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

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.

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 vaccine.^2,21

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 vaccine may not protect 100% of individuals (see CLINICAL PHARMACOLOGY section).

For concomitant administration with other vaccines see PRECAUTIONS section, DRUG INTERACTIONS subsection.

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 throughout the life of the product) should be administered. Immunity develops by the 10th day after primary vaccination.^11,25,45

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.²³ 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, ⁴⁶ and epidemiologic data suggest that a single infection with wild-type yellow fever virus provides lifelong immunity against illness due to subsequent exposure.

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 vaccine 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 vaccine concurrently with other vaccines, 4 weeks should elapse between sequential vaccinations.²

· 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 needle²³ 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

DESENSITIZATION ²³

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                                 4. 0. 15 mL of full strength
2. 0. 05 mL of full strength                                  5. 0. 20 mL of full strength
3. 0. 10 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.

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

CPT® Code:90717

CPT is a registered trademark of the American Medical Association.

YF-VAX vaccine (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.

Store between 2° - 8°C (35° - 46°F). DO NOT FREEZE.

Do not use vaccine after expiration date. YF-VAX vaccine 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 vaccine 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. Half-life is reduced from approximately 14 days at 35°-37°C to 3 - 4 days at 45°- 47°C.

YF-VAX vaccine is formulated to satisfy the current US potency requirements of not less than 4. 74 log₁₀ PFU per 0. 5 mL dose throughout the life of the product and meets the minimum requirements of WHO.¹⁰

^REFERENCES

2. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Yellow Fever Vaccine. 2002. MMWR 2002;51(RR17):1-10.

10. Requirements for yellow fever vaccine. WHO Technical Report Series 594:23-49, 1976.

11. Wisseman CL, et al. Immunological studies with Group B arthropod-borne viruses. Am J Trop Med Hyg 1962;11:550-561.

21. World Health Organization (WHO). International Health Regulations (1969) (3^rd annotated edition). Geneva 1983:30-65.

23. American Academy of Pediatrics. In: Pickering LK, ed. 2000 Red Book: Report of the Committee on Infectious Diseases. 25^th ed. Elk Grove Village, IL: American Academy of Pediatrics 2000;35-38, 174-175.

25. CDC. Health Information for the International Traveler, 2001-2002. Atlanta:US Department of Health and Human Services, Public Health Service 2001;3-6, 12-21, 154-160, 207-220.

45. ACIP. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR02):1-35.

46. Poland JD, et al. Persistence of neutralizing antibody 30-35 years after immunization with 17D yellow fever vaccine. Bull WHO 1981;59(6):895-900.

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