Update on Japanese Encephalitis (JE) Vaccine for U.S. Children

JE vaccines in the U.S.

Inactivated mouse brain-derived JE vaccine (JE-MB [manufactured as JE-VAX]), the only JE vaccine that is licensed for use in children in the United States, is no longer available. JE-MB has been licensed in the United States since 1992 for use in adults and children aged ≥1 year. However, JE-MB is no longer being produced and all remaining doses expired in May 2011.

In 2009, the Food and Drug Administration (FDA) approved an inactivated Vero cell culture-derived JE vaccine (JE-VC [manufactured as IXIARO]) for use in adults aged ≥17 years.  One pediatric clinical trial with JE-VC has been completed in 60 children aged 12 to 35 months in India (48 children received JE-VC and 12 children received an inactivated mouse brain-derived JE vaccine [manufactured as JenceVac]).  A safety and immunogenicity study is ongoing in approximately 1,900 children aged 2 months through 17 years in the Philippines, and a safety and immunogenicity bridging study has been initiated in the United States and other non-endemic countries with a targeted enrollment of approximately 100 children.  Despite these ongoing studies, it will likely be several years before JE-VC is licensed in the United States for use in children. JE-VC product information is available online at the FDA IXIARO webpage.

Other JE vaccines are manufactured and available for pediatric use in Asia but are not licensed in the United States.

 

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Recommendations for the prevention of JE among travelers

For most travelers to Asia, the risk for JE is very low but var­ies on the basis of destination, duration, season, and activities.  The Advisory Committee on Immunization Practices (ACIP) recommends that all travelers, including children, should take precautions to avoid mosquito bites to reduce the risk for JE and other vector-borne infectious dis­eases. These precautions include using insect repellent, permethrin-impregnated clothing, and bed nets, and staying in accommodations with screened or air-conditioned rooms. Additional information on protection against mosquitoes and other arthropods is available in CDC's Health Information for International Travel (Yellow Book).

For some travelers who will be in a high-risk setting based on season, location, duration, and activities, JE vaccine can further reduce the risk for infection.  ACIP recommendations for the use of JE vaccine are available from CDC in the MMWR Recommendations and Reports.

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Current options for obtaining JE vaccine for U.S. children

For U.S. health-care providers interested in obtaining JE vaccine for pediatric patients, current options include:

• Enroll children in the ongoing JE-VC (IXIARO) pediatric clinical trial at one of five U.S. sites: The study is open-label and all enrollees receive two doses of JE-VC administered 28 days apart. A third study visit is required at 56 days after the subject receives the first dose of vaccine. Additional information is available online at the NIH clinical trials webpage. In addition, a list of U.S. clinical trial sites and contact information is provided here. [PDF - 2 pages]
• Administer JE-VC (IXIARO) off-label:  JE-VC is FDA-licensed for use in adults ≥17 years of age.  However, a health-care provider may choose to administer the vaccine off-label in children <17 years of age.  Data from the one completed pediatric study have been published (Kaltenbock et al. Vaccine 2010;28:834-9).  The manufacturer is currently studying a 6µg per 0.5mL dose (regular adult dose) for children ≥3 years of age and a 3µg per 0.25mL dose (half adult dose) for children aged 2 months through 2 years.  Additional information about the use of JE-VC in children is available from Novartis Medical Communications by telephone (877-683-4732) or e-mail (vaccineinfo.us@novartis.com).
• Refer children to an international travelers’ health clinic in Asia:  JE vaccines available at international traveler’s health clinics in Asia include another inactivated mouse brain-derived vaccine manufactured in South Korea, another inactivated Vero cell culture-derived vaccine manufactured in Japan, or live attenuated SA 14-14-2 vaccine manufactured in China.  Each of these vaccines is licensed for pediatric use in one or more Asian countries; however, these vaccines are not licensed by the U.S. FDA. The recommended number of doses and schedule will vary by vaccine and country.  A partial list of international travelers’ health clinics in Asia that administer JE vaccines to children is provided here [PDF - 2 pages]. 

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For more information

• U.S. clinical trial sites evaluating IXIARO JE vaccine in children [PDF - 1 page]
• Travelers’ health clinics in Asia that administer JE vaccines to children [PDF - 2 pages]
• Vaccine Healthcare Centers Network
  

  The Vaccine Healthcare Centers Network is a U.S. Department of Defense organization that supports the military immunization and readiness mission.  They have developed a JE vaccine information paper that “provides the scientific rationale and medical evidence upon which licensed military healthcare providers can base their JE vaccination counseling of parents of children in whom the benefit-risk assessment supports prophylactic JEV vaccination”.

• MMWR Recommendations and Reports
  Advisory Committee on Immunization Practices (ACIP) recommendations for use of JE vaccine
• CDC's Health Information for International Travel (Yellow Book)
  Information about JE risk by country and recommendations for prevention of JE among travelers

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