JE-VAX is indicated for active immunization against JE for persons one year of age and older. For recommended primary immunization series see

DOSAGE AND ADMINISTRATION

JE-VAX should be considered for use in persons who plan to reside in or travel to areas where JE is endemic or epidemic during a transmission season. JE-VAX is NOT recommended for all persons traveling to or residing in Asia. The incidence of JE in the location of intended stay, the conditions of housing, nature of activities, duration of stay, and the possibility of unexpected travel to high-risk areas are factors that should be considered in the decision to administer vaccine. In general, vaccine should be considered for use in persons spending a month or longer in epidemic or endemic areas during the transmission season, especially if travel will include rural areas. Depending on the epidemic circumstances, vaccine should be considered for persons spending less than 30 days whose activities, such as extensive outdoor activities in rural areas, place them at particularly high risk for exposure. ¹

In all instances, travelers are advised to take personal precautions to reduce exposure to mosquito bites. (See PATIENT INFORMATION section.)

Current CDC advisories should be consulted with regard to JE epidemicity in specific locales. ¹

The decision to use JE-VAX should balance the risks for exposure to the virus and for developing illness, the availability and acceptability of repellents and other alternative measures, and the side effects of vaccination. Assessments should be interpreted cautiously because risk can vary within areas and from year to year and available data are incomplete. Estimates suggest that risk of JE in highly endemic areas during the transmission season can reach 1 per 5000 per month of exposure; risk for most short-term travelers may be 1 per million or less. Although JE vaccine is reactogenic, rates of serious allergic reactions (generalized urticaria and or angioedema) are low (approximately 1-104 per 10,000). ¹

Advanced age may be a risk factor for developing symptomatic illness after infection. JE acquired during pregnancy carries the potential for intrauterine infection and fetal death. These factors should be considered when advising elderly persons and pregnant women who plan visits to JE endemic areas. There are no data on the safety and efficacy of JE vaccine in infants under one year of age. Whenever possible, immunization of infants should be deferred until they are one year of age or older. ¹

Research laboratory workers:

Laboratory acquired JE has been reported in 22 cases. JE virus may be transmitted in a laboratory setting through needle sticks and other accidental exposures. Vaccine-derived immunity presumably protects against exposure through these percutaneous routes. Exposure to aerosolized JE virus, and particularly to high concentrations of virus, such as may occur during viral purification, potentially could lead to infection through mucous membranes and possibly directly into the central nervous system through the olfactory mucosa. It is unknown whether vaccine-derived immunity protects against such exposures, but immunization is recommended for all laboratory workers with a potential for exposure to infectious JE virus. ¹

As with any vaccine, vaccination with JE-VAX may not result in protection in all individuals. Long-term protection, as demonstrated by persistence of neutralizing antibody for more than two years, has not yet been shown.

Parenteral drug products should be inspected visually for extraneous particulate matter and or discoloration prior to administration whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.

For persons 3 years of age and older, a single dose is 1.0 mL of vaccine. For children 1 year to 3 years of age, a single dose is 0.5 mL of vaccine. (See PRIMARY IMMUNIZATION SCHEDULE below.)

Single-Dose vial of lyophilized vaccine: Remove plastic tab of flip-off cap. DO NOT REMOVE R.B.E. STOPPER. Cleanse stopper with a suitable disinfectant. Reconstitute only with the supplied 1.3 mL of diluent (Sterile Water for Injection). Shake vial thoroughly. After reconstitution the vaccine should be stored between 2° - 8° C (35° - 46° F) and used within 8 hours. DO NOT FREEZE RECONSTITUTED VACCINE.

10-Dose vial of Iyophilized vaccine: Remove plastic tab of flip-off cap. DO NOT REMOVE R.B.E. STOPPER. Cleanse stopper with a suitable disinfectant. Reconstitute only with the supplied 11 mL of diluent (Sterile Water for Injection). Shake vial thoroughly. After reconstitution the vaccine should be stored between 2° - 8° C (35° - 46° F) and used within 8 hours. DO NOT FREEZE RECONSTITUTED VACCINE.

The vaccine is to be given by subcutaneous administration only.

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of infectious agents from person to person. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.

SHAKE VIAL WELL.

PRIMARY IMMUNIZATION SCHEDULE ¹

The recommended primary immunization series is three doses of 1.0 mL each for individuals > 3 years of age given subcutaneously on days 0, 7, and 30. For children 1 to 3 years of age a series of three doses of 0.5 mL each should be given subcutaneously on days 0, 7, and 30.An abbreviated schedule of days 0, 7, and 14 can be used when the longer schedule is impractical because of time constraints. (When it is impossible to follow one of the above recommended schedules, two doses given a week apart will induce antibodies in approximately 80% of vaccinees; however, this two-dose regimen should not be used except under unusual circumstances.) The last dose should be given at least 10 days before the commencement of international travel to ensure an adequate immune response and access to medical care in the event of delayed adverse reactions.

A booster dose of 1.0 mL (0.5 mL for children from 1 to 3 years of age) may be given after two years. In the absence of firm data on the persistence of antibody after primary immunization, a definite recommendation cannot be made on the spacing of boosters beyond two years.

There are no data on the safety and efficacy of JE vaccine in infants under one year of age. Whenever possible, immunization of infants should be deferred until they are one year of age or older. ¹

The skin at the site of injection first should be cleansed and disinfected. Shake vial thoroughly before each use. Cleanse top of rubber stopper of the vial with a suitable antiseptic and wipe away all excess before withdrawing vaccine.

When JE-VAX and any other vaccines are given concurrently, separate syringes and separate sites should be used.

Vial, Single Dose (3 per package) with vial of Diluent (3 per package) Product No. 49281-680-30

Vial, 10 Dose with vial of Diluent Product No. 49281-680-20

For persons 3 years of age and older, a single dose is 1.0 mL of vaccine. For children 1 year to 3 years of age, a single dose is 0.5 mL of vaccine. (See PRIMARY IMMUNIZATION SCHEDULE above.)

STORAGE

The vaccine should be stored between 2° - 8° C (35° - 46° F). DO NOT FREEZE. After reconstitution the vaccine should be stored between 2° - 8° C (35° - 46° F) and used within 8 hours. DO NOT FREEZE RECONSTITUTED VACCINE.

REFERENCES

1. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Inactivated Japanese Encephalitis Virus Vaccine. MMWR 42: 1- 15, 1993

2. Oya A. Japanese Encephalitis Vaccine. Acta Paediatr Jpn 30: 175- 184, 1988

3. Hoke CH, et al. Protection Against Japanese Encephalitis by Inactivated Vaccines. N Eng J Med 319: 608- 614,1988

4. Poland JD, et al. Evaluation of the Potency and Safety of Inactivated Japanese Encephalitis Vaccine in US Inhabitants. J Infect Dis 161: 878- 882, 1990

5. DeFraites RF. Immunogenicity and Safety of Japanese Encephalitis Vaccine (Inactivated: Nakayama/ BIKEN) in U. S. Army Soldiers: Evaluation of Three Consecutively Manufactured Lots of Vaccine Administered in Two Dosing Regimens. April 30, 1991, and November 12, 1992. Unpublished Data, on file with "BIKEN" and with Walter Reed Army Institute of Research, Washington, DC

6. Berg WS. Systemic Reactions in U. S. Marine Corps Personnel Who Received Japanese Encephalitis Vaccine. Clin Infect Dis 24: 001- 064, 1997

7. Robinson, P, et al. Australian Case-Control Study of Adverse Reactions to Japanese Encephalitis Vaccine. J Travel Med 2: 159- 164, 1995

8. Unpublished data on file with BIKEN and CDC

9. Rojanasuphot S. et al. A field trial of Japanese encephalitis vaccine produced in Thailand. Southeast Asian J Trop Med Publ Health 20: 653- 654, 1989

10. Rao Bhau LN, et al. Safety and efficacy of Japanese encephalitis vaccine produced in India. Indian J Med Res 88: 301- 307, 1988

11. Sanchez JL, et al. Further Experience with Japanese Encephalitis Vaccine. Lancet 335: 972- 973, 1990

12. Japanese Encephalitis Vaccine and Adverse Effects among Travelers. Canada Diseases Weekly Report. Vol. 17- 32: 173- 177, 1991

13. Anderson MM, et al. Side- Effects with Japanese Encephalitis Vaccine. Lancet 337: 1044, 1991

14. Ruff TA, et al. Adverse Reactions to Japanese Encephalitis Vaccine. Lancet 338: 881- 882, 1991

15. Unpublished data on file with Connaught Laboratories, Inc.

16. Kitaoka M. Follow- up on use of vaccine in children in Japan, in McDHammon W, Kitaoka M, Downs WG eds. Immunization for Japanese encephalitis. Excerpta Medica, Amsterdam 275- 277, 1972

17. Unpublished data on file with "BIKEN"

18. Ohtaki E, et al. Acute disseminated encephalomyelitis after Japanese B Encephalitis Vaccination. Pediatric Neurology Vol. 8 No. 2: 137- 139, 1992

19. C.C. Vaccine Adverse Event Reporting System United States. MMWR 39: 730- 733, 1990

20. C.C. National Childhood Vaccine Injury Act. Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197- 200, 1988

21. Food and Drug Administration. New Reporting Requirements for Vaccine Adverse Events. FDA Drug Bull 18( 2), 16-18, 1988

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