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Yellow Fever Vaccine

Pronunciation

(YEL oh FEE ver vak SEEN)

Dosage Forms

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 or 5-dose vial; produced in chicken embryos; contains gelatin; packaged with diluent; vial stopper contains latex]

Brand Names: U.S.

  • YF-VAX

Pharmacologic Category

  • Vaccine
  • Vaccine, Live (Viral)

Pharmacology

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 of Action

≥30 years (possibly life-long protection)

Use: Labeled Indications

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]).

Contraindications

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); acute or febrile disease; immunosuppressed patients (eg HIV infection, leukemia, lymphoma, thymic disease, generalized malignancy, or immunosuppression due to drugs or radiation); breast-feeding women

Dosing: Adult

Immunization: SubQ: One dose (0.5 mL) ≥10 days before travel; Booster: See "Note".

Note: 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 plans to remove the 10-year booster dose requirement from the International Health Regulations by June 2016 (WHO 2014). 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 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).

Dosing: Geriatric

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]).

Dosing: Pediatric

Immunization: SubQ:

Infants 6 months to <9 months (off-label use): One dose (0.5 mL) ≥10 days before travel; Booster: See "Note". (CDC/ACIP [Staples 2010]).

Infants ≥9 months (per manufacturer), Children, and Adolescents: One dose (0.5 mL) ≥10 days before travel; Booster: See "Note".

Note: 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 plans to remove the 10-year booster dose requirement from the International Health Regulations by June 2016 (WHO 2014). 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 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).

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Reconstitution

Reconstitute only with diluent provided. Inject diluent slowly into vial and allow to stand for 1-2 minutes. Gently swirl until a uniform suspension forms; swirl well before withdrawing dose. Avoid vigorous shaking to prevent foaming of suspension.

Administration

For SubQ injection only. Do not administer 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]). To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). U.S. law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

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).

Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.

Storage

Store at 2°C to 8°C (35°F to 46°F); do not freeze. Vaccine must be used within 60 minutes of reconstitution. Keep suspension refrigerated until used.

Drug Interactions

AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification

Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification

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: Canadian labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. U.S. labeling does not mention this. Consider therapy modification

Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Beclomethasone (Oral Inhalation); Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Cytarabine (Liposomal); Deflazacort; Dexamethasone (Systemic); Fludrocortisone; Fluticasone (Oral Inhalation); Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Avoid combination

Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification

Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification

Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of methotrexate should be avoided. Consider therapy modification

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine. Consider therapy modification

Adverse Reactions

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

Frequency not defined (adverse reactions may be increased in patients <9 months or ≥60 years of age)

Central nervous system: Chills, fever (incidence of these reactions have been reported to be as low as <5% and as high as 10% to 30% depending on the study), focal neurological defects, headache, malaise, seizure

Dermatologic: Rash, urticaria

Local: Injection site reactions (edema, erythema, hypersensitivity, mass, pain, pruritus, rash, warmth)

Neuromuscular & skeletal: Myalgia, weakness

Miscellaneous: Guillain-Barré syndrome (GBS), hypersensitivity (immediate), vaccine-associated neurotropic disease (rare), viscerotropic disease (rare; may be associated with multiorgan failure)

Vaccine-associated neurologic disease (YEL-AND) may manifest as meningoencephalitis (neurotropic disease), GBS, acute disseminated encephalomyelitis, and bulbar palsy. Vaccine-associated viscerotropic disease (YEL-AVD) mimics naturally-acquired yellow fever disease; risk may be increased in older patients and those with a history of thymus disease or thymectomy.

Warnings/Precautions

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 (NCIRD/ACIP 2011). 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 (NCIRD/ACIP 2011).

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) (NCIRD/ACIP 2011).

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 inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (NCIRD/ACIP 2011).

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 (IDSA [Rubin 2014]; NCIRD/ACIP 2011); live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible. 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 (Rubin 2014).

• Elderly: Due to an increased incidence of serious adverse events observed in older adults compared to younger adults, use with caution in the elderly ≥65 years of age (per manufacturer) or ≥60 years (per ACIP guidelines), 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]).

• Pregnancy: 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]).

Dosage form specific issues:

• Gelatin: Product may contain gelatin

• Latex: Packaging may contain natural latex rubber.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). 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. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011).

• Malnutrition: Malnourished persons may have a decreased response to vaccination (CDC/ACIP [Staples 2010]).

Monitoring Parameters

Monitor for 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) (CDC/ACIP [Staples 2010]; NCIRD/ACIP 2011).

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. 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. 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. Women should wait 4 weeks after receiving vaccine before conceiving (CDC/ACIP [Staples 2010]).

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, myalgia, asthenia, or irritability or injection site pain or irritation. Have patient report immediately to prescriber illogical thinking, facial paralysis, paresthesia, difficulty with motor activity, severe dizziness, syncope, or signs of severe organ problems (rare) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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