Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type b conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Vaxelis) is a combination vaccine used for immunization against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, and polio. It is indicated as a 3-dose series for infants and children 6 weeks through 4 years of age. The administration of combination vaccines such as Vaxelis is believed to reduce cost and improve compliance with the recommended vaccination schedule by reducing the number of injections received per physician visit. The pertussis antigens in Vaxelis are the same as those found in Pentacel, Quadracel, and Daptacel; therefore, these products are recommended to complete the primary and pertussis vaccination series in patients who receive the 3-dose series with Vaxelis. In 1997, adverse reactions associated with the use of whole-cell pertussis vaccines (DTP) led to recommendations by the Advisory Committee on Immunization Practices (ACIP) that acellular pertussis vaccines (DTaP) be used for routine childhood vaccination in the United States. In 2000, the ACIP recommended that IPV be used for routine childhood polio vaccination in the United States instead of oral poliovirus vaccine (OPV), prompted in part by the rare but serious side-effect of OPV-associated paralytic poliomyelitis. Vaxelis is FDA-approved for use in infants as young as 6 weeks; ideally, administration should occur at 2, 4, and 6 months of age.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
-Inform the patient or parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the parent or guardian before each immunization. This action is required by the National Childhood Vaccine Injury Act of 1986.
-Record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine in the patient's permanent record. These actions are 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; hepatitis B vaccine, recombinant; 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.
Intramuscular Administration
-Use vaccine as supplied; reconstitution is not necessary.
-Prior to use, shake the vial or syringe thoroughly to obtain a uniform suspension.
-Do not mix with any other vaccine.
-A separate syringe and needle should be used for each person receiving a vaccine.
-Vials and prefilled syringes are for single use only and contain no preservatives; discard any unused portion.
Intramuscular Injection
-Vial: Use a sterile syringe and needle to withdraw suspension from the vial.
-Prefilled syringe: Attach a sterile needle to the prefilled syringe.
-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.
Safety data for diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV are available from 2 controlled, clinical studies in which a total of 3,380 infants 46 to 89 days of age received at least 1 dose of the vaccine. Rates of adverse reactions varied by the number of doses of vaccine that were received. The most common adverse reactions that occurred within 5 days after receipt of any dose were irritability (55% or more); crying (45% or more); injection site reaction, such as pain (44% or more), erythema (25% or more), and swelling (18% or more); somnolence or drowsiness (40% or more); decreased appetite or anorexia (23% or more); and vomiting (9% or more).
Hypersensitivity reactions (i.e., rash, urticaria, dyspnea, erythema multiforme), anaphylactoid reactions (i.e., angioedema, edema, facial edema, shock), and extensive swelling of the injected limb (including swelling that involves adjacent joints) have been reported during postmarketing use of other vaccines containing the antigens of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV. 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.
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; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Vaxelis) 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. 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. Instruct patients to report any signs and symptoms of a fever or a systemic reaction. Infants and children experiencing any serious reaction after Vaxelis administration should be evaluated for the appropriateness of continuing Vaxelis immunization versus completing immunization with DT toxoids and separately administered Haemophilus influenzae type B conjugate vaccine, hepatitis B vaccine, and poliovirus 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; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV when deciding when to administer an intramuscular vaccine.
A causal relationship between tetanus toxoid receipt and both brachial neuritis and Guillain-Barre syndrome appears to exist. If Guillain-Barre syndrome occurs within 6 weeks of receipt of a prior vaccine that contained tetanus toxoid, base the decision to give any vaccine containing tetanus toxoid such as diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Vaxelis) 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, meningitis, headache, neuritis, peripheral neuropathy, muscle paralysis, and muscular weakness have been reported with DTaP or the hepatitis B vaccine. 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 (DTwP) 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 Vaxelis that contain acellular DTP vaccines, or if the incidence is different from that of DTwP. 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 DTwP 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 DTwP. 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 DTwP 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.
In clinical trials, fever of 38 degrees C or higher was reported in 19% or more of patients after administration of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV. A vaccine-related serious adverse event was reported in 4 patients who received diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV compared with no control group patients. Three of these 4 patients experienced fever 1 to 2 days after the first study vaccination, and 1 of these 4 patients experienced an apparent life-threatening event (vomiting followed by pallor and lethargy) on the day of the first study vaccination and again 2 days later.
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; hepatitis B vaccine, recombinant; 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.
Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; 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, polymyxin hypersensitivity, and yeast 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; hepatitis B vaccine, recombinant; 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; hepatitis B vaccine, recombinant; 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.
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; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
Deferral of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV administration may be appropriate for a patient with a moderate or severe acute illness such as infection with or without fever. The Advisory Committee on Immunization Practices recommends that vaccinations be delayed during the course of a moderate or severe acute febrile illness and administered after the acute phase of illness has resolved. All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Vaccinate persons with moderate or severe febrile illness as soon as they have recovered from the acute phase of the illness.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; 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.
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; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV to infants born prematurely.
Laboratory test interference may occur with administration of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV as sensitive tests (e.g., Latex Agglutination Kits) may detect polyribosylribitol phosphate (PRP) derived from the H. influenzae type b conjugate vaccine in some patients' urine for at least 30 days after vaccination. Therefore, urine antigen detection may not have definite diagnostic value in suspected H. influenzae type b disease after vaccination.
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; hepatitis B vaccine, recombinant; 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; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV is indicated for intramuscular administration. Therefore, give the vaccine cautiously to persons 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. Steps to avoid hematoma are recommended.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; 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; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Vaxelis) 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 Vaxelis, 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 Vaxelis 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.
General dosing information:
-Children who have completed a 3-dose series with diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Vaxelis) should complete the primary and pertussis vaccination series with Pentacel, Quadracel, or Daptacel, according to the prescribing information in the FDA-approved labeling for each product.
-Vaxelis may be used to complete the first 3 doses of the 5-dose DTaP series in infants and children who have received 1 or 2 doses of Pentacel or Daptacel and are also scheduled to receive the other antigens in Vaxelis. Data are not available on the safety and immunogenicity of such mixed sequences. Data are also not available on the safety and efficacy of using Vaxelis after 1 or 2 doses of a DTaP vaccine from a different manufacturer.
-A 3-dose series of Vaxelis may be given to infants born to hepatitis B surface antigen (HBsAg) negative mothers who received a dose of hepatitis B vaccine shortly after birth, prior to 1 month of age. Vaxelis may be used to complete the hepatitis B vaccination series after 1 or 2 doses of other hepatitis B vaccines, in infants and children born to HBsAg-negative mothers and are also scheduled to receive the other antigens in Vaxelis; however, safety and efficacy data on Vaxelis use in these patients are not available.
-Vaxelis may be administered to infants and children who have received 1 or 2 doses of IPV and are also scheduled to receive the other antigens in Vaxelis; however, safety and efficacy data on Vaxelis use in these patients are not available.
-Vaxelis may be administered to infants and children who have received 1 or 2 doses of Haemophilus influenzae type B conjugate vaccine and are also scheduled to receive the other antigens in Vaxelis; however, safety and efficacy data on Vaxelis use in these patients are not available.
For simultaneous diphtheria prophylaxis, tetanus prophylaxis, pertussis prophylaxis, Haemophilus influenzae type b prophylaxis, hepatitis B prophylaxis, and poliovirus prophylaxis:
Intramuscular dosage:
Infants and Children 6 weeks to 4 years of age: 0.5 mL IM, ideally at 2, 4, and 6 months of age (total 3 doses). Three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis. A 3-dose series does not constitute primary immunization against pertussis; an additional dose of a pertussis-containing vaccine is needed to complete the series.
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 and older: 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.
Hepatitis B Immune Globulin, HBIG: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B 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; hepatitis B vaccine, recombinant; 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 viruses that cause hepatitis B and 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.
-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 Neisseria meningitidis. 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.
-Hepatitis B vaccine, recombinant: Immunization with hepatitis B vaccine stimulates the immune system to produce anti-hepatitis B surface antigen antibodies without exposing the patient to the risks of active infection. An antibody concentration of at least 10 milli-International Units/mL is considered protective. Infection with hepatitis D can occur only with concurrent hepatitis B infection; therefore, vaccination with recombinant hepatitis B vaccine provides protection against hepatitis D as well.
-Inactivated poliovirus vaccine, IPV: Immunization with inactivated poliovirus vaccine (IPV) stimulates the immune system to produce neutralizing anti-poliovirus antibodies against each of the 3 poliovirus serotypes (Types 1, 2, and 3).
Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV is administered intramuscularly. The pharmacokinetics of this vaccine are not well defined.
-Special Populations
Pediatrics
The immunogenicity of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Haemophilus influenzae type B conjugate vaccine; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Vaxelis) was evaluated in infants who received the vaccine at 2, 4, and 6 months of age (n = 688 to 810), with comparison to individual vaccine components (administered as Pentacel and Recombivax HB) (n = 353 to 400). Subjects in both groups also received pneumococcal (Prevnar 13) and rotavirus vaccines. Thirty days after the third vaccine dose, Vaxelis was noninferior to Pentacel and Recombivax HB administered concomitantly at separate sites, as demonstrated by the proportions of participants achieving seroprotective concentrations of antibodies to diphtheria, tetanus, poliovirus, hepatitis B and polyribosylribitol phosphate (PRP) antigens, and pertussis response rates and geometric mean concentrations (except filamentous hemagglutinin [FHA]). The following antibody responses were demonstrated: anti-diphtheria toxoid of 0.1 International Units/mL or more (82.4% Vaxelis vs. 86.3% individual vaccines), anti-tetanus toxoid of 0.1 International Units/mL or more (99.9% vs. 99.5%), anti-pertussis toxin response (98.1% vs. 98.5%), anti-FHA response (87.3% vs. 92%), anti-pertactin response (79.3% vs. 82%), anti-fimbriae types 2 and 3 response (90.2% vs. 86.2%), and anti-polio types 1, 2, and 3 neutralizing antibody titer of 1:8 or higher (100% for Vaxelis for all vs. 98.2%, 99.7%, and 99.8%). Anti-PRP concentrations of 0.15 mcg/mL or more occurred in 97.3% and 92.4% of those immunized with Vaxelis and Pentacel, respectively. Anti-hepatitis B surface antigen concentrations of 10 milli-International Units/mL or more occurred in 99.4% and 98.6% of those immunized with Vaxelis and Recombivax HB, respectively.