Yellow Fever Vaccine

Trade Names:YFVax- Powder for injection, lyophilized, not less than 4.74 log ₁₀ plaque-forming units per 0.5 mL dose when reconstituted

Pharmacology

Live virus vaccine that induces neutralizing antibodies to yellow fever virus.

Pharmacokinetics

Onset

Immunity develops by 10th day after primary vaccination.

Duration

Immunity persists for at least 30 to 35 yr; however, reimmunization is required by International Health Regulations every 10 yr for those at continuing risk of exposure.

Indications and Usage

Active immunization for yellow fever of people 9 mo of age and older traveling to endemic areas (eg, areas of South America or Africa where yellow fever infection is officially reported at the time of travel, travel outside urban areas of countries that do not officially report the disease but lie in a yellow fever endemic zone); the vaccine may be required for international travel; for laboratory personnel who might be exposed to virulent yellow fever virus or to concentrated preparations of the vaccine strain by direct or indirect contact or by aerosols.

Contraindications

Infants younger than 9 mo of age; immunosuppressed patients; history of acute hypersensitivity to eggs or egg products.

Dosage and Administration

Subcutaneous 0.5 mL.

General Advice

• For subcutaneous administration only. Not for intradermal, IM, IV, or intraarterial administration.
• Reconstitute vaccine immediately before use with sterile diluent provided (0.6 mL for single-dose vial of vaccine; 3 mL for 5 dose vial of vaccine). Slowly inject diluent into vial containing vaccine. Allow reconstituted vaccine to sit for 1 to 2 min and then carefully swirl mixture until uniform suspension is achieved. Avoid vigorous shaking. Do not dilute reconstituted vaccine.
• Reconstituted solution should be slightly opalescent and light orange in color. Do not use if solution is discolored, cloudy, or contains particulate matter.
• Swirl vaccine well before withdrawing dose.
• Administer vaccine within 60 min of reconstitution. Properly dispose of all reconstituted vaccine and containers that remain unused after 1 h (eg, sterilize or dispose of in red hazardous waste container).
• The following may be administered with yellow fever vaccine at separate sites: immune globulin, measles vaccine, diphtheria and tetanus toxoids, diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTP), hepatitis A and hepatitis B vaccines, meningococcal vaccine ( Menomune ), typhoid vaccine ( Typhim Vi ). Separate other vaccines by at least 4 wk.

Storage/Stability

Vaccine is shipped frozen in container with solid carbon dioxide. Do not use unless shipping case contains some dry ice upon arrival. Upon receipt, store lyophilized vaccine in freezer (32° to −41°F). Do not refreeze.

Drug Interactions

Immunosuppressive effect of corticosteroid may decrease immunogenicity to yellow fever vaccine and increase the risk of adverse reactions.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Asthenia; fatigue; malaise; mild headaches.

Genitourinary

Renal failure.

Hematologic-Lymphatic

Lymphocytopenia; thrombocytopenia.

Hepatic

Elevated hepatocellular enzymes; histopathologic liver changes (including councilman bodies, microvesicular fatty changes, midzonal necrosis); hyperbilirubinemia.

Hypersensitivity

Immediate hypersensitivity reactions (characterized by asthma, rash, urticaria).

Local

Edema; erythema; hypersensitivity; mass at injection site; pain; rash.

Musculoskeletal

Myalgia.

Pulmonary

Respiratory failure.

Miscellaneous

Encephalitis; low-grade fever; neurotropic disease.

Precautions

Pregnancy

Category C . Seroconversion rate is markedly reduced in pregnant women.

Lactation

Undetermined.

Children

Contraindicated in infants less than 9 mo of age because of risk of encephalitis.

Elderly

Patients older than 65 yr of age have an increased risk for systemic adverse reactions; carefully monitor for adverse reactions for 10 days postvaccination.

Hypersensitivity

Do not administer to patients with history of acute hypersensitivity to eggs or egg products; anaphylaxis may occur. Anaphylaxis also may occur in individuals with no prior history of hypersensitivity to the vaccine components. Epinephrine injection (1:1,000) should always be immediately available.

Monitor patients with asymptomatic HIV infection for adverse effects. If possible, document protective antibody response before travel.

Systemic corticosteroid therapy (eg, prednisone) may have an immunosuppressant effect that potentially decreases immunogenicity and increases risk of adverse effects.

If immunization is imperative in a patient with history of severe egg sensitivity and a positive skin test to yellow fever vaccine, desensitization may be attempted using the following successive doses of yellow fever vaccine administered subcutaneously at 15- to 20-min intervals: 0.05 mL of 1:10 dilution, 0.05 mL of full strength, 0.1 mL of full strength, 0.15 mL of full strength, then 0.2 mL of full strength. Necessary emergency resuscitation equipment must be immediately available during this process.

Yellow fever vaccine, a live virus vaccine, poses a risk of encephalitis or other serious adverse reactions to patients with illnesses that commonly result in immunosuppression (eg, AIDs, generalized malignancy, leukemia), or patients whose immunologic responses are suppressed by drug therapy or radiation. Immunosuppressed patients should not be immunized with yellow fever vaccine; travel to endemic areas should be postponed or avoided. Family members of immunosuppressed patients may receive yellow fever vaccine.

Stopper of the vial contains dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.

Immunologically healthy patients who fail to develop an immune response to an initial vaccination may do so upon revaccination.

Is a known but rare adverse reaction associated with yellow fever vaccination. Risk factors are immunosuppression and younger than 9 mo of age.

Yellow fever vaccine is a possible, but rare, cause of vaccine-associated viscerotropic disease.

Overdosage

Symptoms

None reported.

Patient Information

• Explain name, action, benefits, and potential risks and side effects of vaccine.
• Provide and review the Vaccine Information Statements prior to immunization.
• Provide patient with signed and validated International Certificate of Vaccination and advise patient that certificate is valid for 10 yr commencing 10 days after initial vaccination or revaccination.
• Advise patient or caregiver that injection-site reactions, mild headache, muscle aches, low-grade fever, and/or general body discomfort may occur and may last 5 to 10 days.
• Advise patient or caregiver to use nonaspirin-containing OTC analgesics (eg, acetaminophen, ibuprofen) for fever, muscle aches, or pain or discomfort at injection site.
• Instruct patient or caregiver to immediately notify health care provider of any of the following: rash, hives, difficulty breathing, change in mental alertness.
• Instruct patient or caregiver to report any serious adverse reaction occurring up to 30 days after vaccination to health care provider.

Copyright © 2009 Wolters Kluwer Health.