Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV (Pentacel) is the first FDA-approved pentavalent vaccine for immunization against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b. The pentavalent vaccine reduces the number of required injections for protection against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and polio. The administration of combination vaccines are believed to reduce cost and improve compliance to the recommended vaccination schedule by reducing the number of injections received per physician visit. The DTaP; Hib; IPV vaccine is administered intramuscularly in infants at least 6 weeks of age; ideally, immunization should occur at 2, 4, 6, and 15 to 18 months. Four doses constitute a primary immunization course against pertussis, and three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis. Whole cell DTP (DTwP) was previously used in vaccines, but due to the potential association with acute encephalopathy in children, acellular DTP vaccines (DTaP) replaced DTwP in vaccines in the United States. The FDA approved Pentacel in June 2008.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
-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 Pentacel 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.
-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.
-The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.
Route-Specific Administration
Injectable Administration
-Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV is 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.
-Fractional doses (doses less than 0.5 mL) should not be given.
Intramuscular Administration
Preparation
-The package contains a vial of the DTaP-IPV component and a vial of lyophilized ActHIB vaccine component.
-Gently shake the vial of the DTaP-IPV component, and withdraw the entire liquid content and inject into the vial of the lyophilized ActHIB vaccine component. Gently swirl the vial now containing Pentacel vaccine thoroughly until a cloudy, uniform, white to off-white (yellow tinge) suspension results. Do not administer if it appears otherwise.
-Do not mix with any other vaccine.
-Do not administer the vaccine if it has been frozen.
-Vials are for single use only and contain no preservatives; once the single-dose vial has been penetrated, use the withdrawn vaccine promptly, and discard the vial.
Intramuscular Injection
-A separate syringe and needle should be used for each person receiving Pentacel.
-Older children: Inject into the deltoid muscle of the upper arm. Do NOT administer in the gluteal muscle.
-Infants and young children 1 to 2 years: Inject into the anterolateral aspect of the mid-thigh.
-Injection must be accomplished with a needle long enough to ensure IM deposition of the vaccine.-For pediatric patients 3 years and older, the needle size required for deltoid injection ranges from 5/8- to 1-inch.
-For children 1 to 2 years, a needle at least 1-inch long is preferred for administration into the thigh; a 5/8-inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90-degree angle.
-For the majority of infants younger than 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.
Systemic reactions after diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV (Pentacel) administration were reported at rates similar to those after DaTP (Daptacel) receipt. Lethargy was noted in 24.1% to 45.8% of patients. Rash, urticaria, anaphylactic shock, anaphylactoid reactions, pallor, drowsiness, and cyanosis have been reported in postmarketing surveillance. Instruct patients to report any signs and symptoms of a systemic reaction. Have immediate availability of epinephrine 1 mg/mL injection and other agents used in the treatment of severe anaphylaxis such as anaphylactic shock or dyspnea.
In clinical trials, fever of 38 degrees C or higher (5.8% to 16.3%), irritability (53.5% to 76.9%), and inconsolable crying (35.9% to 59.3%) were reported in patients administered the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV. Hypotonic-hyporesponsive episodes (HHE) have been reported during postmarketing surveillance. HHE 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. Hypotonia not fulfilling criteria for a hypotonic hyporesponsive episode within 7 days after vaccination was reported in 4 of 5,979 vaccine recipients; 1 on the same day as the first dose and 3 on the same day as the third dose. Seizures and febrile seizures have been reported after administration of other vaccines containing the antigens of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV which, like high fever, may be related to the pertussis component of the vaccine. Seizures are more likely to occur in children with a history of seizures or a family history of seizures. Instruct patients to report any signs and symptoms of a fever or a systemic reaction. Infants and children experiencing any serious reaction after Pentacel administration should be evaluated for the appropriateness of continuing Pentacel immunization versus completing immunization with DT toxoids and separately administered Haemophilus influenzae type b conjugate vaccine and poliovirus vaccine.
An injection site reaction consisting of erythema, pain, and swelling is a common adverse reaction of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV. Among vaccine recipients, 39.2% to 56.1% had tenderness, 7.1% to 17.3% had erythema, and 5% to 9.7% had swelling at the injection site. Injection site inflammation, mass, abscess, extensive swelling of the injected limb (including swelling that involved adjacent joints), and skin discoloration have been observed through postmarketing surveillance.
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 the DTaP;IPV 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.
After intramuscular vaccination with other vaccines, 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 with diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV when deciding when to administer an intramuscular vaccine.
Diarrhea, vomiting, and anorexia were reported with the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV during postmarketing surveillance.
Injectable vaccines, including the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV have been associated with episodes of syncope and fainting.
Meningitis, rhinitis, viral infection, cough, vaccination failure/decreased therapeutic response (invasive H. influenzae type b disease), and pallor were reported during postmarketing surveillance.
Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; inactivated poliovirus vaccine, IPV has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as 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.
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, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV to infants born prematurely.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV is only indicated for intramuscular administration; do not give via intravenous administration, subcutaneous administration, or intradermal administration. Incorrect administration may result in inadequate immunity.
If Guillain-Barre syndrome occurs within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give subsequent doses of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV is contraindicated in patients who have had serious hypersensitivity reactions or anaphylaxis associated with a previous dose of this vaccine or any of its components. This includes patients with albumin hypersensitivity, neomycin hypersensitivity, polysorbate 80 hypersensitivity, and polymyxin hypersensitivity as the vaccine contains these components. 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 mg/mL) injection and other agents used in the treatment of severe anaphylaxis.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV is contraindicated in patients who have experienced encephalopathy (i.e., 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 vaccine is also contraindicated in patients with a progressive neurological disease, including infantile spasms, an uncontrolled seizure disorder, or progressive encephalopathy, until a treatment regimen has been established and the condition has stabilized. The ACIP recognizes that vaccination of infants or children with stable neurological disease, including well-controlled seizures, may not contraindicate immunization with a vaccine containing DTaP. Consideration of deferral of vaccination is recommended in unstable, deteriorating, or progressive neurologic disorders, and ACIP and AAP guidelines should be reviewed. If the decision to administer the vaccine is made, the parent or guardian should be informed of the potential risks.
If any of the following occur in temporal relation to administration of a vaccine containing pertussis (whole cell or acellular), the potential benefits and possible risks should be carefully considered when deciding to administer subsequent doses of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV or other pertussis-containing vaccine: fever of at least 40.5 degrees C (105 degrees F) within 48 hours not due to another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours; persistent, inconsolable crying lasting at least 3 hours, occurring within 48 hours; and convulsions with or without fever occurring within 3 days.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV is indicated for intramuscular administration. Therefore, give the vaccine cautiously to patients receiving anticoagulant therapy. Also, monitor patients with thrombocytopenia, coagulopathy (e.g., hemophilia), other bleeding disorders, or vitamin K deficiency closely for bleeding at IM injection sites.
Patients with significant immunosuppression may not have an adequate antibody response to the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV. Immunosuppressed persons may include patients with human immunodeficiency virus (HIV) infection; severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses). Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; inactivated poliovirus vaccine, IPV is not approved for use in women of childbearing age. Therefore, no data are available to assess vaccine-associated pregnancy risks. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial vaccines to pregnant women has not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; inactivated poliovirus vaccine, IPV is not approved for use in women of childbearing age. Therefore, no data are available on its use during breast-feeding to assess the impact of the vaccine on milk production, its presence in breast milk, or its effects on the breastfed infant. According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as Pentacel, 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. While Pentacel is not approved for use in women of childbearing age, the individual vaccine components are and may be potential alternatives to consider during breast-feeding. 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.
Laboratory test interference may occur with administration of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV. Antigenuria has been detected on occasion after ActHIB administration. Therefore, urine antigen detection may not have definite diagnostic value in suspected H. influenzae type b disease within one week of vaccination.
Injectable vaccines, including the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV have been associated with episodes of syncope and fainting. Prior to administration, ensure procedures are in place to prevent falls and manage syncopal reactions.
General dosing information:
-Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine, Hib; Inactivated Poliovirus Vaccine, IPV (Pentacel) may be used as the fourth dose in the 5-dose DTaP series in children who have completed a 3-dose series with Vaxelis.
-Pentacel may be used to complete the first 4 doses of the 5-dose DTaP series in infants and children who have received 1 or more doses of Daptacel and are also scheduled to receive the other antigens in Pentacel. Children who have completed a 4 dose series with Pentacel should receive a fifth dose of DTaP vaccine using Daptacel or Quadracel at 4 to 6 years of age.
-Pentacel may be administered to infants and children who have received 1 or more doses of another licensed IPV vaccine and are scheduled to receive the antigens of Pentacel. When the final dose in the 4-dose IPV series is administered at age 4 years or older (doses given at 2, 4, 6 to 18 months, and 4 to 6 years), a fifth dose of IPV is not necessary. Children who have completed a 4 dose series with Pentacel before 4 years of age (doses given at 2, 4, 6, and 15 to 18 months) should receive a fifth dose of IVP vaccine at 4 to 6 years of age, resulting in a 5-dose IPV series.
-Data are not available on the safety and immunogenicity of using mixed sequences of Pentacel and DTaP, IPV, or Hib individual or combination vaccines from a different manufacturer.
For simultaneous diphtheria prophylaxis, tetanus prophylaxis, pertussis prophylaxis, Haemophilus influenzae type b prophylaxis, and poliovirus prophylaxis:
Intramuscular dosage:
Infants and Children 6 weeks to 4 years: 0.5 mL IM at 2, 4, 6, and 15 to 18 months of age (total of 4 doses). Four doses constitute a primary immunization course against pertussis, and three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis. NOTE: The recommended immunization schedule from the Centers for Disease Control calls for 4 doses of an inactivated poliovirus vaccine (IPV) at 2 months of age, 4 months of age, between 6 and 18 months of age, and 4 to 6 years of age; the recommended minimum interval between dose 1 and 2 and between dose 2 and 3 is at least 4 weeks and a minimum interval between dose 3 and 4 is 6 months. The final dose of a poliovirus vaccine series must be administered at age 4 to 6 years regardless of the number of previous doses. For example, a child who received 4 doses of Pentacel at 2, 4, 5, and 18 months of age needs an additional IPV dose at age 4 to 6 years. The minimum interval between dose 4 and 5 is 6 months.
Maximum Dosage Limits:
-Adults
Safety and efficacy have not been established.
-Geriatric
Safety and efficacy have not been established.
-Adolescents
Safety and efficacy have not been established.
-Children
5 to 12 years: Safety and efficacy have not been established.
1 to 4 years: 0.5 mL/dose IM.
-Infants
6 weeks to 12 months: 0.5 mL/dose IM.
younger than 6 weeks: Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
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, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV confers immunity against the bacteria that cause diphtheria, tetanus, pertussis (whooping cough), and Haemophilus influenzae type b, as well as the virus that causes polio.
-Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP: 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 Unit/mL is considered protective. Exotoxin release by Clostridium 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 Unit/mL is considered protective. Pertussis, or whooping cough, is a highly communicable disease of the respiratory tract caused by Bordetella pertussis infection. The acellular pertussis vaccine contains different pertussis antigens (e.g., filamentous hemagglutinin, pertactin, and pertussis toxin) derived from B. pertussis, which confer immunity by inducing the production of antibodies against these cellular components. A serological concentration indicative of protection against pertussis has not been established.
-Inactivated poliovirus vaccine, IPV: Immunization with inactivated poliovirus vaccine (IPV) stimulates the immune system to produce neutralizing antipoliovirus antibodies against each of the 3 poliovirus serotypes (Types 1, 2, and 3).
-Haemophilus influenzae type b conjugate vaccine: The high virulence of Haemophilus influenzae type b (Hib) is largely due to its polysaccharide capsule, which inhibits phagocytosis by white blood cells. The Hib conjugate vaccine contains the capsule polysaccharides from Hib bound to an outer membrane protein complex (OMPC) of tetanus toxoid. Hib conjugate vaccine exposure stimulates the immune system to produce Hib capsule-specific antibodies that make the organism vulnerable to antibody and cell-mediated immunity. Unconjugated capsule polysaccharide vaccines cause B-cell stimulation only; conjugation of the capsule polysaccharide also results in T-cell stimulation, which makes antibodies more persistent and more likely to be stimulated with subsequent exposure to Hib antigens.
Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; inactivated poliovirus vaccine, IPV is administered intramuscularly.
-Special Populations
Pediatrics
One month after the fourth dose, most Pentacel recipients had a diphtheria and tetanus antitoxin concentration of at least 0.1 International Unit/mL, which is a concentration that is generally regarded as protective. Specifically, 92.9% of Pentacel recipients met the threshold concentration for tetanus, and 96.5% met the threshold concentration for diphtheria. In contrast, 99.4% of Daptacel recipients met the threshold concentration for tetanus, and 95.7% met the threshold concentration for diphtheria. Further, similar protection against polio was afforded by either Pentacel or IPOL. One month after the third dose of either Pentacel or IPOL, at least 99.4% of patients had a neutralizing antibody concentration of at least 1:8 for poliovirus types 1, 2, and 3. In regard to Haemophilus influenzae protection, anti-PRP antibody has been shown to correlate with protection against invasive disease due to Haemophilus influenzae type b. Similar percentages of patients who got either Pentacel or ActHIB achieved an anti-PRP of at least 1 mcg/mL at least 3 weeks after vaccination, which is a concentration that predicts protection through a subsequent 1-year period. In 2 studies, 72.1% to 75.1% of Pentacel recipients and 70.8% to 74.8% of ActHIB recipients met the threshold anti-PRP concentration 1 month after 3 doses of the vaccines given at 2, 4, and 6 months of age. Both Pentacel and Daptacel contain 5 acellular pertussis antigens: pertussis toxin (PT) detoxified, filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM). The amount of PRN and FIM per dose in Pentacel and Daptacel is identical, but Pentacel has twice the amount of PT and four times the amount of FHA as compared with Daptacel. In regard to pertussis protection, similar percentages of patients had at least a 4-fold rise in the anti-PT, anti-PRN, anti-FHA, and anti-FIM concentrations one month after the fourth dose of either Pentacel or Daptacel. However, the geometric mean concentration (GMC) for anti-PRN was lower (93.59 Endotoxin Units/mL) after Pentacel as compared with the GMC after Daptacel (186.07 Endotoxin Units/mL).