Ixiaro® JESPECT® Japanese Encephalitis Vaccine
Valneva SE's Ixiaro® JESPECT® is an inactivated, adsorbed Vero cell culture-derived vaccine targeted against the Japanese encephalitis virus (JEV). It is prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are pooled, clarified, and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The partially purified virus is processed and fractionated through a sucrose density gradient centrifugation. Each fraction is analyzed for the presence of the virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by treatment with formaldehyde. The final preparation is adjusted to a specified protein concentration and formulated by adding aluminum hydroxide.
The IXIARO JEV was developed through a cooperative research and development agreement with the Walter Reed Army Institute of Research. Valneva SE markets and distributes IXIARO® directly to the U.S. military and private markets. The U.S. Department of Defense (DoD) has relied on IXIARO since 2010 to help protect personnel deployed to JE endemic areas for whom JE vaccination is recommended.
Valneva SE's IXIARO is the only Japanese encephalitis vaccine approved by the U.S. Food and Drug Administration (FDA) against JEV. The FDA approved the Ixiaro vaccine (STN: BL 125280) on March 30, 2009. The STN: BL 125280/251 was issued on October 4, 2018, to include data to support the concomitant use of IXIARO primary immunization series, to 0.5 mL doses administered 28 days apart with U.S. licensed rabies vaccines (RabAvert) administered for pre-exposure prophylaxis. In addition, on March 8, 2020, Valneva announced that the FDA approved an extension of the shelf life of IXIARO from 24 months to 36 months.
Ixiaro / JESPECT® is licensed for adults in the U.S., Australia, New Zealand, Europe, Canada, Switzerland, Hong Kong, Singapore, Israel, Norway, Liechtenstein, Iceland, Singapore, Japan, the United Kingdom, and the Republic of Korea. In all other licensed territories, IXIARO®/JESPECT® is indicated for use in persons aged 18 years or more. Also, visit PreventJE.com, a website for travel health professionals and their patients, focusing on the risk and prevention of Japanese encephalitis for travelers to Asia. In the first half of 2023, IXIARO®/JESPECT® sales increased by 147% to €30.3 million compared to €12.3 million in the first half of 2022.
France-based Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) is a specialty vaccine company focused on preventing diseases with significant unmet needs. For more information, visit www.valneva.com. Valneva USA, Inc. is located at 910 Clopper Road, Suite 160S, Gaithersburg, MD 20878, USA.
Ixiaro Indication
Ixiaro is indicated for active immunization to prevent disease caused by the JEV, the leading cause of vaccine-preventable encephalitis, and is approved for use in individuals two months of age and older. JE is a deadly infectious disease. JE is fatal in approximately 30% of those who show symptoms, leaving half of the survivors with permanent brain damage. Vaccination with IXIARO may not protect all individuals. Immunocompromised individuals may have a diminished immune response to IXIARO.
Ixiaro Side Effects
IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Therefore, 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 severe allergic reaction history to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO® might be considered.
The most common ( > 10%) adverse reactions were fever, irritability, diarrhea, and injection site redness in infants two 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.
Ixiaro Dosage
Ixiaro is administered as an intramuscular injection and is approved for use in individuals two months and older. In 2019, the U.S. CDC's ACIP committee strengthened its language on booster doses to say they should be given at least one year after the primary series if the person is experiencing ongoing exposure or re-exposure to the JE virus.
Primary Series: Children 2 months to <3 years of age: Primary immunization with IXIARO consists of two (2) 0.25 mL doses, administered 28 days apart; Individuals 3 years of age and older: Primary immunization with IXIARO consists of two (2) 0.5 mL doses, administered 28 days apart; Complete the primary immunization series at least one week before potential exposure to JEV.
Booster Dose: Individuals 17 years of age and older: If the primary series of two doses was completed more than one year previously, a booster dose might be given if ongoing exposure or re-exposure to JEV is expected; Infants, children, and adolescents two months to <17 years of age: The safety and immunogenicity of a booster dose have not been evaluated.
Japanese Encephalitis Outbreaks
The WHO says JE transmission intensifies during the rainy season, during which vector populations increase. However, there has not yet been evidence of increased JEV transmission following major floods or tsunamis. The U.S. Centers for Disease Control and Prevention (CDC) updated its Alert - Level 2, Practice Enhanced Precautions on December 14, 2022, regarding the JE outbreak in parts of eastern and southeastern Australia. On April 28, 2022, the WHO reported Australia's JEV outbreak had confirmed 35 cases and three fatalities across four states. In addition, Australia's government declared a JEV outbreak in Queensland a Communicable Disease Incident of National Significance in March 2022.
IXIARO Vaccine News 2023
September 21, 2023 - Valneva SE confirmed it distributes IXIARO® directly to the U.S. DoD, and the Company expects to announce a new contract with the U.S. Defense Logistics Agency.
August 18, 2022 - Valneva SE announced that the U.S. DoD decided not to exercise the second option year of the contract to supply its IXIARO as existing inventory levels are sufficient to meet current needs.
July 11, 2022 - A non-peer-reviewed study: Safety and immunogenicity following co-administration of Yellow fever vaccine with Tick-borne encephalitis or Japanese encephalitis vaccines concluded: Inactivated TBEV or JEV vaccines can be co-administered with the live attenuated YFV vaccine without an increased risk of adverse events and reduced development of nAbs to the respective viruses.
May 4, 2022 - The Japanese encephalitis virus is outbreaking on Australian pig farms. "In the space of just over a week, we went from that little northern tip of Queensland to multiple pig farms across multiple states of Australia involved," she said. All these outbreaks are genotype 4 JEV, Dr. Kristy Richards, DVM, added.
March 4, 2022 - Australia's Acting Chief Medical Officer, Dr. Sonya Bennett, declared the unfolding situation concerning the Japanese encephalitis virus a Communicable Disease Incident of National Significance.
September 3, 2021 - Valneva SE announced that the U.S. Department of Defense had exercised the first option of the contract signed in September 2020 to purchase a further supply of its Japanese encephalitis vaccine, IXIARO®.
July 19, 2019 - Japanese Encephalitis Vaccine: The CDC's Advisory Committee on Immunization Practices (ACIP) Recommendations were updated.
June 5, 2019: The European Medicines Agency approved the extension of the shelf life of the Japanese encephalitis vaccine IXIARO from 24 months to 36 months.
March 1, 2019 – According to unanimous votes by the U.S. CDC's ACIP at its February 27, 2019 meeting, the JEV vaccination recommendations have been expanded.
Ixiaro Clinical Trials
Ixiaro Japanese Encephalitis vaccine has been involved in over 60 clinical trials.
