March 26, 2017
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Yellow Fever Vaccine

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Yf-Vax

Indications
Dosage
How Supplied

INDICATIONS

YF-VAX is indicated for active immunization for the prevention of yellow fever in 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, behaviors and seasonal incidence of disease make it difficult to predict the actual risk for a given individual living in or traveling to a known endemic or epidemic area. Greater risk is associated with living in or traveling to areas of South America and Africa where yellow fever infection is officially reported at the time of travel and with traveling outside the urban areas of countries that do not officially report the disease but that lie in a yellow fever endemic zone.

Persons Travelling Internationally Through Countries With Yellow Fever

Some countries require an individual to have a valid International Certificate of Vaccination or Prophylaxis (ICVP) 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. (13) (14)

Laboratory Personnel

Laboratory personnel who handle virulent yellow fever virus or concentrated preparations of the yellow fever vaccine virus strains may be at risk of exposure by direct or indirect contact or by aerosols.(14)

DOSAGE AND ADMINISTRATION

Primary Vaccination: Administer a single subcutaneous injection of 0.5 mL of reconstituted vaccine.

Additional Dosing Information

A single dose of yellow fever vaccine provides long-lasting protection to most healthy individuals. (See CLINICAL PHARMACOLOGY section.) However, an additional dose of yellow fever vaccine may be given to individuals who might not have had an adequate or sustained immune response to prior yellow fever vaccination and who continue to be at risk for exposure to yellow fever virus. Such individuals include women who were vaccinated during pregnancy, hematopoietic stem cell transplant recipients, and HIV-infected persons.

Booster Vaccination: A boosterdose may be given to individuals who were last vaccinated against yellow fever at least 10 years prior and who are at increased risk for yellow fever disease either because of location and duration of travel or because of more consistent exposure to virulent virus. Such individuals include travellers who plan to spend a prolonged period in endemic areas or who plan to travel to highly endemic areas such as rural West Africa, and laboratory personnel who who handle virulent yellow fever virus or concentrated preparations of the yellow fever vaccine virus strains.(10)

Some countries may require for entry evidence of a valid yellow fever vaccination (i.e., ICVP) within the previous 10 years for certain individuals, depending on prior travel itinerary. A booster dose of YFVAX may be given to satisfy this requirement.(10) (37)

Concomitant Administration With Other Vaccines

Limited data are available related to administration of YF-VAX with other vaccines and the potential for immune interference. (See PRECAUTIONS section, DRUG INTERACTIONS subsection.) In instances where vaccines are given concomitantly, administer injections using separate syringes at separate sites. Do not combine or mix YF-VAX with any other vaccine. When not administered concomitantly, wait at least 4 weeks between administration of VF-VAX and other live vaccines. (14)

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). After removing the “flip-off” caps, cleanse the vaccine and diluent vial stoppers with a suitable germicide. Do not remove the vial stoppers or metal seals holding them in place. Using aseptic technique, use a suitable sterile needle and syringe to withdraw the volume of supplied diluent shown on the diluent label and slowly inject the diluent 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. Use aseptic technique and a separate sterile needle and syringe to withdraw each 0.5mL dose from the single dose or multidose vial of reconstituted vaccine.
  • Before reconstitution, YF-VAX is a pinkish color. After reconstitution, YF-VAX is a slight pink/brown suspension. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, do not administer the vaccine.
  • Administer the single dose of 0.5 mL subcutaneously using a suitable sterile needle.
  • Use YF-VAX within 60 minutes of reconstituting the single dose or multi-dose vial.

Properly dispose of all reconstituted vaccine and containers that remain unused after one hour according to locally approved guidelines (eg, sterilized or disposed in red hazardous waste containers). (14)

Desensitization

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

The vial stoppers for YF-VAX vaccine and diluent are not made with natural rubber latex.

1 Dose

Vaccine vial, 1 Dose (NDC 49281-915-58) supplied in a package of 5 vials (NDC 49281-915-01).

Diluent vial, 0.6 mL (NDC 49281-912-59) supplied separately in a package of 5 vials (NDC 49281-912-05).

5 Dose

Vaccine vial, 5 Dose (NDC 49281-915-68) supplied in a package of 1 vial (NDC 49281-915-05).

Diluent vial, 3 mL (NDC 49281-912-69) supplied separately in a package of 1 vial (NDC 49281-912-10).

YF-VAX (Yellow Fever Vaccine) in the US is supplied only to designated Yellow Fever Vaccination Centers authorized to issue 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

Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.

Do not use vaccine after expiration date. YF-VAX does not contain a preservative.

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. Half-life is reduced from approximately 14 days at 35° to 37°C to 3-4.5 days at 45° to 47°C.

REFERENCES

10 Staples JE et al. Yellow Fever Vaccine Booster Doses: Recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR 2015;64(23):647-50.

13 World Health Organization (WHO). International Health Regulations (2005) (2nd edition). Geneva 2008:54-5.

14 Recommendations of the Advisory Committee on Immunization Practices (ACIP). Yellow Fever Vaccine. MMWR 2010;59(RR-7):1-32.

37 World Health Organization (WHO). Vaccines and vaccination against yellow fever. WHO position paper - June 2013. Wkly Epid Rec 2013;27(88):269-84.

Manufactured by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA. Revised: June 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/3/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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