Vaccination against diphtheria, tetanus, and pertussis is accomplished by using combination products that contain various pertussis antigens (isolated from Bordetella pertussis) in combination with diphtheria toxoid (isolated from Corynebacterium diphtheriae) and tetanus toxoid (isolated from Clostridium tetani). The first combination vaccines (DTwP) contained whole cell pertussis; however, concerns about the safety of whole-cell pertussis vaccines prompted the development of acellular vaccines (e.g., DTaP, Tdap) that are less likely to cause adverse events because they contain purified antigenic components. Vaccination with DTaP is indicated for infants and children from 6 weeks through 6 years. Vaccination with Tdap is recommended for patients 10 years and older and during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months. The acellular pertussis vaccines contain different combinations of pertussis antigens but, in general, each formulation combines pertussis exotoxin with various surface proteins from the pertussis organism. Infanrix (DTaP) and Boostrix (Tdap) combine PT with 2 surface proteins (FHA and pertactin). Daptacel (DTaP) and Adacel (Tdap) combine PT with 2 surface proteins (FHA and pertactin) and fimbriae types 2 and 3.
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 vaccine. 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 vaccine; date of administration; and the name, address, and title of the person who administered the vaccine in the recipient's permanent medical record.
-If a prior DTP 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.
-The health care professional should have immediate availability of epinephrine 1 mg/mL injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.
Route-Specific Administration
Injectable Administration
-DTaP and Tdap are administered intramuscularly; do not give intravenously or subcutaneously.
-Do not administer fractional doses (i.e., doses < 0.5 mL).
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Intramuscular Administration
Preparation:
-Shake vial vigorously just before withdrawing dose (use aseptic technique) to ensure a uniform, cloudy suspension. If the vaccine cannot be resuspended, discard it.
-Do not mix Daptacel, Tri-Immunol, Boostrix, Adacel, or Infanrix with any other vaccine.
-When Daptacel and Menactra are to be given together for children 4 through 6 years, the two vaccines should be administered concomitantly or Menactra should be administered before Daptacel. Clinical trials found a reduced meningococcal antibody response when Menactra was administered one month after Daptacel.
-Storage of unopened vials:-Manufacturer recommendations: Store refrigerated at 2 to 8 degrees C (36 to 46 degrees F); do not freeze.
-Off-label storage information (Infanrix only): According to a 2007 published article, storage of Infanrix (GlaxoSmithKline) at room temperature for up to 72 hours is acceptable. NOTE: Because changes in vaccine formulation may affect stability and effectiveness, confirmation of acceptable duration of storage at room temperature directly from the manufacturer for the specific vaccine being administered is recommended.
Intramuscular injection:
-Use a separate syringe and needle for each person receiving DTaP or Tdap.
-Clean skin over the injection site with a suitable cleansing agent before administration.
-The preferred injection sites are the anterolateral aspect of the thigh (particularly for infants) and the deltoid muscle of the upper arm (usually suitable for older children). Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as to the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.
Sudden infant death syndrome (SIDS) has been reported during post-marketing use of DTaP. The Institute of Medicine and other experts reviewed available data and found no evidence of a causal relationship between DTaP vaccination and SIDS.
Immune-mediated adverse reactions have been observed with the use of diphtheria/tetanus toxoids; pertussis vaccine. Anaphylactoid reactions, anaphylactic shock, angioedema, urticaria; erythematous, macular, or maculopapular rash; generalized edema, pruritus, exanthem, Henoch-Schonlein purpura, and hypotension have been observed during postmarketing surveillance. Rash occurred in approximately 2% to 3% of adults and children who received Tdap during clinical safety studies. Other hypersensitivity reactions may include dyspnea. Instruct patients to report any signs and symptoms of a systemic reaction. Also, have immediate availability of epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis.
Of adults and children who received Tdap during clinical studies, approximately 2% to 14% had fever of at least 99.5 degrees F, and approximately 1% to 5% had fever of at least 100.4 degrees F. Among infants and children who received DTaP during clinical studies, fever of higher than 100.4 degrees F occurred in approximately 4% to 30% of patients, and approximately 2% to 10% of patients had fever of at least 101.3 degrees F. Fever typically occurred during the first 3 days post-immunization. Fever of 40.5 degrees C (105 degrees F) or higher not attributable to other causes and occurring within 48 hours of administration is thought to be related to the pertussis component of the vaccine. Febrile convulsions have been reported during postmarketing surveillance. Instruct patients to report any signs and symptoms of a fever to their health care provider.
Seizures have rarely been reported after DTP immunization, which, like high fever, may be related to the pertussis component of the vaccine. Of 4,696 infants who received DTaP during a clinical efficacy trial, 1 experienced a seizure within 48 hours following vaccination. In a German safety study, afebrile seizures occurring within 7 days following DTaP administration were reported at a rate of 0.13/1,000 doses (66,867 doses administered as a 3 dose primary series). During a US study in which children (n = 1,454) received 4 doses of DTaP, 0.3% of children experienced a seizure within 60 days following any dose of the vaccine. One infant experienced an afebrile seizure with apnea on the day of the first vaccination. Seizures are more likely to occur in children with a history of seizures or a family history of seizures. Among infants and children who received diphtheria/tetanus toxoids; pertussis vaccine during clinical studies, approximately 23% to 76% experienced irritability/fussiness and approximately 2% to 14% experienced inconsolable crying (defined as at least 1 hour). Worldwide voluntary reports of serious adverse events with suspected causal connection received for DTP since market introduction include seizures (convulsions), depressed level of consciousness, febrile seizure, hypotonia, hypotonic-hyporesponsive episode, and screaming. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Hypotonic-hyporesponsive episodes are rare, observed in 0.04% of children during 48 hours post-vaccination in an open-label study. Hypotonic-hyporesponsive episodes within 48 hours of administration or persistent, inconsolable crying for 3 hours or more (or high-pitched unusual screaming) occurring within 48 hours may be related to the pertussis component of the vaccine. Instruct patients to report any signs and symptoms of a fever or a systemic reaction. Pediatric patients experiencing any serious reaction after DTaP or Tdap administration should be evaluated for the appropriateness of continuing immunization versus completing immunization with DT or Td toxoids.
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/tetanus toxoids; pertussis vaccine 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. Encephalopathy such as coma, decreased level of consciousness, or prolonged seizures within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine. Whole cell DTP was associated with acute encephalopathy in children. There are insufficient data at this time to determine if there is a causal association of encephalopathy with vaccines such as DTaP or Tdap that contain acellular DTP vaccines, or if the incidence is different from that of whole cell DTP. The results of the National Childhood Encephalopathy Study (NCES) in England concluded that children 2 to 35 months of age who had histories of acute neurologic disorders were more likely to have received whole cell DTP immunization within 7 days of the onset of the neurologic illness than controls. The incidence of these events is estimated at 1 per every 140,000 children vaccinated with whole cell DTP. A follow-up study of the NCES 10 years later concluded that these affected cases were also more likely to have experienced chronic neurologic sequelae. The Advisory Committee on Immunization Practices (ACIP) evaluated the follow-up study and concluded that the data are insufficient to determine whether whole cell DTP administration before the acute neurologic event influenced the potential for chronic neurologic dysfunction 10 years later. Subsequent studies have not been able to prove a causal relationship. Encephalitis, encephalopathy, Guillain-Barre syndrome, brachial neuritis, paresthesias, hypoesthesia, facial palsy, myelitis, autism, demyelinating diseases of the CNS, peripheral neuropathy, and cranial mononeuropathy have all been observed after immunization with DTP vaccines in postmarketing surveillance. One case of severe migraine with unilateral facial paralysis and 1 diagnosis of nerve compression in the neck and arm have been reported in adults after Tdap administration. Other neurological reactions to DTP vaccines reported during clinical studies include headache, which was observed in approximately 12% to 53% of patients who received Tdap.
After intramuscular vaccination with the diphtheria/tetanus toxoids; pertussis vaccine, apnea has been observed in some infants born prematurely. For infants born prematurely, consider the infant's medical status and the potential benefits and possible risks of vaccination when deciding when to administer an intramuscular vaccine such as DTP. Cyanosis and cough have been reported during postmarketing observation with DTaP. Asthma and bronchospasm with hypoxia occurred within 30 days of fifth consecutive dose receipt in 0.4% and 0.2% of children, respectively, who received DTaP and other vaccines during clinical studies.
Thrombocytopenia has been observed during postmarketing experience with diphtheria/tetanus toxoids; pertussis vaccine.
Arthus reaction is occasionally reported following administration of diphtheria/tetanus toxoids; pertussis vaccine. 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 DTP vaccine more frequently than recommended. The local, type III, immune complex mediated hypersensitivity reaction is usually self-limiting, and patients may experience redness at the injection site, which usually appears within 2 to 8 hours of vaccine administration. Persons who experienced Arthus-type hypersensitivity reactions or a temperature of more than 103 degrees F (more than 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 DTP vaccine more frequently than every 10 years, even if they have a wound that is neither clean nor minor.
Diphtheria/tetanus toxoids; pertussis vaccine is generally well tolerated. The most common adverse reactions are local reactions (i.e., injection site reaction) consisting of pain, erythema, swelling, or tenderness. Among Tdap recipients, 21% to 88% had pain, 8% to 39% had swelling, and 11% to 48% had erythema at the injection site. Moderate to severe pain (defined as pain that was spontaneously painful, interfered with activities, necessitated medical care or absenteeism, or was incapacitating) occurred in 1% to 18% of patients given Tdap. Increases in arm circumference were reported in up to 28% of adolescents. Among DTaP recipients in clinical studies, approximately 30% to 53% experienced pain. Moderate to severe pain (defined as spontaneously painful injection areas, crying when injected limb moved, protesting to touch, or prevention of normal activities) occurred in approximately 4% to 12% of infants and children given DTaP. DTaP was associated with local erythema (6% to 50%), tenderness (38% to 62%), and swelling (4% to 33%) during clinical safety studies. Increases in limb circumference (mid thigh or arm) were reported in up to 38% of patients. A retrospective study that examined the occurrence of medically attended local reactions (e.g., limb swelling, cellulitis, limb pain) in a cohort of children 1 to 6 years who received 91,510 DTaP vaccines found reactions on the thigh and arm occurred at rates of 25.3 and 66.8 per 10,000 vaccinations, respectively. Children ages 12 to 35 months had a significantly higher risk of medically attended local reactions when given DTaP in the arm vs. the thigh (RR 1.88, 95% CI 1.34 to 2.65, p less than 0.001); older children also had increased risk with arm administration compared to thigh (RR 1.41, 95% CI 0.84 to 2.34) but the difference was not statistically significant. These results support current guidelines to administer IM DTaP vaccinations in the thigh for children 12 to 35 months of age. Local reactions reported during postmarketing use include injection site induration or mass, cellulitis, abscess or sterile abscess, rash, pruritis, warmth, bruising, and nodules. A nodule may be palpable at the injection site for several weeks, as these have been reported after the use of adsorbed products. Large injection site reactions (more than 50 mm) and extensive limb swelling (including joints) have been observed. Many injection site reactions occurred within 3 days of immunization during clinical studies and resolved within 5 days without sequelae. Local reactions are usually self-limiting and do not require therapy; however, persistent reactions that require medical care have occurred.
Gastrointestinal adverse reactions, including nausea, vomiting, diarrhea, and/or abdominal pain were reported in approximately 8% to 16% of adults and 26% of children who received diphtheria/tetanus toxoids; pertussis vaccine (Tdap) in clinical studies. In one study in adults and children who received Tdap vaccine, nausea was reported in 9% to 13% of patients, diarrhea in approximately 10% of patients, and vomiting in approximately 3% to 5% of patients. Across all clinical studies of DTaP vaccine that included infants and children, vomiting was reported in 4% to 7% of patients and anorexia in 8% to 28% of patients. Instruct patients to report any signs and symptoms of a systemic reaction.
Syncope has been reported during postmarketing experience with diphtheria/tetanus toxoids; pertussis vaccine. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Have procedures in place to avoid falling injury and to restore cerebral perfusion after syncope.
During clinical safety studies with diphtheria/tetanus toxoids; pertussis vaccine, body aches and muscle weakness (myasthenia) occurred in approximately 22% to 30% of adults and children within 1 week after Tdap administration. Chills occurred in 8% to 15% of adults and children given Tdap. Arthralgia, or sore/swollen joints, was reported in approximately 9% to 18% of patients; joint swelling had a mean duration of 2 days. Malaise was reported in approximately 33% to 38% of adults and myalgia was reported in approximately 58% to 61% of adults after a second dose of Tdap. Myositis, muscle spasms, back pain, and myalgia have also been noted during postmarketing surveillance.
Infection has been observed during clinical studies with diphtheria/tetanus toxoids; pertussis vaccine, including bronchiolitis, which was reported in 1.9% of children. Pneumonia and cellulitis that occurred within 30 days of vaccination were reported in 0.1% of children who received a fifth dose in the DTaP series. Bronchitis, respiratory tract infections, myocarditis, meningitis, sepsis, pertussis (post-dose 1), and otalgia have also been reported. Lymphadenopathy was reported in approximately 7% of adults and children who received Tdap during clinical studies, and it has also been observed with the use of DTaP vaccines. Lymphadenitis has been observed during postmarketing experience with diphtheria/tetanus toxoids; pertussis vaccine.
Fatigue was among the most common adverse reactions to the diphtheria/tetanus toxoids; pertussis vaccine. In adults and children who received Tdap during clinical studies, fatigue or tiredness was reported in approximately 12% to 37% of patients. Among infants and children who received DTaP, approximately 18% to 54% had drowsiness. Decreased activity and lethargy occurred within 3 days after DTaP receipt in approximately 13% to 51% of infants and children. Instruct patients to report any signs or symptoms of a systemic reaction.
Diphtheria/tetanus toxoids; pertussis vaccine, DTP is contraindicated in patients who have had an immediate anaphylactic reaction temporally associated with a previous dose of this vaccine or any of its components. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. Have epinephrine 1 mg/mL injection and other agents used in the treatment of severe anaphylaxis immediately available in the event of a serious allergic reaction to the vaccine. If immunizations are to be considered in a patient with a history of a severe allergic reaction to the vaccine or a component of the vaccine, referral of the potential vaccine recipient to an allergist may be appropriate. Patients who have experienced an Arthus-type hypersensitivity reaction after a tetanus toxoid dose should not be given Tdap as an emergency or routine booster vaccination until 10 years after the last dose of a tetanus toxoid containing vaccine.
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 the diphtheria/tetanus toxoids; pertussis vaccines (DTP) to infants born prematurely. The DTaP vaccines (Infanrix and Daptacel) are not recommended in adults or children >= 7 years of age, and safety and efficacy in neonates or infants < 6 weeks of age have not been established. Safety and efficacy of the Tdap vaccines (Boostrix and Adacel) have not been established in pediatric patients < 10 years of age; however, the ACIP and AAP recommend a single dose of Tdap for children 7-10 years old who do not have a contraindication to pertussis vaccine and who are not fully vaccinated against pertussis (defined as 5 doses of DTaP, 4 doses if the fourth dose was administered on or after the fourth birthday) or have an unknown immunization history. Further, a dose of Tdap is recommended as the first of a 3-dose vaccine regimen containing tetanus and diphtheria toxoids for children 7 through 10 years who were never vaccinated against tetanus, diphtheria, or pertussis or who have unknown vaccination status.
Do not give DTP or Tdap vaccines via intravenous administration or subcutaneous administration. The vaccines are for intramuscular (IM) use only. Take care to avoid injecting into a blood vessel (avoid intraarterial administration). Prior to administration, health care personnel should inform the patient, parent, guardian, or responsible adult of the vaccine's benefits and risks. This should include the provision of the vaccine information statement from the manufacturer. The responsible adult should report any adverse reaction following vaccine administration to the health care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. This includes, but is not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 800-822-7967.
Careful consideration of the potential risks and benefits of diphtheria/tetanus toxoids; pertussis vaccine, DTP is needed if a patient had Guillain-Barre syndrome within 6 weeks of receipt of a prior vaccine that contained tetanus toxoid. The Institute of Medicine (IOM) has found evidence suggesting a causal relationship between tetanus toxoid receipt and both brachial neuritis and Guillain-Barre syndrome.
Diphtheria/tetanus toxoids; pertussis vaccine, DTP is contraindicated in patients who have experienced encephalopathy (coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another cause. The DTaP vaccine is also contraindicated in patients with a progressive neurological disease including infantile spasms, an uncontrolled seizure disorder, or progressive encephalopathy; do not administer the pertussis vaccine to patients with these conditions until a treatment regimen has been established and the condition has stabilized. Tdap vaccines should be used with caution in patients progressive or unstable neurologic conditions, which may also include uncontrolled seizure disorders and acute encephalopathic conditions, as well as cerebrovascular events (i.e., stroke); vaccination may be deferred until the condition stabilizes. The Advisory Committee on Immunization Practices (ACIP) recognizes that immunization with a vaccine containing DTaP in infants or children with stable neurological disease, including well-controlled seizures, may not be contraindicated. For children at higher risk of seizures than the general population, the ACIP recommends that acetaminophen or ibuprofen be administered at the time of vaccination and for 24 hours after to reduce the possibility of postvaccination pyrexia.
Certain events were previously regarded as contraindications to continuation of DTP immunization but are now considered precautions to subsequent DTP doses according to 1996 recommendations of the ACIP. This is due to the recognition that there may be circumstances when pertussis vaccination benefits outweigh possible risks, and these events have not been proven to cause permanent sequelae. If any of the following events occur in temporal relation to DTP, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered: hypotonia (shock like state with hyporesponsiveness) within 48 hours, seizure within 3 days, inconsolable crying for >= 3 hours occurring within 48 hours, or fever of >= 40.5 degrees C (105 degrees F) not attributable to other causes and occurring within 48 hours of immunization. If a decision is made to withhold the pertussis vaccine, booster immunization of patients 10-18 years of age should be made with the Td vaccine instead of Tdap.
Any condition that contraindicates the use of intramuscular (IM) injections contraindicates the use of DTP or Tdap. These conditions include thrombocytopenia, coagulopathy, or other bleeding disorders. The manufacturer states that DTP or Tdap may be used in such individuals if the potential benefits clearly outweigh the risks of administration. Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy (e.g., hemophilia) or receiving anticoagulant therapy should be monitored closely when given DTP or Tdap because bleeding can occur at the IM injection site. All steps to avoid hematoma formation are recommended.
DTP immunization should be postponed in patients with moderate or severe febrile illness, a severe respiratory infection, or acute infection. DTP immunization should also be deferred in areas experiencing an outbreak of poliomyelitis because of the risk of provoking paralysis. Minor illness, such as a mild upper respiratory infection with or without low grade fever, does not preclude DTP administration.
Patients suffering significant immunosuppression may not have an adequate antibody response to vaccination with DTP toxoids and vaccines. The vaccine should be administered before or 1 month after completing immunosuppressive therapy, if possible. According to the guidelines for prevention and treatment of opportunistic infections, patients with human immunodeficiency virus (HIV) infection should receive the Tdap immunization.
Safety data of Tdap from a randomized, controlled clinical trial of a non-U.S. formulation of Boostrix during the third trimester (341 pregnant patients received a non-U.S. formulation of Boostrix, 346 pregnant patients received placebo) did not reveal any vaccine-related adverse effects on pregnancy or on the fetus and/or newborn child. Safety data during the first and second trimester of pregnancy are not available. An assessment of U.S. pregnancy registry data from 2005 to 2022 included reports of Boostrix (n = 1,523) and Adacel administration (n = 1,236) prior to conception or during pregnancy. Of these, there were 256 reports (Boostrix) and 286 reports (Adacel) with known pregnancy outcomes. During the first trimester, 19 patients were exposed to Boostrix with no major birth defects reported. Additionally, no apparent birth defects were reported with 3 spontaneous abortions. Patients were exposed during the second trimester (n = 28) and third trimester (n = 199) with no major birth defects reported. Ten patients were exposed with unknown timing in pregnancy and no birth defects were reported. During the first trimester, 118 patients were exposed to Adacel with 1 congenital anomaly and 14 spontaneous abortions; 54 patients were exposed in the second trimester with 1 congenital anomaly; 114 patients were exposed in the third trimester with 2 congenital anomalies; and 76 patients were exposed at an unknown trimester with 1 congenital anomaly. An assessment of U.S. spontaneous reports and postmarketing data including 810 prospective reports of Boostrix exposure during pregnancy included 138 reports with known pregnancy outcomes. Seventeen patients were exposed to Boostrix during the first trimester with no major birth defects reported and 2 spontaneous abortions occurred with no apparent birth defects. Patients were exposed during the second trimester (n = 26) and third trimester (n = 92) with no major birth defects reported. Three patients were exposed with unknown timing in pregnancy and no birth defects were reported. Health care providers are encouraged to register pregnant patients by calling 1-888-452-9622 or visiting http://pregnancyregistry.gsk.com/boostrix.html for Boostrix and calling 1-800-822-2463 or visiting https://www.sanofipasteurpregnancyregistry.com for Adacel. Available data suggest infants of mothers who receive a Tdap vaccination may receive early protection against pertussis from Tdap-induced transplacental maternal antibodies. The half-life of transferred maternal pertussis antibodies is approximately 6 weeks.
There is no information on the excretion of DTP antigens or antibodies in breast milk or the effects on the breastfed infant or milk production. According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as DTaP and Tdap, pose no risk for nursing mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. 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.
Syncope has been associated with the administration of diphtheria/tetanus toxoids; pertussis vaccine, DTP. These events may be accompanied by transient visual disturbance, paresthesia, and tonic-clonic limb movements. Prior to administration of the vaccine, ensure procedures are in place to prevent falls and restore cerebral perfusion.
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.
-Recommended childhood immunization schedule:
--Diphtheria, tetanus, and acellular pertussis vaccine (DTaP): 5-dose series at 2, 4, 6, 15 to 18 months and 4 to 6 years.
-Tetanus, diphtheria, and acellular pertussis vaccine (Tdap): 1 dose at 11 to 12 years.
-Consult CDC Immunization Schedules for catch-up schedules and special populations.
-It is recommended that the same brand of DTaP vaccine be given for the entire immunization series because safety and efficacy data regarding interchangeability are not available. No data are available regarding the use of Tdap for the primary series or the completion of the series.
-Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with DTaP vaccine. There is no need to start the primary series over again regardless of the time between doses.
-If any recommended dose of pertussis vaccine cannot be given, Td should be given as needed to complete the primary series or subsequent booster immunizations according to current immunization schedules.
-If prophylaxis of tetanus in wound management is needed, Tdap (Adacel) may be substituted for Td in children and adolescents 10 years and older if at least 5 years have elapsed since previous receipt of a tetanus toxoid-containing vaccine. Boostrix may be substituted for Td in children and adolescents 10 years or older if the patient has not previously received Tdap.
-Immunize premature infants according to their chronological age, regardless of birth weight.
For diphtheria prophylaxis, tetanus prophylaxis, and pertussis prophylaxis:
Intramuscular dosage (Daptacel, DTaP):
Infants and Children 6 weeks to 6 years: 0.5 mL IM for 3 doses at intervals of 6 to 8 weeks, ideally given at 2, 4, and 6 months of age. A fourth dose is recommended at 15 to 20 months with an interval between the third and fourth dose of at least 6 months. If a fourth dose is inadvertently administered early, but is administered at least 4 months, but less than 6 months, after the third dose, it need not be replaced. A fifth dose is recommended at 4 to 6 years of age, prior to the child entering school. A fifth dose is not necessary if the fourth dose was given at age 4 years or older.
Intramuscular dosage (Infanrix, DTaP):
Infants and Children 6 weeks to 6 years: 0.5 mL IM for 3 doses at intervals of 4 to 8 weeks (preferably 8 weeks), ideally given at 2, 4, and 6 months of age. A fourth dose is recommended at 15 to 20 months with an interval between the third and fourth dose of at least 6 months. If a fourth dose is inadvertently administered early, but is administered at least 4 months, but less than 6 months, after the third dose, it need not be replaced. A fifth dose is recommended at 4 to 6 years of age, prior to the child entering school. A fifth dose is not necessary if the fourth dose was given at age 4 years or older.
Intramuscular dosage (Boostrix, Tdap):
Adults: 0.5 mL IM. Use Td or Tdap for subsequent booster immunizations. A dose of Tdap is recommended instead of Td to replace 1 of the 10-year Td boosters if Tdap has not been previously received or if vaccine status is unknown. Tdap may be administered as an additional dose 9 years or more after the initial Tdap dose. Administration of Tdap as soon as feasible is advised for all postpartum women not vaccinated during pregnancy, close contacts of infants younger than 12 months of age, and health care personnel with direct patient contact. Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.
Pregnant Adults in the third trimester: 0.5 mL IM, preferably during the early part of gestational weeks 27 through 36. Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.
Pregnant Adolescents in the third trimester: 0.5 mL IM, preferably during the early part of gestational weeks 27 through 36. Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.
Children and Adolescents 11 to 17 years: 0.5 mL IM. Give 1 dose of Tdap to patients at 11 to 12 years of age; Td or Tdap booster needed every 10 years thereafter. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series.
Children 10 years: 0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Patients who receive Tdap at 10 years should not receive the routine dose at 11 to 12 years.
Children 7 to 9 years*: 0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Patients 7 to 9 years who receive Tdap should also receive the routine dose at 11 to 12 years.
Intramuscular dosage (Adacel, Tdap):
Adults: 0.5 mL IM. Use Td or Tdap for subsequent booster immunizations. A dose of Tdap is recommended instead of Td to replace 1 of the 10-year Td boosters if Tdap has not been previously received or if vaccine status is unknown. Administration of Tdap as soon as feasible is advised for all pregnant women (preferably during the early part of gestational weeks 27 through 36), for all postpartum women not vaccinated during pregnancy, close contacts of infants 12 months and younger, and health care personnel with direct patient contact. Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.
Pregnant Adults in the third trimester: 0.5 mL IM, preferably during the early part of gestational weeks 27 through 36. Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.
Pregnant Adolescents in the third trimester: 0.5 mL IM, preferably during the early part of gestational weeks 27 through 36. Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.
Children and Adolescents 11 to 17 years: 0.5 mL IM. Give 1 dose of Tdap to patients at 11 to 12 years of age; Td or Tdap booster needed every 10 years thereafter. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Give 1 dose of Tdap to pregnant adolescents during each pregnancy (preferably during the early part of gestational weeks 27 through 36); administer regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.
Children 10 years: 0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Patients who receive Tdap at 10 years should not receive the routine dose at 11 to 12 years.
Children 7 to 9 years*: 0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Patients 7 to 9 years who receive Tdap should also receive the routine dose at 11 to 12 years.
Intramuscular dosage (whole-cell pertussis DTP, DTwP, Tri-Immunol):
Infants and Children 2 months to 6 years: NOTE: This product is not commercially available in the U.S. 0.5 mL IM at intervals of 4 to 8 weeks for 3 doses beginning at 2 months of age. A fourth dose is recommended 6 to 12 months after the third dose, and a fifth dose is recommended at 4 to 6 years of age prior to the child entering school. A fifth dose is not necessary if the fourth dose was given at age 4 years or older. The vaccine may be used up to the seventh birthday.
-for prophylaxis against diphtheria and tetanus for wound management in patients who also need the pertussis component:
Intramuscular dosage (Adacel, Boostrix, Tdap):
Adults: 0.5 mL IM. A single dose of Tdap is preferred to Td if patients have 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. If a tetanus toxoid-containing vaccine is indicated for a pregnant woman, use Tdap. 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 10 to 17 years: 0.5 mL IM. A single dose of Tdap is preferred to Td if patients have 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 if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
Children 7 to 9 years*: 0.5 mL IM. A single dose of Tdap is preferred to Td if patients have 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.
Intramuscular dosage (Daptacel, Infanrix, DTaP):
Children 1 to 6 years*: 0.5 mL IM. If 3 doses or more of a tetanus toxoid-containing vaccine have been given, give vaccine for all wounds except clean, minor wounds if 5 years or more have elapsed since the last tetanus toxoid-containing vaccine.
Maximum Dosage Limits:
-Adults
0.5 mL/dose IM for Tdap (Boostrix or Adacel). Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.
-Geriatric
0.5 mL/dose IM for Boostrix; safety and efficacy have not been established for Adacel. Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.
-Adolescents
0.5 mL/dose IM for Tdap (Boostrix or Adacel). Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.
-Children
10 to 12 years: 0.5 mL/dose IM for Tdap (Boostrix or Adacel). Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.
7 to 9 years: 0.5 mL/dose IM for Tdap (Boostrix or Adacel) may be used; however, Tdap and DTaP vaccines are not FDA-approved in this age group.
1 to 6 years: 0.5 mL/dose IM for DTaP (Infanrix or Daptacel). Do not use Tdap (Boostrix or Adacel); safety and efficacy have not been established in this age group.
-Infants
6 weeks and older: 0.5 mL/dose IM for DTaP (Daptacel or Infanrix). Do not use Tdap (Boostrix or Adacel); safety and efficacy have not been established in this age group.
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.
The pathologic sequelae of Corynebacterium diphtheriae infections are mediated by diphtheria exotoxin, an extracellular protein metabolite of toxogenic strains of C. diphtheriae. Diphtheria toxoid induces the production of antibodies against the exotoxin, which inactivate it, presumably by standard antibody-antigen interactions. Infection with C. diphtheriae does not necessarily confer immunity, and previously infected individuals should still receive toxoid.
Tetanus, the neuromuscular dysfunction associated with C. tetani infections, is caused by exotoxin elaboration. The tetanus toxoid contains antigens that induce the production of antibodies against the exotoxin, thereby inactivating it. Natural immunity to C. tetani does not occur in the U.S., and even patients previously infected with C. tetani should receive the tetanus toxoid.
Bordetella pertussis has a variety of cellular components that contribute to the pathogenesis of whooping cough by mechanisms that are poorly understood. The various acellular vaccines contains different pertussis antigens (e.g., agglutinogen, filamentous hemaggutinin, pertactin, and pertussis toxin) derived from B. pertussis, which confer immunity by inducing the production of antibodies against these cellular components. Clinical studies suggest it has an efficacy of 79-93% in protecting against clinical pertussis after household exposure. In addition, pertussis occurring in vaccinees is typically less severe than pertussis in unimmunized patients.
DTP vaccines are administered intramuscularly. After 3 doses of DTP, 70% to 90% of recipients develop protective antibodies against B. pertussis. In patients receiving 4 doses of DTP, immunity has been shown to persist for 10 years or more. In those receiving 4 doses of DTP, immunity starts to decline 4 to 6 years after immunization, and fewer than 50% of recipients have protective antibodies against B. pertussis 10 years after immunization. Lifelong immunity occurs, however, most likely from subsequent B. pertussis infections.
The immunogenicity of Boostrix was compared with Adacel when administered as a single-dose booster to 2,284 adults, ages 19 to 64 years, who had not received a tetanus-diphtheria booster within 5 years. One month after a single dose, the anti-tetanus seroprotective rate (0.1 International Units/mL or more) of Boostrix was non-inferior to the seroprotective rate of Adacel (99.6% vs.100% respectively). Similarly, the anti-diphtheria seroprotective rate of Boostrix was also non-inferior to that of Adacel (98.2% vs. 98.6%). In addition, the pertussis antigen response was evaluated for Boostrix. The anti-pertussis exotoxin, anti-filamentous hemagglutinin antigen, and anti-pertactin antibody concentrations in adults 1 month after a single dose of Boostrix were non-inferior to those of infants after a primary vaccination series with Infanrix.
-Special Populations
Pediatrics
Infants and Children 6 weeks to 6 years
The immunogenicity of DTaP vaccines was evaluated in infants and children who received Daptacel at 2, 4, 6, and 15 to 17 months of age. Diphtheria antitoxin concentrations of 0.1 International Units/mL or more were detected in 98.5% of infants (n = 1,099) after 3 doses and diphtheria antitoxin concentrations were 1 International Unit or more in 96.5% of children (n = 659) after 4 doses. Similarly, tetanus antitoxin concentrations of 0.1 International Units/mL were detected in 100% of infants (n = 1,037) after 3 doses and tetanus antitoxin concentrations were 1 International Unit or more in 98.8% of children (n = 681) after 4 doses. Immunogenicity studies that evaluated the ability of infant sera to neutralize diphtheria and tetanus toxins 1 month after a 3-dose primary series of Infanrix demonstrated positive results, and 100% of infants achieved diphtheria and tetanus antitoxin concentrations of 0.01 International Units/mL or more. Although a serologic correlate indicative of pertussis protection is not established, antibody responses to pertussis antigens were associated with clinical efficacy.
Children and Adolescents 10 to 17 years
Increased tetanus and diphtheria antitoxin concentrations are obtained after a single booster vaccination with Boostrix or Adacel (Tdap) in patients who receive the recommended primary vaccination series in childhood. Of over 2,400 Boostrix recipients 10 to 18 years of age, 89.7% had at least a 4-fold increase from the pre-vaccination tetanus antitoxin concentration, and 90.6% had at least a 4-fold increase from the pre-vaccination diphtheria antitoxin concentration 1 month after booster vaccine receipt. Similar responses were obtained from 527 Adacel recipients 11 to 17 years old (91.7% and 95.1%, respectively). As compared with either Adacel or Boostrix, a single Td vaccination yielded similar antibody responses. Increased serum antibodies to pertussis antigens also occurred after Boostrix or Adacel receipt. At least a 2-fold increase from the pre-vaccination pertussis antibody concentration occurred for each of the 3 pertussis antigens in 84.5% of the patients who received Boostrix. Furthermore, the antibody concentrations 1 month after Boostrix receipt were non-inferior to concentrations achieved after a primary vaccination series with Infanrix in infants. Of patients who received Adacel, at least a 2-fold increase from the pre-vaccination pertussis antibody concentration occurred for each of the 4 pertussis antigens in 85.6% of 524 patients 11 to 17 years old. Antibody concentrations to all 4 pertussis antigens 1 month after Adacel receipt were greater than concentrations achieved after a primary vaccination series with Daptacel in infants.