Yf-vax

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Yf-vax Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Yellow fever vaccine live; for SC inj; contains sorbitol, gelatin; preservative-free.

    Pharmacological Class

    Yellow fever vaccine.

    How Supplied

    Available only to Yellow Fever Vaccination Centers.

    Storage

    Store at 2° to 8° C (35° to 46° F). Do not freeze.

    Manufacturer

    Sanofi Pasteur, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Vaccination with 17D strain vaccines is predicted to elicit an immune response identical in quality to that induced by wild-type infection. This response is presumed to result from initial infection of cells in the dermis or other subcutaneous tissues near the injection site, with subsequent replication and limited spread of virus leading to the processing and presentation of viral antigens to the immune system, as would occur during infection with wild-type yellow fever virus.

    Yf-vax Indications

    Indications

    Yellow fever immunization.

    Yf-vax Dosage and Administration

    Adults and Children

    Give at least 10 days before expected exposure; may repeat every 10yrs. <9 months: not recommended. ≥9 months: 0.5mL SC.

    Administration

    Concomitant Administration with other Vaccines

    • Limited data are available related to administration of YF-Vax with other vaccines and the potential for immune interference.
    • When 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.

    Desensitization

    If immunization is imperative and the individual has a history of severe egg sensitivity and has a positive skin test to the vaccine, may use this desensitization procedure to administer the vaccine. The following successive doses should be administered subcutaneously at 15–20 minute intervals:

    • 0.05 mL of 1:10 dilution
    • 0.05 mL of full strength
    • 0.10 mL of full strength
    • 0.15 mL of full strength
    • 0.20 mL of full strength

    Desensitization must be performed under the direct supervision of a physician experienced in the management of anaphylaxis with necessary emergency equipment immediately available.

    Yf-vax Contraindications

    Contraindications

    Infants <9 months of age. Hypersensitivity to eggs or chicken protein (consider skin test and desensitization; see full labeling). Severe immunosuppression, immunodeficiency syndrome, or concomitant immunosuppressants (eg, systemic corticosteroid therapy, chemotherapy, radiation). Thymic dysfunction. Nursing mothers (to infants <9 months of age).

    Yf-vax Boxed Warnings

    Not Applicable

    Yf-vax Warnings/Precautions

    Warnings/Precautions

    Have epinephrine (1:1000) available. Syncope. Elderly (increased risk of systemic events; evaluate prior to, and monitor for at least 10 days after, vaccination). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Testing for Hypersensitivity Reactions

    Do not give YF-Vax to an individual with a history of hypersensitivity to egg or chicken protein. If an individual is suspected of being an egg-sensitive individual, the following test can be performed before the vaccine is administered:

    • 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 15–20 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.
    • 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 Administration).

    Syncope

    • Syncope can occur after or even before vaccination.
    • Procedures should be in place to prevent falling and injury.

    Pregnancy Considerations

    Animal reproduction studies have not been conducted with YF-Vax. It is also not known whether YF-Vax 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.

    Nursing Mother Considerations

    There is 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. 

    Children aged <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. 

    Geriatric Considerations

    There is an increased risk of severe systemic adverse reactions to YF-Vax in individuals ≥60 years of age. Monitor elderly individuals for signs/symptoms of yellow fever vaccine-associated viscerotropic disease, which typically occurs within 10 days post-vaccination.

    Yf-vax Pharmacokinetics

    See Literature

    Yf-vax Interactions

    Interactions

    Concomitant vaccines: see full labeling.

    Yf-vax Adverse Reactions

    Adverse Reactions

    Inj site reactions, rash, headache, malaise, myalgia, fever; rare neurotropic or viscerotropic disease.

    Yf-vax Clinical Trials

    Clinical Trials

    In 24 uncontrolled studies conducted world-wide between 1962 and 1997 evaluating neutralizing antibody responses to 17D strain vaccines among a total of 2529 adults and 991 infants and children, the seroconversion rate was greater than 91% in all but two studies and never lower than 81%. There were no significant age-related differences in immunogenicity. 

    Five of these 24 studies were conducted in the US between 1962 and 1993 and included 208 adults who received YF-Vax. The seroconversion rate was 81% in one study involving 32 participants, and 97–100% in the other 4 studies. 

    In 2001, YF-Vax was used as a control in a double-blind, randomized comparison trial with another 17D-204 strain vaccine, conducted at 9 centers in the US.

    • YF-Vax was administered to 725 adults ≥18 years old with a mean age of 38 years.
    • Three hundred twelve of these participants who received YF-Vax were evaluated serologically, and 99.3% of them seroconverted with a mean log10 neutralization index (LNI, measured by a plaque reduction assay) of 2.21.
    • The LNI was slightly higher among males compared to females and slightly lower among Hispanic and African-American participants compared to others, but these differences were not associated with differences in protective effect of the vaccine. 

    For most healthy individuals, a single dose of yellow fever vaccine provides long-lasting protection. In controlled studies where the immune response to vaccination was evaluated, the small percentage of immunologically normal individuals who failed to develop an immune response to an initial vaccination typically did so upon re-vaccination. In two separate clinical trials of 17D-204 strain vaccines, 90% of participants seroconverted within 10 days after vaccination, and 100% of participants seroconverted within 14 days. Therefore, International Health regulations stipulate that the vaccination certificate for yellow fever is valid 10 days after administration of YF-Vax. 

    Yf-vax Note

    Not Applicable

    Yf-vax Patient Counseling

    Patient Counseling

    Prior to YF-Vax administration, ask potential recipients about their recent health status and history of yellow fever vaccination. 

    Inform about the benefits/risks of immunization and potential for adverse reactions to YF-Vax administration. 

    Advise to report to their health-care providers all serious adverse events that occur up to 30 days post-vaccination.

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