INDICATION & USAGE

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

Important Safety Information

Severe allergic reaction 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 is considered.

Vaccination with IXIARO may not protect all individuals. Individuals with a weakened immune system may have a diminished immune response to IXIARO. Fainting may occur when receiving any injection, including IXIARO. Tell your healthcare practitioner if you have a history of fainting from injections.

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, muscle pain, and injection site pain and tenderness in adults.

You 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. You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

INDICATION & USAGE

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

Important Safety Information

Severe allergic reaction 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 is considered.

Vaccination with IXIARO may not protect all individuals. Individuals with a weakened immune system may have a diminished immune response to IXIARO. Fainting may occur when receiving any injection, including IXIARO. Tell your healthcare practitioner if you have a history of fainting from injections.

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, muscle pain, and injection site pain and tenderness in adults.

You 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. You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

Thailand

Vietnam

Vietnam

Important Safety Information

Indication & Usage

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

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, other Japanese encephalitis vaccine, any 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 is considered.

Vaccination with IXIARO may not protect all individuals. Individuals with a weakened immune system may have a diminished immune response to IXIARO. Fainting may occur when receiving any injection, including IXIARO. Tell your healthcare practitioner if you have a history of fainting from injections.

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, muscle pain, and injection site pain and tenderness in adults.

You 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. You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

Important Safety Information | Prescribing Information

Valneva USA, Inc.
4550 Montgomery Ave.,
Suite 460
Bethesda, MD 20814 USA

Japanese Encephalitis
Treatment & Protection
Ixiaro®
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Others

Risk areas and transmission season for Japanese encephalitis (JE), by country^*,†,‡

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

^*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 JE 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 JE 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.

Risk for Japanese Encephalitis by Country^4*

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.