YF-VAX (Yellow Fever Vaccine) - Indications and Dosage

INDICATIONS AND USAGE

YF-VAX® is recommended for active immunization of persons 9 months of age and older in the following categories:

PERSONS LIVING IN OR TRAVELING TO ENDEMIC AREAS

While the actual risk for contracting yellow fever during travel is probably low, variability of itineraries and behaviors and the seasonal incidence of disease make it difficult to predict the actual risk for a given individual traveling to a known endemic or epidemic area. Persons greater than or equal to 9 months of age traveling to or living in areas of South America and Africa where yellow fever infection is officially reported at the time of travel should be vaccinated. Vaccination is also recommended for travel outside the urban areas of countries that do not officially report the disease but that lie in a yellow fever endemic zone.

INTERNATIONAL TRAVEL

Yellow fever vaccination may be required for international travel. Some countries in Africa require evidence of vaccination from all entering travelers and some countries may waive the requirements for travelers staying less than 2 weeks that are coming from areas where there is no current evidence of significant risk for contracting yellow fever. Some countries require an individual, even if only in transit, to have a valid International Certificate of Vaccination if the individual has been in countries either known or thought to harbor yellow fever virus. The certificate becomes valid 10 days after vaccination with YF-VAX®. ^2,21

In no instance should infants less than 9 months of age receive yellow fever vaccine, because of the risk of encephalitis (see CONTRAINDICATIONS and ADVERSE REACTIONS sections).

LABORATORY PERSONNEL

Those laboratory personnel who might be exposed to virulent yellow fever virus or to concentrated preparations of the yellow fever vaccine strain by direct or indirect contact or by aerosols should be vaccinated. ²

As with any vaccine, vaccination with YF-VAX® may not protect 100% of susceptible individuals (see CLINICAL PHARMACOLOGY section).

For simultaneous administration of other vaccines see PRECAUTIONS section, Drug Interactions subsection.

DOSAGE AND ADMINISTRATION

Primary vaccination: For all eligible persons, a single subcutaneous injection of 0.5 mL of reconstituted vaccine (formulated to contain not less than 4.74 log₁₀ PFU) should be administered. Immunity develops by the 10th day after primary vaccination.^11,23,44

Booster Doses: Re-immunization with 17D vaccine is recommended every 10 years for those at continuing risk of exposure and is required by International Health Regulations. ²² Revaccination boosts antibody titer, although evidence from several studies suggests that yellow fever vaccine immunity persists for at least 30 to 35 years and probably for life,⁴⁵ and epidemiologic data suggest that a single infection with wild-type yellow fever virus provides lifelong immunity against illness due to subsequent exposure.

SIMULTANEOUS ADMINISTRATION OF OTHER VACCINES

Determination of whether to administer yellow fever vaccine and other immunobiologics simultaneously should be made on the basis of convenience to the traveler in completing the desired vaccinations before travel and on information regarding possible interference. Limited data are available related to administration of YF-VAX® with other vaccines. (See PRECAUTIONS section, Drug Interactions subsection.) In those specific instances where vaccines may be given concurrently, injections should be administered at separate sites. Where there are no data to support administration of YF-VAX® concurrently with other vaccines, 4 weeks should elapse between sequential vaccinations. ²

VACCINE PREPARATION:

• Reconstitute the vaccine using only the diluent supplied (0.6 mL vial of Sodium Chloride Injection USP for single dose vial of vaccine and 3 mL vial of Sodium Chloride Injection USP for 5 dose vial of vaccine). Draw the volume of the diluent, shown on the diluent label, into a suitable size syringe and slowly inject into the vial containing the vaccine. Allow the reconstituted vaccine to sit for one to two minutes and then carefully swirl mixture until a uniform suspension is achieved. Avoid vigorous shaking as this tends to cause foaming of the suspension. Do not dilute reconstituted vaccine.
• The vaccine should appear slightly opalescent and light orange in color after reconstitution. If the product contains extraneous particulate matter or is discolored, do not administer the vaccine.
• SWIRL VACCINE WELL before withdrawing each dose. Administer the single immunizing dose of 0.5 mL subcutaneously using a 5/8- to 3/4-inch long needle²² within 60 minutes of reconstituting the vial.

Properly dispose of all reconstituted vaccine and containers that remain unused after one hour (eg, sterilized or disposed in red hazardous waste containers). ²

DESENSITIZATION²²

If immunization is imperative and the individual has a history of severe egg sensitivity and has a positive skin test to the vaccine, this desensitization procedure may be used to administer the vaccine.

The following successive doses should be administered subcutaneously at 15- to 20-minute intervals:

1.0.05 mL of 1:10 dilution

2.0.05 mL of full strength

3.0.10 mL of full strength

4.0.15 mL of full strength

5.0.20 mL of full strength

Desensitization should only be performed under the direct supervision of a physician experienced in the management of anaphylaxis with necessary emergency equipment immediately available.

HOW SUPPLIED

Vial, 1 Dose (5 per package) with 0.6 mL vial of diluent (5 per package) for administration with needle and syringe. Product No. 49281-915-01

Vial, 5-Dose, with 3 mL vial of diluent, for administration with needle and syringe. Product No. 49281-915-05

YF-VAX® (Yellow Fever Vaccine) in the US is supplied only to designated Yellow Fever Vaccination Centers authorized to issue valid certificates of Yellow Fever Vaccination. Location of the nearest Yellow Fever Vaccination Centers may be obtained from the Centers for Disease Control and Prevention, Atlanta, GA 30333, state or local health departments.

STORAGE

SHIPPING CONDITIONS AND TEMPERATURES

YF-VAX® is shipped frozen in a container with solid carbon dioxide; do not use unless the shipping case contains some dry ice upon arrival.

Upon receipt, lyophilized vaccine must be maintained continuously at 0° - 5°C (32° - 41°F). DO NOT REFREEZE.

YF-VAX® does not contain a preservative; therefore, all reconstituted vaccine and containers which remain unused after one hour must be properly disposed (eg, sterilized or disposed in red hazardous waste containers). ²

The following stability information for YF-VAX® is provided for those countries or areas of the world where an adequate cold chain is a problem and inadvertent exposure to abnormal temperatures has occurred.

YF-VAX® is formulated to satisfy the current US potency requirements of not less than 4.74 log₁₀ PFU per 0.5 mL dose and meets the minimum requirements of WHO. ¹⁰