscular use.
Indication and Usage
Reason the product has been approved for sale on the market.
Adacel is a vaccine indicated for:
- active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in persons 10 through 64 years of age.
- immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.
BOOSTRIX is a vaccine indicated for:
- active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older.
- immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.
Manufacturer Insert
Ingredients
Also known as “excipients” for vaccines.
Adacel is a sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on aluminum phosphate, for intramuscular injection. Each 0.5 mL dose contains 5 Lf tetanus toxoid (T), 2 Lf diphtheria toxoid (d), and acellular pertussis antigens [2.5 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)]. Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 mcg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The antigens are the same as those in DAPTACEL; however, Adacel is formulated with reduced quantities of diphtheria and detoxified PT.
BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine,
Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated FHA and PRN). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens. Each 0.5-mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.3 mg aluminum) and 4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80).
Contraindications
Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.
Severe allergic reaction (e.g., anaphylaxis) to any component of Adacel/BOOSTRIX or any other diphtheria toxoid, tetanus toxoid and pertussis antigen-containing vaccine.
Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen containing vaccine.
Warnings and Precautions
Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.
If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barré syndrome may be increased following a subsequent dose of tetanus toxoid-containing vaccine, including Adacel/BOOSTRIX.
Progressive or unstable neurologic conditions are reasons to defer vaccination with a pertussis-containing vaccine, including Adacel/BOOSTRIX. Progressive or unstable neurologic conditions (e.g., cerebrovascular events, acute encephalopathic conditions) are reasons to defer vaccination with a pertussis-containing vaccine. It is not known whether administration to persons with an unstable or progressive neurologic disorder might hasten manifestations of the disorder or affect the prognosis.
Administration to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.
Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive Adacel/BOOSTRIX unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine.
Additionally, the Adacel insert states “syncope (fainting) can occur in association with administration of injectable vaccines, including Adacel. Procedures should be in place to
prevent falling injury and manage syncopal reactions.”
Manufacturer-Listed Adverse Reactions
Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.
TDAP (Adacel) can cause: Anaphylactic reaction, Guillain-Barré syndrome, Facial palsy, Syncope (Fainting), Myelitis, Myocarditis, Urticaria (Hives), Angioedema, Edema (Swelling), Rash, Hypotension (Low blood pressure), Hypoesthesia (Numbness), Convulsion, Pruritus (Itchy skin), Myositis, Muscle spasm, Large injection site reactions, Extensive limb swelling from the injection site beyond one or both joints, Injection site bruising, Sterile abscess (Pus), Arthus hypersensitivity, Brachial neuritis, Paresthesia.
TDAP (Boostrix) can cause: Encephalitis (Brain inflammation), Loss of consciousness, Exanthem, Henoch-Schönlein purpura, Lymphadenitis, Lymphadenopathy, Allergic reactions, anaphylactic and anaphylactoid reactions, Myocarditis, Extensive swelling of the injected limb, Arthralgia (Joint pain), Injection site induration, inflammation, mass, pruritus, nodule, warmth, reaction, Back pain, Myalgia (Muscle pain), Convulsions (with and without fever), Facial palsy, Paresthesia (Skin crawling), Syncope (Fainting), Angioedema, Rash, Urticaria (hives).
Specific Populations
Pregnancy
Available data from the pregnancy registry and from spontaneous and postmarketing reports suggest that the rates of major birth defects and miscarriage in women who received Adacel/BOOSTRIX within 28 days prior to conception or during pregnancy are consistent with estimated background rates.
Human Data: Safety data from a randomized (1:1), controlled clinical study (NCT02377349)
(341 non-U.S. formulation of BOOSTRIX, 346 placebo pregnancy outcomes) in which the non U.S. formulation of BOOSTRIX was administered to pregnant women during the third trimester did not reveal any vaccine-related adverse effects on pregnancy or on the fetus/newborn child. Safety data from prospective clinical studies on the use of BOOSTRIX during the first and second trimester of pregnancy are not available.
An assessment of data from the ongoing pregnancy registry included 1236 prospective reports of exposure to Adacel during pregnancy since 10 June 2005 through 16 October 2022. Among the 286 reports with known pregnancy outcomes, 118 women were exposed to Adacel in the first trimester with 1 congenital anomaly and 14 spontaneous abortions; 54 women were exposed to Adacel in the second trimester with one congenital anomaly; 114 women were exposed to Adacel in the third trimester with 2 congenital anomalies; 76 women were exposed to Adacel at an unknown trimester with 1 congenital anomaly. The rates of assessed outcomes in the prospective population were consistent with estimated background rates.
A retrospective passive surveillance study (NCT00258882) included women who received
Adacel during pregnancy (n=225) and controls (n=675) matched by age and date of first positive pregnancy test. Of the 225 Adacel recipients, 39 women received Adacel within two weeks prior to the date of their last menstrual period (LMP), 110 were vaccinated during the 1st trimester (< 12 weeks gestation), 33 during the 2nd trimester (12 to < 27 weeks gestation), 14 in 3rd trimester (11 from 27 to <36 weeks gestation and 3 from ≥36 weeks gestation), and 29 were unknown. There were 21 reports of spontaneous abortion (9.3%) and 15 congenital anomalies (6.7%) in the Adacel exposed group, and 102 spontaneous abortions (15%) and 57 congenital anomalies (8.4%) in the control group.
However, it is important to note, that the control group referenced above still received a vaccine. According to the details of the study, “Overall, 124,139 people received Tdap5 vaccine from September 2005 through mid-October 2006, and 203,154 in the comparison cohort received a tetanus and diphtheria toxoid adsorbed vaccine (and no live virus vaccine) during the year prior to initiation of this study.”
Breastfeeding
It is not known whether Adacel/BOOSTRIX vaccine components are excreted in human milk. Data are not available to assess the effect of administration of Adacel/BOOSTRIX on breast-fed infants or on milk production/excretion.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Adacel/BOOSTRIX has not been evaluated for carcinogenic or mutagenic potential, or impairment of male fertility.
Pediatric
Adacel/BOOSTRIX is not indicated for use in children aged younger than 10 years. Safety and
effectiveness of Adacel/BOOSTRIX in this age group have not been established.
Mechanism of Action
This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.
Tetanus
Tetanus is a disease manifested primarily by neuromuscular dysfunction caused by a potent
exotoxin released by C tetani. Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assay is considered the minimum protective level.
Diphtheria
Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C diphtheriae.
Protection against disease is due to the development of neutralizing antibodies to diphtheria
toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally regarded as protective. Levels of 1.0 IU/mL have been associated with long-term protection.
Pertussis
Adacel: Pertussis (whooping cough) is a respiratory disease caused by B pertussis. This Gram negative coccobacillus produces a variety of biologically active components, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined.
BOOSTRIX: Pertussis (whooping cough) is a disease of the respiratory tract caused by B. pertussis. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood.
Analytical Deep Dive
What is informed consent?
Alternatives
Looking for alternatives? Here are some products to research:
Disclaimer: This guide is for informational purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional. May contain affiliate links. Product photos/descriptions provided by company websites. This is not medical advice.
The alternative to the TDAP vaccine is to not accept it and treat the conditions naturally when needed. Here are some things to research:
Pertussis FAQ
Do you worry about pertussis and have been recommended the TDAP or DTAP vaccines? Click the image above for prevention and treatment protocols + products to research for educated and empowered medical decisions.
Diphtheria FAQ
Do you worry about diphtheria and have been recommended the Tetanus, TDAP, or DTAP vaccines? Click the image above for prevention and treatment protocols + products to research for educated and empowered medical decisions.
Tetanus FAQ
Do you worry about tetanus and have been recommended the Tetanus vaccine? Click the image above for prevention and treatment protocols + products to research for educated and empowered medical decisions.