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Last update 25 Mar 2025

Japanese encephalitis vaccine, inactivated(Valneva SE)

Last update 25 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Ixiaro, Japanese-encephalitis vaccine (inactivated, adsorbed), Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)

+ [11]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesOther Diseases

Active Indication

Encephalitis, ViralEncephalitis, Japanese

Inactive Indication-

Originator Organization

Valneva SE

Active Organization

Valneva SEVALNEVA Austria GmbH

Adimmune Corp.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Australia (16 Mar 2009),

Encephalitis, Japanese

RegulationOrphan Drug (United States)

Clinical Trials associated with Japanese encephalitis vaccine, inactivated(Valneva SE)

CTRI/2023/07/055155

/ Not yet recruitingNot ApplicableIIT

Immunogenicity and safety of JENVAC and JEEV vaccines administered for prevention of Japanese encephalitis in an interchangeable dosing schedule among healthy Indian children: A multicentric, phase IV, open-labeled, randomized controlled trial - Nil

Start Date10 Nov 2023

Sponsor / Collaborator

Indian Council of Medical Research

NCT03971058

/ Unknown statusPhase 4IIT

Characterisation of Cellular and Humoral Immune Responses Following the First Booster Immunisation With the Inactivated, Purified Japanese Encephalitis Vaccine IXIARO® in Elderly Compared to Young Individuals.

The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis vaccine in elderly subjects (above 60 years of age) in comparison to a young study group.

Start Date01 Mar 2019

Sponsor / Collaborator

Medical University of Vienna

[+1]

EUCTR2013-001954-88-FI

/ Unknown statusNot ApplicableIIT

Immune response to intradermally administrated Ixiaro in healthy adults: a randomized study

Start Date03 Dec 2015

Sponsor / Collaborator-

100 Clinical Results associated with Japanese encephalitis vaccine, inactivated(Valneva SE)

100 Translational Medicine associated with Japanese encephalitis vaccine, inactivated(Valneva SE)

100 Patents (Medical) associated with Japanese encephalitis vaccine, inactivated(Valneva SE)

Literatures (Medical) associated with Japanese encephalitis vaccine, inactivated(Valneva SE)

19 Oct 2024·Journal of travel medicine

A randomized, placebo-controlled, blinded phase 1 study investigating a novel inactivated, Vero cell-culture derived Zika virus vaccine

Article

Author: Ramljak, Irena Čorbić ; Lingnau, Karen ; Dubischar, Katrin L ; Wressnigg, Nina V ; Hochreiter, Romana ; Schneider, Martina ; Eder-Lingelbach, Susanne ; Obersriebnig, Michaela J ; Bézay, Nicole I

Abstract:

Background:

Zika virus (ZIKV) is an emerging public health threat, rendering development of a safe and effective vaccine against the virus a high priority to face this unmet medical need. Our vaccine candidate has been developed on the same platform used for the licensed vaccine IXIARO®, a vaccine against Japanese Encephalitis virus, another closely related member of the Flaviviridae family.

Methods:

Between 24 February 2018 and 16 November 2018, we conducted a randomized, observer-blinded, placebo controlled, single center phase 1 study to assess the safety and immunogenicity of an adjuvanted, inactivated, purified whole-virus Zika vaccine candidate in the USA. A total of 67 healthy flavivirus-naïve adults aged 18–49 years were randomly assigned to one of five study arms to receive two immunizations of either high dose or low dose (6 antigen units or 3 antigen units) with both dose levels applied in two different immunization regimens or placebo as control.

Results:

Our vaccine candidate showed an excellent safety profile independent of dose and vaccination regimen with predominantly mild adverse events (AEs). No serious AE has been reported. The ZIKV vaccine induced neutralizing antibodies in all tested doses and regimens with seroconversion rates up to 85.7% (high dose), which remained up to 40% (high dose) at 6 months follow-up. Of note, the rapid regimen triggered a substantial immune response within days.

Conclusions:

The rapid development and production of a ZIKV vaccine candidate building on a commercial Vero-cell manufacturing platform resulted in a safe and immunogenic vaccine suitable for further clinical development. To optimize antibody persistence, higher doses and a booster administration might be considered.

01 Oct 2023·The Lancet. Infectious diseases

Safety and immunogenicity of a purified inactivated Zika virus vaccine candidate in adults primed with a Japanese encephalitis virus or yellow fever virus vaccine in the USA: a phase 1, randomised, double-blind, placebo-controlled clinical trial

Article

Author: Valencia-Ruiz, Anais ; Lin, Leyi ; Keiser, Paul B ; Michael, Nelson L ; Adedeji, Oluwaseun ; Darden, Janice ; Sondergaard, Erica L ; Lee, Christine ; Donofrio, Gina ; Gromowski, Gregory D ; Krebs, Shelly J ; Modjarrad, Kayvon ; Curley, Justin M ; Mills, Kristin T ; Hutter, Jack N ; Costanzo, Margaret ; Peel, Sheila ; De La Barrera, Rafael ; Thomas, Stephen J ; Dussupt, Vincent ; Koren, Michael A ; Crowell, Trevor A ; Eckels, Kenneth H ; Copeland, Nathanial K ; Mebrahtu, Tsedal ; Robb, Merlin L ; Hamer, Melinda J ; Jarman, Richard G ; Amare, Mihret F

BACKGROUND:

Zika virus infection is a threat to at-risk populations, causing major birth defects and serious neurological complications. Development of a safe and efficacious Zika virus vaccine is, therefore, a global health priority. Assessment of heterologous flavivirus vaccination is important given co-circulation of Japanese encephalitis virus and yellow fever virus with Zika virus. We investigated the effect of priming flavivirus naive participants with a licensed flavivirus vaccine on the safety and immunogenicity of a purified inactivated Zika vaccine (ZPIV).

METHODS:

This phase 1, placebo-controlled, double-blind trial was done at the Walter Reed Army Institute of Research Clinical Trials Center in Silver Spring, MD, USA. Eligible participants were healthy adults aged 18-49 years, with no detectable evidence of previous flavivirus exposure (by infection or vaccination), as measured by a microneutralisation assay. Individuals with serological evidence of HIV, hepatitis B, or hepatitis C infection were excluded, as were pregnant or breastfeeding women. Participants were recruited sequentially into one of three groups (1:1:1) to receive no primer, two doses of intramuscular Japanese encephalitis virus vaccine (IXIARO), or a single dose of subcutaneous yellow fever virus vaccine (YF-VAX). Within each group, participants were randomly assigned (4:1) to receive intramuscular ZPIV or placebo. Priming vaccinations were given 72-96 days before ZPIV. ZPIV was administered either two or three times, at days 0, 28, and 196-234. The primary outcome was occurrence of solicited systemic and local adverse events along with serious adverse events and adverse events of special interest. These data were analysed in all participants receiving at least one dose of ZPIV or placebo. Secondary outcomes included measurement of neutralizing antibody responses following ZPIV vaccination in all volunteers with available post-vaccination data. This trial is registered at ClinicalTrials.gov, NCT02963909.

FINDINGS:

Between Nov 7, 2016, and Oct 30, 2018, 134 participants were assessed for eligibility. 21 did not meet inclusion criteria, 29 met exclusion criteria, and ten declined to participate. 75 participants were recruited and randomly assigned. 35 (47%) of 75 participants were male and 40 (53%) were female. 25 (33%) of 75 participants identified as Black or African American and 42 (56%) identified as White. These proportions and other baseline characteristics were similar between groups. There were no statistically significant differences in age, gender, race, or BMI between those who did and did not opt into the third dose. All participants received the planned priming IXIARO and YF-VAX vaccinations, but one participant who received YF-VAX dropped out before receipt of the first dose of ZPIV. 50 participants received a third dose of ZPIV or placebo, including 14 flavivirus-naive people, 17 people primed with Japanese encephalitis virus vaccine, and 19 participants primed with yellow fever vaccine. Vaccinations were well tolerated across groups. Pain at the injection site was the only adverse event reported more frequently in participants who received ZPIV than in those who received placebo (39 [65%] of 60 participants, 95% CI 51·6-76·9 who received ZPIV vs three [21·4%] of 14 who received placebo; 4·7-50·8; p=0·006). No patients had an adverse event of special interest or serious adverse event related to study treatment. At day 57, the flavivirus-naive volunteers had an 88% (63·6-98·5, 15 of 17) seroconversion rate (neutralising antibody titre ≥1:10) and geometric mean neutralising antibody titre (GMT) against Zika virus of 100·8 (39·7-255·7). In the Japanese encephalitis vaccine-primed group, the day 57 seroconversion rate was 31·6% (95% CI 12·6-56·6, six of 19) and GMT was 11·8 (6·1-22·8). Participants primed with YF-VAX had a seroconversion rate of 25% (95% CI 8·7-49·1, five of 20) and GMT of 6·6 (5·2-8·4). Humoral immune responses rose substantially following a third dose of ZPIV, with seroconversion rates of 100% (69·2-100; ten of ten), 92·9% (66·1-99·8; 13 of 14), and 60% (32·2-83·7, nine of 15) and GMTs of 511·5 (177·6-1473·6), 174·2 (51·6-587·6), and 79 (19·0-326·8) in the flavivirus naive, Japanese encephalitis vaccine-primed, and yellow fever vaccine-primed groups, respectively.

INTERPRETATION:

We found ZPIV to be well tolerated in flavivirus naive and primed adults but that immunogenicity varied significantly according to antecedent flavivirus vaccination status. Immune bias towards the flavivirus antigen of initial exposure and the timing of vaccination may have impacted responses. A third ZPIV dose overcame much, but not all, of the discrepancy in immunogenicity. The results of this phase 1 clinical trial have implications for further evaluation of ZPIV's immunisation schedule and use of concomitant vaccinations.

FUNDING:

Department of Defense, Defense Health Agency; National Institute of Allergy and Infectious Diseases; and Division of Microbiology and Infectious Disease.

01 Feb 2023·Vaccine

Comparative frequency of specified adverse events following Vero cell culture-derived Japanese encephalitis and Vi capsular polysaccharide typhoid vaccines in U.S. military personnel, July 2011–August 2019

Article

Author: Seshadri, Srihari ; Martin, Stacey W ; Collins, Limone C ; Hills, Susan L

Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC; Ixiaro) was approved in the United States in 2009. The previous JE vaccine, an inactivated mouse brain-derived vaccine, had been associated with rare, but serious, allergic and neurologic adverse events (AE). Studies and AE surveillance have supported JE-VC's safety, but one evaluation among military personnel found elevated hypersensitivity and neurologic AE rates. However, co-administration of multiple vaccines to some personnel might have affected results. We retrospectively compared rates of hypersensitivity and neurologic AEs within 28 days following vaccination of military personnel with JE-VC or parenteral Vi capsular polysaccharide typhoid vaccine administered without other vaccines from July 1, 2011, through August 31, 2019. Rates of most events were similar between the vaccines. Only delayed hypersensitivity reactions occurred more frequently following JE-VC (rate ratio: 4.2, 95 % CI 1.2-15.3; p = 0.03), but rates were low for both vaccines. These results support JE-VC's safety.

News (Medical) associated with Japanese encephalitis vaccine, inactivated(Valneva SE)

18 Feb 2025

·www.globenewswire.com

Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook

Met 2024 growth targets for sales revenue (+13% vs 2023) and total revenues (+10% vs 2023)Strong year-end cash position of €168.3 millionSubstantial clinical and regulatory progress in 2024, leading to multiple anticipated data readouts, product approvals and label extensions in 20252025 outlook reflects solid revenue growth and positive commercial cash flows to support strategic R&D investments with lower operating cash burn Saint-Herblain (France), February 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its preliminary unaudited full-year 2024 revenue and cash results1 and provided a 2025 outlook. The Company will publish its 2024 audited consolidated financial statements and host an analyst call on March 20, 2025. 2024 Performance Total revenues were €169.6 million for the year ended December 31, 2024 compared to €153.7 million in the year ended December 31, 2023, an increase of 10%Product sales revenue reached €163.3 million for the year ended December 31, 2024 compared to €144.6 million in the same period of 2023, an increase of 13%Cash and cash equivalents were €168.3 million as at December 31, 2024, compared to €126.1 million at December 31, 2023. Year-end cash of €168.3 million, significantly augmented by the sale of the Priority Review Voucher2 and successful Private Placement3 2025 Financial Outlook Sales revenues expected to grow to €170-180 million, driving positive cash-flows for the overall commercial businessTotal revenues expected to reach €180-190 millionTotal R&D investments expected between €90 - €100 million, which will be partially offset by grant funding and anticipated R&D tax creditsContinued stringent focus on cash management supporting sufficient cash runway to reach key inflection points; substantially lower operating cash burn expected in 2025, less than 30 million compared to over €60.0 million in 2024 Peter Bühler, Valneva’s Chief Financial Officer, commented, “Once again, we successfully delivered double digit sales growth, despite lower than anticipated launch-year IXCHIQ® sales in the U.S. We made significant clinical and regulatory progress last year, setting the stage for several important catalysts to drive value in 2025, most notably with the first Phase 3 study results for our lead Lyme disease vaccine candidate, VLA15. In 2025, we will continue to focus on commercial execution while investing strategically in advancing our science-driven pipeline to generate substantial future value. With over €168 million of cash at the end of 2024, we are entering 2025 in a good financial position to support these objectives.” Regulatory, R&D and Strategic Highlights Continued to progress Lyme disease program according to plan, including completion of primary vaccination in ongoing Phase 3 study, reporting of further positive Phase 2 booster results, and publication of Phase 2 data in the LancetSecured three additional regulatory approvals for world’s first chikungunya vaccine, IXCHIQ® (Canada, Europe, UK); filed adolescent label extension submissions; awarded new $41.3 million grant from the Coalition for Epidemic Preparedness (CEPI)4Augmented clinical pipeline with a leading tetravalent Shigella vaccine candidate5 and initiated Phase 2b trial; Granted Fast Track Designation by the United States Food and Drug Administration (FDA) Advanced novel Zika vaccine candidate into Phase 1 clinical development Finalized new $32.8 million IXIARO® supply contract with the U.S. Department of Defense in January 20256 Key Upcoming Catalysts: Lyme disease Phase 3 first data readout by the end of 2025Further chikungunya vaccine approvals, including the first endemic country (Brazil) and adolescent label extensions for IXCHIQ® in major travel marketsInitiation of Phase 3 pediatric trial of IXCHIQ® to support further potential label expansionPhase 2b efficacy data from Human Challenge Study (CHIM) of tetravalent Shigella vaccine candidate in mid-2025 and launch of pediatric studyPhase 1 results for Zika vaccine candidate in the first half of 2025 About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first chikungunya vaccine, as well as certain third-party vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP, Global Communications and European Investor RelationsM +33 (0)6 4516 7099investors@valneva.com Joshua Drumm, Ph.D.VP, Global Investor Relations M +001 917 815 4520joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to business partnerships and the progress, timing, results and completion of technology transfer and regulatory approvals in additional markets. 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 sustained 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 and delays 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. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 The financial figures presented in this release are preliminary and unaudited. The final audited financial results, which remain subject to approval by the Board of Directors, are expected to be published on March 20.2 Valneva Announces Sale of Priority Review Voucher for $103 Million - Valneva3 Valneva Announces the Success of its Private Placement Raising approximately €60 Million - Valneva4 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World’s First Chikungunya Vaccine - Valneva5 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate - Valneva6 Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32.8 Million - Valneva Attachment 2025_02_18_FY2024_RevCash_PR_EN_Final

Phase 3VaccineClinical ResultFinancial StatementPhase 2

03 Feb 2025

·www.fiercepharma.com

Valneva snares $33M contract to supply US with Japanese encephalitis vaccine

Valneva hauled in a $32.8 million contract to supply the U.S. Department of Defense with vaccines to treat Japanese encephalitis. While much of Valneva's focus these days is centered on its landmark vaccine for chikungunya virus, the French immunization specialist's catalog of older shots continues to serve up fresh government deals.Valneva has obtained a $32.8 million contract to supply the U.S. Department of Defense with an undisclosed number of vaccine doses to treat Japanese encephalitis, which is endemic in Southeast Asia, India and China.The vaccine, Ixiaro, is the only Japanese encephalitis approved for use by the U.S. military, the company said in a Jan. 30 press release. It was developed through an R&D agreement with the Walter Reed Army Institute of Research, according to the company.The vaccine is specifically cleared to help prevent Japanese encephalitis in people two months of age and older who travel to or live in areas where the disease is endemic. In the U.S., Valneva sells and distributes Ixiaro directly to the military and in the private travel vaccination market. Japanese encephalitis causes inflammation of the brain and is typically transmitted through the bite of infected Culex species mosquitoes. The disease is thought to affect around 70,000 people in Asia each year and is fatal to an estimated 30% of those who show symptoms. About half of the survivors suffer permanent brain damage, Valneva said. Under the terms of Valneva's one-year contract, the U.S. will purchase a minimum of $32.8 million worth of the vaccine, with the option to buy additional doses over the next 12 months. Deliveries of Ixiaro doses continued last year under a supply contract inked in September 2023, Valneva noted in its release. The new contract timeline begins immediately.“The U.S. military has trusted Ixiaro for over 10 years to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease,” Dipal Patel, Valneva’s chief commercial officer, said in the release.Ixiaro was first approved in the U.S. in 2009. The vaccine also boasts regulatory clearances for European Union member states, as well as in Canada, Norway, Liechtenstein, Iceland, Singapore, Hong Kong, Japan, the Republic of Korea and Israel. While Ixiaro and the the cholera vaccine Dukoral make up two-thirds of Valneva's commercial portfolio, the company has been more squarely focused on its chikungunya vaccine, Ixchiq, in recent months, following the shot's initial FDA approval in late 2023. Last Spring, Valneva said that the launch of Ixchiq would take priority over the advancement of experimental vaccines for Lyme disease and the Zika virus.

Drug ApprovalVaccineLicense out/in

30 Jan 2025

·www.globenewswire.com

Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32.8 Million

Saint Herblain (France), January 30, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32.8 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.Under this new one-year contract, the DoD will buy a minimum of $32.8 million worth of IXIARO® vaccines and has the possibility to purchase additional doses during the coming twelve months. Deliveries of IXIARO® doses have continued in 2024 under the supply contract signed in September 20231. The new contract will commence immediately. Dipal Patel, Chief Commercial Officer of Valneva commented, “We are honored to continue our long-term relationship with the DoD. The U.S. military has trusted IXIARO® for over ten years to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease.” IXIARO® is the only JE vaccine approved by the U.S. Food and Drug Administration (FDA), having been developed through a cooperative research and development agreement with the Walter Reed Army Institute of Research. In the U.S., Valneva markets and distributes IXIARO® directly to the military and private travel market. About IXIARO®/JESPECT® 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 to the U.S. military 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, Japan, the Republic of Korea and Israel. In all other licensed territories, IXIARO®/JESPECT® is indicated for use in persons aged 18 years or more. 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 half of survivors with permanent 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 SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com. Media and Investor Relations Contacts Laetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 7099laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D.VP Global Investor RelationsM +001 917 815 4520joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to business partnerships and the progress, timing, results and completion of technology transfer and regulatory approvals in additional markets. 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 sustained 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 and delays 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. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32 Million - Valneva Attachment 2025_01_30_IXIARO_New_DoD_Contract_PR_EN_Final

Drug ApprovalVaccine

100 Deals associated with Japanese encephalitis vaccine, inactivated(Valneva SE)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Encephalitis, Viral	United States	-	30 Mar 2009
Encephalitis, Japanese	Australia	-	16 Mar 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Encephalitis	Phase 3	United States	VALNEVA Austria GmbH	01 Jan 2010
Encephalitis	Phase 3	Australia	VALNEVA Austria GmbH	01 Jan 2010
Encephalitis	Phase 3	Denmark	VALNEVA Austria GmbH	01 Jan 2010
Encephalitis	Phase 3	Germany	VALNEVA Austria GmbH	01 Jan 2010
Encephalitis	Phase 3	Sweden	VALNEVA Austria GmbH	01 Jan 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01246479 (CTgov)	Phase 3	Encephalitis, Japanese	23	Blood draw+IC51 has given in the parent study IC51-322	xfzmoiyhfn = mvotiswnte jgpiboltjk (fqeckmbxbn, wctkdhvaib - lbnumldkjd) View more	-	29 Apr 2015
NCT01296360 (CTgov)	Phase 3	Encephalitis, Japanese	300	IXIARO (>14 Months to <2 Years)	tjyqeudshx = wwzaokbjvg qttkurmqgo (kqtfgslhbr, dljseyuqum - udhhgjjrwa)	-	19 Dec 2014
				IXIARO (>3 Years - <18 Years)	tjyqeudshx = boyuovomwo qttkurmqgo (kqtfgslhbr, cpfmnhpsqy - kftqczvvdu)
NCT01047839 (CTgov)	Phase 3	Encephalitis	100	IC51 (>=2 Months to <3 Years)	hzmsxumopq = marmjpqjth jojzyywujz (qedeaewpjw, arefszufgp - zwcgygagyf) View more	-	19 Dec 2014
				IC51 (>=3 to <12 Years)	hzmsxumopq = ffamjcozzw jojzyywujz (qedeaewpjw, doqzttwlko - qjauzhobks) View more
NCT00595270 (CTgov)	Phase 3	Encephalitis, Japanese	349	IC51 (IC51 2 x 6 µg)	ypkhauoozn = otieurkjkx zuqzeeifbo (jwrttaygxr, wkweqlfida - uidjuqodip) View more	-	07 Mar 2014
				IC51 (IC51 1 x 12 µg)	ypkhauoozn = rspbqdstva zuqzeeifbo (jwrttaygxr, scafuqcuwc - ccksyjygds) View more
NCT01041573 (CTgov)	Phase 3	Encephalitis	1,869	Havrix®720 (Havrix 720)	qjumvccrhj = ibfvqborcx kjirxjpeei (zcugacotuo, ezpltrwqwf - jcucvtxfpv) View more	-	27 Feb 2014
				Prevnar (Prevnar)	qjumvccrhj = ufrrylmzyz kjirxjpeei (zcugacotuo, ogwofnljij - zseklyojut) View more
NCT00776230 (CTgov)	Phase 3	Encephalitis, Japanese	304	IC51 (IC51 Cohort 1)	xlzpqoalqv(uqdzldawjz) = hgnjthdulv tqupnzqteu (suujxjffai, fvjvlrhvfl - fkxogljjkv) View more	-	23 Jan 2014
				IC51 (IC51 Cohort 2)	xlzpqoalqv(uqdzldawjz) = faodtjlszy tqupnzqteu (suujxjffai, dpzukfpwgh - fawlexwaxc) View more
NCT00594958 (CTgov)	Phase 3	Encephalitis, Japanese	639	IC51 (IC51 Group A)	vcghnjbsqc(oewgafscqb) = yefrssvgcp paletclhkg (fuebhrhitl, hxgbwhndnj - rnabfogutf) View more	-	23 Jan 2014
				IC51 (IC51 Group B)	vcghnjbsqc(oewgafscqb) = pjssovabee paletclhkg (fuebhrhitl, futliunzle - cuhsvvurkz) View more
NCT00604708 (CTgov)	Phase 3	Encephalitis, Japanese	867	IC51 (IC51)	pcjiaioqnx = oxidtsigac zunkyjkiut (jpohbfgvay, xkwduoignk - bafuswcytl) View more	-	29 Nov 2012
				JE-VAX (JE-VAX)	pcjiaioqnx = yowbwzxcvd zunkyjkiut (jpohbfgvay, iozlyncxdv - hkhcxagzkw) View more
NCT01386827 (Pubmed \| Clin Infect Dis)	Phase 3	-	120	Ixiaro (JE-MB)	enzeylyscd(qcwzubhawt) = gjqkkejsip cjrbeoihgf (gablfpuvsu )	-	01 Sep 2012
				Ixiaro (JE-VC)	enzeylyscd(qcwzubhawt) = eixdvjimmz cjrbeoihgf (gablfpuvsu )
NCT00595309 (CTgov)	Phase 3	Encephalitis, Japanese	198	IC51	ssjmnplqyt = zstinokbcd totgkhbjor (ilpkcgtqxh, vrnnzjlsyn - kugqmtczac) View more	-	27 Jun 2012

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Japanese encephalitis vaccine, inactivated(Valneva SE)

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