YF-VAX Powder for suspension Ref.[9904] Active ingredients: Yellow fever, live attenuated

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 booster dose 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 travelers 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 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 s ection, Drug Interactions subs ection). 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 YF-VAX and other live vaccines (14).

Vaccine Preparation

• Reconstitute the vaccine using only the diluent supplied (0.6 mL single dose vial of Sodium Chloride Injection USP for single 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 0.5 mL dose from the single dose vial of reconstituted vaccine.
• Before reconstitution, YF-VAX is a pinkish color. After reconstitution, YF-VAX is a slight pinkbrown 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 vial.
• Discard unused portion.

Properly dispose of all reconstituted vaccine and containers that remain unused after one hour according to locally approved guidelines (e.g. 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.

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.