Vaccine Information: YF-VAX (Page 3 of 4)

• Nervous System Disorders (1) (32) (33) (34)

Isolated cases of Yellow Fever Vaccine-Associated Neurotropic Disease (YEL-AND), sometimes fatal, have been reported to occur within 30 days following vaccination with YF-VAX, and other yellow fever vaccines. (See WARNINGS section, Yellow fever vaccine-associated neurotropic disease subsection.) Age less than 9 months and congenital or acquired immunodeficiency have been identified as risk factors for this event. (See WARNINGS and CONTRAINDICATIONS sections.) Twenty-one cases of YEL-AND associated with all licensed 17D vaccines have been reported between 1952 and 2004. Eighteen of these cases were in children or adolescents. Fifteen of these cases occurred prior to 1960, thirteen of which occurred in infants 4 months of age or younger, and two of which occurred in infants six and seven months old. The incidence of vaccine-associated neurologic disease in infants less than 4 months old is estimated to be between 50 and 400 cases per 1,000,000, based on two historical reports where denominators are available. (33) (34) (35) A study in Senegal (34) described two fatal cases of encephalitis possibly associated with 17D-204 vaccination among 67,325 children between the ages of 6 months and 2 years, for an incidence rate of 3 per 100,000. The incidence of YEL-AND in the United States is less than 1:100,000 doses administered. (17)

Other neurological complications have included Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis (ADEM), and bulbar palsy.

• Infections and infestations

Isolated cases of Yellow Fever Vaccine-Associated Viscerotropic Disease YEL-AVD, formerly described as “Febrile Multiple Organ-System-Failure”, sometimes fatal, have been reported following YF-VAX and other yellow fever vaccines. (See WARNINGS section, Yellow fever vaccine-associated viscerotropic disease subsection.) In the majority of cases reported, the onset of signs and symptoms was within 10 days after the vaccination. Initial signs and symptoms are non-specific and may include pyrexia, myalgia, fatigue and headache, potentially progressing quickly to liver and muscle cytolysis and possibly to thrombocytopenia, lymphopenia and acute renal failure. (18) The pathophysiological mechanism of such reactions has not been established. In some individuals with YEL-AVD a medical history of thymic disease has been reported. (36) Age older than 60 has also been identified as a risk factor for this event. (9) During surveillance in the U.S. between 1996 and 1998, four individuals (ages 63, 67, 76, and 79) became severely ill 2 to 5 days after vaccination with YF-VAX vaccine. Three of these 4 subjects died. The incidence rate for these serious adverse events was estimated at 1 per 400,000 doses of YF-VAX vaccine, based on the total number of doses administered in the U.S. civilian population during the surveillance period. (21) YEL-AVD has occurred after yellow fever vaccination in fewer than 1:100,000 U.S. vaccinees, (14) most commonly in individuals 60 years of age and older.

In a CDC analysis of data submitted to the Vaccine Adverse Events Reporting System (VAERS) between 1990 and 1998, the rate of systemic adverse events following vaccination was 2.5-fold higher in the 65 years or older age group (6.2 events per 100,000 doses of vaccine) compared to the 25 to 44 year-old age group (2.5 events per 100,000 doses of vaccine). (31)

Reporting of Adverse Events

To report SUSPECTED ADVERSE REACTIONS, contact the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or https://vaers.hhs.gov.

DOSAGE AND ADMINISTRATION

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 YF-VAX 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 section, Drug Interactions subsection.) 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 pink-brown 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.

HOW SUPPLIED

The vial stoppers for YF-VAX vaccine and diluent are not made with natural rubber latex.

Vaccine, single dose vial (NDC 49281-915-58) supplied in a package of 5 vials (NDC 49281-915-01).

Diluent, single dose vial, 0.6 mL (NDC 49281-912-59) supplied separately in a package of 5 vials (NDC 49281-912-05).

YF-VAX (Yellow Fever Vaccine) in the US is supplied only to designated Yellow Fever Vaccination Centers authorized to issue certificates of Yellow Fever Vaccination. Location of the nearest Yellow Fever Vaccination Centers may be obtained from the Centers for Disease Control and Prevention, Atlanta, GA 30333, state or local health departments.

STORAGE

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.

REFERENCES

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Monath TP et al. Yellow fever vaccine. In: Plotkin SA, Orenstein WA and Offit PA, eds. Vaccines. 6th Ed. Elsevier Saunders Inc. 2013:870-968.
2
Mason RA, et al. Yellow fever vaccine: Direct challenge of monkeys given graded doses of 17D vaccine. Appl Microbiol 1973;25(4):539-44.
3
Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines. WHO Technical Report Series. 2013;978:264.
4
Wisseman CL, et al. Immunological studies with Group B arthropod-borne viruses. Am J Trop Med Hyg 1962;11:550-61.
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.
6
Meyer HM, et al. Response of Volta children to jet inoculation of combined live measles, smallpox, and yellow fever vaccines. Bull World Health Org 1964;30:783-94.
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Jackson J, et al. Comparison of Antibody Response and Patient Tolerance of Yellow Fever Vaccine Administered by the Bioject Needle-Free Injection System versus Conventional Needle/Syringe Injection. Third International Conference on Travel Medicine; Paris 1993;April:25-29;264:209.
8
Monath TP, et al. Comparative safety and immunogenicity of two yellow fever 17D vaccines (ARILVAX and YF-VAX) in a Phase III multicenter, double-blind clinical trial. Am J Trop Med Hyg 66(5)2002;533-41.
9
World Health Organization (WHO). Yellow fever vaccine — position paper. Wkly Epid Rec 2003;40(78):349-60.
10
Staples JE et al. Yellow Fever Vaccine Booster Doses: Recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR 2015;64(23):647-50.
11
Bonnevie-Nielson V, et al. Lymphocytic 2′,5′ — Oligoadenylate synthetase activity increases prior to the appearance of neutralizing antibodies and Immunoglobulin M and Immunoglobulin G antibodies after primary and secondary immunization with yellow fever vaccine. Clin Diag Lab Immunol 1995;2:302-6.
12
Smithburn KC, et al. Immunization against yellow fever: Studies on the time of development and the duration of induced immunity. Am J Trop Med Page 7 of 8 Hyg 1945;45:217-23.
13
World Health Organization (WHO). International Health Regulations (2005) (2nd edition). Geneva 2008:54-5.
14
Recommendations of the Advisory Committee on Immunization Practices (ACIP). Yellow Fever Vaccine. MMWR 2010;59(RR-7):1-32.
15
Centers for Disease Control and Prevention. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60(No. RR2):(1-64).
16
Sanofi Pasteur Inc. Data on File – 080601;120104.
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 diphtheria-pertussis-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 case-control 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.
32
Jennings AD, et al. Analysis of a yellow fever virus isolated from a fatal case of vaccine-associated human encephalitis. J Infect Dis 1994;169:512-8.
33
Louis JJ, et al. A case of encephalitis after 17D strain yellow fever vaccination. Pediatr 1981;36(7):547-50.
34
Rey M, et al. Epidemiological and clinical aspects of encephalitis following yellow fever vaccination. Bull Soc Méd Afr Noire Lgue fr 1966;v XI,(3),560-74.
35
Stuart G. Reactions following vaccination against yellow fever. In Smithburn KC, Durieux C, Koerber R, et al (eds.). Yellow Fever Vaccination. Geneva, WHO 1956;143-189.
36
Data on file at sanofi pasteur. Global Pharmacovigilance Department Rationale for adding ‘thymic disease’ in the CCDS of AvP France Yellow Fever Vaccine Nov 2004.
37
World Health Organization (WHO). Vaccines and vaccination against yellow fever. WHO position paper — June 2013. Wkly Epid Rec 2013;27(88):269-84.

YF-VAX, Menomune, and Typhim Vi are registered trademarks of Sanofi Pasteur and its subsidiaries.

Product Information as of March 2020.

Manufactured by:

Sanofi Pasteur Inc.

Swiftwater, PA 18370 USA

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