March 28, 2017
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Yellow Fever Vaccine

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Yf-Vax




Side Effects
Interactions

SIDE EFFECTS

Data From Clinical Studies

Adverse reactions to YF-VAX include mild headaches, myalgia, low-grade fevers, or other minor symptoms for 5 to 10 days. Local reactions including edema, hypersensitivity, pain or mass at the injection site have also been reported following yellow fever vaccine administration. Immediate hypersensitivity reactions, characterized by rash, urticaria, and/or asthma, occur principally among persons with histories of allergy to eggs or other substances contained in the vaccine.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

No placebo-controlled trial has assessed the safety of YF-VAX. However, between 1953 and 1994, reactogenicity of 17D-204 vaccine was monitored in 10 uncontrolled clinical trials. The trials included a total of 3,933 adults and 264 infants greater than 4 months old residing in Europe or in yellow fever endemic areas. Self-limited and mild local reactions consisting of erythema and pain at the injection site and systemic reactions consisting of headache and/or fever occurred in a minority of subjects (typically less than 5%) 5 to 7 days after immunization. In one study involving 115 infants age 4 to 24 months the incidence of fever was as high as 21%. Also in this study, reactogenicity of the vaccine was markedly reduced among a subset of subjects who had serological evidence of previous exposure to yellow fever virus. Only two of the ten studies provided diary cards for daily reporting; this method resulted in a slightly higher incidence of local and systemic complaints. YF-VAX was used as a control in a double-blind, randomized comparative trial with another 17D-204 vaccine, conducted at nine centers in the US. YF-VAX was administered to 725 adults ≥ 18 years old with a mean age of 38 years. Safety data were collected by diary card for days 1 through 10 after vaccination and by interview on days 5, 11, and 31. Among subjects who received YF-VAX, there were no serious adverse events, and 71.9% experienced non-serious adverse events judged to have been related to vaccination. Most of these were injection site reactions of mild to moderate severity. Four such local reactions were considered severe. Rash occurred in 3.2%, including two subjects with urticaria. Systemic reactions (headache, myalgia, malaise, and asthenia) were usually mild and occurred in 10% to 30% of subjects during the first few days after vaccination. The incidence of non-serious adverse reactions, including headache, malaise, injection site edema, and pain, was significantly lower in subjects > 60 years compared to younger subjects. Adverse events were less frequent in the 1.7% of vaccinated subjects who had pre-existing immunity to yellow fever virus, compared to those without pre-existing immunity. (8)

Data From Post-marketing Experience

The following additional adverse events have been spontaneously reported during the post-marketing use of YF-VAX worldwide. Because these events are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or establish a causal relationship to vaccine exposure. This list includes adverse events based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to YF-VAX.

  • Immune System Disorders (14)
    Immediate hypersensitivity reactions or anaphylaxis, characterized by rash and/or urticaria and/or respiratory symptoms (e.g., dyspnea, bronchospasm, or pharyngeal edema) occur principally among persons with histories of allergies to egg or other substances contained in the vaccine.
  • 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 vaccineassociated 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-Barre 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.

Read the Yf-Vax (yellow fever vaccine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Data are limited in regard to the interaction of YF-VAX with other vaccines.

  • Measles (Schwartz strain) vaccine, diphtheria and tetanus toxoids and whole cell pertussis vaccine (DTP), (22) Hepatitis A and Hepatitis B vaccines, (5) (14) (23) (24) meningococcal vaccine, Menomune®A/C/Y/W-135, and typhoid vaccine, Typhim Vi®, (5) (14) (23) have been administered with yellow fever vaccine at separate injection sites.
  • The potential for interference between yellow fever vaccine and rabies or Japanese encephalitis vaccines has not been established. (14)
  • In a prospective study, persons given 5 cc of commercially available immune globulin did not experience alterations in immunologic responses to the yellow fever vaccine.(14) (25) (26)
  • Although chloroquine inhibits replication of yellow fever vaccine in vitro, it does not appear to adversely affect antibody responses to yellow fever vaccine among persons receiving chloroquine. (14) (27)

Patients On Corticosteroid Therapy

Oral Prednisone or other systemic corticosteroid therapy, depending on dose and duration of exposure, may have an immunosuppressive effect on recipients of yellow fever vaccine that potentially decreases immunogenicity and increases the risk of adverse events. Intra-articular, bursal, or tendon injections with corticosteroids should not constitute an increased hazard to recipients of yellow fever vaccine.

Patients With Asymptomatic Human Immunodeficiency Virus (HIV) Infection

The rate of seroconversion following YF-Vax is reduced in individuals with asymptomatic HIV infection and appears to depend on HIV viral load and CD4 + T-cell count. (14) Therefore, documentation of a protective antibody response is recommended before travel. (See CLINICAL PHARMACOLOGY section.) For discussion of this subject and for documentation of the immune response to vaccine where it is deemed essential, contact the CDC at 1-970-221-6400.

REFERENCES

1 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.

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.

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.

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.

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 vaccineassociated 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 Med 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.

Read the Yf-Vax Drug Interactions Center for a complete guide to possible interactions

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

Last reviewed on RxList: 11/3/2016

Side Effects
Interactions

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.


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