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IXIARO HCP

The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research suspended the license for IXCHIQ® on August 22, 2025. IXCHIQ® may not be distributed or administered in the United States until further notice.


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Stylized illustration of dice being rolled in the sky. Instead of dots, the dice are adorned with images of mosquitos. A rural Asian countryside is pictured in the background.

Don't let travelers leave their health to chance

Help protect them from Japanese encephalitis (JE) with IXIARO.1

What is JE?

JE is a potentially fatal mosquito-borne disease, for which no treatment is available.2–5

JE virus (JEV) is the leading cause of vaccine-preventable encephalitis in Asia and the western Pacific.2,3,6 Although symptomatic JE is rare, an estimated 68,000 clinical cases occur globally each year.7

Photo of a mosquito.

~30%

of people who develop JE die3,8

~13,600 to 20,400

people die annually from JE7,9

With JE, survival is not synonymous with recovery3,8,10,11

Only
19%
of people fully recover from JE10
Based on a small study (n=144) conducted in Vietnam. Participants were mostly children.10
Up to
50%
of people have enduring neurological, cognitive, and physical disabilities3,8

JE can be devastating.2,3,9

Hear JE-survivors and their families discuss their life-altering experience with the disease.

Video preview thumbnail of Chelsea, a survivor of Japanese Encephalitis.

Chelsea’s story

Chelsea details the long-lasting impact JE has had on her life after contracting the virus in Thailand.

Preview image from a video about the devastating consequences of Japanese Encephalitis, as told by John's parents.

John’s story

John’s parents discuss the life-changing effects of JE and the impact the disease has had on their son, John, now left with quadriplegia.

Preview image from a video about the devastating consequences of Japanese Encephalitis, as told by Sophie's father.

Sophie’s story

Sophie’s father shares the devastating consequences of JE, as his daughter remains paralyzed from the waist up after being infected with the virus.

The long-term effects of JE can be a major burden for those infected, their families, and society3

Inability to drive12

Decorative icon of a car steering wheel with a line cutting across it, indicating an inability to drive.

Inability to live independently11,12

Decorative icon of a house with a line cutting through it, indicating the inability to live independently.

Loss of income12

Decorative icon of a dollar symbol and an arrow pointing downwards, indicating a loss of income.

Medical costs13

Decorative icon of two documents and a dollar symbol, indicating medical costs.

Inability to study/work12

Decorative icon of book with a line cutting across it, indicating an inability to read.

Loss of
disability-adjusted life years11,13

Decorative icon of a clock and calendar, indicating loss of disability-adjusted life years.

Emotional effects12

Decorative icon of a head with illustrated brain matter, indicating emotional effects.
Photo of a woman in an undisclosed rural area in Asia. Two baskets of vegetables are attached to a long bamboo pole resting across her shoulder.
Photo of a woman in an undisclosed rural area in Asia. Two baskets of vegetables are attached to a long bamboo pole resting across her shoulder.

Travelers to any of these 25 JE-endemic countries may be at risk14

Map of Asia and Oceania depicting the 25 countries where populations and visitors are at risk for Japanese Encephalitis.
  • Australia
  • Bangladesh
  • Bhutan
  • Brunei Darussalam
  • Burma (Myanmar)
  • Cambodia
  • China
  • India
  • Indonesia
  • Japan
  • Lao People’s Democratic Republic
  • Malaysia
  • Nepal
  • North Korea
  • Malaysia
  • Nepal
  • North Korea
  • Pakistan
  • Papua New Guinea
  • Philippines
  • Russia
  • Singapore
  • South Korea
  • Sri Lanka
  • Taiwan
  • Thailand
  • Timor-Leste
  • Vietnam
  • Sri Lanka
  • Taiwan
  • Thailand
  • Timor-Leste
  • Vietnam

Risk areas as of June 2024.14

Risk areas and transmission season for Japanese encephalitis, by country14*†‡

Transmission seasons table

* Destination and transmission season information should be considered in association with travel duration and activities when making decisions on vaccination.

† Data are based on published and unpublished reports. Risk assessments should be performed cautiously, because risk can vary within areas and from year to year, and surveillance data regarding human cases and Japanese encephalitis virus transmission are often incomplete. In some endemic areas, human cases among residents are limited because of vaccination or natural immunity among older people. However, because Japanese encephalitis virus is maintained in an enzootic cycle between animals and mosquitoes, susceptible visitors to these areas still may be at risk for infection.

‡ Outbreaks previously occurred in the Western Pacific Islands of Guam (1947—1948) and Saipan (1990), but as they are no longer considered risk areas, they are not included in the table.

The risk of JE infection starts at day 1.15
JE does not only affect long-term travelers (e.g., 1 month or longer) or those spending time in rural locations,15–17 with studies showing that:

Over a third of cases occur in short-term travelers (<1 month)15

Decorative icon of a calendar.

The risk of virus transmission exists in urban areas16,18

Decorative icon of city buildings.

Identify travelers who should be vaccinated.

The travel health consultation should include an individual risk assessment of JE.15,19 The Centers for Disease Control and Prevention (CDC) recommends vaccination for:

  • People moving to an area where JE is endemic or epidemic17
  • Longer-term travelers (e.g., 1 month or longer) going to South Asia, Southeast Asia, and/or the Far East8,14,17
  • Shorter-term travelers if the risk is considered sufficient (e.g., spending time close to rice fields or pig farms)9,17
  • Travelers should undergo a careful risk assessment, taking into consideration:17
Photo of a mosquito.
Decorative icon of a calendar.

Duration

A set of four decorative icons (small leaves, the sun, a maple leaf, and a snowflake), indicating the seasons.

Season

Decorative icon of two rural houses.

Location

Decorative icon of a person hiking.

Activities

Decorative icon of a tent.

Accommodations

Prioritize vaccination for at-risk travelers

What is IXIARO?

IXIARO is a vaccine indicated for the prevention of disease caused by JEV, approved for use in individuals 2 months of age and older.1

The only licensed and recommended JE vaccine available in the US, which is supported by over 14 years of experience1,2,17

IXIARO can offer protection from infancy to adulthood.1

IXIARO can create protective antibodies against JE.1

Chart depicting immune response kinetics after primary immunization.
Chart depicting immune response kinetics after primary immunization.

Adult (28-day schedule)

The immunogenicity of IXIARO was evaluated in a randomized, active-controlled, observer-blind, multicenter, phase 3 clinical trial of healthy male and female subjects given IXIARO or the US licensed JE vaccine JE-VAX (given on day 0 and day 28). The co-primary endpoint was seroconversion and geometric mean titers at day 56.1,20

Adult (7-day rapid schedule)

The immunogenicity of IXIARO administered to adults (18-65 years old) in the 7-day vaccination schedule compared to the 28-day schedule was evaluated in a randomized, observer-blind, phase 3 clinical trial. The primary objective related to JE vaccination was to establish noninferiority of the immune response to the 7-day schedule compared to the 28-day schedule measured 28 days after completion of the schedule (day 35 for the 7-day schedule and day 56 for the 28-day schedule).1,21

Pediatric

The safety and immunogenicity of IXIARO (given on day 0 and day 28) was evaluated in children and adolescents (2 months to <18 years old) in a randomized, controlled, open-label, phase 3 clinical trial conducted in the Philippines, where JE is endemic. The safety profile of IXIARO was compared to hepatitis A and diphtheria vaccines (primary endpoint: rate of adverse events up to day 56). One of the objectives of the study was to assess the immunogenicity of IXIARO in terms of geometric mean titers and seroconversion rate at day 56. Other objectives included dose establishment, age-related differences in the immunogenicity profile of IXIARO, and the effects of 
pre-existing antibody status.1,22

IXIARO has an established safety profile.1

The safety profile of IXIARO was evaluated in several clinical studies.1,23

Decorative illustration of an exclamation mark, indicating an import statement or topic of concern.

Common adverse reactions included:1

  • Infants 2 months to <1 year of age: redness at injection site (>15%), fever (>20%), irritability (>15%), and diarrhea (>10%)
  • Children 1 year to <3 years of age: fever (>20%)
  • Children 3 to <12 years of age: fever (>10%)
  • Adolescents 12 to <18 years of age: pain at injection site (15%) and tenderness at injection site (10%)
  • Adults 18 years of age and older: pain at injection site (>25%), tenderness at injection site (>25%), headache (>20%), and myalgia (>10%)
Photo of a woman walking with her luggage through an airport terminal. An airplane and mountains are visible in the background.
Photo of a woman walking with her luggage through an airport terminal. An airplane and mountains are visible in the background.

Help protect at-risk travelers. Recommend IXIARO to help prevent JE1

IXIARO is a 2-dose vaccine with a flexible administration schedule1

IXIARO is a 2-dose vaccine with a flexible administration schedule1

28-day schedule
Help protect all travelers aged 2 months and older with the 28-day schedule.1

28-day schedule

Help protect all travelers aged 2 months and older with the 28-day schedule.1

Illustration depicting a 7 day IXIARO vaccine administration schedule, with 28 days between doses. The second dose is administered a minimum of 7 days prior to travel.

28-day schedule

Help protect all travelers aged 2 months and older with the 28-day schedule.1

28-day schedule

Help protect all travelers aged 2 months and older with the 28-day schedule.1

Please note that children from 2 months to <3 years of age receive two 0.25 mL doses spaced 28 days apart. Children and adults ≥3 years of age receive two 0.5 mL doses spaced 28 days apart on this schedule.1

7-day rapid schedule

Help protect last-minute travelers* with the 7-day rapid schedule.1

*Only travelers aged 18-65 years are eligible for the 7-day dosing schedule.1

Illustration depicting a 7 day IXIARO vaccine administration schedule, with 7 days between doses. The second dose is administered a minimum of 7 days prior to travel.

*Only travelers aged 18-65 years are eligible for the 7-day dosing schedule.1

Please note that children from 2 months to <3 years of age receive two 0.25 mL doses spaced 28 days apart. Children and adults ≥3 years of age receive two 0.5 mL doses spaced 28 days apart on this schedule.1

7-day rapid schedule

Help protect last-minute travelers* with the 7-day rapid schedule.1

*Only travelers aged 18-65 years are eligible for the 7-day dosing schedule.1

For both the 28-day and 7-day schedules, primary immunization should be completed at least 1 week prior to potential exposure to JEV.1

For both the 28-day and 7-day schedules, primary immunization should be completed at least 1 week prior to potential exposure to JEV.1

Recommend a booster dose to eligible travelers.17

A booster dose of IXIARO should be given at least 11 months after completion of the primary immunization series if ongoing exposure or re-exposure to JEV is expected.1,17

  • Children 14 months to <3 years of age should receive a single
0.25 mL booster dose.1
  • All individuals ≥3 years of age should receive a single 0.5 mL booster dose.1
Illustration depicting the recommended IXIARO vaccine booster dose to eligible travelers.
Illustration depicting the recommended IXIARO vaccine booster dose to eligible travelers.

2 doses elicited a greater immune response compared to only 1 dose1

Learn More

Find out how to order IXIARO

INDICATION

IXIARO® is a vaccine indicated for the prevention of disease caused by Japanese encephalitis (JE) virus, approved for use in individuals 2 months of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO. Because of uncertainty as to which component of the vaccine may be responsible, individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

WARNINGS AND PRECAUTIONS

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.

Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Vaccination with IXIARO may not protect all individuals.

Immunocompromised individuals may have a diminished immune response to IXIARO.

Adverse Reactions

In infants 2 months to <1 year of age, the most common injection site reaction was redness (>15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%) and diarrhea (>10%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). In adults 18 years of age and older, the most common injection site reactions were pain (>25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%).

Use in Special Populations

Pregnancy

There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact Valneva at 1-844-349-4276 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 1-844-349-4276.

Please click here for full Prescribing Information.

INDICATION

IXIARO® is a vaccine indicated for the prevention of disease caused by Japanese encephalitis (JE) virus, approved for use in individuals 2 months of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO. Because of uncertainty as to which component of the vaccine may be responsible, individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

WARNINGS AND PRECAUTIONS

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.

Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Vaccination with IXIARO may not protect all individuals.

Immunocompromised individuals may have a diminished immune response to IXIARO.

Adverse Reactions

In infants 2 months to <1 year of age, the most common injection site reaction was redness (>15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%) and diarrhea (>10%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). In adults 18 years of age and older, the most common injection site reactions were pain (>25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%).

Use in Special Populations

Pregnancy

There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact Valneva at 1-844-349-4276 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 1-844-349-4276.

Please click here for full Prescribing Information.

INDICATION

IXIARO® is a vaccine indicated for the prevention of disease caused by Japanese encephalitis (JE) virus, approved for use in individuals 2 months of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO. Because of uncertainty as to which component of the vaccine may be responsible, individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

WARNINGS AND PRECAUTIONS

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.

Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Vaccination with IXIARO may not protect all individuals.

Immunocompromised individuals may have a diminished immune response to IXIARO.

Adverse Reactions

In infants 2 months to <1 year of age, the most common injection site reaction was redness (>15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%) and diarrhea (>10%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). In adults 18 years of age and older, the most common injection site reactions were pain (>25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%).

Use in Special Populations

Pregnancy

There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact Valneva at 1-844-349-4276 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 1-844-349-4276.

Please click here for full Prescribing Information.

INDICATION

IXIARO® is a vaccine indicated for the prevention of disease caused by Japanese encephalitis (JE) virus, approved for use in individuals 2 months of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO. Because of uncertainty as to which component of the vaccine may be responsible, individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

WARNINGS AND PRECAUTIONS

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.

Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Vaccination with IXIARO may not protect all individuals.

Immunocompromised individuals may have a diminished immune response to IXIARO.

Adverse Reactions

In infants 2 months to <1 year of age, the most common injection site reaction was redness (>15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%) and diarrhea (>10%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). In adults 18 years of age and older, the most common injection site reactions were pain (>25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%).

Use in Special Populations

Pregnancy

There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact Valneva at 1-844-349-4276 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 1-844-349-4276.

Please click here for full Prescribing Information.

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