Version May 2024
Yellow fever, prevention:
Primary immunization: SubQ: One dose (0.5 mL) ≥10 days before travel
Booster: Based on currently available data, the World Health Organization (WHO) and CDC/ACIP have determined that vaccine failure is rare and booster doses are generally not needed. A single dose of the vaccine is adequate for most travelers. The World Health Assembly removed the 10-year booster dose requirement from the International Health Regulations in July 2016 (WHO 2016a). However, booster dose(s) are recommended for certain patient populations with conditions at the time of their initial dose that may limit immune response (eg, pregnant women, hematopoietic stem cell transplant recipients, HIV patients). A booster dose may also be given (≥10 years after last dose) to those who may be at increased risk for yellow fever disease (eg, certain laboratory workers [depending on antibody titers] and travelers to endemic locations for prolonged periods) (CDC/ACIP [Staples 2015]; WHO 2013).
Fractionated doses during community outbreak: Refer to WHO guidelines for information regarding fractional dosing as a vaccine dose-sparing initiative (WHO 2016b).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing. Monitor closely due to an increased incidence of serious adverse events in patients ≥60 years of age, particularly in patients receiving their first dose. The ACIP guidelines note that if travel is unavoidable, the decision to vaccinate travelers ≥60 years should be made after weighing the risks vs benefits (CDC/ACIP [Staples 2010]).
(For additional information see "Yellow fever vaccine: Pediatric drug information")
Yellow fever prevention (immunization):
Primary immunization (CDC/ACIP [Staples 2010]):
Infants 6 months to <9 months: Limited data available: SubQ: 0.5 mL as a single dose ≥10 days before travel
Infants ≥9 months, Children, and Adolescents: SubQ: 0.5 mL as a single dose ≥10 days before travel
Booster: Based on currently available data, the World Health Organization (WHO) and CDC/ACIP have determined that vaccine failure is rare and booster doses are generally not needed. A single dose of the vaccine is adequate for most travelers. The World Health Assembly removed the 10-year booster dose requirement from the International Health Regulations in July 2016 (WHO 2016). However, additional dose(s) are recommended for certain patient populations with conditions at the time of their initial dose that may limit immune response (pregnant women, hematopoietic stem cell transplant recipients, HIV patients). A booster dose may also be given (≥10 years after last dose) to those who may be at high risk for yellow fever disease (eg, certain laboratory workers [depending on antibody titers] and travelers to endemic locations for prolonged periods) (CDC/ACIP [Staples 2015]).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Nervous system: Headache, malaise
Neuromuscular & skeletal: Asthenia, myalgia
Miscellaneous: Fever
1% to 10%: Dermatologic: Skin rash (3%)
Frequency not defined: Local: Erythema at injection site, localized edema (at injection site), pain at injection site
<1%, postmarketing, and/or case reports: Acute disseminated encephalomyelitis, anaphylaxis, cranial nerve palsy (bulbar), Guillain-Barré syndrome, hypersensitivity at injection site, hypersensitivity reaction, injection site blister formation, residual mass at injection site, urticaria, yellow fever vaccine-associated neurotropic disease (rare), yellow fever vaccine-associated viscerotropic disease (rare; may be associated with multi-organ failure)
Acute hypersensitivity to egg or chick embryo protein, or any component of the formulation, including gelatin; infants <9 months (per manufacturer); infants <6 months (CDC/ACIP 2010 guidelines); severely immunosuppressed patients (eg HIV infection, leukemia, lymphoma, thymic disease, generalized malignancy, or immunosuppression due to drugs or radiation); lactating women providing breast-milk to infants <9 months
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]). Use is contraindicated in patients with immediate-type hypersensitivity reactions to eggs. Less severe or localized manifestations of allergy are not contraindications; in general, persons who are able to eat eggs or egg products may receive the vaccine. A hypersensitivity screening test and desensitization procedure is available for persons with suspected or known severe egg sensitivity. Consult manufacturer's labeling for details.
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).
• Vaccine-associated neurotropic disease (YEL-AND): Isolated cases of post-vaccine encephalitis (some fatal) have been reported within 30 days after administration. Risk factors include age <9 months, age >60 years, and immunodeficiency.
• Vaccine-associated viscerotropic disease (YEL-AVD): Has been reported following first dose of vaccine; may present as non-specific multi-organ system failure or symptoms similar to fulminant wild-type yellow fever virus (including potentially fatal hepatic failure and internal bleeding). Age >60 years is a risk factor.
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Use is contraindicated in patients with severe or febrile illness; vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).
Concurrent drug therapy issues:
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist (ACIP [Kroger 2023]).
Special populations:
• Altered immunocompetence: Patients who are immunosuppressed have a theoretical risk of encephalitis with yellow fever vaccine administration; consider delaying travel or obtaining a waiver letter. Patients on low-dose or short-term corticosteroids are not considered immunosuppressed and may be offered the vaccine. If vaccination is only to satisfy an international requirement (as opposed to decreasing risk of infection), efforts should be made to obtain a waiver letter. Per the ACIP guidelines, use is contraindicated in patients with symptomatic HIV infection or patients with CD4+ counts <200/mm3 (or <15% of total lymphocytes in children <6 years); use caution when administering the vaccine to patients with asymptomatic infection with CD4+ counts 200 to 499/mm3 (or 15% to 24% of total lymphocytes in children <6 years) (CDC/ACIP [Staples 2010]). In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines (ACIP [Kroger 2023]; IDSA [Rubin 2014]). Live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live vaccines should not be administered for at least 3 months after immunosuppressive therapy. Specific recommendations for use of this vaccine in immunocompromised patients considering international travel as well as contacts of immunocompromised patients are available from the IDSA (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Older adult: Due to an increased incidence of serious adverse events observed in older adults compared to younger adults, use with caution in the elderly ≥60 years, particularly in patients who have not previously received the vaccine. The risk for vaccine-associated neurologic disease (YEL-AND) and vaccine-associated viscerotropic disease (YEL-AVD) is also increased. The ACIP guidelines note that if travel is unavoidable, the decision to vaccinate travelers ≥60 years should be made after weighing the risks vs benefits (CDC/ACIP [Staples 2010]).
• Pediatric: The manufacturer contraindicates use in infants <9 months of age due to risk of encephalitis. The CDC allows for use in infants 6-8 months of age when possible exposure with the yellow fever virus is unavoidable and the risk of infection exists (CDC/ACIP [Staples 2010]).
Dosage form specific issues:
• Gelatin: Product may contain gelatin
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Blood donation: Transfusion-related transmission of yellow fever vaccine virus has been reported; wait 2 weeks after immunization with yellow fever vaccine to donate blood (CDC/ACIP [Staples 2010]).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
• Malnutrition: Malnourished persons may have a decreased response to vaccination (CDC/ACIP [Staples 2010]).
Use in infants <6 months (<9 months per manufacturer) is contraindicated due to an increased risk for encephalitis. A higher incidence of encephalitis was also observed in infants who received the yellow fever vaccine between 6 to 9 months of age; reported incidence variable: historic (prior to vaccine age restrictions) estimations were 50 to 400 cases per 100,000 and within VAERS (ages >9 months), the reported rate is 0.4 to 0.8 per 100,000. The ACIP guidelines allow for use in this age group (6 to 9 months) if risks of exposure are determined to be greater than the risk of adverse vaccine effects. Travel to rural areas in yellow fever endemic zones or to countries with epidemics should be postponed or avoided in this age group, whenever possible (CDC/ACIP [Staples 2015]).
Sanofi Pasteur announced that effective April 5, 2021, Yellow Fever Vaccine (YF-VAX) is available for purchase in the United States for authorized YF-VAX providers. Shipments of Stamaril (Yellow Fever Vaccine [Live]) as part of the Expanded Access Program (EAP) will stop on May 6, 2021.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [17D-204 strain] [preservative free]:
Stamaril: ≥1000 units per 0.5 mL dose [produced in chicken embryos; packaged with diluent; contains lactose]
YF-VAX: ≥4.74 log10 plaque-forming units (PFU) per 0.5 mL dose [single-dose or 5-dose vial; produced in chicken embryos; contains gelatin; packaged with diluent]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [17D-204 strain]:
YF-VAX: ≥4.74 log10 plaque-forming units (PFU) per 0.5 mL dose [single-dose vial; produced in chicken embryos; contains gelatin; packaged with diluent]
In the US, yellow fever vaccine is distributed only through approved vaccinating centers, including travel clinics and some health departments. These designated centers are listed in a registry at the CDC travel website: https://wwwnc.cdc.gov/travel/yellow-fever-vaccination-clinics/search
SubQ: For SubQ injection only. Do not administer intradermal, IM, or IV; if inadvertently administered IM, the dose does not need repeated. Use of expired vaccine is not considered a valid dose and should be repeated after 28 days. For booster doses, if the date of previous vaccination cannot be determined and the patient requires vaccination, the booster dose can be given (CDC/ACIP [Staples 2010]). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2023]). If purchased under Centers for Disease Control and Prevention contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
Blood donation following vaccine administration: Transfusion-related transmission of yellow fever vaccine virus has been reported; wait 2 weeks after immunization with yellow fever vaccine to donate blood (CDC 59[2] 2010).
Parenteral: SubQ: Use within 60 minutes following reconstitution; keep suspension refrigerated until used. Swirl well before withdrawing dose; avoid vigorous shaking to prevent foaming of suspension. Administer by SubQ injection into the anterolateral aspect of the thigh or arm; not for intradermal, IV, or IM administration. If inadvertently administered IM, the dose does not need to be repeated. Use of expired vaccine is not considered a valid dose and should be repeated after 28 days. For booster doses, if the date of previous vaccination cannot be determined and the patient requires vaccination, the booster dose can be given (CDC/ACIP [Staples 2010]). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (ACIP [Kroger 2023]). If purchased under Centers for Disease Control and Prevention contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
In the United States, the appropriate Centers for Disease Control and Prevention (CDC)-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/yf.html.
Yellow fever prevention: Active immunization against yellow fever virus, primarily among persons traveling to or living in areas where yellow fever infection exists and laboratory workers who may be exposed to the virus; vaccination may also be required for some international travelers
The Advisory Committee on Immunization Practices (ACIP) (CDC/ACIP [Staples 2010]) recommends vaccination for:
• Persons traveling to or living in areas at risk for yellow fever transmission
• Persons traveling to countries which require vaccination for international travel
• Laboratory personnel who may be exposed to the yellow fever virus or concentrated preparations of the vaccine
Although the vaccine is approved for use in children ≥9 months, the CDC recommends use in children as young as 6 months under unusual circumstances (eg, travel to an area where exposure is unavoidable) (CDC/ACIP [Staples 2010]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Etrasimod: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Etrasimod may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Fotemustine: May enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk for vaccine-related disease may be increased. Risk X: Avoid combination
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Leniolisib: May diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy
Methotrexate: May enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Methotrexate may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Teplizumab: May enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification
Vaccines (Live): May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 week later. Risk C: Monitor therapy
Women should wait 4 weeks after receiving vaccine before conceiving (CDC/ACIP [Staples 2010]).
Avoid use in pregnant women unless travel to high-risk areas is unavoidable. Pregnant women may not produce an adequate immune response to the vaccine, particularly in the third trimester (CDC/ACIP [Staples 2015]). Adverse events were not observed in the mother or fetus following vaccination during the third trimester of pregnancy in Nigerian women (n=101, including 89 in their third trimester); however, maternal seroconversion was reduced (39% seroconversion at 2 to 4 weeks after administration) (Nasidi 1993). Inadvertent exposure early in the first trimester of pregnancy (n=480, mean gestational age 5.7 ± 4.9 weeks) in Brazilian women did not show decreased maternal seroconversion (98.2% seropositive at ≥6 weeks after administration); no increased risk for major congenital abnormalities was observed (Suzano 2006). Cord blood from an infant whose mother was vaccinated during the first trimester tested positive for IgM antibodies (indicating congenital infection); no adverse events were noted in the infant (Tsai 1993).
Vaccine should be administered if travel to an endemic area is unavoidable and the infant should be monitored after birth. Tests to verify maternal immune response may be considered (CDC/ACIP [Staples 2010]). If a pregnant woman is to be vaccinated only to satisfy an international requirement (as opposed to decreasing risk of infection), efforts should be made to obtain a waiver letter.
Due to variable seroconversion during pregnancy, women who were initially vaccinated while pregnant may need a booster dose prior to traveling again to an area at risk for yellow fever virus infection (CDC/ACIP [Staples 2015]).
Yellow fever vaccine is contraindicated by the manufacturer in lactating women who are providing breast milk to infants <9 months. Three cases of vaccine-associated neurotropic disease have been reported in exclusively breast fed infants <1 month of age following maternal vaccination with a yellow fever vaccine. A report describes details of laboratory confirmed transmission of 17DD yellow fever vaccine virus via breastfeeding in one case. Yellow fever vaccine was administered to a nursing mother 15 days postpartum. She was exclusively breastfeeding her newborn. Eight days after maternal vaccination, the infant developed a fever, was irritable, refused to nurse, then was hospitalized for seizures the next day. Yellow fever virus specific to the vaccine and IgM antibodies were detected in the newborn CSF. The child was discharged after 24 days in the hospital; growth and neurodevelopment were normal through 6 months (CDC 59[5] 2010). If travel to an endemic area cannot be avoided or postponed, women who are nursing should be vaccinated. Breastfeeding does not adversely affect response to immunization (CDC/ACIP [Staples 2010] 2010; WHO 2013).
Monitor for hypersensitivity and syncope for 15 minutes following administration. If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion. Monitor for adverse effects 10 days after vaccination (specifically in the elderly) (ACIP [Kroger 2023]; CDC/ACIP [Staples 2010]).
Yellow fever vaccine is a live vaccine that offers active immunization against yellow fever infection at an effective immune response rate of nearly 100% of patients.
Onset of action: Seroconversion: 10 to 14 days
Duration: ≥30 years (possibly life-long protection)
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