February 24, 2017
Recommended Topic Related To:

Yellow Fever Vaccine

"Rubella is usually mild in children. But for some peopleā€”especially pregnant women and their babiesā€”rubella can be serious. Make sure you and your child are protected from rubella by getting vaccinated on schedule.

Rubella Facts

"...

A A A

Yf-Vax




Warnings
Precautions

WARNINGS

Severe Allergic Reactions

Severe allergic reactions (e.g., anaphylaxis) may occur following the use of YF-VAX, even in individuals with no prior history of hypersensitivity to the vaccine components. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Yellow Fever Vaccine-Associated Viscerotropic Disease

Age greater than 60 years is a risk factor for yellow fever vaccine-associated viscerotropic disease (YEL-AVD) (14) which may present as non-specific multi-organ system failure or can be similar to fulminant yellow fever caused by wild-type yellow fever virus, with liver failure and internal bleeding, leading to death. (See ADVERSE REACTIONS section). Available evidence suggests that the occurrence of this syndrome may depend upon undefined host factors, rather than intrinsic virulence of the yellow fever strain 17D vaccine, based on characterization of vaccine viruses isolated from individuals with YEL-AVD. YEL-AVD has been reported to occur only after the first dose of yellow fever vaccine; there have been no reports of YEL-AVD following booster dose.(17) The decision to vaccinate individuals 60 years of age and older needs to weigh the risks and benefits of vaccination and the risk for exposure to yellow fever virus. (18)(19) (20) (21)

Yellow Fever Vaccine-Associated Neurotropic Disease

Age greater than 60 years and immunosuppression are risk factors for post-vaccinal encephalitis, also known as yellow fever vaccine-associated neurotropic disease (YEL-AND). (See ADVERSE REACTIONS section.) Almost all cases of YEL-AND have been in first-time vaccine recipients. (17) The decision to vaccinate individuals 60 years of age and older and immunosuppressed individuals needs to weigh the risks and benefits of vaccination and the risk for exposure to yellow fever virus.

PRECAUTIONS

General

Vaccination with YF-VAX may not protect 100% of individuals.

Do not administer YF-VAX by intravascular, intramuscular, or intradermal routes.

Use a separate, sterile syringe and needle for each patient to prevent transmission of blood borne infectious agents. Do not recap needles. Dispose of needles and syringes according to biohazard waste guidelines.

Testing For Hypersensitivity Reactions

Do not administer YF-VAX to an individual with a history of hypersensitivity to egg or chicken protein (see CONTRAINDICATIONS section). However, if an individual is suspected of being an egg-sensitive individual, the following test can be performed before the vaccine is administered:

  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 (superficial bump) 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, consider desensitization (see DOSAGE AND ADMINISTRATION section, Desensitization subsection).

Carcinogenesis, Mutagenesis, Impairment Of Fertility

YF-VAX has not been evaluated for its carcinogenic or mutagenic potential or its effect on fertility.

Pregnancy

Animal reproduction studies have not been conducted with YF-VAX. It is also not known whether YFVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. YF-VAX should be given to a pregnant woman only if clearly needed.

YF-VAX has not been evaluated in pregnant women. However, based on experience of other yellow fever vaccines, the following findings have been determined for safety and effectiveness. A casecontrol study of Brazilian women found no significant difference in the odds ratio of spontaneous abortion among vaccinated women compared to a similar unvaccinated group. (28) In a separate study in Trinidad, 100 to 200 pregnant females were immunized, no adverse events related to pregnancy were reported. In addition, 41 cord blood samples were obtained from infants born to mothers immunized during the first trimester. One of these infants tested positive for IgM antibodies in cord blood. The infant appeared normal at delivery, and no subsequent adverse sequelae of infection were reported. However, this result suggests that transplacental infection with 17D vaccine viruses can occur. (29) In another study involving 101 Nigerian women, the majority of whom (88%) were in the third trimester of pregnancy, none of the 40 infants who were delivered in a hospital tested positive for IgM antibodies as a criterion for transplacental infection with vaccine virus. However, the percentage of pregnant women who seroconverted was reduced compared to a non-pregnant control group (38.6% vs. 81.5%). (30)

For further discussion of vaccination with YF-VAX during pregnancy and for documentation of a protective immune response to vaccine where it is deemed essential, contact the CDC at 1-970-2216400.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from YF-VAX, a decision should be made whether to discontinue nursing or not to administer the vaccine, taking into account the importance of the vaccine to the mother. As of July, 2015, three vaccine-associated neurotropic disease cases have been reported worldwide in exclusively breastfed infants whose mothers were vaccinated with yellow fever vaccines, including one case reported after vaccination with YF-VAX. All three infants were diagnosed with encephalitis and were less than one month of age at the time of exposure. (17) Because age less than 9 months is a risk factor for yellow fever vaccine-associated neurotropic disease, YF-VAX is contraindicated in lactating women who are providing breastmilk to infants younger than 9 months of age. (see CONTRAINDICATIONS section.) Discuss the risks and benefits of vaccination with lactating women who are providing breastmilk to infants 9 months of age and older. (14)

Pediatric Use

Vaccination of infants less than 9 months of age is contraindicated because of the risk ofyellow fever vaccine-associated neurotropic disease. (See CONTRAINDICATIONS and ADVERSE REACTIONS sections.)

Geriatric Use

There is an increased risk of severe systemic adverse reactions to YF-VAX in individuals 60 years of age and older. Monitor elderly individuals for signs and symptoms of yellow fever vaccine-associated viscerotropic disease, which typically occurs within 10 days post-vaccination. (See WARNINGS and ADVERSE REACTIONS sections).(16) (31)

REFERENCES

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

16 Sanofi Pasteur Inc. Data on File - 080601;120104.

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

17 Centers for Disease Control and Prevention. CDC Health Information for International Travel 2016. New York: Oxford University Press 2016;3:346-60.

18 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.

19 Galler R, et al. Phenotypic and molecular analyses of yellow fever 17DD vaccine viruses associated with serious adverse events in Brazil. Virology 2001;290:309-19.

20 Chan RC, et al. Hepatitis and death following vaccination with yellow fever 17D-204 vaccine. Lancet 2001;358:121-2.

21 Vasconcelos PFC, et al. Serious adverse events associated with yellow fever 17DD vaccine in Brazil: a report of two cases. Lancet 2001;358:91-7.

22 Ruben FL, et al. Simultaneous administration of smallpox, measles, yellow fever, and diphtheriapertussis- tetanus antigens to Nigerian children. Bull WHO 1973;48:175-81.

23 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;14:160-7.

24 Coursaget P, et al. Simultaneous injection of plasma-derived or recombinant hepatitis B vaccines with yellow fever and killed polio vaccines. Vaccine 1995;13:109-11.

25 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):585-90.

26 Edupuganti S, et al. A Randomized, Double-Blind, Controlled Trial of the 17D Yellow Fever Virus Vaccine Given in Combination with Immune Globulin or Placebo: Comparative Viremia and Immunogenicity. Am J Trop Med Hyg 2013;88(1): 172-7.

27 Tsai TF, et al. Chloroquine does not adversely affect the antibody response to yellow fever vaccine. J Infect Dis 1986;154(4):726-7.

28 Nishioka SA, et al. Yellow fever vaccination during pregnancy and spontaneous abortion: a casecontrol study. Trop Med Int Health 1998;3(1):29-33.

29 Tsai TF, et al. Congenital yellow fever virus infection after immunization in pregnancy. J Infect Dis 1993;168:1520-1523.

30 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;87:337-9.

31 Martin M, et al. Advanced age a risk factor for illness temporally associated with yellow fever vaccination. Emerg Infect Dis 2001;7:945-51.

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

Last reviewed on RxList: 11/3/2016

Warnings
Precautions

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.


Women's Health

Find out what women really need.