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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.

    

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.

    

 

 

Japanese Encephalitis (JE)

Unpredictable. Dangerous.
Preventable.

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

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

What is JE?

Japanese encephalitis is a mosquito-borne disease of the genus Flavivirus, which is related to mosquito-borne Zika, dengue, yellow fever, and West Nile viruses.2 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

Australia
Bangladesh
Bhutan
Brunei
Burma (Myanmar)
Cambodia
China
East Timor
India
Indonesia
Japan
Korea, North
Korea, South

Laos
Malaysia
Nepal
Pakistan
Papua New Guinea
Philippines
Russia
Singapore
Sri Lanka
Taiwan
Thailand
Vietnam
Western Pacific Islands

Anyone traveling to Asia should be assessed for risk and educated about JE prevention strategies.

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

Progression of JE4,7,8,9

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 JE4,7,8,9

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. 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 include1,3,4 :

  • 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.

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 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).

Please see full Prescribing Information.

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