Adverse reactions to JE vaccine manifesting as generalized urticaria or angioedema may occur within minutes following vaccination. A possibly related reaction has occurred as late as 17 days after vaccination. Most reactions occur within 10 days with the majority occurring within 48 hours. 1 (See ADVERSE REACTIONS section)

Vaccinees should be observed for 30 minutes after vaccination and warned about the possibility of delayed generalized urticaria, often in a generalized distribution or angioedema of the extremities, face and oropharynx, especially of the lips. ¹

Vaccinees should be advised to remain in areas where they have ready access to medical care for 10 days after receiving a dose of JE vaccine. Vaccinees should be instructed to seek medical attention immediately upon onset of any reaction. ¹

Persons should not embark on international travel within 10 days of JE-VAX immunization because of the possibility of delayed allergic reactions. ¹

Persons with a past history of urticaria after hymenoptera envenomation, drugs, physical or other provocations, or of idiopathic cause appear to have a greater risk of developing reactions to JE vaccine (relative risk 9.1, 95% confidence interval 1.8 to 50.9). ⁶ This history should be considered when weighing risks and benefits of the vaccine for an individual patient. When patients with such a history are offered JE vaccine, they should be alerted to their increased risk for reaction and monitored appropriately. There are no data supporting the efficacy of prophylactic antihistamines or steroids in preventing JE vaccine-related allergic reactions. ¹

Another case control study consisting of 5 cases and 15 controls identified an increased risk of hypersensitivity reactions to JE vaccine in individuals who had unusual alcohol consumption during the two days following vaccination (p= 0.005). ⁷ Recipients should be advised to avoid more than the usual alcohol intake during the 48 hours following JE vaccination.

In the same study an increased risk for hypersensitivity reactions was seen in individuals who received other vaccines within the 7- day period prior to receipt of JE vaccine. Where possible JE vaccine should be administered concurrently with other vaccines. ⁷

Epinephrine and other medications and equipment to treat anaphylaxis should be available at vaccine administration centers.

General

Epinephrine Injection (1:1000) must be immediately available should an acute anaphylactic reaction occur due to any component of the vaccine.

Prior to injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible sensitivity to this vaccine, a similar vaccine or allergic disorders in general (see CONTRAINDICATIONS section).

A separate, sterile syringe and needle or a 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.

Although substantial neutralizing antibody titers are elicited by JE-VAX in more than 90% of US travelers without history of prior JE immunization or of prior exposure to JE, the precise relationship between antibody level and efficacy has not been established even though these titers persisted for at least two years after immunization. ⁸

The decision to administer JE vaccine should balance the risks for exposure to the virus and for developing illness, the availability and acceptability of repellents and other alternative protective measures, and the side effects of vaccination.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been performed to evaluate carcinogenicity, mutagenic potential, or impact on fertility.

Pregnancy

REPRODUCTIVE STUDIES - PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Japanese Encephalitis Virus Vaccine. It is not known whether Japanese Encephalitis Virus Vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Pregnant women who must travel to an area where risk of JE is high should be immunized when the theoretical risks of immunization are outweighed by the risk of infection to the mother and developing fetus. Japanese Encephalitis Virus Vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether JE-VAX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when JE-VAX is administered to a nursing woman.

Pediatric Use

SAFETY AND EFFECTIVENESS OF JE- VAX IN INFANTS UNDER ONE YEAR OF AGE HAVE NOT BEEN ESTABLISHED. (See DOSAGE AND ADMINISTRATION section.)

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