INDICATION & USAGE

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

Important Safety Information

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese encephalitis vaccine, or any component of IXIARO, including protamine sulfate ─ a compound known to cause hypersensitivity reactions in some individuals ─ is a contraindication to administration of IXIARO. 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 might be considered.

Vaccination with IXIARO may not protect all individuals. Immunocompromised individuals may have a diminished immune response to IXIARO. Syncope can occur in association with administration of injectable vaccines, including IXIARO. Procedures should be in place to prevent injury from falling and manage syncopal reactions.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, myalgia, and injection site pain and tenderness in adults.

Healthcare practitioners are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 844-349-4276 (8443-IXIARO).

Please see full Prescribing Information.

Register Here

INDICATION & USAGE

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

Important Safety Information

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese encephalitis vaccine, or any component of IXIARO, including protamine sulfate ─ a compound known to cause hypersensitivity reactions in some individuals ─ is a contraindication to administration of IXIARO. 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 might be considered.

Vaccination with IXIARO may not protect all individuals. Immunocompromised individuals may have a diminished immune response to IXIARO. Syncope can occur in association with administration of injectable vaccines, including IXIARO. Procedures should be in place to prevent injury from falling and manage syncopal reactions.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, myalgia, and injection site pain and tenderness in adults.

Healthcare practitioners are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 844-349-4276 (8443-IXIARO).

Please see full Prescribing Information.

Learn about the devastating consequences of JE through first-person accounts, as real patients and families affected by JE share their stories.

What is JE? Where Does JE Occur? When Does JE Occur?

What is JE?
Where Does JE Occur?
When Does JE Occur?

Japanese Encephalitis (JE)

Unpredictable. Dangerous.
Preventable.

A traveler to any of 24 countries in Asia can be infected with Japanese encephalitis virus,¹which is related to mosquito-borne Zika, dengue, yellow fever, and West Nile viruses.²In rare cases, JE viral infection can result in life-threatening encephalitis.¹

What is JE?

Japanese encephalitis, a mosquito-borne viral disease, is a form of encephalitis caused by JE virus that can lead to brain damage or death.² JE virus is a mosquito-borne flavivirus related to Zika, dengue, yellow fever, and West Nile viruses.¹ JE virus is the leading cause of vaccine-preventable encephalitis in Asia and the western Pacific.¹

The JE virus life cycles involves mosquitoes and vertebrate hosts, including wading birds and pigs. When bitten by an infected mosquito, humans can be infected. Humans are dead-end hosts of the virus, but not a viral reservoir. Therefore, vaccination protects the individual, but there is no herd immunity. Person-to-person transmission does not occur.* ⁴

*Cases of JE transmission through the blood supply during transfusion of blood and platelets have been reported.⁵

Where does JE occur?

JE is not just in Japan

While JE is endemic to Japan, it may be more appropriate to think of JE as an Asian encephalitis. The JE virus is endemic to 24 countries across Asia, Southeast Asia, and parts of the western Pacific.¹

* Australian Government Department of Health. March 2022.
https://www.health.gov.au/health-alerts/japanese-encephalitis-virus-jev/about#current-status.
Accessed September 21, 2022.

JE is not just in rural areas

In the past, Japanese encephalitis was thought of as occurring only in rural areas. However, the risk for Japanese encephalitis virus transmission may be shifting, as the boundaries between rural and urban areas are blurred.⁶

• The most recent cases of JE in US travelers to Asia were in urban and peri-urban regions.⁶

When does JE occur?

Many cases of JE occur during rainy season, and these months vary by country.⁴ Travelers to Asia may also be bitten outside of rainy season and transmission of the JE virus can occur year-round.¹⁰ Environmental factors such as global warming can play a key role in mosquito-borne transmission, increasing favorable breeding conditions.¹¹

JE Seasonality by Country

Progression of JE^4,7,8,9

Select Stage to Learn More

INCUBATION PERIOD

5-15 days after being bitten
by an infected mosquito

NON-SPECIFIC SYMPTOMS

• Fever

• Diarrhea

• Headache

• Myalgia

• Nausea and Vomiting

CNS MANIFESTATIONS

• Acute encephalopathy

• Change in mental status

• Mild confusion to agitation to coma

• Parkinsonian syndrome

• Upper and lower motor neuron paralysis

• Seizures

Gradual recovery or
persistence of CNS signs

LONG-TERM IMPAIRMENT

• Severe Cognitive and memory impairments

• Psychiatric and behavioral disturbances

• Neuromuscular dysfunction

• Impairment of activities of daily living (ADLs)

• Seizures

Progression of JE^4,7,8,9

Select Stage to Learn More

INCUBATION PERIOD

5-15 days after being bitten by an infected mosquito

NON-SPECIFIC SYMPTOMS

• Fever

• Diarrhea

• Headache

• Myalgia

• Nausea and Vomiting

CNS MANIFESTATIONS

• Acute encephalopathy

• Change in mental status

• Mild confusion to agitation to coma

• Parkinsonian syndrome

• Upper and lower motor neuron paralysis

• Seizures

Gradual recovery or
persistence of CNS signs

LONG-TERM IMPAIRMENT

• Severe Cognitive and memory impairments

• Psychiatric and behavioral disturbances

• Neuromuscular dysfunction

• Impairment of activities of daily living (ADLs)

• Seizures

The Natural History of JE

Most people infected with JE virus will experience mild symptoms, such as fever and headache, or no symptoms at all.

Approximately 1 in 250 infections results in severe clinical illness.¹ In these cases, the consequences can be devastating.¹

Potential consequences of encephalitis

%

Mortality Rate

%

Long-Term Sequelae

Specific Treatment

%

Mortality Rate

Up to 30% of those who develop symptomatic JE will die.^1,4

%

Long-Term Sequelae

Up to 50% of survivors continue to have neurologic, cognitive, and psychiatric impairments.^1,4

Specific Treatment

There is no specific treatment for JE, but it can be prevented.^1,3,4

Up to 30% of those who develop symptomatic JE will die.^1,4

Up to 50% of survivors continue to have neurologic, cognitive, and psychiatric impairments.^1,4

There is no specific treatment for JE, but it can be prevented.^1,3,4

Complications of JE can include^1,3,4 :

Cognitive and behavioral disturbances
Memory impairment
Cranial nerve defects

Sensory disturbances, including pain
Seizures
Neuromuscular dysfunction

Neurochemical and hormonal disturbances
Impairment of activities of daily living (ADLs)

JE can cause a heavy burden for survivors who must live with disability, as well as for their families, friends, and colleagues.

JE Epidemiology

Though the number of JE cases in US travelers to Asia reported to the Centers for Disease Control & Prevention is few, JE does occur and consequences of the disease are potentially devastating.

Approximately 68,000 symptomatic cases of JE are estimated to occur each year in Asia. In fact, JE is the most common vaccine-preventable encephalitis in Asia and the leading cause of viral-induced neurologic disability.¹
Data show that more than one-third of travelers who developed JE were short-term travelers to Asia.¹²

Mosquitoes may bite as soon as travelers arrive

JE cases by duration of travel for 37 reported travelers from 1973-2008¹²

Long-Term
Travelers

Expatriates
Students studying in Asia
Soldiers

Short-Term
Travelers

Tourists

JE vaccination campaigns in Asia

In many countries where JE is a public health priority, JE vaccination is part of a national immunization schedule.¹³ Unfortunately, because the virus lifecycle is human independent, immunization of the local population does not reduce the risk of JE to travelers.⁴

Mosquitoes may bite as soon as travelers arrive

JE cases by duration of travel for 37 reported travelers from 1973-2008¹²

Long-Term
Travelers

Expatriates
Students studying in Asia
Soldiers

Short-Term
Travelers

Tourists

JE vaccination campaigns in Asia

In many countries where JE is a public health priority, JE vaccination is part of national immunization schedule.¹³ Unfortunately, because the virus lifecycle is human-independent, immunization of the local population does not reduce the risk of JE to travelers.⁴

Indication & Usage

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

Important Safety Information

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese encephalitis vaccine, or any component of IXIARO, including protamine sulfate ─ a compound known to cause hypersensitivity reactions in some individuals ─ is a contraindication to administration of IXIARO. 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 might be considered.

Vaccination with IXIARO may not protect all individuals. Immunocompromised individuals may have a diminished immune response to IXIARO. Syncope can occur in association with administration of injectable vaccines, including IXIARO. Procedures should be in place to prevent injury from falling and manage syncopal reactions.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, myalgia, and injection site pain and tenderness in adults.

Healthcare practitioners are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967. Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 844-349-4276 (8443-IXIARO), or +1-301-556-4500.

Please see full Prescribing Information.

Important Safety Information | Prescribing Information | Treatment & Prevention | References

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Suite 460
Bethesda, MD 20814
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Country	Affected areas	Transmission season	Comments
Australia	Outer Torres Strait Islands, northern Cape York	December–May; all human cases reported February–April	Rare cases reported from Outer Torres Strait Islands and 1 case previously reported from northern Queensland mainland Vaccine only recommended for Outer Torres Strait Islands
Bangladesh	Widespread	Year-round with most cases reported May–November	Cases reported from multiple areas, including Chittagong, Dhaka, Khulna, Rajshahi, Ranjpur, and Sylhet Divisions, so transmission likely countrywide
Bhutan	Presumed transmission in nonmountainous areas	Unknown	Rare cases reported but limited data Proximity to endemic areas of India and presence of vectors suggests transmission likely
Brunei Darussalam	Presumed widespread	Unknown	Limited data but outbreak reported in 2013 Proximity to Sarawak, Malaysia suggests ongoing transmission likely
Burma (Myanmar)	Presumed widespread	Year-round with most cases reported July–September
Cambodia	Widespread	Year-round with peak season May–October	Cases reported from majority of provinces, so transmission likely countrywide
China	All provinces except Xinjiang and Qinghai	Peak season June–October
India	Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Goa, Haryana, Jharkhand, Karnataka, Kerala, Maharashtra, Manipur, Meghalaya, Nagaland, Odisha, Punjab, Tamil Nadu, Telangana, Tripura, Uttar Pradesh, Uttarakhand, West Bengal	Peak season May–November, especially in northern India; the season may be extended or yearround in some areas, especially in southern India
Indonesia	Widespread	Year-round, with peak season varying by island	Cases reported from many islands, including Sumatra, Java, Kalimantan, Bali, Nusa Tenggara, and Papua, so transmission likely on all islands Several traveler cases reported in recent years from Bali
Japan	All islands	June–October	Rare sporadic cases reported from all islands except Hokkaido Enzootic transmission without reported human cases on Hokkaido
Lao People’s Democratic Republic	Widespread	Year-round with peak season June–September
Malaysia	Widespread	Year-round, with peak season in Sarawak from October–December	Much higher rates of disease reported from Sarawak than peninsular Malaysia
Nepal	Southern lowlands (Terai), some hill and mountain districts	Peak season June–October	Highest rates of disease reported from southern lowlands (Terai) Vaccine not routinely recommended for those trekking in high-altitude areas
North Korea	Presumed widespread	Unknown Proximity to South Korea suggests peak transmission May–November
Pakistan	Unknown	Unknown	Very limited data Rare cases reported from Sindh Province
Papua New Guinea	Widespread	Presumed year-round	Sporadic cases reported from Western Province, serologic evidence of disease from Gulf and Southern Highland Provinces, and 1 case reported from near Port Moresby, so transmission likely countrywide
Philippines	Widespread	Year-round with peak season April–August	Human, animal, and mosquito studies have indicated transmission in 32 provinces, so transmission likely on all islands
Russia	Primorsky Krai	June–September	Cases previously reported from Primorsky Krai Vaccine not routinely recommended
Singapore	Presumed in focal areas	Year-round	Very rare sporadic cases reported Vaccine not routinely recommended
South Korea	Widespread	May–November
Sri Lanka	Widespread except in mountainous areas	Year-round with peak season November–February
Taiwan	Widespread	Peak season May–October
Thailand	Widespread	Year-round with peak season May–October, especially in northern Thailand	Highest rates of disease reported from Chiang Mai Valley Several traveler cases reported in recent years from resort and coastal areas of southern Thailand
Timor-Leste	Presumed widespread	No data Proximity to West Timor suggests year-round
Viet Nam	Widespread	Year-round with peak season May–October, especially in northern Viet Nam

Country	Affected areas	Transmission season
Australia	Outer Torres Strait islands	December–May; all human cases reported February–April
Bangladesh	Presumed widespread	Most human cases reported May–October
Bhutan	Very rare reports; probably endemic in nonmountainous areas	No data
Brunei	Very rare reports; presumed to be endemic countrywide	Unknown; presumed year round
Burma (Myanmar)	Limited data; presumed to be endemic countrywide	Unknown; most human cases reported May–October
Cambodia	Presumed to be endemic countrywide	Year round; peak season May–October
China	Human cases reported from all provinces except Xizang (Tibet), Xinjiang and Qinghai.	Most human cases reported June–October
East Timor	Sporadic human cases reported; presumed to be endemic countrywide	No data; cases reported year round in neighboring West Timor
India	Human cases reported from all states except Dadra, Daman, Diu, Gujarat, Himachal Pradesh, Jammu and Kashmir, Lakshadweep, Meghalaya, Nagar Haveli, Punjab, Rajasthan and Sikkim	Most human cases reported May–October, especially in northern India; the season may be extended or year round in some areas, be extended or year round in some areas, especially in southern India
Indonesia	Presumed to be endemic countrywide	Year round; peak season varies by island
Japan**	Rare sporadic human cases on all islands except Hokkaido; enzootic activity ongoing	Most human cases reported July–October
Korea, North	Limited data; presumed to be endemic countrywide	No data; proximity to South Korea suggests peak transmission is likely to be May–October
Korea, South**	Rare sporadic human cases countrywide; enzootic activity ongoing	Most human cases reported May–October
Laos	Limited data; presumed to be endemic countrywide	Year round; peak season June–September
Malaysia	Endemic in Sarawak; sporadic cases reported from all other states; occasional outbreaks reported	Year round; in Sarawak, peak season October–December
Nepal	Endemic in southern Iowlands (Terai); cases also reported from hill and montain districts, including the Kathmandu valley	Most human cases reported June-October
Pakistan	Limited data; human cases reported from around Karachi	Unknown
Papua New Guinea	Limited data; probably widespread	Unknown; probably year round
Philippines	Limited data; presumed to be endemic on all islands	Year round; peak season June–September
Russia	Rare human cases reported from the Far Eastern maritime areas south of Khabarovsk	Most human cases reported July–September
Singapore	Rare sporadic human cases reported	Year round
Sri Lanka	Endemic countrywide except in mountainous areas	Year round; variable peaks based on monsoon rains
Taiwan^**	Rare sporadic human cases islandwide	Most human cases reported May–October
Thailand	Endemic countrywide; seasonal epidemics in the northern provinces	Year round; peak season May–October, provinces especially in the north
Vietnam	Endemic countrywide; seasonal epidemics in the northern provinces	Year round; peak season May–October, especially in the north
Western Pacific Islands	Outbreaks of human disease reported in Guam in 1947–1948 and Saipan in 1990	Unknown; most human cases reported October–March
*Data are based on published reports and personal correspondence. Risk assessments should be performed cautiously, because risk can vary within areas and from year to year, and surveillance data regarding human cases and JE virus transmission are incomplete.
**In some endemic areas, human cases among residents are limited because of natural immunity among older people or vaccination. However, because JE virus is maintained in an enzootic cycle between animalsand mosquitoes, susceptible visitors to these areas still may be at risk of infection.

INDICATION & USAGE

Important Safety Information

INDICATION & USAGE

Important Safety Information

What is JE? Where Does JE Occur? When Does JE Occur?

What is JE?Where Does JE Occur?When Does JE Occur?

Japanese Encephalitis (JE)

Unpredictable. Dangerous.Preventable.

What is JE?

Where does JE occur?

JE is not just in Japan

JE is not just in rural areas

When does JE occur?

Progression of JE4,7,8,9

Select Stage to Learn More

5-15 days after being bitten by an infected mosquito

• Fever

• Diarrhea

• Headache

• Myalgia

• Nausea and Vomiting

• Acute encephalopathy

• Change in mental status

• Mild confusion to agitation to coma

• Parkinsonian syndrome

• Upper and lower motor neuron paralysis

• Seizures

Gradual recovery or persistence of CNS signs

• Severe Cognitive and memory impairments

• Psychiatric and behavioral disturbances

• Neuromuscular dysfunction

• Impairment of activities of daily living (ADLs)

• Seizures

Progression of JE4,7,8,9

Select Stage to Learn More

5-15 days after being bitten by an infected mosquito

• Fever

• Diarrhea

• Headache

• Myalgia

• Nausea and Vomiting

• Acute encephalopathy

• Change in mental status

• Mild confusion to agitation to coma

• Parkinsonian syndrome

• Upper and lower motor neuron paralysis

• Seizures

Gradual recovery or persistence of CNS signs

• Severe Cognitive and memory impairments

• Psychiatric and behavioral disturbances

• Neuromuscular dysfunction

• Impairment of activities of daily living (ADLs)

• Seizures

The Natural History of JE

Potential consequences of encephalitis

Mortality Rate

Long-Term Sequelae

Specific Treatment

Mortality Rate

Long-Term Sequelae

Specific Treatment

Complications of JE can include1,3,4 :

JE Epidemiology

Mosquitoes may bite as soon as travelers arrive

Long-TermTravelers

Short-TermTravelers

JE vaccination campaigns in Asia

Mosquitoes may bite as soon as travelers arrive

Long-TermTravelers

Short-TermTravelers

JE vaccination campaigns in Asia

Indication & Usage

Important Safety Information

This website is intended for US-based healthcare professionals.

What is JE?
Where Does JE Occur?
When Does JE Occur?

Unpredictable. Dangerous.
Preventable.

Progression of JE^4,7,8,9

5-15 days after being bitten
by an infected mosquito

Gradual recovery or
persistence of CNS signs

Progression of JE^4,7,8,9

Gradual recovery or
persistence of CNS signs

Complications of JE can include^1,3,4 :

Long-Term
Travelers

Short-Term
Travelers

Long-Term
Travelers

Short-Term
Travelers