CORRECTING and REPLACING CDC Publishes Updated Recommendations for Valneva’s Japanese Encephalitis Vaccine IXIARO®

ACIP Guidelines Recommend Vaccination for All Longer-Term U.S. Travelers to JE-Endemic Countries; Shorter-Term Travelers Should Also Consider Vaccination

GAITHERSBURG, Md.–(BUSINESS WIRE)–In the numbered list, the bulleted section under number 3 should read: For adults and children, a booster dose (i.e. third dose) is recommended at ≥1 year after completion of the primary JE vaccination series if ongoing or re-exposure to JE virus is expected (instead of For adults and children, a booster dose (i.e. third dose) is recommended at ≤1 year after completion of the primary JE vaccination series if ongoing or re-exposure to JE virus is expected.)

The corrected release reads:

CDC PUBLISHES UPDATED RECOMMENDATIONS FOR VALNEVA’S JAPANESE ENCEPHALITIS VACCINE IXIARO^®

ACIP Guidelines Recommend Vaccination for All Longer-Term U.S. Travelers to JE-Endemic Countries; Shorter-Term Travelers Should Also Consider Vaccination

Valneva USA, Inc. (“Valneva USA”), the US subsidiary of Valneva SE (“Valneva”), a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, today announced that the Centers for Disease Control and Prevention (CDC) has published updated recommendations from its Advisory Committee on Immunization Practices (ACIP) for the Japanese encephalitis (JE) vaccine, IXIARO^® (Japanese Encephalitis Vaccine, Inactivated, Adsorbed). Among other things, these three new recommendations, published on July 19, 2019, simplify and clarify the types of travelers who are at risk for JE.

The mosquito-borne JE virus is the most common vaccine-preventable cause of encephalitis in Asia, occurring throughout most of Asia and parts of the western Pacific. Approximately 20%–30% of patients who develop JE die. Of those who survive, 30%–50% have long-term neurologic, cognitive, or behavioral issues as a result of the disease. IXIARO^® is the only JE vaccine licensed and available in the United States.

“We are delighted with these new simpler and clearer recommendations for protecting U.S. travelers from Japanese encephalitis,” said Wolfgang Bender, M.D., Ph.D., Chief Medical Officer of Valneva. “These ACIP recommendations, based on newly available data about JE and its impact, provide important guidance to travelers and their physicians. Our objective is to prevent this morbid disease that can lead to brain damage or death.”

1. Recommendation for U.S. travelers at increased risk for JE:

• JE vaccine is recommended for persons moving to a JE-endemic country to take up residence, longer-term (e.g., more than one month) travelers to JE-endemic areas, and frequent travelers to JE-endemic areas.
• JE vaccine should also be considered for shorter-term (e.g., less than one month) travelers with an increased risk of JE based on planned travel duration, season, location, activities, and accommodations.
• Vaccination should also be considered for travelers to endemic areas who are uncertain of specific duration of travel, destinations, or activities.
• JE vaccine is not recommended for travelers with very low-risk itineraries, such as urban travel only for a short duration, or travel outside of a well-defined JE virus transmission season.

2. Recommendation for an accelerated primary series in adults (18-65 years):

• In adults 18‒65 years, the recommended primary vaccination schedule is two doses administered intramuscularly on days 0 and 7‒28.
  
  Please note that these recommendations differ from the label for IXIARO ^®. According to the Prescribing Information for IXIARO ^®, in adults 18-65 years, two doses should be administered 7 days apart (accelerated schedule) or 28 days apart (standard schedule), and vaccination should be completed seven days before departure.

3. New recommendation for booster dose:

• For adults and children, a booster dose (i.e. third dose) is recommended at ≥1 year after completion of the primary JE vaccination series if ongoing or re-exposure to JE virus is expected.

  Please note that these recommendations differ from the label for IXIARO ^®. According to the Prescribing Information for IXIARO ^®, a booster dose (third dose)* may be given at least 11 months after completion of the primary immunization series if ongoing exposure or re-exposure to JE virus is expected.

  *Children from 14 months to less than three years of age should receive a single 0.25 mL booster dose. Individuals three years of age and older should receive a single 0.5 mL booster dose.

About IXIARO^®

Valneva’s Japanese encephalitis vaccine is indicated for active immunization for the prevention of the disease for people who travel to, or live in, endemic areas. It has received marketing approval in the U.S., Europe, Canada, Hong Kong, Singapore, and Israel under the trade name IXIARO® and in Australia and New Zealand where it is marketed as JESPECT^®. It is the only vaccine available in the U.S. for Japanese Encephalitis. IXIARO^® is approved for use in individuals two months of age and older in the U.S. and EU member states, Canada, Norway, Liechtenstein, Iceland, Singapore, Hong Kong, and Israel. In all other licensed territories, IXIARO^®/JESPECT^® is indicated for use in persons aged 18 years or more.

Full U.S. Prescribing Information is available at: https://www.valneva.us/download.php?dir=ixiaro&file=181004_US_PI__final.pdf

Important Safety Information about IXIARO^®

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.

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^®).

About Japanese Encephalitis

Japanese encephalitis is a deadly infectious disease found mainly in Asia. About 70,000 cases of JE are estimated to occur in Asia each year, although the actual number of cases is likely much higher due to underreporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms, and leaves up to half of survivors with long-term brain damage. The disease is endemic in Southeast Asia, India and China, a region with a population of more than three billion. In 2005, JE killed more than 1,200 children in only one month during an epidemic outbreak in Uttar Pradesh, India, and Nepal.

About Valneva USA, Inc.

Valneva USA, Inc. is a subsidiary of Valneva SE, a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs.

Valneva USA, Inc. is focused on the marketing and distribution of Valneva’s vaccines, including IXIARO^®, in the United States. For more information, visit https://www.valneva.us/en/ or follow Valneva USA on Twitter @ValnevaUSA or on Facebook.

Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of those in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

1907-US-IX-025

Contacts

Valneva USA Media Contacts

Durae Hardy

Account Manager

Health+Commerce

M 707.337.1903

[email protected]