Pharmaceutical Name

Trade (marketing or proprietary) name: TENIVAC, TDVAX™

Generic (nonproprietary or active ingredient) name: Tetanus and Diphtheria Toxoids Adsorbed Suspension for Intramuscular Injection

Indication and Usage

Reason the product has been approved for sale on the market.

TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.

TDVAX is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

Each 0.5 mL dose of TENIVAC contains the following active ingredients: Tetanus Toxoid 5 Lf and Diphtheria Toxoid 2 Lf. Other ingredients per 0.5 mL dose include 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant and ≤5.0 mcg of residual formaldehyde.

Each 0.5 mL dose of MassBiologics’ TDVAX is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Each 0.5 mL dose also contains aluminum adjuvant (not more than 0.53 mg aluminum by assay), < 100 mcg (0.02%) of residual formaldehyde, and a trace amount of thimerosal [mercury derivative, (< 0.3 mcg mercury/dose)] (not as a preservative) from the manufacturing process.

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.

TENIVAC

Hypersensitivity: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of TENIVAC or any other tetanus toxoid or diphtheria toxoid-containing vaccine or any other component of this vaccine is a contraindication to administration of TENIVAC. Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

TDVAX™

A severe allergic reaction (e.g., anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration of MassBiologics’ TDVAX vaccine. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

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.

TENIVAC

Management of Acute Allergic Reactions: Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

Latex: The tip caps of the TENIVAC prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals.

Frequency of Administration: More frequent doses of TENIVAC than described in Section 2, Dosage and Administration, may be associated with increased incidence and severity of adverse reactions.

Arthus Reactions: Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive TENIVAC more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.

Guillain-Barré Syndrome and Brachial Neuritis: A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillian-Barré syndrome. If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give TENIVAC or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

Limitations of Vaccine Effectiveness: Vaccination with TENIVAC may not protect all individuals.

Altered Immunocompetence: If TENIVAC is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

Syncope: Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling and injury and to manage syncope.

Immunosuppressive Treatments: Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to TENIVAC.

TDVAX™

FREQUENCY OF ADMINISTRATION: More frequent administration of MassBiologics’ TDVAX than described in DOSAGE AND ADMINISTRATION may be associated with an increased incidence and severity of adverse reactions.

ARTHUS REACTIONS: Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive MassBiologics’ TDVAX more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.

GUILLAIN-BARRÉ SYNDROME: A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and Guillain-Barré Syndrome. If Guillain-Barré Syndrome occurred within 6 weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of MassBiologics’ TDVAX or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

Vaccination with MassBiologics’ TDVAX may not protect all individuals.

Epinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.

Prior to the administration of MassBiologics’ TDVAX, the vaccine recipient’s current health status and health history should be reviewed. This includes a review of the immunization history of the patient, the presence of any contraindications to immunization, and any adverse events after previous immunizations to allow an assessment of the benefits and risks of vaccination. If MassBiologics’ TDVAX is administered to immunocompromised persons (whether from disease or treatment) the expected immune response may not be obtained.

No safety and immunogenicity data are available on the concomitant administration of MassBiologics’ TDVAX vaccine with other U.S. licensed vaccines.

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.

TENIVAC can cause: Lymphadenopathy, Erythematous rash, Maculopapular rash, Urticaria (hives), Pruritus (itchy skin), Bronchospasm, Angioedema, Paresthesia, Dizziness, Syncope (fainting), Guillain-Barré syndrome, Vomiting, Myalgia (muscle pain), Pain in extremities, Injection site reactions (including inflammation, mass, edema, induration, warmth, pruritus, cellulitis, discomfort), Edema peripheral, Fatigue.

TDVAX™ can cause: Arthus Reactions, Guillain-Barré syndrome, Dizziness, Headache, Convulsions, Myalgia (muscle pain), Musculoskeletal stiffness or pain, Arthralgia (joint pain), Rash, Nausea.

Limitations of Effectiveness

Vaccination with TENIVAC may not protect all individuals.

Vaccination with MassBiologics’ TDVAX may not protect all individuals.

Specific Populations

Pregnancy

There are no adequate and well-controlled studies of TENIVAC administration in pregnant women in the U.S. There are insufficient human data from TENIVAC administered during pregnancy to establish the presence or absence of a vaccine-associated risk.

Animal reproduction studies have not been conducted with MassBiologics’ TDVAX. It is also not known whether MassBiologics’ TDVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MassBiologics’ TDVAX should be given to a pregnant woman only if clearly needed.

Breastfeeding

It is not known whether TENIVAC components are excreted in human milk. Data are not available to assess the effect of administration of TENIVAC on breastfed infants or on milk production/excretion.

It is not known whether MassBiologics’ TDVAX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MassBiologics’ TDVAX is administered to a nursing woman.

Fertility

TENIVAC has not been evaluated for carcinogenic or mutagenic potential or impairment of male fertility in animals.

No studies have been performed with MassBiologics’ TDVAX to evaluate carcinogenicity, mutagenic potential, or impairment of fertility.

Pediatric

TENIVAC is not approved for use in infants and children younger than 7 years of age. Safety and effectiveness of TENIVAC in this age group have not been established.

MassBiologics’ TDVAX is not approved for use in infants and children younger than 7 years of age. The safety and effectiveness of MassBiologics’ TDVAX 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.

TENIVAC

Tetanus: Tetanus is an acute disease caused by an extremely potent neurotoxin produced 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. A tetanus antitoxoid level of ≥0.1 IU/mL as measured by the ELISA used in some clinical studies of TENIVAC is considered protective.

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. A level of at least of 1.0 IU/mL has been associated with long-term protection.

TDVAX™

Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of 0.01 IU/mL measured via a neutralization assay is considered the minimum protective level. The efficacy against tetanus of MassBiologics’ TDVAX is supported by the following:

1. Response to primary series. Of 20 adults with less than 0.0025 units/mL of tetanus antitoxin in preimmunization serum, 14 (70%) had antitoxin concentrations of 0.01 or greater after 2 doses of TDVAX (2 Lf tetanus toxoid dose). After 3 doses of TDVAX, 16 of 16 adults achieved 0.01 antitoxin units/mL.
2. Response to booster doses. Booster doses of TDVAX at doses of 1 Lf and 5 Lf of tetanus toxoid induced tetanus antitoxin levels greater than 0.01 units/mL when administered to all 36 adults who had received prior tetanus immunizations.

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. The efficacy against diphtheria of MassBiologics’ TDVAX is supported by the following:

1. Response to primary series. Of 10 adults with less than 0.001 units/mL of diphtheria antitoxin in preimmunization serum, 50% had antitoxin concentrations of 0.01 or greater after 2 doses of TDVAX (2 Lf diphtheria toxoid dose). After 3 doses of TDVAX, 6 of 6 adults achieved 0.01 antitoxin units/mL.
2. Response to booster doses. In clinical trials, booster doses of TDVAX formulated to contain 1 Lf and 5 Lf of diphtheria toxoid, both induced antitoxin levels greater than 0.01 units/mL when administered to adults with prior diphtheria immunity. 5, 7, 8 In 140 adolescent males given a single booster dose of the 1 Lf formulation, all achieved an antitoxin titer of 0.01 units/mL or higher.

Analytical Deep Dive

What is informed consent?

Alternatives

Looking for Tetanus vaccine alternatives? Here are some products to research:

The alternative to the tetanus vaccine is to not accept it and treat it naturally when needed. Here are some things to research if you suspect you or your child developed an infection.

Tetanus FAQ

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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.