Valneva Receives FDA Approval for Accelerated Vaccine Dosing Schedule for IXIARO®

Japanese encephalitis – a rare but serious disease and the most common form of vaccine-preventable encephalitis and viral-induced neurologic disability in Asia – is endemic to 24 countries in Asia and parts of the Western Pacific.ⁱ For effective protection from JE virus, adults aged 18 to 65 years may now receive two separate doses of IXIARO seven days apart. Previously, the time between doses for this age group was 28 days. The standard 28-day schedule still applies to children two months to 17 years and adults 66 years and older; adults aged 18 to 65 years may also follow this schedule. The accelerated and the standard dosing schedules must be completed at least seven days before travel to endemic areas.

“The FDA approval of this accelerated 7-day dosing schedule is a positive step toward protecting more people from JE,” said Charles Daily, Valneva General Manager, U.S. “For travelers who do seek protection with a vaccine prior to travel, oftentimes they are not aware of the dosing schedule and therefore have not visited their doctor soon enough to allow for two doses. Eliminating this time barrier will make it easier for patients to plan for their travel health needs and to better protect themselves.”

A recent survey found that 72 percent of U.S. adults who traveled to Asia for 10 or more days reported visiting at least one area, or participating in an activity, that put them at increased risk for exposure to JEⁱⁱ virus and, based on guidelinesⁱⁱⁱ, should consider a vaccine along with other protective measures. However, the same survey found that more than one-third began preparing for travel less than a month before departure.

“I encourage anyone planning international travel to visit a travel health practitioner well in advance of their anticipated departure date to learn about preventative measures for travel-related diseases,” said Dr. Scott Morcott, family physician and Medical Director of Passport Health Chicago. “For those whose travel plans change unexpectedly, this shorter vaccine dosing regimen may help to protect them in less time.”

According to the World Health Organization, JE is endemic to 24 countries across Asia and parts of the western Pacific. While most people infected with JE virus – which is transmitted by mosquitoes – are asymptomatic or experience only mild symptoms^iv, it can be fatal or cause long-term serious complications. There is no specific treatment for JE, and the Centers for Disease Control and Prevention (CDC) recommends that, in addition to personal protective measures, travelers who spend 30 days or more in a JE-endemic region be vaccinated prior to arrival. In addition, shorter-term travelers should consider vaccination if their activities or location put them at risk for a mosquito bite.

About the Survey

The survey of 776 adults (18+) from across the United States was conducted in May-June 2018 to better understand the awareness and knowledge of health risks related to international travel. Of those queried, 514 participants had traveled to Asia for 10-29 days within the past 24 months, and 262 participants had traveled for 30 or more days.

About IXIARO^®

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

For adults aged 18 to 65, the vaccine is given in two doses, seven days apart (accelerated schedule) or 28 days apart (standard schedule), and vaccination should be completed seven days prior to potential exposure to JE virus.

For pediatric (two months to <18 years) and older adult (66+ years) travelers, the vaccine is given in two doses, 28 days apart (standard schedule), and vaccination should be completed seven days prior to potential exposure to JE virus.

IMPORTANT SAFETY INFORMATION

Severe allergic reaction after a previous dose of IXIARO, any other JE 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 JE 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.

About Japanese Encephalitis

JE is a deadly infectious disease that is endemic to 24 countries across Asia, Southeast Asia, and the western Pacific. About 68,000 cases of JE are estimated to occur each year, although the actual number of cases is likely much higher due to underreporting in rural areas. JE is fatal in up to 30 percent of those who show symptoms, and up to half of survivors continue to have neurologic, cognitive, and psychiatric impairment. In 2005, JE killed more than 1,200 children in only one month during an epidemic outbreak in Uttar Pradesh, India, and Nepal.

According to the CDC^v, the risk of JE is low for most travelers to Asia but can vary based on various factors, such as where a person spends time, when and for how long they are traveling and their activities. Travelers staying one month or longer (for example, military members and their families, study abroad students, or employees with extended work assignments) in parts of Asia where the JE virus is found are recommended for vaccination. Vaccination should be considered for travelers who have an increased risk of being exposed to mosquitoes carrying JE virus if they spend substantial time outdoors or in rural areas, especially at night; participate in extensive active outdoor activities such as camping, hiking, biking, fishing, or hunting, or sleep in accommodations without mosquito nets; or whose plans are uncertain or may change. JE vaccine is not recommended for short-term travel restricted to urban areas or outside of the JE virus transmission season.

For more information about JE and IXIARO, or for the full prescribing information, visit www.PreventJE.com.

About VALNEVA USA, Inc.

Valneva USA, Inc. is a subsidiary of Valneva SE, a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines.

Valneva USA is focused on the marketing and distribution of Valneva’s vaccines, including IXIARO, in the United States. For more information, follow Valneva on Twitter @ValnevaUSA or on Facebook.

ⁱ World Health Organization. Japanese encephalitis Fact sheet no.386. December 2015. http://www.who.int/mediacentre/factsheets/fs386/en. Accessed October 1, 2018.

ⁱⁱ Data on file.

ⁱⁱⁱ Centers for Disease Control and Prevention. Japanese encephalitis. Updated August 2015. https://www.cdc.gov/japaneseencephalitis/. Accessed October 1, 2018.

^iv World Health Organization. Japanese encephalitis Fact sheet no.386. December 2015. http://www.who.int/mediacentre/factsheets/fs386/en. October 1, 2018.

^v Prevention, C. (2018). Japanese Encephalitis - Chapter 3 - 2018 Yellow Book | Travelers’ Health | CDC. [online] wwwnc.cdc.gov. Available at: https://wwwnc.cdc.gov/travel/yellowbook/2018/infectious-diseases-related-to-travel/japanese-encephalitis [Accessed October 1, 2018].

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