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Yellow Fever Vaccine

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Yf-Vax

Yf-Vax

WARNINGS

The stopper of the vial contains dry natural latex rubber that may cause allergic reactions.

Anaphylaxis may occur following the use of YF-VAX (yellow fever vaccine) 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.)

PRECAUTIONS

General

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse events. The revious immunization history, current health status, and medical historyp should be reviewed for previous hypersensitivity reactions and other adverse events related to this vaccine or similar vaccines and for possible sensitivity to dry natural latex rubber. The stopper of the vial contains dry natural latex rubber that may cause allergic reactions. In some instances where symptoms appear soon after a vaccine is administered, differentiation between allergic reaction to the vaccine and reaction to an environmental allergen may not be possible. (23)

EPINEPHRINE INJECTION (1:1000) SHOULD ALWAYS BE IMMEDIATELY AVAILABLE IN CASE OF AN UNEXPECTED ANAPHYLACTIC OR OTHER SERIOUS ALLERGIC REACTION.

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of blood borne infectious agents. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.

Hypersensitivity Reactions

YF-VAX (yellow fever vaccine) vaccine should not be administered to an individual with a history of hypersensitivity to egg or chicken protein (see CONTRAINDICATIONS section). However, if a subject is suspect as being an egg-sensitive individual, the following test can be performed before the vaccine is administered: (23)

  1. Scratch, prick, or puncture test: Place a drop of a 1:10 dilution of the vaccine in physiologic saline on a superficial scratch, prick, or puncture on the volar surface of the forearm. Positive (histamine) and negative (physiologic saline) controls should also be used. The test is read after 15 to 20 minutes. A positive test is a wheal 3 mm larger than that of the saline control, usually with surrounding erythema. The histamine control must be positive for valid interpretation. If the result of this test is negative, an intradermal (ID) test should be performed.
  2. Intradermal test: Inject a dose of 0.02 mL of a 1:100 dilution of the vaccine in physiologic saline. Positive and negative control skin tests should be performed concurrently. A wheal 5 mm or larger than the negative control with surrounding erythema is considered a positive reaction.

If vaccination is considered essential, despite a positive skin test, then desensitization can be considered (see DOSAGE AND ADMINISTRATION section, Desensitization subsection).

Carcinogenesis, Mutagenesis, Impairment of Fertility

YF-VAX (yellow fever vaccine) vaccine has not been evaluated for its carcinogenic or mutagenic potential or its effect on fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with YF-VAX (yellow fever vaccine) vaccine. It is also not known whether YF-VAX (yellow fever vaccine) vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. YF-VAX (yellow fever vaccine) vaccine should be given to a pregnant woman only if clearly needed. The seroconversion rate to 17D vaccines is markedly reduced in pregnant women. (See CLINICAL PHARMACOLOGY section.) (18) For discussion of this subject and for documentation of a protective immune response to vaccine where it is deemed essential, the CDC may be contacted at 1-970-221-6400.

Nursing Mothers

As there is a theoretical risk of transmission of vaccine components to the infants from breast-feeding mothers, lactation constitutes a contraindication, particularly when infants are below 9 months of age because of the risk of encephalitis. (See CONTRAINDICATIONS section) The risks and benefit should therefore be assessed before making the decision as to whether to immunize a nursing woman. (2)

Pediatric Use

Vaccination of infants less than 9 months of age IS CONTRAINDICATED because of the risk of encephalitis. (See CONTRAINDICATIONS and ADVERSE REACTIONS sections.)

Geriatric Use

Vaccination of subjects greater than 65 years of age should be limited to individuals who are traveling to or reside in known yellow fever endemic or epidemic areas, because of the increased risk for systemic adverse events in this age group. When vaccination is deemed necessary, the health status of such individuals should be evaluated prior to vaccination. Additionally, if vaccinated, elderly subjects should be carefully monitored for adverse events for 10 days post-vaccination (see ADVERSE REACTIONS section). (24) (38)

REFERENCES

1. Monath TP. Yellow Fever. Plotkin SA, Orenstein WA (eds.). Vaccines. 3rd Edition, WB Saunders Company. 1999;815-879.

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

12. Dukes C, et al. Safety and Immunogenicity of Simultaneous Administration of Typhim Vi (TV), YF-VAX (yellow fever vaccine) (YV), and Menomune (MV). [abstract]. American Society for Microbiology. The 36th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC): 1996; September 15-18:159.

17. Goujon C, et al. Good Tolerance and Efficacy of Yellow Fever Vaccine Among Subjects Carriers of Human Immunodeficiency Virus. Fourth International Conference on Travel Medicine; Acapulco, Mexico 1995; April:23-27;32:63.

18. Nasidi A, et al. Yellow fever vaccination and pregnancy: a four-year prospective study. Transactions of the Royal Society of Tropical Medicine and Hygiene 1993;87:337-339.

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

24. Sanofi Pasteur Inc. Data on File ú 080601;120104.

26. Martin M, et al. Fever and multisystem organ failure associated with 17D-204 yellow fever vaccination: a report of four cases. Lancet 2001;358:98-104.

27. Galler R, et al. Phenotypic and molecular analyses of yellow fever 17DD vaccine viruses associated with serious adverse events in Brazil. Virology 2001;290:309-319.

28. Chan RC, et al. Hepatitis and death following vaccination with yellow fever 17D-204 vaccine. Lancet 2001;358:121-122.

29. Vasconcelos PFC, et al. Serious adverse events associated with yellow fever 17DD vaccine in Brazil: a report of two cases. Lancet 2001;358:91-97.

33. Ruben FL, et al. Simultaneous administration of smallpox, measles, yellow fever, and diphtheria-pertussistetanus antigens to Nigerian children. Bull WHO 1973;48:175-181.

34. Dumas R, et al. Safety and immunogenicity of a new inactivated hepatitis A vaccine and concurrent administration with a typhoid fever vaccine or a typhoid fever + yellow fever vaccine. Adv Therapy 1997;14:160-167.

35. Coursaget P, et al. Simultaneous injection of plasma-derived or recombinant hepatitis B vaccines with yellow fever and killed polio vaccines. Vaccine 1995;13:109-111.

36. Kaplan JE, et al. The effect of immune globulin on the response to trivalent oral poliovirus and yellow fever vaccinations. Bull WHO 1984;62(4):585-590.

37. Tsai TF, et al. Chloroquine does not adversely affect the antibody response to yellow fever vaccine. J Infect Dis 1986;154(4):726-727.

38. Martin M, et al. Advanced age a risk factor for illness temporally associated with yellow fever vaccination. Emerg Infect Dis 2001;7:945-951.

Last reviewed on RxList: 11/25/2008
This monograph has been modified to include the generic and brand name in many instances.

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