Diphtheria and tetanus toxoids (Td) is an intramuscular vaccine indicated for the prevention of diphtheria and tetanus. Diphtheria toxoid is isolated from Corynebacterium diphtheriae whereas tetanus toxoid is isolated from Clostridium tetani. Td is FDA-approved for primary and booster immunization in people 7 years and older; it may be administered off-label to people 6 weeks to 6 years in whom concomitant immunization against pertussis is contraindicated (i.e., encephalopathy). Encephalopathy, within 7 days of vaccination, is a contraindication when it's not attributable to another identifiable cause. A causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome has been established. If individuals experience Guillain-Barre syndrome within 6 weeks of receipt of prior vaccine containing tetanus toxoid, base the decision to administer a vaccine containing tetanus toxoid on the potential risks and benefits.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
-Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the toxoid. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
-Record the manufacturer and lot number of the toxoid, date of administration, and the name, address, and title of the person that administered the toxoid in the recipient's permanent medical record.
-Health care professionals administering DT or Td toxoids should take appropriate precautions to prevent an allergic reaction.
-The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to DT or Td.
-If a prior DT or Td dose has been given, question the parent, guardian, or patient about any symptoms or signs of an adverse reaction after the previous dose. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Also, report an adverse event to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated (see Contraindications).
Route-Specific Administration
Injectable Administration
-DT and Td are only administered intramuscularly; do not give intravenously or subcutaneously.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Intramuscular Administration
Preparation:
-Shake vial or syringe vigorously just before withdrawing dose (use aseptic technique) to ensure a uniform, cloudy suspension. The suspension should be whitish-gray in color. If the vaccine cannot be resuspended, discard it.
-A separate syringe and needle should be used for each person receiving DT or Td.
-Do not mix in the same syringe with any other vaccine or medication.
-Single use preparations do not contain preservatives. Unused product should be discarded immediately.
Intramuscular (IM) injection:
-Before administration, clean skin over the injection site with a suitable cleansing agent.
-Intramuscular injections should be made into the lateral mid-thigh (vastus lateralis) for infants or the outer aspect of the upper arm (deltoid) for older children and adults. Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
-If administering multiple vaccines or toxoids concurrently, inject into different areas within the recommended sites.
Diphtheria toxoid; tetanus toxoid adsorbed, DT, Td vaccine is generally well tolerated. The most common adverse reactions are local reactions (i.e., injection site reaction) consisting of erythema and induration with or without tenderness. Among DT recipients, 0-3.6% had hardness >= 2.5 cm, 0-3.6% had erythema >= 2.5 cm, 2.2-11% had slight pain, and 0-1.4% had moderate pain at the injection site. Among Td recipients, 29.4-80.1% had pain, 15.8-25.6% had erythema, and 13-17% had swelling at the injection site. Also, warmth and cellulitis at the injection site have been observed through post-marketing surveillance. Local reactions are usually self-limiting and do not require therapy. A nodule may be palpable at the injection site for several weeks after the injection. Persistent nodules have been reported following the use of adsorbed products. These nodules are likely due to poor IM administration technique. The nodule is usually not associated with pain, is self limited, and does not require therapy. Warming the Td vaccine in hands or by using a warmer has not been associated with a reduction in pain or adverse reactions following injection.
Arthus reaction is occasionally reported after administration of diphtheria toxoid; tetanus toxoid adsorbed, DT, Td. Arthus-type hypersensitivity reactions may be associated with high levels of circulating antitoxin in persons who have had overly frequent injections of tetanus toxoid. Do not administer the DT or Td vaccine more frequently than recommended. The local, type III, immune complex mediated hypersensitivity reaction is usually self-limiting, and patients may experience redness and erythema at the injection site, which usually appears within 2-8 hours of vaccine administration. Persons who experienced Arthus-type hypersensitivity reactions or a temperature of > 103 degrees F (> 39.4 degrees C) after a prior dose of tetanus toxoid usually have high serum tetanus antitoxin concentrations and should not be given even emergency doses of Td vaccine more frequently than every 10 years, even if they have a wound that is neither clean nor minor.
Anaphylactoid reactions, bronchospasm, angioedema, urticaria, maculopapular rash, pruritus, and rash (unspecified) have been observed through post-marketing surveillance with the diphtheria toxoid; tetanus toxoid adsorbed, DT, Td vaccine. Also noted post-marketing are myalgia, muscle stiffness, fatigue, drowsiness, peripheral edema, lymphadenopathy, nausea, vomiting, syncope, and dizziness. Procedures should be in place to manage syncopal episodes and prevent falling injury. Fever has been reported in 0.7-6.6% of patients depending on the patient's age, formulation used, and which dose in the series that was administered (i.e. first, second, or third dose). Arthralgia (7.4-15.7%), headache (10.8-25.1%), and malaise (8.8-17%) were noted with Td in clinical trials. Patients should be advised to report any signs and symptoms of a fever or a systemic reaction (headache, malaise, or pain) to their health care provider. Also, have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of anaphylaxis.
Guillain-Barre syndrome has been reported during post-marketing observation with Td vaccine. A causal relationship between tetanus toxoid receipt and both brachial neuritis and Guillain-Barre syndrome appears to exist. If Guillain-Barre syndrome occurs within 6 weeks of receipt of a prior vaccine that contained tetanus toxoid, base the decision to give any vaccine containing tetanus toxoid such as diphtheria toxoid; tetanus toxoid adsorbed, DT, Td on careful consideration of the potential benefits and possible risks, as the risk for Guillain-Barre syndrome may be increased. When a decision is made to withhold tetanus toxoid, administer other available vaccines, as indicated. Other neurological reactions reported during post-marketing experience with DT or Td vaccine include convulsions or seizures, paresthesias, dizziness, and syncope. Procedures should be in place to manage syncopal episodes and prevent falling injury. In addition, muscle weakness has been reported in 4.9-32.3% of patients who received the Td vaccine in clinical trials.
Do not administer a DT or Td vaccine to a patient with thimerosal hypersensitivity. All DT and Td products may contain at least trace amounts of thimerosal. The single dose, preservative free products may contain trace thimerosal concentrations (e.g., Decavac < 0.00012% or 0.3 mcg/mercury per dose) due to the manufacturing process. The Center for Disease Control considers these products to be 'thimerosal free' in regards to adverse reactions to thimerosal. Also, the packaging of some DT or Td vaccines may contain dry, natural rubber. Thus health care professionals should administer vaccines with caution to patients with a history or a condition with the potential for latex hypersensitivity (e.g., spina bifida). DT or Td immunization is contraindicated in any patient with a history of allergy or anaphylactic reactions to any of the components of the vaccine or any other tetanus or diphtheria toxoid containing vaccine. Because of uncertainty as to which component of the vaccine may be responsible, no further vaccination with diphtheria or tetanus components should be carried out. If further immunizations are to be considered, referral to an allergist for evaluation may be warranted. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to DT or Td.
The clostridium tetani cultures for the Decavac brand of Diphtheria Toxoid; Tetanus Toxoid Adsorbed, DT, Td are grown in a peptone-based medium containing an extract of bovine muscle tissue. While caution may be warranted in patients with bovine protein hypersensitivity, no warnings are relayed by the manufacturer or the CDC.
No adequate and well-controlled studies have been conducted with diphtheria toxoid; tetanus toxoid, adsorbed (Td) in pregnant women and the risk to a human fetus or effect on reproductive capacity is unknown. According to the Advisory Committee on Immunization Practices (ACIP), there are no data to suggest risk of fetal harm after administration of toxoids to pregnant women and pregnant women should receive Td vaccine, if indicated. Previously vaccinated pregnant women who have not received a Td vaccination within the last 10 years should receive a booster dose during the second or third trimester. Pregnant women who are not vaccinated or only partially immunized against tetanus should complete the primary series. Women for whom the vaccine is indicated but who have not completed the recommended 3-dose series during pregnancy should receive follow-up after delivery to ensure series completion. Pregnant adolescents and adults who received the last tetanus-containing vaccine less than 10 years previously are generally recommended to receive Tdap after delivery to ensure pertussis immunity. To prevent neonatal tetanus, pregnant adolescents who received the last dose of tetanus-toxoid containing vaccine more than 10 years previously should generally receive Td in preference to Tdap while they are pregnant, although Tdap is not contraindicated during pregnancy. If the pregnant woman has an indication for Td but is likely to have sufficient protection against tetanus and diphtheria and has not previously received a dose of Tdap, the ACIP states that Tdap may be administered in the immediate postpartum period rather than Td being administered during pregnancy.
Data are limited regarding use of the diphtheria toxoid; tetanus toxoid, adsorbed vaccine during breast-feeding and its' excretion in human milk is unknown. The FDA-approved labeling recommends caution when administering to nursing mothers; however, according to the Advisory Committee on Immunization Practices (ACIP), toxoids pose no risk to mothers or their infants. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
Safety and efficacy in neonates or infants < 6 weeks of age have not been established. It is recommended to not administer DT to individuals in these patient populations.
Do not give DT or Td vaccines via intravenous administration or subcutaneous administration. DT or Td vaccines are for intramuscular (IM) use only. Take care to avoid injecting DT or Td into a blood vessel (avoid intraarterial administration). Any condition that contraindicates the use of intramuscular (IM) injections contraindicates the use of DT or Td. The manufacturer recommends avoidance of DT or Td for persons with any bleeding disorder or coagulopathy, such as hemophilia or thrombocytopenia, or for persons with vitamin K deficiency or on anticoagulant therapy unless the potential benefit clearly outweighs the risk of administration. If the decision is made to administer the vaccine in such persons, it should be given with caution, with steps taken to avoid the risk of bleeding and hematoma formation following injection.
DT or Td immunization should be postponed in patients with moderate or severe febrile illness, a severe respiratory infection, shock, or acute infection. Minor illness, such as a mild upper respiratory infection with or without low grade fever, does not preclude vaccine administration. Patients receiving antibiotic therapy may receive this vaccine. If a contraindication to using DT or Td exists, passive immunization with TIG should be considered whenever an injury resulting in broken skin other than a clean or minor wound is sustained.
Patients suffering significant immunosuppression may not have an adequate antibody response to vaccination with DT or Td toxoids and vaccines. The vaccine should be administered before or 1 month after completing immunosuppressive therapy, if possible. According to the CDC, patients with HIV infection may receive DT or Td immunization. Vaccines given to immunocompromised patients cannot be assumed to be as effective as when given to normal individuals. Post administration antibody measurement can be done if available. In the absence of specific antibody information, appropriate immune globulins should be considered for exposures to vaccine-preventable diseases.
If Guillain-Barre Syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give subsequent doses of any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
In some premature neonates, apnea after intramuscular vaccination has been observed. Consider the infant's medical status and the vaccine's potential benefits and possible risks when deciding when to administer an intramuscular vaccine such as diphtheria toxoid; tetanus toxoid adsorbed (DT) to infants born prematurely.
General Dosing Information
-NOTE: It is anticipated that the supply of tetanus and diphtheria (Td) vaccine will be constrained due to the discontinued production of TdVax. Preserve the limited supply of Td for those with a contraindication to receiving pertussis-containing vaccines. The CDC recommends vaccination providers transition to use of diphtheria, tetanus, and acellular pertussis (Tdap) vaccine in lieu of Td vaccine whenever possible while Td vaccine supplies are constrained. Tdap vaccine is an acceptable alternative to Td vaccine, including when a tetanus booster is indicated for wound management. Tdap vaccine is not an acceptable alternative only when a person has a specific contraindication to pertussis-containing vaccines, which is very rare.
-DTaP vaccine is for use in infants and children 6 weeks up to 7 years of age for primary immunization; Td is recommended off-label for infants and children 6 weeks to 7 years who have a contraindication to pertussis-containing vaccines.
-Td vaccine is for use in people 7 years of age or older for booster and catch-up immunization; Td may be used to complete the primary immunization series for tetanus and diphtheria after 1 or more doses of DTaP.
-Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with Td vaccine. There is no need to start the primary series over again, regardless of the time between doses.
For diphtheria prophylaxis and tetanus prophylaxis:
-for primary immunization against diphtheria and tetanus:
Intramuscular dosage:
Adults: 0.5 mL IM for 3 doses. For Tenivac dosing, the first 2 doses are administered 2 months apart and the third dose is administered 6 to 8 months after the second dose. For TDVAX dosing, the first 2 doses are administered 1 to 2 months apart and the third dose is administered 6 to 12 months after the second dose. Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
Children and Adolescents 7 to 17 years: 0.5 mL IM for 3 doses. For Tenivac dosing, the first 2 doses are administered 2 months apart, and the third dose is administered 6 to 8 months after the second dose. For TDVAX dosing, the first 2 doses are administered 1 to 2 months apart, and the third dose is administered 6 to 12 months after the second dose. For patients never immunized against diphtheria, tetanus, or pertussis, or with unknown immunization, a 3-dose series is recommended, with an interval of 4 to 8 weeks between doses 1 and 2, and an interval of 6 to 8 months between doses 2 and 3. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. For catch-up immunization in patients who are not fully vaccinated, a single dose of Tdap is recommended if the patient has not received Tdap before, followed by doses of Td or Tdap as necessary to complete the catch-up series. If the first dose of diphtheria or tetanus toxoid-containing vaccine was administered before 12 months of age, the minimum interval between doses 2 and 3 may be lowered to 4 weeks, and a fourth dose of Td or Tdap is recommended at least 6 months after the third dose. Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
Infants and Children 6 weeks to 6 years*: 0.5 mL IM at 2, 4, 6, 15 to 18 months, and 4 to 6 years. Use in place of DTaP for primary immunization in people with a contraindication to a pertussis containing vaccine.
-for booster immunization against diphtheria and tetanus:
Intramuscular dosage:
Adults: 0.5 mL IM. A Td or Tdap booster is recommended every 10 years. Wait at least 10 years before giving a tetanus toxoid-containing vaccine for emergency prophylaxis if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
Adolescents: 0.5 mL IM. A single dose of Tdap is recommended, followed by Td or Tdap booster every 10 years; Td may be substituted for Tdap if immunization against pertussis is not indicated. Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
Children 11 to 12 years: 0.5 mL IM when at least 5 years have passed since the last dose of toxoid-containing vaccine. Tdap is recommended if there are no contraindications, followed by Td or Tdap booster every 10 years; Td may be substituted for Tdap if immunization against pertussis is not indicated.
-for prophylaxis against diphtheria and tetanus for patients with large, contaminated wounds:
Intramuscular dosage:
Adults: 0.5 mL IM. A single dose of Tdap is preferred to Td if the patient has not previously received Tdap. If immunization history is unknown or less than 3 doses of a tetanus toxoid vaccine have previously been given, give vaccine for clean, minor wounds or other severe or contaminated wounds. If 3 doses or more of a tetanus toxoid-containing vaccine have been given, give vaccine for clean, minor wounds if 10 years or more have elapsed since the last tetanus toxoid-containing vaccine, or for other severe or contaminated wounds if 5 years or more have elapsed since the last tetanus toxoid-containing vaccine. Wait at least 10 years before giving a tetanus toxoid-containing vaccine for emergency prophylaxis if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
Children and Adolescents 7 to 17 years: 0.5 mL IM. A single dose of Tdap is preferred to Td if the patient has not previously received Tdap. If immunization history is unknown or less than 3 doses of a tetanus toxoid vaccine have previously been given, give vaccine for clean, minor wounds or other severe or contaminated wounds. If 3 doses or more of a tetanus toxoid-containing vaccine have been given, give vaccine for clean, minor wounds if 10 years or more have elapsed since the last tetanus toxoid-containing vaccine, or for other severe or contaminated wounds if 5 years or more have elapsed since the last tetanus toxoid-containing vaccine. Wait at least 10 years before giving a tetanus toxoid-containing vaccine for emergency prophylaxis if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
-for prophylaxis against diphtheria for case contacts:
Intramuscular dosage:
Adults: 0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, or with unknown immunization, a 3-dose series is recommended, with an interval of 4 to 8 weeks between doses 1 and 2, and an interval of 6 to 8 months between doses 2 and 3. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. For catch-up immunization in patients who are not fully vaccinated, a single dose of Tdap is recommended if the patient has not received Tdap before, followed by doses of Td or Tdap as necessary to complete the catch-up series. If the first dose of diphtheria or tetanus toxoid-containing vaccine was administered before 12 months of age, the minimum interval between doses 2 and 3 may be lowered to 4 weeks, and a fourth dose of Td or Tdap is recommended at least 6 months after the third dose. Close contacts who have completed a primary series of 3 or more doses of a diphtheria toxoid-containing vaccine and who have not been vaccinated with diphtheria toxoid in the previous 5 years should receive a booster dose of a diphtheria toxoid-containing vaccine. Tdap is recommended in patients 11 years and older who have not previously received the vaccine. Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
Children and Adolescents 7 to 17 years: 0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, or with unknown immunization, a 3-dose series is recommended, with an interval of 4 to 8 weeks between doses 1 and 2, and an interval of 6 to 8 months between doses 2 and 3. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. For catch-up immunization in patients who are not fully vaccinated, a single dose of Tdap is recommended if the patient has not received Tdap before, followed by doses of Td or Tdap as necessary to complete the catch-up series. If the first dose of diphtheria or tetanus toxoid-containing vaccine was administered before 12 months of age, the minimum interval between doses 2 and 3 may be lowered to 4 weeks, and a fourth dose of Td or Tdap is recommended at least 6 months after the third dose. Close contacts who have completed a primary series of 3 or more doses of a diphtheria toxoid-containing vaccine and who have not been vaccinated with diphtheria toxoid in the previous 5 years should receive a booster dose of a diphtheria toxoid-containing vaccine. Tdap is recommended in patients 11 years and older who have not previously received the vaccine. Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
Maximum Dosage Limits:
-Adults
0.5 mL/dose IM.
-Geriatric
0.5 mL/dose IM.
-Adolescents
0.5 mL/dose IM.
-Children
7 to 12 years: 0.5 mL/dose IM.
1 to 6 years: 0.5 mL/dose IM has been used off-label.
-Infants
6 weeks and older: 0.5 mL/dose IM has been used off-label.
Younger than 6 weeks: Use not recommended.
-Neonates
Use not recommended.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Albuterol; Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Betamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Bimekizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticosteroids (systemic): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticotropin, ACTH: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Cortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deflazacort: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Dexamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hydrocortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Methylprednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Prednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Prednisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Triamcinolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Vamorolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Diphtheria toxoid; tetanus toxoid, Td confers immunity against the bacteria that cause diphtheria and tetanus.
Diphtheria Toxoid: Corynebacterium diphtheriae infections are mediated by diphtheria exotoxin, an extracellular protein metabolite of toxogenic strains of C. diphtheriae. Diphtheria toxoid induces the production of neutralizing antibodies against the exotoxin. A serum diphtheria antitoxin concentration of at least 0.1 International Units/mL is considered protective.
Tetanus Toxoid: Exotoxin release by C. tetani causes the neuromuscular dysfunction associated with tetanus. The tetanus toxoid contains antigens that induce the production of antibodies against the exotoxin. A serum tetanus antitoxin concentration of at least 0.1 International Units/mL is considered protective.
DT or Td toxoid formulations are administered intramuscularly. Clinical studies have been performed to determine the serological responses after immunization. Protective levels of diphtheria and tetanus antitoxins (0.01 AU/mL) were detected in 100% of children after receiving 2 doses of DT; however, maternal antibody may have contributed to the additional immunity. Immunization with Td provided protective levels of antibody in greater than 90% of the study population after the entire primary immunization series. Antitoxin titers wane over the years, resulting in decreased efficacy. Most individuals have antitoxin levels below the optimal level 10 years after their last toxoid dose. Booster doses provide immunity in 100% of the individuals with preexisting antibody responses.
-Special Populations
Pediatrics
Protective levels of diphtheria and tetanus antitoxins (0.01 AU/ml) were detected in 100% of children after receiving 2 doses of DT; however, maternal antibody may have contributed to the additional immunity.
Geriatric
Clinical studies of Decavac (Td toxoid) did not include elderly subjects aged 59 years and over to determine whether they respond differently than younger adults. Similar to other Td formulations, the manufacturer does not recommend a dosage adjustment in these patients.