Yf-vax
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Questions & Answers
Side Effects & Adverse Reactions
The stopper of the vial contains dry natural latex rubber that may cause allergic reactions.
Anaphylaxis may occur following the use of YF-VAX vaccine, even in individuals with no prior history of hypersensitivity to the vaccine components.
EPINEPHRINE INJECTION (1:1000) SHOULD ALWAYS BE IMMEDIATELY AVAILABLE IN CASE OF AN UNEXPECTED ANAPHYLACTIC OR OTHER SERIOUS ALLERGIC REACTION.
Yellow fever vaccines must be considered as a possible, but rare, cause of vaccine-associated viscerotropic disease (2) (previously described as multiple organ system failure), (2) (26) that is similar to fulminant yellow fever caused by wild-type yellow fever virus. Available evidence suggests that the occurrence of this syndrome may depend upon the presence of undefined host factors, rather than intrinsic virulence of the yellow fever strain 17D vaccine viruses isolated from subjects with vaccine-associated viscerotropic disease. (26) (27) (28) (29) (See ADVERSE REACTIONS section.)
Vaccine-associated neurotropic disease (2), previously described as post-vaccinal encephalitis (1), is a known rare adverse event associated with yellow fever vaccination. Age less than 9 months and immunosuppression are known risk factors for this adverse event. (See CONTRAINDICATIONS and ADVERSE REACTIONS sections.)
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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)
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).
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.
History
There is currently no drug history available for this drug.
Other Information
YF-VAX®, Yellow Fever Vaccine, for subcutaneous use, is prepared by culturing the 17D-204 strain of yellow fever virus in living avian leukosis virus-free (ALV-free) chicken embryos. The vaccine contains sorbitol and gelatin as a stabilizer, is lyophilized, and is hermetically sealed under nitrogen. No preservative is added. The vaccine must be reconstituted immediately before use with the sterile diluent provided (Sodium Chloride Injection USP – contains no preservative). YF-VAX vaccine is formulated to contain not less than 4.74 log10 plaque forming units (PFU) per 0.5 mL dose throughout the life of the product. YF-VAX vaccine is a slight pink-brown suspension after reconstitution.
Sources
Yf-vax Manufacturers
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Sanofi Pasteur Inc.
![Yf-vax (Yellow Fever Virus Strain 17d-204 Live Antigen) Injection, Powder, Lyophilized, For Suspension Sodium Chloride Injection [Sanofi Pasteur Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Yf-vax | Sanofi Pasteur Inc.
Primary VaccinationFor 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) (46)
Booster DosesRe-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, (47) and epidemiologic data suggest that a single infection with wild-type yellow fever virus provides lifelong immunity against illness due to subsequent exposure.
Concomitant Administration with other VaccinesDetermination 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)
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. YF-VAX vaccine is a slight pink-brown suspension 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 needle (23) 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 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 strengthDesensitization should only be performed under the direct supervision of a physician experienced in the management of anaphylaxis with necessary emergency equipment immediately available.
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