A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Yf-Vax Side Effects, and Drug Interactions - Yellow Fever Vaccine
Yf-Vax Side Effects, and Drug Interactions - Yellow Fever Vaccine
SIDE EFFECTS
Local reactions including edema, hypersensitivity, pain or mass at the injection site have been reported following yellow fever vaccine administration.3
Reactions to 17D yellow fever vaccines are generally mild. Two percent to 5% of vaccinees have mild headaches, myalgia, low-grade fevers, or other minor symptoms 5 to 10 days after vaccination. Fewer than 0.2% of the vaccinees curtail regular activities.3,8
In 2001, YF-VAX® [Yellow Fever Vaccine] was used as a control in a double-blind, randomized comparative trial with another 17D-204 vaccine, conducted at nine centres in the US. YF-VAX® was administered to 725 adults ³18 years old with a mean age of 38 years. 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% and urticaria in two subjects. 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 who had not been previously exposed.24
Serious and severe adverse reactions are extremely rare.2 They fall into three major categories: hypersensitivity reactions, neurotropic disease and viscerotropic disease.
Hypersensitivity Reactions
Immediate hypersensitivity reactions, characterized by rash, urticaria, and/or asthma, are very rare (estimated incidence of 1:130,000 to 1:250,000) and occur principally among persons with histories of egg allergy.6,8 Recently gelatin stabilizers have been implicated as a cause of allergic reactions in other vaccines.8
Anaphylaxis may occur following the use of YF-VAX® even in persons with no prior history of hypersensitivity to the vaccine components.
Neurotropic Disease
Vaccine-associated neurotropic disease,6 (previously described as post-vaccinal encephalitis1) is a known serious adverse event associated with 17D vaccination. Age less than 9 months and immunosuppression are known risk factors. Twenty-one cases of vaccine-associated neurotropic disease associated with all licensed 17D vaccines have been reported between 1952 and 2002, fourteen of which occurred in infants £4 months old and two of which occurred in infants 6 and 7 months old. Two additional cases occurred in children, a thirteen-year-old and a three-year-old. The three-year-old died from encephalitis and a genetic variant of the vaccine virus was isolated from the child’s brain.25 This is the only verified fatality due to yellow fever vaccine-associated neurotropic disease. The three remaining cases of vaccine-associated neurotropic disease occurred in adults.6
The incidence of vaccine-associated neurotropic disease in infants less than 4 months old is estimated to be between 0.5 and 4 per 1,000, based on two historical reports where denominators are available.1 No data are available for calculation of an age-specific incidence rate in the 4- to 9-month-age group. A study in Senegal26 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. One study conducted in Kenya in 1993 detected four cases of encephalitis temporally associated with vaccination, one in a 2-year-old child and three in adults, for an incidence of 5.3 cases per million vaccinees of all ages.1
Viscerotropic Disease
Between 1996 and 1998, four American vacinees, ages 63, 67, 76 and 79, became severely ill 2 to 5 days after vaccination with YF-VAX®. Three of these 4 subjects died. The clinical presentations were characterized by a non-specific febrile syndrome with fatigue, myalgia and headache, rapidly progressing to a severe illness including respiratory failure, elevated hepatocellular enzymes, lymphocytopenia and thrombocytopenia, hyperbilirubinemia and renal failure requiring hemodialysis.9 None of these subjects had vaccine-associated neurotropic disease. This severe adverse event is known as a ‘vaccine-associated viscerotropic disease’6 (previously described as multiple organ system failure9). Genetic testing of vaccine virus isolated in two of these cases suggests that the isolates had not undergone a mutation associated with an increase in virulence. The incidence rate for these serious adverse events was estimated at 1 per 400,000 doses of YF-VAX®, based on the total number of doses administered in the US during the surveillance period.6
Additional cases of vaccine-associated viscerotropic disease temporally associated with yellow fever vaccination have been reported in Australia and Brazil. These reports suggest that both the 17D-204 and the 17DD yellow fever vaccines, may be considered as a possible, but rare, cause of vaccine-associated viscerotropic disease,6 which is similar to fulminant yellow fever caused by wild-type yellow fever virus.
An analysis of data by the US Centers for Disease Control and Prevention (CDC) of data submitted to the Vaccine Adverse Event Reporting System (VAERS) between 1990 and 1998 suggests that patients aged 65 or older are at increased risk for systemic adverse events temporally associated with vaccination, compared to the 25- to 44-year old age group. (See PRECAUTIONS, Geriatric Use.) The rate of systemic adverse events occurring post-vaccination in patients aged 65 to 74 was 2.5 times higher than the rate occurring in patients aged 25 to 44, based on incidence rates of 6.21 and 2.49 per 100,000 doses of vaccine in the two groups, respectively.16
The Division of Immunization has reviewed Canadian data on yellow fever adverse events reported by passive voluntary surveillance between 1987-2000. During this time, there were 159 reports of adverse events following yellow fever vaccination, either alone or in combination with other vaccines. No deaths were reported. Most reported cases involved young adults, only 14 reports (9.3%) were received concerning persons over 60 years of age.27
Physicians, nurses and pharmacists should report any adverse occurrences temporally related to the administration of the product in accordance with local requirements and to the Global Pharmacovigilance Department, Aventis Pasteur Limited, 1755 Steeles Avenue West, Toronto, ON, M2R 3T4, Canada. 1-888-621-1146 (phone) or 416- 667-2435 (fax).
DRUG INTERACTIONS
Administration with Other Vaccines
Data are limited in regard to the interaction of YF-VAX® with other vaccines. Studies have shown that the serologic response to yellow fever vaccine is not inhibited by the administration of certain other vaccines concurrently at separate sites or at various intervals of a few days to one month.17 Measles (Schwartz strain) vaccine, smallpox, diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTP),18 hepatitis A and B vaccines,19,20,21 meningococcal vaccine, Menomune® A/C/Y/W-135 and typhoid vaccine, Typhim Vi®,19,22 have been administered concurrently with yellow fever vaccine at separate injection sites. No data exists on possible interference between yellow fever and rabies or Japanese encephalitis vaccine.6 Concurrent administration of other live vaccines, including live oral cholera, live oral typhoid vaccines, or with oral inactivated travellers’ diarrhea and cholera vaccine, DUKORAL™3, does not inhibit the serological response to yellow fever vaccine. If live vaccines are not given concurrently, they should be spaced at least 4 weeks apart.8
Inactivated vaccines (except inactivated parenteral cholera vaccine) may also be administered during the same patient visit with other vaccines commonly administered to international travellers.8
The administration of immune globulin and yellow fever vaccine either simultaneously or within a short span of time, does not alter the immunologic response, because immune globulin is unlikely to contain antibody to yellow fever virus.8,17
Although chloroquine inhibits replication of yellow fever virus in vitro, it does not adversely affect antibody responses to yellow fever vaccine in humans receiving antimalaria prophylaxis.8,23
REFERENCES
1. Monath TP. Yellow Fever. In: Plotkin SA and Orenstein WA, editors. Vaccines, 3rd ed. Philadelphia, PA: WB Saunders Company,1999:815-79.
2. Monath TP, et al. Prevention of yellow fever in persons traveling to the tropics. Clin Infect Dis 2002;34:1369-78.
3. Data on file at Aventis Pasteur Inc.
4. 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.
6. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Yellow Fever Vaccine. MMWR 2002;51(RR-17):1-10.
8. National Advisory Committee on Immunization. General Considerations. Yellow Fever Vaccine. In: Canadian Immunization Guide, 6th ed. Her Majesty the Queen in Right of Canada, represented by the Minister of Public Works and Government Services Canada, 2002:14-8,233-41.
9. Martin M, et al. Fever and multisystem organ failure associated with 17D-204 yellow fever vaccination. Lancet 2001;358:98-104.
14. American Academy of Pediatrics. Hypersensitivity Reactions to Vaccine Constitutents. Treatment of Anaphylactic Reactions. Arboviruses. In: Pickering LK, ed. 2003 Red Book, Report of the Committee on Infectious Diseases, 26th ed. Elk Grove Village, IL: American Academy of Pediatrics 2003:46-7,63-6,199-205. Published erratum - Red Book 2003 Report of the Committee on Infectious Diseases Errata 2003:3.
15. Plott RT, et al. Iatrogenic contamination of multidose vials in simulated use. Arch Dermatol 1990;126:1441-4.
16. Martin M, et al. Advanced age a risk factor for illness temporally associated with yellow fever vaccination. Emerg Infect Diseases 2001;7(6):945-51.
17. Kaplan JE, et al. The effect of immune globulin on the response to trivalent oral poliovirus and yellow fever vaccinations. Bull WHO 1984;62:585-90.
18. 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. 19. Jong EJ, et al. An open randomized study of inactivated hepatitis A vaccine administered concurrently with typhoid fever and yellow fever vaccines. J Travel Med 2002;9:66-70.
20. 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.
21. 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.
22. Dukes C, et al. Safety and immunogenicity of simultaneous administration of Typhim Vi (TV), YF-VAX (YV), and Menomune (MV). [Abstract] 36th ICAAC, New Orleans, 1996:G86.
23. Tsai TF, et al. Chloroquine does not adversely affect the antibody response to yellow fever vaccine. J Infect Dis 1986;154:726.
24. 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 2002;66(5):533-41.
25. 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.
26. Rey M, et al. Epidemiological and clinical aspects of encephalitis following yellow fever vaccination (based on a study of 248 cases observed at four hospitals in Dakar subsequent to the 1965 vaccination campaign). Bull Soc Med Afr Noire Lgue Fr 1966;11:560.
27. Health Canada. Review of adverse events reported following use of yellow fever vaccine -Canada, 1987-2000. CCDR 2002;28(2):9-15.
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