Anthrax vaccine is a noninfectious vaccine developed from an avirulent, nonencapsulated strain of Bacillus anthracis. The protective component of the vaccine is adsorbed to aluminum hydroxide. Anthrax vaccine, adsorbed contains no whole bacteria, dead or alive, and it is impossible to contract the disease from the vaccine. The precursor to anthrax vaccine, adsorbed was developed from a different strain of anthrax and was found to be 92.5% protective towards cutaneous anthrax in humans. Inhalation anthrax occurs too infrequently to assess the protective effect; a review of the Center for Disease Control data for the period 1962 to 1974 in at-risk industrial settings indicated that no inhalational cases occurred in fully immunized workers. BioThrax is FDA-approved for the active immunization for the prevention of disease caused by Bacillus anthracis in adults at high risk of exposure. It is also approved for post-exposure prophylaxis after suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs. Cyfendus is FDA-approved for post-exposure prophylaxis after suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs. Routine immunization of the general public is not recommended.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
-According to US federal laws, the health care provider must record in the patient's permanent record: the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine.
-Obtain a patient's current health status and immunization history to determine vaccine adverse reactions.
-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. Depending on the adverse reaction, subsequent vaccination, if needed, 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 anaphylaxis in the event of a serious allergic reaction.
Route-Specific Administration
Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The vaccine is a milky-white suspension. If the product appears discolored or has visible particulate matter, do NOT use.
-Use as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used.
-Do not mix the vaccine with any other products.
Intramuscular Administration
BioThrax
-For pre-exposure prophylaxis, IM administration is preferred. Although subcutaneous administration is preferred for post-exposure prophylaxis, IM administration may be used during a large-scale emergency response.
-Shake the vial thoroughly to ensure that the suspension is homogeneous during withdrawal.
-Administer intramuscularly into the deltoid muscle.
Cyfendus
-Gently swirl or roll the vial to ensure that the vaccine is a homogeneous milky-white suspension. To avoid foaming, DO NOT shake.
-Administer intramuscularly into the deltoid muscle.
Subcutaneous Administration
BioThrax
-Subcutaneous administration is preferred for post-exposure prophylaxis. Although IM administration is preferred for pre-exposure prophylaxis vaccination, subcutaneous administration may be used in persons who are at risk for hematoma formation.
-Shake the vial thoroughly to ensure that the suspension is homogeneous during withdrawal.
-Administer subcutaneously into the deltoid muscle.
Adverse events that occur with the anthrax vaccine, adsorbed should be reported to the US Department of Health and Human Services Vaccine Adverse Event Reporting System (VAERS) at (800) 822-7967.
In general, anthrax vaccine, adsorbed is well tolerated. The most common reactions tend to be local and self-limiting in nature. Injection site reactions were reported in 93% to 94.9% of patients receiving vaccination. Tenderness (overall incidence, 88.1% to 89.9%; grade 3 incidence, 0.8% to 1.7%), pain (overall incidence, 86.3% to 87.9%; grade 3 incidence, 0.9% to 2.1%), arm motion limitation (overall incidence, 51.4% to 63.7%; grade 3 incidence, 0.4% to 1.7%), warmth (overall incidence, 51.2% to 68.7%; grade 3 incidence, 0.2% to 0.7%), induration (overall incidence, 37.5% to 75.5%; grade 3 incidence, 0.3% to 1.1%), itching (overall incidence, 21.9% to 58.8%; grade 3 incidence, 0.4% to 0.8%), swelling (overall incidence, 19.7% to 55.4%; grade 3 incidence, 0.4% to 1.3%), erythema or redness (overall incidence, 17.9% to 53.9%; grade 3 incidence, 0.9% to 1.9%), bruising (overall incidence, 17.2% to 34.9%; grade 3 incidence, 0.3%). Roughly 30% of BioThrax vaccinees develop a reaction consisting of 1 to 2 cm of minor erythema with localized tenderness that tends to subside within 48 hours. Moderate local inflammatory reactions (greater than 5 cm), some with pruritus, occurred in 4% of recipients with the second injection. Moderate local reactions may occur in anyone with a previous history of anthrax infection. Subcutaneous nodules and arm motion limitation may also occur. More severe local reactions, consisting of extensive forearm edema and inflammation occur in less than 1% of vaccinees. Local reactions tend to increase in severity until the fifth injection, then may subside with subsequent doses. All local reactions have been shown to be reversible. A study (n = 1,564 healthy patients) comparing the safety of intramuscular (IM) administration with subcutaneous administration of anthrax vaccine, absorbed for pre-exposure prophylaxis resulted in a statistically significant reduction in cutaneous adverse reactions when administered via the IM route. Injection site adverse reactions consistently occurred at lower frequencies and for shorter duration in participants given anthrax vaccine, absorbed by the IM route. In an open-label study evaluating the safety of anthrax vaccine, absorbed for pre-exposure prophylaxis, 15,907 doses were administered subcutaneously to 7,000 at risk individuals. In terms of doses administered, 8.63% of the 15,907 doses reported mild local reactions (erythema only or an induration less than 30 mm), 0.94% reported moderate local reactions (edema or induration greater than 30 mm and less than 120 mm), and 0.15% of doses administered caused severe local reactions (edema or induration greater than 120 mm or accompanied by marked limitation of arm motion or axillary node tenderness). Localized reactions (tenderness, warmth, erythema, induration, and subcutaneous nodules) are more common after subcutaneous administration than IM administration and occur more frequently in women (60%) than in men (30%). It is not known why women report higher rates of local reactions than men. Women also report more systemic adverse reactions than men, but these gender differences were not influenced by route of administration. No patterns of unexpected systemic or local reactions have been identified. In a study evaluating the subcutaneous administration of anthrax vaccine, absorbed for post-exposure prophylaxis (n = 200 healthy patients), the most common adverse reactions reported 7 days after each vaccination comprised localized reactions, including symptoms of lump, tenderness, and erythema.
In the open-label safety study involving 15,907 subcutaneously administered doses of anthrax vaccine, only 4 cases of transient systemic reactions (less than 0.06% of doses administered) were reported during the 5-year study period. This value of 0.06% is unusually low, compared to other vaccines and compared to data collection with the licensed anthrax vaccine. The US Department of Defense evaluation of safety in the Anthrax vaccination program notes that from 5% to 35% of vaccinees may notice systemic reactions. Reactions may manifest as rash (16%) or urticaria (16%), headache (overall incidence, 14% to 58%; severe, 2.1% to 3.2%), arthralgia (12% to 15%), malaise (6% to 17%), myalgia (overall incidence, 3% to 75.2%; severe, 1.9% to 3.5%), nausea (3% to 9%) vomiting (3% to 9%), chills (2% to 6%), and fever (overall incidence, 1% to 6.8%; severe, 0.4% to 0.7%). Anorexia or dizziness may also occur. In a trial of 200 patients receiving subcutaneous anthrax vaccine for post-exposure prophylaxis, headache (4%), fatigue (3.5%), skin hyperpigmentation (3.5%), decreased joint range of motion (2.5%), and myalgia (2.5%) were the most commonly reported systemic reactions. During postmarketing use, anaphylactic shock, angioedema, rash, urticaria, pruritus, erythema multiforme, anaphylactoid reactions, Stevens-Johnson syndrome, arthropathy, and rhabdomyolysis have been reported.
Eight serious events were reported with 6 patients and determined to be possibly related to the administration of BioThrax. They included a case of generalized allergic reaction, a case of ANA positive autoimmune disease or disorder manifesting as a moderate bilateral arthralgia of the metacarpophalangeal (MCP) joints, a right shoulder supraspinatus tendon tear, a case of bilateral pseudotumor cerebri with bilateral disc edema, a case of generalized seizures and hospitalization for evaluation of hydrocephalus and endoscopic fluid ventriculostomy, and a case of bilateral ductal carcinoma of the breast (breast cancer). Three adverse events of autoimmune etiology occurred that were possibly related to Cyfendus administration. A case of ulcerative colitis occurred 208 days after Cyfendus administration, a case of chronic idiopathic urticaria occurred 76 days after Cyfendus administration, and a case of diffuse alopecia occurred 17 days after anthrax vaccine administration. Alopecia has also been reported during postmarketing use. Infrequent reports of multisystem disorders defined as chronic symptoms involving at least 2 of the following 3 categories: fatigue, mood-cognition, and musculoskeletal system were also received.
Lymphadenopathy, paresthesias, syncope, tremor, ulnar nerve neuropathy, pain, cellulitis, influenza-like symptoms, insomnia, and flushing have been reported during postmarketing use of anthrax vaccine.
After exposure to anthrax spores, the anthrax vaccine, adsorbed alone is not effective in preventing anthrax disease. For post-exposure prophylaxis, a recommended course of antibiotic treatment should be initiated. If the anthrax vaccine is administered post-exposure, the length of antibiotic therapy may be shortened.
Do not give anthrax vaccine via intravenous administration or intradermal administration. The vaccine is for intramuscular administration (BioThrax or Cyfendus) or subcutaneous administration (BioThrax) only. Patients with coagulation disorders, such as thrombocytopenia, vitamin K deficiency, a coagulopathy (e.g., hemophilia), or persons receiving anticoagulant therapy, are at an increased risk of bleeding after IM administration. These patients should receive BioThrax via the subcutaneous route. Subcutaneous administration of BioThrax should be reserved for patients who should not get intramuscular injections, as more local adverse reactions may occur with subcutaneous 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 US 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.
As with any biologic product, the prescriber or health care professional should have procedures in place to manage 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 in the event of a serious allergic reaction to the anthrax vaccine. Anaphylactic reactions to anthrax vaccine have occurred. A previous severe reaction to the anthrax vaccine, including anaphylaxis, is a contraindication to immunization with the vaccine. The decision to administer or to delay vaccination with the anthrax vaccine because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. Consider delaying vaccinations during the course of a moderate or severe acute illness or infection with or without fever and administer after the acute phase of illness has resolved. All vaccines can be administered to persons with mild illnesses. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.
Patients with significant immunosuppression may not have an adequate antibody response to the anthrax vaccine. 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 (i.e., leukemia or lymphoma), or an immune system compromised by radiation therapy or drug therapy (i.e., 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.
Pregnant individuals should not be vaccinated against anthrax unless the potential benefits outweigh the risk to the fetus. Human data are available for BioThrax administration to pregnant individuals from both an observational study and pregnancy exposure registry. In the observational study, there were more birth defects in infants born to individuals vaccinated with BioThrax in the first trimester compared to individuals vaccinated post pregnancy or individuals never vaccinated. Data from the BioThrax pregnancy exposure registry do not establish the presence or absence of vaccine-associated risks in pregnancy. There are no adequate and well-controlled studies of Cyfendus in pregnant individuals. Available human data on Cyfendus administered to pregnant individuals did not establish the presence or absence of vaccine-associated risks in pregnancy. In an observational study, infants born to 37,140 US military service personnel administered BioThrax were examined for birth defects. The results showed an increased rate of birth defects in those infants exposed during the first trimester (4.68%) when compared with infants of individuals vaccinated post pregnancy (3.85%; odds ratio = 1.2, 95% confidence interval: 1.005, 1.43). Of 91 individuals who reported pregnancy outcomes in the BioThrax pregnancy exposure registry, the majority of exposures were in the first trimester (n = 89), and there were 2 infants with major birth defects (2.2%) and no miscarriages. If this vaccine is used during pregnancy or if the patient becomes pregnant during the administration series, inform the patient of the potential risk to the fetus. Consider registering pregnant individuals exposed to the anthrax vaccine in the Emergent's vaccination pregnancy registry by calling 619-553-9255.
It is unknown whether anthrax vaccine is excreted in human milk. Human data are not available to assess the impact of the vaccine on milk production, its presence in breast milk, or its effects on the breastfed child. According to the Advisory Committee on Immunization Practices (ACIP), inactivated or killed vaccines pose no risk to mothers or their child 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.
Anthrax vaccine, adsorbed (Biothrax) should be administered cautiously to patients with a possible history of latex hypersensitivity because the vial stopper contains dry natural rubber. The vial stoppers for Cyfendus vaccine are not made with natural rubber latex.
General dosing information:
-The anthrax vaccine is only recommended for high-risk groups (e.g., laboratory workers who work with high concentrations of B. anthracis; industry workers such as farmers, veterinarians, and livestock handlers who may handle infected animals or contaminated animal products; US military personnel deployed to areas designated as high risk for exposure; and some persons involved in emergency response activities).
-Groups at risk for repeated exposures to B. anthracis spores should be given priority for pre-exposure prophylaxis.
-Routine immunization of the general population is not recommended.
For anthrax prophylaxis:
-for pre-exposure anthrax prophylaxis in those with potential exposure risk:
NOTE: Intramuscular route is preferred. Subcutaneous administration is recommended ONLY for those at risk for bleeding or hematoma after intramuscular injection.
Intramuscular dosage (BioThrax):
Adults 18 to 65 years: 0.5 mL IM at 0, 1, and 6 months (total of 3 doses for primary series). Persons are not considered protected until after completion of the 3-dose series. Booster doses of 0.5 mL IM are recommended at 6 and 12 months after completion of the primary series. Additional booster doses of 0.5 mL IM may be given annually for those who remain at high exposure risk. For those who have completed the series and are not at high risk, booster doses of 0.5 mL IM may be given every 3 years. Interruption of the vaccination schedule does not require restarting the entire series or the addition of extra doses. Optimal schedule for catch up of missed or delayed booster doses is not known.
Subcutaneous dosage (BioThrax):
Adults 18 to 65 years: 0.5 mL subcutaneously at 0, 2, and 4 weeks and 6 months (total of 4 doses for primary series). Persons are not considered protected until after completion of the 4-dose series. Booster doses of 0.5 mL subcutaneously are recommended at 6 and 12 months after completion of the primary series. Additional booster doses of 0.5 mL subcutaneously may be given annually for those who remain at high exposure risk. For those who have completed the series and are not at high risk, booster doses of 0.5 mL subcutaneously may be given every 3 years. Interruption of the vaccination schedule does not require restarting the entire series or the addition of extra doses. Optimal schedule for catch up of missed or delayed booster doses is not known.
-for postexposure anthrax prophylaxis after suspected or confirmed exposure in combination with appropriate antibacterial drugs:
NOTE: Although subcutaneous administration is preferred for postexposure prophylaxis, IM administration may be used if the subcutaneous route poses signficant material, personnel, or clinical challenges.
Subcutaneous or Intramuscular* dosage (BioThrax):
Adults 66 years and older*: 0.5 mL subcutaneously or IM at 0, 2, and 4 weeks. If demand exceeds supply, alternative dose-sparing regimens may be needed. Two 0.5 mL doses at 0 and either 2 or 4 weeks or three 0.25 mL doses at 0, 2, and 4 weeks may be given. The anthrax vaccine is only available for postexposure prophylaxis at the time of an event under appropriate emergency use regulatory provisions.
Adults 18 to 65 years: 0.5 mL subcutaneously or IM at 0, 2, and 4 weeks. If demand exceeds supply, alternative dose-sparing regimens may be needed. Two 0.5 mL doses at 0 and either 2 or 4 weeks or three 0.25 mL doses at 0, 2, and 4 weeks may be given.
Infants, Children, and Adolescents 6 weeks to 17 years*: 0.5 mL subcutaneously or IM at 0, 2, and 4 weeks. If demand exceeds supply, alternative dose-sparing regimens may be needed. Two 0.5 mL doses at 0 and either 2 or 4 weeks or three 0.25 mL doses at 0, 2, and 4 weeks may be given. The anthrax vaccine is only available for postexposure prophylaxis at the time of an event under appropriate emergency use regulatory provisions.
Intramuscular dosage (Cyfendus):
Adults 18 to 65 years: 0.5 mL IM at 0 and 2 weeks.
Maximum Dosage Limits:
-Adults
0.5 mL/dose IM or subcutaneously.
-Geriatric
66 years and older: Safety and efficacy have not been established.
-Adolescents
Safety and efficacy have not been established; however, 0.5 mL/dose IM or subcutaneously has been recommended off-label for postexposure prophylaxis.
-Children
Safety and efficacy have not been established; however, 0.5 mL/dose IM or subcutaneously has been recommended off-label for postexposure prophylaxis.
-Infants
6 weeks and older: Safety and efficacy have not been established; however, 0.5 mL/dose IM or subcutaneously has been recommended off-label for postexposure prophylaxis.
1 to 5 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.
Active immunization with anthrax vaccine, adsorbed leads to production of antibodies that confer protection against anthrax infection. The vaccine is made from the filtrate of a nonencapsulated, attenuated strain of Bacillus anthracis. Anthrax vaccine, adsorbed contains three primary antigenic proteins: protective antigen (PA), edema factor (EF) and lethal factor (LF). PA, EF and LF are all proteins produced by B. anthracis that lead to exotoxin development and eventual onset of disease symptoms. PA assists the movement of EF and LF into the host cell. EF forces the hosts cell machinery into producing excessive cyclic AMP via alteration of calmodulin. Excess cyclic AMP leads to cell leakage and death. LF destroys the white blood cells brought in by the host cells. In the current vaccine, PA must be present for vaccine efficacy and is the most important immunogen. The anthrax vaccine also contains aluminum hydroxide to adsorb protective antigen (PA) and to serve as an adjuvant that will stimulate humoral but not cell-mediated immunity.
Anthrax vaccine, adsorbed is administered subcutaneously (BioThrax) or intramuscularly (BioThrax and Cyfendus). A significant number of patients rapidly develop an immune response to the anthrax vaccine, absorbed. Roughly 95% of vaccinees seroconvert with a 4-fold rise in antibody titers after 3 doses. In a study that measured IgG antibodies directed against anthrax protective antigen (PA), the serum IgG concentration was found to be 478 mcg/mL 8 weeks after 3 subcutaneous doses (0, 2, and 4 weeks). The study defined seroconversion as an anti-PA IgG concentration of 25 mcg/mL or greater. As a result of the quick response to the vaccine, interruption of the vaccination schedule does not require restarting the entire series or the addition of extra doses.
-Route-Specific Pharmacokinetics
Intramuscular Route
BioThrax
A study to examine the impact on immunogenicity of changing the administration route from subcutaneous to intramuscular resulted in similar outcomes. Patients were randomized to receive the anthrax vaccine, absorbed either subcutaneous or intramuscular at a dosing schedule of 0, 2, and 4 weeks and again at 6 months. At the 7-month follow-up examination, 100% of those patients receiving the IM vaccine had a 4-fold rise in antibody titers over baseline. Compared to the percentage of patients achieving a 4-fold rise in antibody titers in the subcutaneous study group (99.28%), the IM administration route proved to be non-inferior. This study also included a third study group to evaluate the change in antibody response resulting from decreasing the number of doses administered. The patients in this group were given IM anthrax vaccine, absorbed at 0, 1, and 6 months. The percentage of these patients to achieve a 4-fold increase in antibody titers at the 7-month follow-up was 99.27%. This result was determined to be non-inferior when compared to subcutaneous administration at weeks 0, 2, 4, and month 6.