OREGON HEALTH AUTHORITY IMMUNIZATION PROTOCOL FOR PHARMACISTS INACTIVATED JAPANESE ENCEPHALITIS VIRUS VACCINE

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1 OREGON HEALTH AUTHORITY IMMUNIZATION PROTOCOL FOR PHARMACISTS INACTIVATED JAPANESE ENCEPHALITIS VIRUS VACCINE Update as of Addition of IXIARO, Inactivated, Adsorbed vaccine; grown in tissue culture cells. For individuals 17 years old. Two dose series, 28 days apart. NOTE: JE VAX is now reserved for individuals 1 16 years of age. I. Order: 1. Screen clients 11 years for contraindications. 2. Provide an Adolescent Well Visit Flyer to those years of age. 3. Provide a current Vaccine Information Sheet (VIS) answering any questions. 4. See section IV. Pg. 4 for administration of IXIARO a. Shake syringe thoroughly prior to administration; solution will be cloudy. b. Give IXIARO intramuscularly (IM) as a 2 dose series of 0.5mL to clients 17 years of age on days 0 and See section IV. Pg 3. For administration of JE VAX a. Do not remove vaccine from refrigerator until ready to reconstitute it with the diluents supplied. b. Reconstitute only with the 1.3 ml of diluents supplied. Shake vial thoroughly; solution will be clear. c. After reconstitution the vaccine should be stored at 2 8 C (35 46 F) and used within 8 hours. d. Give JE VAX subcutaneously (SC) as a 3 dose series of 1.0mL to individuals years of age on days 0, 7 and 30. Pharmacist Signature Date Revised: Reviewed: Original:

2 Japanese Encephalitis Page 2 of 10 II. LICENSED VACCINE HERE: Product name Vaccine component(s) Acceptable age range IXIARO 1 6mcg purified, inactivated JEV proteins and 250 mcg of aluminum hydroxide. 17 years Thimerosal No JE VAX <50ng mouse serum protein, 500µg gelatin <100 µg formaldehyde years 0.007% III. A. RECOMMENDATIONS FOR USE: A. Persons for whom Japanese Encephalitis vaccination is recommended JE Vaccine is recommended for travelers who plan to spend a month or longer in endemic areas 1 during the Japanese encephalitis virus (JEV) transmission season. This includes longer term travelers, recurrent travelers, or expatriates who will be based in urban areas but are likely to visit endemic rural or agricultural areas during a high risk period of JEV transmission. Short term travelers (<1 month) to endemic areas during the JEV transmission season if they plan to travel outside of an urban area and have an increased risk of JEV exposure: Spending substantial time outdoors in rural or agricultural areas, especially during the evening or night. Participating in extensive outdoor activities (e.g., camping, hiking, trekking, biking, fishing, hunting, or farming). Staying in accommodations without air conditioning, screens, or bed nets. Travelers to an area with an ongoing JE outbreak. Travelers to endemic areas who are uncertain of specific destinations, activities, or duration of travel.

3 Japanese Encephalitis Page 3 of 10 III. B. RECOMMENDATIONS FOR USE B. Laboratory Workers JE vaccine is recommended for laboratory personnel who work with live, wildtype JEV strains. Vaccinated, at risk laboratory personnel should receive appropriate booster doses of JE vaccine or be evaluated regularly for JEV specific neutralizing antibodies to assure adequate titers. C. Persons for whom Japanese Encephalitis vaccination is NOT recommended JE vaccine is not recommended for short term travelers whose visit will be restricted to urban areas or times outside of a well defined JEV transmission season. 1 1 Information on expected JEV transmission by country can be obtained from CDC at: 2/japaneseencephalitis.aspx These data should be interpreted cautiously since JEV transmission activity varies within countries from year to year. MMWR available at

4 Japanese Encephalitis Page 4 of 10 IV. VACCINE SCHEDULE: A. IXIARO AGE DOSE VOLUME DOSAGE SCHEUDLE BOOSTER 17 years mL (IM) deltoid Two dose series on days 0 and 28 Unknown 1,2 1 The full duration of protection following immunization is not known. There are no data regarding timing or efficacy of booster immunization. 2 There are no data on the use of IXIARO as a booster for JE VAX. If a previously vaccinated person age 17 years or older needs a booster dose, you should administer a full series (2 doses separated by at least 28 days of IXIARO. 3 IXIARO has not been tested in individuals <17 years of age or >65 years of age. B. JE VAX AGE DOSE VOLUME DOSAGE BOOSTER SCHEDULE years mL (SQ) Three dose series on days 0, 7, and 30 1 After 2 years 2,3 1 An abbreviated schedule of days 0, 7and 14 can be used when the longer schedule is impractical or inconvenient because of time constraints. (Two doses administered a week apart will confer short term immunity among 80% of vaccines. However this schedule should be administered at least 10 days before the commencement of travel to ensure an adequate immune response and access to medical care in the event of delayed adverse reactions. 2 A booster dose of 1.0mL may be given after 2 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 2 years. 3 There are no data on the use of IXIARO as a booster for JE VAX. If a previously vaccinated person age 17 years or older needs a booster dose, you should administer a full series (2 doses separated by at least 28 days of IXIARO.

5 Japanese Encephalitis Page 5 of 10 V. IXIARO CONTRAINDICATIONS VI. IXIARO PRECAUTIONS A. Severe allergic reaction (e.g., anaphylaxis) after a previous dose. A. Hypersensitivity to protamine sulfate. B. Immunocompetence: There is no safety or efficacy data regarding the use of IXIARO in immunocompromised individuals. Immunocompromised individuals may have a diminished immune response to IXIARO. C. There are no data regarding the use of IXIARO concomitantly with immunosuppressive therapies, e.g., irradiation, antimetabolites, alkylating agents, cytotoxic drugs, or corticosteroids used in greater than physiologic doses. D. Drug Interactions: There is no evidence for interference with the immune response when used concomitantly with Havrix. Data are not available on concomitant administration of IXIARO with other USlicensed vaccines. E. Pregnancy and Lactation: Use only if clearly needed. F. Pediatric / Geriatric: Not tested in individuals 17 or 65 years of age. G. For someone with a history of fainting with injections, a 15 minute observation period is recommended after vaccination.

6 Japanese Encephalitis Page 6 of 10 V. JE VAX CONTRAINDICATIONS VI. JE VAX PRECAUTIONS A. Adverse reactions to a prior dose of JE VAX vaccine manifesting as generalized urticaria and angioedema. 1,2 B. Proven or suspected hypersensitivity to proteins of rodent or neural origin. 2 C. Hypersensitivity to thimerosal. A. Vaccinees should be observed for 30 minutes after vaccination and warned about the possibility of delayed generalized urticaria, often in generalized distribution or angioedema of the extremities, face, and oropharynx, especially of the lips. B. Because of the possibility of delayed allergic reactions, vaccines 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 and to seek medical attention immediately upon onset of any reaction. C. Individuals with urticaria reactions after insect bites or stings 3,4 should be alerted to their increased risk for reaction and monitored appropriately. D. Recipients should be advised to avoid more than the usual alcohol intake during the 48 hours following JE VAX vaccine. E. Altered immune states: The only data on the use of inactivated JE VAX vaccine in patients with altered immune states come from a small study among children. These data did not suggest a changed pattern of adverse reactions or immune response after vaccination.

7 Japanese Encephalitis Page 7 of 10 F. Simultaneous administration of other vaccines or drugs: No data exist on the effect of concurrent administration of other vaccines, drugs (e.g., chloroquine, mefloquine), or biological on the safety and immunogenicity of JE VAX vaccine. However, the package insert on product information indicates that where possible, JE vaccine should be administered concurrently with other vaccines. G. For someone with a history of fainting with injections, a 15 minute observation period is recommended after vaccination. 1 These reactions may occur within minutes following vaccination. Most reactions occur within 48 hours but may occur as long as 2 weeks after vaccination. 2 JE VAX vaccine is produced in mouse brains. 3 A person with hymenoptera envenomation has been stung by a bee, wasp, hornet, or fire ant. 4 There are no data supporting the efficacy of prophylactic antihistamines or steroids in preventing JE VAX vaccine related allergic reactions. VII. JE VAX SIDE EFFECTS AND ADVERSE REACTIONS 1. JE VAX vaccine is associated with a moderate frequency of local and mild systemic adverse effects. 2. Tenderness, redness, swelling and other local effects occur in about 20% (<1% to 31%) of vaccines. 3. Systemic side effects principally fever, headache, malaise, rash, and other reactions, such as chills dizziness, myalgia, nausea, vomiting and abdominal pain occur in about 10% of vaccines. 4. Less than 5% of US travelers immunized with a three dose regimen of the vaccine reported headache, flu like symptoms, fever, and other systemic complaints. Hives and facial swelling were reported in 0.2% and 0.1% of vaccines, respectively. Local soreness occurred in 5.9% and local redness in 2.9%/ 5. Generalized urticaria or angioedema may occur shortly after vaccination or up to 17 days (usually within 10 days) of vaccination.

8 Japanese Encephalitis Page 8 of 10 VII. IXIARO SIDE EFFECTS AND ADVERSE REACTIONS 1. Overall 60% of recipients reported at least one adverse event. 1 a. Mild: 34% b. Moderate: 20% c. Severe: 5% 2. Tenderness, redness, swelling and other local effects occur in 10% Systemic side effects including headache, myalgia, fatigue, influenza like illness, nausea and rash occur 10% of vaccines. 1 Mild: Awareness of signs or symptoms, but easily tolerated. Moderate: discomfort enough to interfere with usual activity. Severe: Incapable of work or usual activity. (IXIARO Package insert: 2009) VIII. OTHER CONSIDERATIONS Although 1% of JEV infections results in clinical disease, JE is a devastating illness that has a case fatality ratio of approximately 30% and causes neurologic sequelae in approximately 50% of survivors. No specific treatment exists In all instances, travelers are advised to take personal precautions to reduce exposure to mosquito bites The decision to use IXIARO 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. 4. Risk of JE for travelers to highly endemic areas during the transmission season can reach 1 per 5,000 per month of exposure; the risk for most short term travelers may be 1 per million or less 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

9 Japanese Encephalitis Page 9 of 10 death. These special factors should be considered when advising elderly persons and pregnant women who plan visits to areas where JE is endemic. 1 Japanese Encephalitis Among Three U.S. Travelers Returning from Asia, MMWR 2009; 58(27); Advisory Committee on Immunization Practices (ACIP) MMWR, 2010: 59 (RR 1) IX. STORAGE AND HANDLING JE VAX IXIARO 1. Store in refrigerator at 2 to 8 C (35 F 46 F) 2. Do not freeze before or after reconstitution. 3. Shake well before use: Clear solution. 4. After reconstitution the vaccine can be refrigerated and used within 8 hours. 5. Unused vaccine should be discarded 8 hours after reconstitution. 1. Store in refrigerator at 2 to 8 C (35 F 46 F) 2. Do not freeze. 3. Shake well before use: Cloudy solution. 4. Store in original package to protect from light. 5. Do not use after the expiration date shown on the label. X. ADVERSE EVENTS REPORTING Adverse events following immunization must be reported to the Vaccine Adverse Events Reporting System (VAERS) at Forms and procedures can be found at the VAERS website: In addition, a copy of the reporting form should be reported to the patient s primary provider, per Oregon Revised Statute (ORS) (4).

10 Japanese Encephalitis Page 10 of 10 REFERENCES 1. CDC. Japanese Encephalitis Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR 2010; 59(RR 1); 1 32 available at 2. Japanese encephalitis among three U.S. travelers returning from Asia, MMWR 2009; 58(27); Available at: 3. CDC. Japanese encephalitis. In: Health Information for International Travel Atlanta: U.S. Department of Health and Human Services, Public Health Service, Available at: 2/japaneseencephalitis.aspx 4. IXIARO package insert, , Available at: edproducts/ucm pdf 5. JE VAX package insert, , Available at: edproducts/ucm pdf 6. CDC. Inactivated Japanese encephalitis virus vaccine, Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR 1993; 42 (RR 1) Available at: To request this material in an alternative format (e.g., Braille) or to clarify any part of the above order, contact the Oregon Health Authority Immunization Program at For other questions, consult with the vaccine recipient s primary health care provider or a consulting physician. Electronic copy of this protocol available at: #24I:\IMM\Standing Orders\2011 Pharmacy Protocol\Pharm_JEV_01_2011.docx