Typhim Vi

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Typhim Vi

Classes

Typhoid and Paratyphoid Vaccines

Administration

 
NOTE: 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.
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 patient, parent, or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
If a typhoid vaccine has been previously given, question the patient, parent, or guardian about any symptoms or signs of an adverse reaction.
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.
Health care professionals administering injectable vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients. 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.

Oral Administration Oral Solid Formulations

Administer on an empty stomach, approximately 1 hour prior to a meal with a cold or lukewarm drink.
Swallow capsules whole immediately after placing in the mouth. Do not chew the capsules.
Ingestion of all 4 doses on alternating days (e.g., days 1, 3, 5, and 7) is required to achieve a maximal protective immune response; immunization should be completed at least 1 week prior to potential exposure.

Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration. The typhoid vaccine is a clear and colorless solution. Inspect the syringe or vial and its packaging for evidence of leakage, premature activation of the plunger, or a faulty tip seal prior to use. Do not administer if any of these conditions exist.
Do not mix typhoid vaccine with any other vaccine or product in the same syringe. Separate injection sites should be used in the case of concomitant administration.

Intramuscular Administration

Use vaccine as supplied; reconstitution is not necessary.
A separate syringe and needle MUST be used for each patient.
Inject deeply into a large muscle; do NOT inject into the gluteal area or areas where there may be a nerve trunk. For adults, the dose is typically given intramuscularly in the deltoid. For pediatric patients, the dose is typically given intramuscularly in the deltoid or the anterolateral thigh.[43467]

Adverse Reactions
Severe

angioedema / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
glomerulonephritis / Delayed / Incidence not known
serum sickness / Delayed / Incidence not known
seizures / Delayed / Incidence not known

Moderate

erythema / Early / Incidence not known
hypotension / Rapid / Incidence not known
neutropenia / Delayed / Incidence not known
dyspnea / Early / Incidence not known
lymphadenopathy / Delayed / Incidence not known

Mild

injection site reaction / Rapid / 2.9-98.0
malaise / Early / 4.1-37.0
headache / Early / 4.8-27.0
nausea / Early / 2.0-8.2
myalgia / Early / 2.0-7.4
abdominal pain / Early / 6.4-6.4
fever / Early / 0-3.3
diarrhea / Early / 0-3.1
vomiting / Early / 0-1.9
rash / Early / 1.0-1.0
urticaria / Rapid / Incidence not known
tremor / Early / Incidence not known
asthenia / Delayed / Incidence not known
arthralgia / Delayed / Incidence not known
pruritus / Rapid / Incidence not known
syncope / Early / Incidence not known

Common Brand Names

Typhim Vi, Vivotif (PaxVax, Inc.)

Dea Class

Rx

Description

Vaccine for typhoid fever; available as a polysaccharide vaccine for intramuscular use and an oral live attenuated vaccine
Used to promote active immunity to typhoid disease (Salmonella typhi)
Routine vaccination not recommended in US; select immunization for travelers to endemic areas, persons with intimate exposure to S. typhi carriers, and lab workers with frequent S. typhi exposure

Dosage And Indications
For primary immunization against typhoid disease cause by Salmonella typhi (typhoid prophylaxis) in persons at risk of infection.
NOTE: Routine vaccination against typhoid disease is not recommended in the US.
NOTE: Vaccination against typhoid disease is recommended for: travelers to areas where the risk of exposure to typhoid exists, persons with intimate exposure (i.e., continued household contact) to a documented typhoid carrier, and microbiology laboratory employees with frequent exposure to Salmonella typhi.
NOTE: The vaccine is not effective in preventing infections caused by Salmonella paratyphi A or B, non-Salmonella typhi species of Salmonella enterica serovar Typhi, or other bacteria that cause enteric disease.
Intramuscular dosage (Typhim Vi) Adults

0.5 mL IM as a single dose given at least 2 weeks prior to potential exposure. Reimmunize every 2 years if repeated or continued exposure occurs.

Children and Adolescents 2 to 17 years

0.5 mL IM as a single dose given at least 2 weeks prior to potential exposure. Reimmunize every 2 years if repeated or continued exposure occurs.

Oral dosage (Vivotif) Adults

1 capsule PO once daily given for 4 alternate days (days 1, 3, 5, and 7), taken 1 hour before meals with a cold or lukewarm drink. Complete ingestion of all 4 doses at least 1 week prior to potential exposure. Reimmunize (using same schedule as primary immunization) every 5 years if repeated or continued exposure occurs.

Children and Adolescents 6 to 17 years

1 capsule PO once daily given for 4 alternate days (days 1, 3, 5, and 7), taken 1 hour before meals with a cold or lukewarm drink. Complete ingestion of all 4 doses at least 1 week prior to potential exposure. Reimmunize (using same schedule as primary immunization) every 5 years if repeated or continued exposure occurs.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

Abatacept: (Contraindicated) If possible, administer all needed vaccines before abatacept initiation. Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation. The immune response of the immunocompromised patient to vaccines may be decreased and adjusted doses or boosters that are more frequent may be required. The immune response to an inactive vaccine may still be suboptimal. Live virus vaccines may induce the illness they are intended to prevent and are contraindicated for use during immunosuppressive treatment. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Abrocitinib: (Contraindicated) Avoid administration of live virus vaccines with immunosuppressive drug therapy and prior to immune recovery following treatment with immunosuppressive drug therapy. When feasible, administer indicated live virus vaccines at least four weeks before planned immunosuppression or wait until at least three months after discontinuation. The time to restoration of immune competence may be longer in some patients. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence.
Adalimumab: (Contraindicated) Do not administer live vaccines to adalimumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving adalimumab. Before initiation of adalimumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Adalimumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Aldesleukin, IL-2: (Contraindicated) Aldesleukin, IL-2 is associated with impaired neutrophil function. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Alemtuzumab: (Contraindicated) Do not administer live vaccines to alemtuzumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving alemtuzumab. At least 6 weeks before initiation of alemtuzumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Alemtuzumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Alkylating agents: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Alpha interferons: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient, including those receiving Interferon therapy. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Altretamine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Anakinra: (Major) Avoid concurrent use of live vaccines during treatment with anakinra due to potentially increased risk of infections; clinical safety of live vaccines during anakinra treatment has not been established. Live virus vaccines should generally not be administered to an immunosuppressed patient, as they may induce the illness they are intended to prevent. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving anakinra. The interval between live vaccinations and initiation of anakinra therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
Anifrolumab: (Major) Avoid concurrent use of live vaccines during treatment with anifrolumab; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving anifrolumab. Before initiation of anifrolumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines.
Antimetabolites: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Antithymocyte Globulin: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Atovaquone; Proguanil: (Major) If administered concurrently, atovaquone; proguanil can impair the immunologic response to the oral typhoid vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the oral typhoid vaccine. In a study to determine the effects of antimalarials on the vaccine, thirty individuals were administered proguanil (200 mg daily) concurrently with the oral typhoid vaccine. Administration of proguanil with the vaccine significantly decreased the immune response to the vaccine; therefore, it is recommended to avoid administration of proguanil within 10 days of the final oral typhoid vaccine dose.
Axicabtagene Ciloleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during axicabtagene ciloleucel therapy, and prior to immune recovery following treatment with axicabtagene ciloleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence.
Azathioprine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Baricitinib: (Major) Do not administer live virus vaccines to patients taking baricitinib, as no data are available on the secondary transmission of infection by live vaccines. Also, no data are available on the response to vaccination with any vaccine during baricitinib receipt. Before baricitinib initiation, review the vaccination status of patients, and update immunizations in agreement with current immunization guidelines.
Basiliximab: (Contraindicated) Do not administer live vaccines to basiliximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving basiliximab. At least 2 weeks before initiation of basiliximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Basiliximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Belatacept: (Contraindicated) Avoid the use of live vaccines such as the intranasal influenza vaccine; measles/mumps/rubella vaccines, MMR; Bacillus Calmette-Guerin Live, BCG; yellow fever vaccine; oral polio vaccine; varicella virus vaccine live; and TY21a typhoid vaccine during belatacept treatment. Further, inactive vaccine receipt may not illicit an acceptable response; belatacept may blunt the effectiveness of some immunizations. Consult the most current CDC guidances for vaccination recommendations.
Belimumab: (Major) Live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. Because of its mechanism of action, belimumab may interfere with the response to immunizations. No data are available on the secondary transmission of infection from persons receiving live vaccines. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Bexarotene: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Blinatumomab: (Contraindicated) Do not administer live vaccines to blinatumomab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving blinatumomab. At least 2 weeks before initiation of blinatumomab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Blinatumomab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Brexucabtagene Autoleucel : (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during brexucabtagene autoleucel therapy, and prior to immune recovery following treatment with brexucabtagene autoleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence.
Brodalumab: (Major) Avoid administration of live vaccines to brodalumab recipients. Before initiation of brodalumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving brodalumab therapy.
Busulfan: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Canakinumab: (Major) Do not administer live vaccines to a patient who is receiving canakinumab; other vaccination schedules should be complete as recommended prior to initiating canakinumab treatment. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving canakinumab. The immune response to vaccines or toxoids may be decreased, as canakinumab may interfere with normal immune response to new antigens. Limited data are available on the effectiveness of vaccination with inactivated antigens in patients receiving canakinumab. Because interleukin-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with canakinumab, adult and pediatric patients receive any recommended vaccination (including pneumococcal vaccine and inactivated influenza vaccines).
Carmustine, BCNU: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Certolizumab pegol: (Contraindicated) Do not administer live vaccines concurrently with certolizumab. No data are available on the response to vaccinations or to the secondary transmission of infection by live vaccines in patients receiving certolizumab. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Chlorambucil: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Ciltacabtagene Autoleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during ciltacabtagene autoleucel therapy, and prior to immune recovery following treatment with ciltacabtagene autoleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence.
Cisplatin: (Contraindicated) Do not administer live vaccines to cisplatin recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving cisplatin. At least 2 weeks before initiation of cisplatin therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Cisplatin recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Clofarabine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Cortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
Cyclosporine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Cytarabine, ARA-C: (Contraindicated) Do not administer live vaccines to cytarabine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving cytarabine. At least 2 weeks before initiation of cytarabine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Cytarabine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Dacarbazine, DTIC: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Deflazacort: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
Deucravacitinib: (Major) Avoid administration of live vaccines to deucravacitinib recipients. Before initiation of deucravacitinib therapy, consider completion of all age-appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving deucravacitinib therapy.
Dexamethasone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
Docetaxel: (Contraindicated) Do not administer live vaccines to docetaxel recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving docetaxel. At least 2 weeks before initiation of docetaxel therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Docetaxel recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Dupilumab: (Major) Avoid administration of live vaccines to dupilumab recipients. Before initiation of dupilumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving dupilumab therapy.
Efgartigimod Alfa: (Major) Avoid the use of live vaccines and live attenuated vaccines during efgartigimod treatment. Live vaccinations may be less effective during efgartigimod treatment and may carry the risk of infection. Administer indicated vaccines prior to initiating efgartigimod.
Efgartigimod Alfa; Hyaluronidase: (Major) Avoid the use of live vaccines and live attenuated vaccines during efgartigimod treatment. Live vaccinations may be less effective during efgartigimod treatment and may carry the risk of infection. Administer indicated vaccines prior to initiating efgartigimod.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to 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.
Emapalumab: (Major) Do not administer live or live attenuated vaccines to patients receiving emapalumab and for at least 4 weeks after the last dose of emapalumab. The safety of immunization with live vaccines during or after emapalumab therapy has not been studied.
Estramustine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Etanercept: (Contraindicated) Etanercept has not been found to act as a general immunosuppressant; however, the patient's underlying disease state may result in the immunosuppression. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Everolimus: (Contraindicated) Do not administer live vaccines to everolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving everolimus. Before initiation of everolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Everolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Fingolimod: (Contraindicated) Do not administer live vaccines to a patient who is receiving fingolimod or has discontinued the drug in the last 2 months because of the risk of infection. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving fingolimod. Before fingolimod initiation, test patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) for antibodies to VZV. Consider VZV vaccination of antibody-negative patients before fingolimod initiation, and do not start fingolimod for 1 month to allow the full effect of vaccination to occur. In addition to the concerns with live virus vaccines, the immune response to inactive vaccines or toxoids may be decreased, as fingolimod may interfere with normal immune response to new antigens. No data are available on the effectiveness of vaccination with inactivated antigens in patients receiving fingolimod. Vaccination may be less effective during and for up to 2 months after fingolimod discontinuation. For example, as compared with the response of placebo recipients, the capacity to mount a skin delayed-type hypersensitivity reaction to Candida and to tetanus toxoid was decreased by approximately 30% among fingolimod 0.5 mg daily recipients. Further, in healthy patients, antigen-specific IgM titers were decreased by 25% in response to pneumococcal polysaccharide vaccine (PPV-23) immunization as compared with the response by placebo recipients. Similarly, IgG titers were decreased by 50% among fingolimod recipients as compared with placebo.
Floxuridine: (Contraindicated) Do not administer live vaccines to floxuridine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving floxuridine. At least 2 weeks before initiation of floxuridine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Floxuridine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Fludrocortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
Fluorouracil, 5-FU: (Contraindicated) Do not administer live vaccines to fluorouracil recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving fluorouracil. At least 2 weeks before initiation of fluorouracil therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Fluorouracil recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Folate analogs: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Golimumab: (Contraindicated) Do not administer live vaccines to golimumab recipients. Limited data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Guselkumab: (Major) Avoid use of live vaccines in patients being treated with guselkumab; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving guselkumab. In addition, guselkumab may decrease the vaccine-induced immune response. Before initiation of guselkumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines.
Hydrocortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
Idecabtagene Vicleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during idecabtagene vicleucel therapy, and prior to immune recovery following treatment with idecabtagene vicleucell. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence.
Ifosfamide: (Contraindicated) Do not administer live vaccines to ifosfamide recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving ifosfamide. Before initiation of ifosfamide therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Ifosfamide recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Imatinib: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Inebilizumab: (Major) Administer all immunizations according to immunization guidelines at least 4 weeks before initiation of inebilizumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. In a neonate or infant with in utero exposure to inebilizumab, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in the exposed infant may increase the risks from live or live-attenuated vaccines.
Infliximab: (Contraindicated) Do not administer live vaccines to infliximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving infliximab. Before initiation of infliximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Infliximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Interferon Gamma-1b: (Major) Avoid the concomitant use of interferon gamma-1b with other immunological preparations such as live vaccines due to the risk of an unpredictable or amplified, immune response.
Ixabepilone: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Ixekizumab: (Major) Do not administer live vaccines to ixekizumab recipients. Before initiation of ixekizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving Ixekizumab therapy.
Leflunomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Lenalidomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Leniolisib: (Moderate) Patients receiving leniolisib may have a diminished response to live vaccines. Counsel patients receiving leniolisib about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Lisocabtagene Maraleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during lisocabtagene maraleucel therapy, and prior to immune recovery following treatment with lisocabtagene maraleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence.
Lomustine, CCNU: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Mafenide: (Major) Avoid use of sulfonamides and other antibiotics during the oral typhoid vaccination series at concurrent administration may result in a reduced immune response. In order to provided immunity, the oral typhoid vaccine requires initiation of a limited infection localized within the gastrointestinal tract. Antibiotics prevent this bacterial infection from occurring, thereby, reducing the vaccines protective immune response.
Mechlorethamine, Nitrogen Mustard: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Mefloquine: (Moderate) When antimalarial medications are administered concurrently with oral live typhoid vaccine, attenuation of immunization cannot be excluded. Therefore, the manufacturer of mefloquine recommends waiting at least 3 days after use of the vaccine before administering the first dose of mefloquine. However, in a study to determine the effects of antimalarials on the immune response to the vaccine, 30 individuals were administered mefloquine (250 mg weekly) concurrently with the oral typhoid vaccine. Concomitant administration did not significantly reduce the immune response. Based on these findings, the manufacturer of the vaccine allows for simulaneous administration; however, caution is advised whenever these medications are administered concurrently.
Melphalan Flufenamide: (Contraindicated) Avoid administration of live virus vaccines in patients who are receiving melphalan. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period or altered immunocompetence.
Melphalan: (Contraindicated) Avoid administration of live virus vaccines in patients who are receiving melphalan. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period or altered immunocompetence.
Methylprednisolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
Mitoxantrone: (Contraindicated) Do not administer live vaccines to mitoxantrone recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving mitoxantrone. At least 2 weeks before initiation of mitoxantrone therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Mitoxantrone recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Mycophenolate: (Contraindicated) Do not administer live vaccines to mycophenolate recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving mycophenolate. At least 2 weeks before initiation of mycophenolate therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Mycophenolate recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Nanoparticle Albumin-Bound Sirolimus: (Contraindicated) Do not administer live vaccines to sirolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving sirolimus. At least 2 weeks before initiation of sirolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Sirolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Natalizumab: (Contraindicated) The immune response to vaccines or toxoids may be decreased in patients who receive natalizumab; however, no data are available. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Nelarabine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Nilotinib: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Obinutuzumab: (Contraindicated) Do not administer live vaccines to obinutuzumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving obinutuzumab. Before initiation of obinutuzumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Obinutuzumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Ocrelizumab: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. 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 live and live-attenuated vaccines according to immunization guidelines at least 4 weeks before initiation of ofatumumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment with ofatumumab; wait until B-cell recovery occurs after discontinuation of ofatumumab before administering these vaccines to a patient.
Ozanimod: (Major) Avoid the use of live vaccines and live attenuated vaccines during ozanimod treatment and for up to 3 months after discontinuation of ozanimod treatment. Live vaccinations may be less effective during ozanimod treatment and also may carry the risk of infection.
Paclitaxel: (Contraindicated) Do not administer live vaccines to paclitaxel recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving paclitaxel. At least 2 weeks before initiation of paclitaxel therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Paclitaxel recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Penicillins: (Major) Antibiotics which possess bacterial activity against salmonella typhi organisms may interfere with the immunological response to the live typhoid vaccine. Allow 24 hours or more to elapse between the administration of the last dose of the antibiotic and the live typhoid vaccine.
Ponesimod: (Contraindicated) Avoid vaccines containing live virus (live attenuated vaccines) during treatment with ponesimod. If a live attenuated vaccine is required, administer at least 1 month (4 weeks) before initiation of ponesimod. The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during ponesimod treatment and for 1 to 2 weeks after discontinuation of ponesimod. During treatment, and for up to 1 to 2 weeks after discontinuation of ponesimod, vaccinations may also be less effective.
Prednisolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
Prednisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
Procarbazine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Purine analogs: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Rilonacept: (Contraindicated) Do not administer live vaccines to a patient who is receiving

rilonacept. No data are available regarding the use of live vaccines during rilonacept treatment. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Risankizumab: (Major) Avoid administration of live vaccines to risankizumab recipients. Before initiation of risankizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving risankizumab therapy.
Ritlecitinib: (Contraindicated) Avoid administering live virus vaccines with immunosuppressive drug therapy and prior to immune recovery following treatment with immunosuppressive drug therapy. When feasible, administer indicated live virus vaccines at least four weeks before planned immunosuppression or wait until at least three months after discontinuation. The time to restoration of immune competence may be longer in some patients. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence.
Rituximab: (Contraindicated) Do not administer live vaccines to rituximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving rituximab. At least 4 weeks before initiation of rituximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Rituximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Rituximab; Hyaluronidase: (Contraindicated) Do not administer live vaccines to rituximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving rituximab. At least 4 weeks before initiation of rituximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Rituximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Sarilumab: (Major) Avoid concurrent use of live vaccines during treatment with sarilumab due to potentially increased risk of infections; clinical safety of live vaccines during sarilumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving sarilumab. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
Satralizumab: (Major) Administer all live vaccines according to immunization guidelines at least 4 weeks before initiation of satralizumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment with satralizumab.
Secukinumab: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab.
Siltuximab: (Contraindicated) Do not administer live vaccines to siltuximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving siltuximab. Before initiation of siltuximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Siltuximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Siponimod: (Major) Avoid the use of live vaccines during treatment with siponomid and for 4 weeks after stopping treatment due to the risk of secondary infection. Additionally, vaccines may be less effective if administered during siponimod treatment and for 4 weeks after siponimod treatment discontinuation.
Sirolimus: (Contraindicated) Do not administer live vaccines to sirolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving sirolimus. At least 2 weeks before initiation of sirolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Sirolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Spesolimab: (Major) Avoid administration of live vaccines to spesolimab recipients. Before initiation of spesolimab therapy, consider completion of all age-appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving spesolimab therapy.
Streptozocin: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Sulfadiazine: (Major) Avoid use of sulfonamides and other antibiotics during the oral typhoid vaccination series at concurrent administration may result in a reduced immune response. In order to provided immunity, the oral typhoid vaccine requires initiation of a limited infection localized within the gastrointestinal tract. Antibiotics prevent this bacterial infection from occurring, thereby, reducing the vaccines protective immune response.
Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole: (Major) Avoid use of sulfonamides and other antibiotics during the oral typhoid vaccination series at concurrent administration may result in a reduced immune response. In order to provided immunity, the oral typhoid vaccine requires initiation of a limited infection localized within the gastrointestinal tract. Antibiotics prevent this bacterial infection from occurring, thereby, reducing the vaccines protective immune response.
Sulfasalazine: (Major) Avoid use of sulfonamides and other antibiotics during the oral typhoid vaccination series at concurrent administration may result in a reduced immune response. In order to provided immunity, the oral typhoid vaccine requires initiation of a limited infection localized within the gastrointestinal tract. Antibiotics prevent this bacterial infection from occurring, thereby, reducing the vaccines protective immune response.
Sulfonamides: (Major) Avoid use of sulfonamides and other antibiotics during the oral typhoid vaccination series at concurrent administration may result in a reduced immune response. In order to provided immunity, the oral typhoid vaccine requires initiation of a limited infection localized within the gastrointestinal tract. Antibiotics prevent this bacterial infection from occurring, thereby, reducing the vaccines protective immune response.
Tacrolimus: (Contraindicated) Do not administer live vaccines to tacrolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving tacrolimus. At least 2 weeks before initiation of tacrolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Tacrolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Temozolomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Temsirolimus: (Contraindicated) The use of live vaccines should be avoided during treatment with temsirolimus. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Teriflunomide: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during teriflunomide use, concomitant vaccination with live vaccines is not recommended. The long half-life of teriflunomide should be considered when contemplating administration of a live vaccine after stopping the medication if the teriflunomide drug elimination procedure has not been performed.
Tezepelumab: (Major) Avoid administration of live vaccines to tezepelumab recipients. Before initiation of tezepelumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available regarding the response to live vaccines in patients receiving tezepelumab therapy.
Thiotepa: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Tildrakizumab: (Major) Avoid administration of live vaccines to tildrakizumab recipients. Before initiation of tildrakizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving tildrakizumab therapy.
Tisagenlecleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during tisagenlecleucel therapy, and prior to immune recovery following treatment with tisagenlecleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence.
Tocilizumab: (Major) Avoid concurrent use of live vaccines during treatment with tocilizumab due to potentially increased risk of infections; clinical safety of live vaccines during tocilizumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving tocilizumab. The interval between live vaccinations and initiation of tocilizumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
Tofacitinib: (Major) Do not administer live virus vaccines to patients taking tofacitinib, as no data are available on the secondary transmission of infection by live vaccines. Also, no data are available on the response to vaccination with any vaccine during tofacitinib receipt. Before tofacitinib initiation, review the vaccination status of patients, and update immunizations in agreement with current immunization guidelines.
Tositumomab: (Contraindicated) Do not administer live vaccines to tositumomab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving tositumomab. At least 2 weeks before initiation of tositumomab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Tositumomab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Tralokinumab: (Major) Avoid administration of live vaccines to tralokinumab recipients. Before initiation of tralokinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving tralokinumab therapy.
Triamcinolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available.
Ublituximab: (Contraindicated) Avoid administration of live vaccines with immunosuppressive drug therapy and prior to immune recovery following treatment with immunosuppressive drug therapy. When feasible, administer indicated live virus vaccines at least four weeks before planned immunosuppression or wait until at least three months after discontinuation. The time to restoration of immune competence may be longer in some patients. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence.
Upadacitinib: (Major) Avoid use of live vaccines during or immediately prior to upadacitinib therapy initiation. Before initiating upadacitinib, it is recommended that patients be brought up to date with all immunizations, including varicella zoster or prophylactic herpes zoster vaccinations, in agreement with current vaccination guidelines.
Ustekinumab: (Contraindicated) If possible, administer all recommended vaccines before ustekinumab initiation. Ustekinumab recipients may receive inactive vaccines, but the elicited immune response may be insufficient to prevent disease. Do not administer live vaccines to a ustekinumab recipient. Furthermore, do not administer BCG live vaccines for either 1 year before or 1 year after ustekinumab receipt, due to the infectious risk for Mycobacteria. No data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration of other live vaccines to ustekinumab recipients. Cautious administration of ustekinumab to household contacts of ustekinumab recipients may be warranted due to the potential risk for shedding from the household contact and transmission to the patient. Practitioners should also refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.
Vaccinia Immune Globulin, VIG: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines.
Vedolizumab: (Major) Avoid administering live vaccines to vedolizumab recipients unless the benefits outweigh the risks; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vedolizumab. Before initiation of vedolizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vedolizumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Venetoclax: (Major) Avoid live vaccines to venetoclax recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving venetoclax. Before initiation of venetoclax therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Venetoclax recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Vincristine Liposomal: (Contraindicated) Do not administer live vaccines to vincristine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vincristine. At least 2 weeks before initiation of vincristine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vincristine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Vincristine: (Contraindicated) Do not administer live vaccines to vincristine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vincristine. At least 2 weeks before initiation of vincristine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vincristine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Vinorelbine: (Contraindicated) Do not administer live vaccines to vinorelbine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vinorelbine. Before initiation of vinorelbine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vinorelbine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased.
Voclosporin: (Major) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.

How Supplied

Typhim Vi Intramuscular Inj Sol: 0.5mL, 25mcg
Vivotif (PaxVax, Inc.) Oral Cap

Maximum Dosage
Adults

0.5 mL/dose IM for Typhim Vi; 1 capsule/dose PO for Vivotif (total of 4 capsules/immunization regimen).

Geriatric

0.5 mL/dose IM for Typhim Vi; 1 capsule/dose PO for Vivotif (total of 4 capsules/immunization regimen).

Adolescents

0.5 mL/dose IM for Typhim Vi; 1 capsule/dose PO for Vivotif (total of 4 capsules/immunization regimen).

Children

6 to 12 years: 0.5 mL/dose IM for Typhim Vi; 1 capsule/dose PO for Vivotif (total of 4 capsules/immunization regimen).
2 to 5 years: 0.5 mL/dose IM for Typhim Vi; safety and efficacy have not been established for Vivotif.
1 year: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

The exact mechanism by which typhoid vaccines protect against typhoid disease is unknown; however, it is known that administration of these vaccines produces a humoral antibody response. The typhoid vaccines will only provide protection against Salmonella typhi infections. The vaccines will not protect against viruses or other bacteria that cause enteric disease.
 
After administration of the intramuscular polysaccharide typhoid vaccine, serum anti-capsular antibodies become elevated. The specific post-vaccination antibody concentration required to confer protection against a S. typhi infection has not been determined.
 
Administration of the oral typhoid vaccine results in a local immune response in the intestinal tract. This local immunity occurs when the S. typhi TY21a vaccine strain, which contains limited quantities of essential lipopolysaccharide (LPS)-producing enzymes, infects the intestinal tract. Since the vaccine strain contains low concentrations of complete LPS, the infection is aborted; however, during this incomplete infection, anti-S. typhi LPS antibodies are produced.

Pharmacokinetics

Typhoid vaccines are administered orally (Vivotif) and intramuscularly (Typhim Vi). Vaccination does not ensure immunity.

Oral Route

A number of studies have been conducted to evaluate the efficacy of the oral typhoid vaccine in adults and pediatric patients older than 6 years of age. These studies were conducted in endemic areas, outside of the US, and utilized a variety of dosing regimens. The study with a dosing regimen that most closely mirrors FDA-approved dosing was a field study conducted in Santiago, Chile. During this study, school-aged children were administered 2, 3, or 4 doses of the enteric-coated vaccine on alternate days. The incidence of typhoid fever was lowest for those receiving the 4 dose regimen (p less than 0.004; 95% CI = 71 to 121). For individuals in non-endemic areas, post-vaccination seroconversion is defined as a 0.15 or more increase in optical density units over baseline as determined by ELISA.

Intramuscular Route

Administration of the intramuscular typhoid vaccine results in an increased serum anti-capsular antibody concentration. It is this increase in serum antibodies that is thought to be the basis of protection against typhoid fever; however, the post-vaccination antibody concentration required for prophylaxis against typhoid fever has not been determined. Two studies have been conducted to evaluate the immunogenicity of the injectable typhoid vaccine in the US adult population (ages 18 to 40 years). In both studies, serum antibody concentrations were measured prior to and 4 weeks after administration of a single intramuscular dose. The majority of vaccine recipients, 96% (n = 52/54) in the first study and 88% (n = 85/97) in the second, experienced at least a 4-fold increase in anti-capsular antibody concentration. Another study evaluated the need for re-immunization in US adults who were previously immunized with the intramuscular typhoid vaccine. Study participants were divided into 1 of 2 groups. The first group received re-immunization 27 months after the initial vaccine dose; the second group received re-immunization 34 months after the initial dose. Individuals in both treatment groups achieved antibody concentrations similar to concentrations attained after their primary immunization.

Pregnancy And Lactation
Pregnancy

Both the oral and parenteral typhoid vaccines are classified as FDA pregnancy risk category C. There are no adequate, well controlled studies in pregnant humans; animal reproduction studies have not been conducted. It is not known if administration of the vaccine can cause fetal harm or affect the reproductive system.[43467] [43468] In general, live, attenuated vaccines like the oral typhoid vaccine should be avoided in pregnancy unless urgently needed, due to a theoretical risk to the fetus. No evidence exists of risk to the fetus from vaccinating pregnant women with inactivated bacterial vaccines; however, use is usually reserved for when the likelihood of disease exposure is high, an infection would pose a risk to mother or fetus, and when the vaccine is unlikely to cause harm.[43236] Typhoid vaccine should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. According to FDA-approved labeling for injectable typhoid vaccine, delaying vaccination until the second or third trimester may be a reasonable precaution to minimize the possibility of teratogenicity.[43467]

It is not known whether the oral or injectable typhoid vaccine is excreted in human breast milk. There is no data to warrant their use in nursing mothers. The Advisory Committee on Immunization Practices (ACIP) states neither live nor inactivated vaccines affect the safety of breast-feeding for nursing mothers or their infants. According to the ACIP, polysaccharide vaccines pose no risk during breast-feeding and live virus vaccines, while they may result in infection if excreted in milk, are well tolerated due to attenuation of the virus. 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 ingested drug, health care providers are encouraged to report the adverse effect to the FDA.