Valneva SE (VALN) Quote

VLA1601/Zika virus/Phase 1 trial
https://valneva.com/press-release/valneva-initiates-phase-1-trial-of-second-generation-zika-vaccine-candidate/


March 26, 2024

Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV). There are currently no preventive vaccines or effective treatments available against ZIKV. As such, this mosquito-borne disease remains a public health threat and is included in the Food and Drug Administration’s Tropical Disease Priority Review Voucher Program[1].

The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States. Participants will receive a low, medium or high dose of VLA1601. In addition, the low dose of VLA1601 will be evaluated with an additional adjuvant, either the CpG 1018® adjuvant from Dynavax Technologies Corporation or 3M-052-AF adjuvant from the Access to Advanced Health Institute (AAHI). Topline data from the trial are expected in the first half of 2025.

VLA1601 is being developed on the original manufacturing platform of Valneva’s licensed Japanese encephalitis (JE) vaccine IXIARO®, which was further optimized to develop the Company’s inactivated, adjuvanted COVID-19 vaccine VLA2001, the first COVID-19 vaccine to receive a standard marketing authorization in Europe. Phase 1 results from Valneva’s first-generation Zika vaccine candidate were reported in 2018 showing a favorable safety profile and immunogenicity in all tested doses and schedules[2].

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “Valneva’s commitment to our vision – to live in a world in which no one dies or suffers from a vaccine-preventable disease – fuels our pursuit for preparedness solutions against the Zika virus. As global temperatures rise and rainfall increases, the habitat for disease-carrying mosquitoes expands, presenting an ongoing public health challenge.”

A vaccine against ZIKV would nicely complement Valneva’s portfolio of travel vaccines against mosquito-borne diseases. The Company received U.S. approval for its chikungunya vaccine IXCHIQ®, the world first and only chikungunya vaccine to address this unmet medical need, in November 2023, and has been commercializing its JE vaccine IXIARO®, for over ten years. Some health authorities and scientific leaders in the field have indicated a preference for a purified inactivated vaccine method compared to other vaccine technologies. This preference stems from the understanding that the primary recipients of a Zika vaccine are anticipated to be women of childbearing age, potentially including those who are pregnant.



About the Zika Virus

The Zika virus (ZIKV) is a mosquito-borne flavivirus that was first discovered in 1947. The first human cases were detected in 1952. Since then, disease outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and, in 2015, in the Americas. Zika virus is currently circulating in Mexico, Central and South America, many countries and territories in the Caribbean region, and in a small number of geographically limited areas of the continental United States. To date, a total of 89 countries and territories have reported evidence of mosquito transmitted Zika virus infection; however, surveillance remains limited globally.

According to the World Health Organization, there is scientific consensus that ZIKV is a cause of microcephaly and Guillain-Barré syndrome. Since 2013, 31 countries and territories have reported cases of microcephaly and other central nervous system malformations associated with ZIKV infection.



About VLA1601

VLA1601 is a highly purified inactivated vaccine candidate against the Zika virus (ZIKV), developed on the original manufacturing platform of Valneva’s licensed Japanese encephalitis vaccine IXIARO®, which was further optimized to develop the Company’s inactivated, adjuvanted COVID-19 vaccine VLA2001, the first COVID-19 vaccine to receive a standard marketing authorization in Europe. Valneva reported positive Phase 1 results for VLA1601 in 2018[3]. The vaccine candidate was immunogenic and showed a favorable safety profile in all tested doses and schedules that was comparable to IXIARO® and other clinical stage ZIKV vaccines.



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 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 IXCHIQ®

In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.

Full Year 2023 Results and Provides Business Updates and Outlook
https://valneva.com/press-release/valneva-reports-full-year-2023-results-and-provides-business-updates-and-outlook/

IXCHIQ: U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine IXCHIQ®

https://valneva.com/press-release/u-s-cdc-advisory-committee-acip-recommends-use-of-valnevas-single-dose-chikungunya-vaccine-ixchiq/


February 29, 2024

Recommendation for use in travelers and laboratory workers follows U.S. Food and Drug Administration (FDA) approval in November 2023[1]
IXCHIQ® is the first and only vaccine approved to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the chikungunya virus

Saint-Herblain (France), February 29, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend use of Valneva’s single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV).

ACIP recommends IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak. Additionally, it may be considered for persons traveling to a country or territory without an outbreak but with evidence of CHIKV transmission within the last five years, who are aged >65 years and likely to have at least moderate exposure to mosquitos (at least two weeks, cumulatively) or who are traveling for a longer duration (six months or more, cumulatively). ACIP also recommended chikungunya vaccination for laboratory workers with potential for exposure to CHIKV.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “Chikungunya poses a significant risk to individuals journeying to or residing in regions where the chikungunya virus and its mosquito vectors thrive. IXCHIQ offers advantages to travelers on vacation and visiting family and to people engaged in business ventures, missions, or laboratory duties. We embrace the ACIP endorsement, marking IXCHIQ® as the only approved and recommended vaccine for the target population. We will continue collaborating with regulatory authorities worldwide to increase the accessibility of IXCHIQ® across regions.”

The ACIP recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (MMWR) to advise healthcare providers on appropriate use of the vaccine.

About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite[2]. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[3]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[4]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[5] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Before IXCHIQ®, there were no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

To make the vaccine more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[6]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[7], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program. Regulatory review by the Brazilian authority ANVISA is ongoing.

About IXCHIQ®
In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.

Please click here for full Prescribing Information for IXCHIQ®.

About Valneva SE
We 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 as well as certain third-party vaccines leveraging our established commercial infrastructure.

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, as well as vaccine candidates against the Zika virus and other global public health threats.

Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com

Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com

Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the approval and use of products and product candidates. 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 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.

[1] Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® – Valneva

[2] Staples, J.E. Hills, S.L. Powers, A.M. “Chikungunya.” In CDC Yellow Book 2020: Health Information for International Travel, by Centers for Disease Control and Prevention. New York: Oxford University Press, 2020

[3] VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020

[4] https://www.who.int/news-room/fact-sheets/detail/chikungunya

[5] PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.

[6] Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries

[7] CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine

Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance
https://valneva.com/press-release/valneva-reports-full-year-2023-revenue-and-cash-provides-first-2024-guidance/

Valneva Announces Sale of Priority Review Voucher for $103 Million
https://valneva.com/press-release/valneva-announces-sale-of-priority-review-voucher-for-103-million/

Thomas Lingelbach, Chief Executive Officer of Valneva, said, “This non-dilutive capital provides an important source of additional funding to advance the continued development of our clinical pipeline. As shown with the recent approval of our chikungunya vaccine, we remain committed to growing our portfolio of vaccines addressing unmet medical needs which have the potential to transform people’s lives.”

Under the tropical Disease Priority Review Voucher Program, FDA awards priority review vouchers to sponsors of tropical disease product applications that meet certain criteria. The program is intended to encourage development of new drugs and biologics for the prevention and treatment of tropical diseases. PRVs can be redeemed to receive priority review of a subsequent marketing application for a different product, sold or transferred.

LET`S GO BACK TO $ 10 AND MORE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine
January 10, 2024

Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine. The Company reported positive pivotal Phase 3 data in adolescents two months ago confirming the immunogenicity and safety profile observed in adults[1].

There is currently no approved chikungunya vaccine for children and Valneva’s vaccine IXCHIQ® is currently the only licensed chikungunya vaccine[2] to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus. Once available, the Phase 2 pediatric data are intended to support a Phase 3 pivotal study in children with the objective to extend the label in this age group following initial regulatory approvals in adults and possibly in adolescents.

The multicenter, prospective, randomized, observer-blinded, Phase 2 clinical trial is planned to enroll approximately 300 healthy children one to eleven years of age at three trial sites in the Dominican Republic and Honduras. Following a safety run-in phase, participants will be randomized to receive either a full dose formulation of the vaccine (120 participants), a half dose formulation (120 participants) or a control vaccine (60 participants).

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This pediatric trial is extremely important. Given the significant threat that chikungunya poses to individuals living in or traveling to endemic areas, it is crucial to make the vaccine accessible to all age groups. By doing so, we can broaden the protection against and reduce the impact of this debilitating disease.”

Valneva was granted approval from the U.S. Food and Drug Administration (FDA) for its chikungunya vaccine IXCHIQ® in November 2023[3]. Three marketing applications are currently under review by the European Medicines Agency, Health Canada and the Brazilian Health Regulatory Agency (Anvisa) with potential approvals in 2024.

About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite[4]. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[5]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[6]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[7] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Before IXCHIQ®, there were no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

To make the vaccine more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[8]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[9], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program.

About IXCHIQ®
In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.

Please click here for full Prescribing Information for IXCHIQ.

About Phase 2 Trial VLA1553-221
VLA1553-221 is a multi-center, randomized, observer-blinded, dose response Phase 2 clinical trial in approximately 300 healthy children aged one to eleven years. The trial will be performed at three trial sites in the Dominican Republic and potentially Honduras. The primary and secondary objectives of the trial are to evaluate the safety and immunogenicity of two different dose levels of Valneva’s single-shot chikungunya vaccine. Additional information, including a detailed description of the trial design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT06106581).

About Valneva SE
We 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 two proprietary travel vaccines as well as certain third-party vaccines leveraging our established commercial infrastructure.

Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the world’s first vaccine against the chikungunya virus and the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.
Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com

Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com

Very bad news on 29 December, 2023!!!!!!!!!!!!!!!!!!!

VLA15: Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate


December 4, 2023

9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic
Trial conclusion expected by year-end 2025
Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026

New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15. The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.

“We are pleased that the Phase 3 trial recruitment is complete. Lyme disease is the most prevalent vector-borne infectious disease in the United States and Europe, can sometimes even lead to long lasting consequences,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer. “If approved, a vaccine could prevent the disease and ease the burden of acute, severe and sometimes persistent consequences in both adults and children. We look forward to progressing the trial with the goal of submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026, subject to positive data.”

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said: “The completion of enrollment is indeed an important milestone in the development of a potential vaccine for Lyme disease. VLA15 has the potential to address a high need in North America and Europe, as it has been designed to offer coverage for the most common circulating types of Borrelia bacteria that cause Lyme disease in these regions. We’re excited about the ongoing trials and the progress towards potentially offering a vaccine against this disease which can result in debilitating sequelae and excessive healthcare usage.”

The VALOR trial, which was initiated in August 2022, has enrolled 9,437* participants five years of age and older, at sites in areas where Lyme disease is highly endemic across the U.S., Europe and Canada. As part of the primary series, participants receive three doses of VLA15 or a saline placebo (1:1 ratio) within the first year, and one booster dose approximately one year after completion of the primary immunization.

The VLA15 candidate has demonstrated a strong immune response and had a favorable safety profile across all dose and age groups in pre-clinical and clinical trials so far.1,2 No vaccine-related serious adverse events (SAEs) and no safety concerns were observed by an independent Data Safety Monitoring Board (DSMB).1,2 A second Phase 3 trial (C4601012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population, is also fully recruited.

The VALOR trial is expected to be concluded by the end of 2025. Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4

About VLA15
There are currently no approved human vaccines for Lyme disease, and VLA15 is the most advanced Lyme disease vaccine candidate currently in clinical development, with two Phase 3 trials in progress. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine candidate covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 is an alum-adjuvanted formulation, administered intramuscularly and has demonstrated a strong immune response as well as satisfactory safety profile in pre-clinical and clinical trials so far.

About the VALOR trial
VALOR is an ongoing randomized, observer-blind, placebo-controlled Phase 3 trial which has enrolled 9,437* participants 5 years of age and older to receive VLA15 or a saline placebo (1:1 ratio). As part of the primary series, participants receive three doses of VLA15 within the first year at months 0, 2 and 5-9, and one booster dose 9-12 months after completion of the primary immunization.5 The final primary series vaccination for participants occurs just before the peak Lyme disease season for the region. Participants will be followed for the occurrence of Lyme disease. The trial is conducted at sites located in areas where Lyme disease is highly endemic across the U.S., Canada and Europe and has enrolled volunteers with a cleared past infection with Borrelia burgdorferi as well as Borrelia burgdorferi naïve volunteers.

About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by the bite of an infected Ixodes ticks.6 It is considered the most common vector-borne illness in the Northern Hemisphere.7,8 While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the U.S. and 129,000 people in Europe.8,9 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system.9,10 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.11

* Number of evaluable participants

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer

Pfizer Disclosure Notice
The information contained in this release is as of December 4, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about an investigational Lyme disease vaccine candidate, VLA15, and a collaboration between Pfizer and Valneva for VLA15, including their potential benefits, Phase 3 clinical trials and the timing of potential regulatory submissions, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, including uncertainties relating to the time needed to accrue cases in the Phase 3 trial and uncertainties relating to an agreement with regulatory authorities on any modifications to the clinical trial plan as needed, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for VLA15; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether VLA15 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of VLA15; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; whether our collaboration with Valneva will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov/ and www.pfizer.com/.

About Valneva SE
We 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 two proprietary travel vaccines as well as certain third-party vaccines leveraging our established commercial infrastructure.

Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the world’s first vaccine against the chikungunya virus, the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

Valneva Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates. 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 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 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.

Media Contacts

Pfizer
Media Relations:
PfizerMediaRelations@pfizer.com
+1 212-733-1226

Investor Relations:
IR@pfizer.com
+1 212-733-4848

Valneva
Laëtitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com

Joshua Drumm, Ph.D.
VP Global Investor Relations
M +1 917 815 4520
joshua.drumm@valneva.com

References

Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate, September 2023. Available at: https://valneva.com/press-release/valneva-and-pfizer-report-positive-pediatric-and-adolescent-phase-2-booster-results-for-lyme-disease-vaccine-candidate/, Accessed: November 2023.
Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate, April 2022. Available at: https://valneva.com/press-release/valneva-and-pfizer-report-positive-phase-2-pediatric-data-for-lyme-disease-vaccine-candidate/ Accessed: November 2023
Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15. April 2020. Available at: https://valneva.com/press-release/valneva-and-pfizer-announce-collaboration-to-co-develop-and-commercialize-lyme-disease-vaccine-vla15/Accessed: November 2023.
Valneva and Pfizer Enter into Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15. June 2022. Available at: https://valneva.com/press-release/valneva-and-pfizer-enter-into-an-equity-subscription-agreement-and-update-terms-of-collaboration-agreement-for-lyme-disease-vaccine-candidate-vla15/Accessed: November 2023.
ClinicalTrials.gov. An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR). July 2022. Available from: https://www.clinicaltrials.gov/ct2/show/NCT05477524. Accessed: November 2023.
Stanek et al. Lyme Borreliosis, 2012, The Lancet 379:461–473
Burn L, et al. Incidence of Lyme Borreliosis in Europe from National Surveillance Systems (2005–2020). 2023. Vector Borne and Zoonotic Diseases. 23(4): 156–171.
Kugeler KJ, et al. Estimating the frequency of Lyme disease diagnoses—United States, 2010-2018. 2021. Emergency Infectious Disease. 27(2).
Centres for Disease Control. Lyme disease. Signs and Symptoms. Available from: https://www.cdc.gov/lyme/signs_symptoms/index.html. Accessed: September
Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nature Reviews Disease Primers. 2016;2:16090.
Centres for Disease Control. Understanding Lyme and Other Tickborne Diseases. May 2022. Available from: https://www.cdc.gov/ncezid/dvbd/media/lyme-tickborne-diseases-increasing.html Accessed: November 2023

https://valneva.com/press-release/pfizer-and-valneva-complete-recruitment-for-phase-3-valor-trial-for-lyme-disease-vaccine-candidate-vla15/

Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ®

December 4, 2023

Primary endpoint met with 97% seroresponse rate 24 months after a single vaccination
Antibody levels remained high and well above the seroresponse threshold, further supporting the anticipated long-term durability of the immune response
No safety concerns identified in long-term follow up

Saint-Herblain (France), December 4, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data twenty-four months after vaccination with a single dose of its chikungunya vaccine IXCHIQ®, further supporting the anticipated long-term durability of the immune response and in line with positive twelve-month persistence data the Company reported in December 2022[1]. These persistence data are intended to supplement the existing approval by U.S. FDA and ongoing regulatory approval processes.

97% of the 316 healthy adults still enrolled in the trial retained neutralizing antibody titers above the seroresponse threshold[2] twenty-four months after the single-dose vaccination. The persistence of antibodies in older adults aged 65 and above was as robust as in younger adults, and even slightly higher in terms of geometric mean titers (GMTs) and seroconversion rates (SRRs). This outcome underscores the vaccine’s potential to offer strong and lasting protection against chikungunya across different age groups. These results follow completion of the pivotal Phase 3 study published in the Lancet[3] in which a seroresponse rate of 96% six months after a single vaccination1 was reported.

Study VLA1553-303 collected long-term safety by following any Adverse Event of Special Interest (AESI) from the preceding study and collecting new-onset SAEs. No safety concerns were identified for the duration of the 24-month follow-up and, as reported in the 12-months data analysis, no AESI was ongoing when participants were enrolled in the trial.

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are very pleased about these twenty-four-month data which confirm IXCHIQ®‘s ability to induce a robust, long-lasting antibody response in both younger and older adults with a single vaccination. Being the world’s first approved vaccine against chikungunya, each positive outcome further strengthens the defense against this significant and expanding public health threat.”

Valneva was granted U.S. FDA approval[4] for its chikungunya vaccine IXCHIQ® in November 2023[5]. Two marketing applications are currently under review by EMA and Health Canada with potential approvals in mid-2024. A clinical study in adolescents is also ongoing in Brazil for which the Company reported positive pivotal Phase 3 data in November 2023[6]. This study is intended to support label extension in this age group and licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations.

https://valneva.com/press-release/valneva-reports-positive-24-month-antibody-persistence-data-for-its-single-shot-chikungunya-vaccine-ixchiq/

VLA1553: (EMA) European Medicines Agency accepts Accelerated Assessment

https://valneva.us20.list-manage.com/track/click?u=a02496e8d59d3bd53cf21eaa7&id=3c8557b507&e=9da0e1dd5c


November 27, 2023

Saint-Herblain (France), November 27, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has performed a technical validation of the Marketing Authorization Application (MAA) for Valneva’s single-shot chikungunya vaccine candidate VLA1553 and has determined that all essential regulatory elements required for scientific assessment were included in the application. The MAA was granted accelerated assessment[1] last month by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”[2].

Accelerated assessment reduces the timeframe for EMA’s CHMP to review a MAA once it is accepted for review from 210 days under the standard review procedure to 150 days. This does not, however, include clock stops when applicants must provide additional information during the review process, which is common in review procedures.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s MAA review acceptance and will work closely with them to bring VLA1553 to market. Chikungunya virus, or CHIKV, has already spread to over 110 countries and the risk of chikungunya spreading in Europe is relatively high due to the possibility of infected travelers[3]. No vaccine or specific treatments are currently available for this debilitating disease which therefore constitutes an unmet medical need. Following approval of VLA1553 in the United States[4], we will continue to work diligently to bring VLA1553 to other territories as soon as possible.”

VLA1553 received approval from the U.S. Food and Drug Administration (FDA)[5] at the beginning of the month under the brand name IXCHIQ®. In the U.S., the vaccine is indicated for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

Mid-November, Valneva also reported positive pivotal Phase 3 immunogenicity data in adolescents for VLA1553 which are intended to support label extension in this age group[6]. The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations.

About Chikungunya

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite[7]. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[8]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[9]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[10] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. In Europe, there is no preventive vaccines or effective treatments available and, as such, chikungunya is considered a major public health threat.

About VLA1553

VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries[11]. It has been designed by deleting a part of the chikungunya virus genome.

Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[12], final lot-to-lot consistency results in May 2022[13], positive twelve-month persistence data in December 2022[14] and positive pivotal Phase 3 data in adolescents in November 2023[15].

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[16]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[17], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.

VLA1553 received FDA approval in November 2023 under the brand name IXCHIQ® and is indicated for the prevention of disease caused by CHIKV in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. Continued approval of IXCHIQ® in the United States is contingent upon verification of clinical benefit in confirmatory studies.

VLA1553 was also granted PRIority MEdicine (PRIME) designation and accelerated assessment by the European Medicines Agency (EMA) in 2020 and 2023 respectively.

The Company intends to commercialize this vaccine by leveraging its existing manufacturing and commercial operations.

Chikungunya/INDIA: French specialty vaccine company Valneva is planning to bring its chikungunya vaccine, the world’s first, to India.

“Our objective is to make this vaccine available in all the countries were it is needed, India included. We are indeed planning to have regulatory interactions with The Drug Controller General of India (DCGI) to discuss how and when we could make this vaccine available in India,” a Valneva spokesperson told businessline.

https://www.thehindubusinessline.com/news/valneva-keen-to-bring-its-chikungunya-vaccine-the-worlds-first-to-india/article67561937.ece

Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

https://valneva.com/press-release/valneva-reports-positive-pivotal-phase-3-immunogenicity-data-in-adolescents-for-its-single-shot-chikungunya-vaccine-candidate/

Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553. These results complement the initial Phase 3 safety data the Company reported for the trial in August 2023[1].

Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union’s Horizon 2020 program, and conducted in collaboration with Instituto Butantan, the VLA1553-321 adolescent trial is intended to support label extension in this age group following recent regulatory approval in adults from the Food and Drug Administration (FDA) in the United States (U.S)[2]. The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations. Additionally, the trial is expected to support regulatory approval in Europe and the initial safety data were included in the submission to the European Medicines Agency (EMA) in October 2023[3]. VLA1553-321 represents the first clinical trial Valneva is conducting in an endemic area and with individuals previously infected with CHIKV.

The pivotal immunogenicity data showed that a single-dose vaccination with VLA1553 induced a robust immune response in adolescents aged 12 to 70%).

The vaccine was highly immunogenic with a Geometric Mean Titer (GMT) of 3890 in baseline seronegative participants. Neutralizing antibody GMTs at Day 29 in baseline seronegative participants were similar to GMTs observed in seropositive participants at baseline, indicating that VLA1553 induces levels of antibodies comparable to those in individuals with a history of CHIKV wild type infection.

As reported previously, VLA1553 administered as a single-dose was generally well tolerated in adolescents aged 12 to

U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ®

November 10, 2023

Saint-Herblain (France), November 10, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved IXCHIQ®, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

The Company will hold an analyst call and a webcast at 3:00pm CET or 9:00am EDT on Monday, November 13, 2023. The link will be available on the Company’s investor page. Please refer to this link Investors – Valneva.

As sponsor of the first chikungunya vaccine approved in the U.S., Valneva has received a Priority Review Voucher (PRV) from the FDA, which it intends to monetize to help finance its research and development (R&D) programs.

With this U.S. approval, IXCHIQ® becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva[1] has brought from early R&D to approval. Valneva reported final pivotal Phase 3 data for the vaccine in March 2022 showing a 98.9% seroresponse rate at 28 days with a single vaccination[2] and final lot-to-lot consistency results in May 2022[3]. IXCHIQ®-induced seroresponse was sustained over time with a 96.3% seroresponse rate six months post-vaccination2. Valneva will continue to evaluate antibody persistence for at least five years[4]. The Company’s pivotal Phase 3 results were published in the Lancet in June 2023.

https://valneva.com/press-release/valneva-announces-u-s-fda-approval-of-worlds-first-chikungunya-vaccine-ixchiq/

VLA1553: EMA and CHMP Accelerated Assessment


October 25, 2023

Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553. Valneva was also granted accelerated assessment[1] for the application by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”.

VLA1553 is currently the first and only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. A Biologic License Application (BLA) is currently under priority review by the U.S. Food and Drug Administration (FDA)[2] with a Prescription Drug User Fee Act (PDUFA) action date planned for the end of November 2023[3]. Additionally, a marketing application is under review by Health Canada[4].

If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s accelerated assessment and will work closely with them to bring this vaccine to market. Chikungunya virus, or CHIKV, is a serious and debilitating mosquito-borne viral infection that poses a significant unmet need and the risk of chikungunya spreading in Europe is relatively high due to the possibility of infected travelers[5]. No vaccine or specific treatments are currently available for this debilitating disease. We will continue to work diligently to bring VLA1553 to different territories as soon as possible.”

The regulatory submissions with the EMA, FDA and Health Canada follow final pivotal Phase 3 data in March 2022[6] (Lancet article), final lot-to-lot consistency results in May 2022[7], twelve-month persistence data in December 2022[8] and positive initial Phase 3 safety data in adolescents[9].

VLA1553 was granted PRIority MEdicine (PRIME) designation by EMA in 2020 and received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively.

About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[10]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[11]. As of July 2022, more than three million cases have been reported in the Americas[12] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries[13]. It has been designed by deleting a part of the chikungunya virus genome.

Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[14], final lot-to-lot consistency results in May 2022[15], positive twelve-month persistence data in December 2022[16] and positive initial Phase 3 safety data in Adolescents[17]. The pivotal Phase 3 data were published in The Lancet[18](article link), the world’s leading peer-reviewed medical journal, in June 2023.

If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[19]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[20], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.

IXIARO®: Supply Contract (32 MIO)
https://valneva.com/press-release/valneva-announces-new-ixiaro-supply-contract-with-the-u-s-government-worth-a-minimum-of-32-million/

Product sales more than doubled in the first half of 2023 to €69.7 million compared to
€33.3 million in the first half of 2022
https://valneva.com/press-release/valneva-reports-half-year-2023-financial-results-and-provides-corporate-updates/

VAL15: https://www.usinenouvelle.com/article/dans-les-pipelines-valneva-j-j-roche.N2170652

Phase II positive sur Lyme pour Valneva

Le candidat-vaccin de la biotech contre la maladie de Lyme, le VLA15 a obtenu des résultats satisfaisants dans sa phase II chez les enfants et les adolescents. En un mois, avec une dose de rappel, le médicament a permis une forte réponse immunitaire, comme ce qui a déjà été observé chez les adultes. Sous réserve des résultats de phase III, Valneva et son partenaire Pfizer espèrent déposer des demandes réglementaires auprès de la FDA et de l’EMA d’ici à 2026.
Essai interrompu pour le macitentan de J&J

Johnson & Johnson (J&J) a annoncé l’arrêt de l’essai de phase III évaluant le macitentan chez des patients souffrant d'hypertension pulmonaire thromboembolique chronique (CTEPH) pour cause de futilité. Cette décision a été prise, suite à la recommandation du comité indépendant de surveillance des données. J&J commercialise ce composé contre l’hypertension artérielle pulmonaire sous le nom d’Opsumit depuis sa première autorisation en 2013.

------------------
Positive Lyme Phase II results for Valneva

The biotech's Lyme disease vaccine candidate, VLA15, has achieved satisfactory results in its Phase II trial in children and adolescents. In one month, with a booster dose, the drug produced a strong immune response, as already observed in adults. Subject to Phase III results, Valneva and its partner Pfizer hope to file regulatory applications with the FDA and EMA by 2026.
Trial halted for J&J's macitentan

Johnson & Johnson (J&J) has announced the discontinuation of the Phase III trial evaluating macitentan in patients with chronic thromboembolic pulmonary hypertension (CTEPH) on the grounds of futility. This decision was taken following the recommendation of the independent Data Monitoring Committee. J&J has been marketing this compound for pulmonary arterial hypertension under the name Opsumit since its first approval in 2013.

Investor Conferences in the United States and Europe

Saint-Herblain (France), August 31, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that members of its senior leadership team are scheduled to participate in 1-on-1 meetings with institutional investors at the following investor conferences in September 2023.

The Company will discuss its single-dose vaccine candidate against the chikungunya virus (VLA1553), currently under priority review by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) action date planned for end of November 2023[1], as well as its Lyme disease vaccine candidate (VLA15), which is currently in Phase 3 clinical trials led by Valneva’s development partner Pfizer. The Company will also discuss its existing commercial vaccine portfolio, which has been resuming strong revenue growth since the lifting of the COVID-19 travel restrictions.

Additionally, the Company will hold a live conference call and webcast for its first half 2023 financial results on Thursday September 21, 2023, at 3 p.m. CEST / 9 a.m. EDT. Please refer to the following links.



Morgan Stanley 21st Annual Global Healthcare Conference

Date: Monday, September 11, 2023

Location: New York, NY



Kepler Cheuvreux Autumn Conference 2023

Date: Tuesday, September 12, 2023

Location: Paris, France



H.C. Wainwright 25th Annual Global Investment Conference

Date: September 12-13, 2023

Location: New York, NY



To request a meeting, please contact your representative at the respective hosting banks.

https://valneva.com/press-release/valneva-to-participate-in-investor-conferences-in-the-united-states-and-europe-in-september-2023/

VLA1553: Health Canada Accepts Valneva’s Chikungunya Vaccine License Application for Review


August 29, 2023

Saint-Herblain (France), August 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has completed screening validation of the Company’s regulatory application for marketing approval of its single-shot chikungunya vaccine candidate VLA1553 in persons aged 18 years and above, and has determined that the New Drug Submission (NDS) application is sufficiently complete to permit a substantive review. Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023. A Biologic License Application (BLA) is currently under priority review[1] by the U.S. Food and Drug Administration (FDA)[2].

VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need. It would also represent the third vaccine Valneva[3] has brought from early research and development to approval.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for U.S. and Canadian travelers. This threat continues to grow as shown by the recent epidemiological alert issued by the Pan American Health Organization (PAHO)[4]. No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to make VLA1553 available in different territories as quickly as possible.”

The regulatory submissions with Health Canada and the FDA follow final pivotal Phase 3 data in March 2022[5], final lot-to-lot consistency results in May 2022[6] and positive twelve-month persistence data in December 2022[7]. The Company’s pivotal Phase 3 results were published in the Lancet in June 2023.

A clinical study of VLA1553 in adolescents aged 12 to 17 years is ongoing in Brazil[8], for which Valneva reported initial Phase 3 safety data in adolescents yesterday[9]. This study, conducted by Valneva’s partner Instituto Butantan and funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is intended to support label extension in this age group following a potential initial regulatory approval in adults from the FDA. The study is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations, as well as regulatory submission in Europe.

The vaccine was granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020 and also received FDA Fast Track, Breakthrough Therapy and Priority Review designations in 2018, 2021 and 2023 respectively.

About Chikungunya

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[10]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[11]. As of July 2022, more than three million cases have been reported in the Americas[12] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

About VLA1553

VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries[13]. It has been designed by deleting a part of the chikungunya virus genome.

Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[14], final lot-to-lot consistency results in May 2022[15] and positive twelve-month persistence data in December 2022[16].

If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[17]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[18], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.

VLA1553 received FDA Fast Track, Breakthrough Therapy designations and Priority Review in 2018, 2021 and 2023, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020.

About Valneva SE

Valneva is a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to commercialize three vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against the chikungunya virus and Lyme disease.

https://valneva.com/press-release/health-canada-accepts-valnevas-chikungunya-vaccine-license-application-for-review/

VLA1553: Positive Initial Phase 3 Safety Data


August 28, 2023

Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553. Immunogenicity data for the trial are expected in November 2023.

Funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted in collaboration with Instituto Butantan, the VLA1553-321 adolescent trial is intended to support label extension in this age group following a potential initial regulatory approval in adults from the Food and Drug Administration (FDA) in the United States (U.S). The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations. The present safety analysis is also expected to enable regulatory submission to the European Medicines Agency (EMA) later this year.

Initial safety data generated in the ongoing trial VLA1553-321, Valneva’s first clinical trial in an endemic area and with individuals previously infected with CHIKV, showed that VLA1553 was generally safe and well tolerated in adolescents aged 12 to 17 years, regardless of previous CHIKV infection.

754 individuals were vaccinated in trial VLA1553-321, and the present analysis includes safety data up to Day 29. An independent DSMB has continuously evaluated safety data during the trial and has not identified any safety concerns. Overall, the adverse event profile is consistent with the profile observed in Valneva’s pivotal Phase 3 trial in adults. The majority of solicited adverse events observed following VLA1553 administration were mild or moderate and resolved within three days. Importantly, the initial data suggest a favorable safety profile in seropositive participants, confirming the observations following re-vaccination of individuals in Phase 1 trial VLA1553-101[1].

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “These new safety data in a younger population and in individuals previously infected with the chikungunya virus confirm the safety profile we previously observed in adults and the elderly. Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus is endemic, it is therefore our objective to make this vaccine available to all age groups, especially as no vaccine or specific treatments are currently available for this debilitating disease.”

Valneva reported final pivotal Phase 3 data in 4,115 adults aged 18 years and above in March 2022[2] and the Lancet subsequently published these results in June 2023[3]. Final lot-to-lot consistency results were published in May 2022[4] and positive twelve-month persistence data in December 2022[5].

A Biologic License Application (BLA) for VLA1553 is currently under priority review by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) action date planned for end of November 2023[6].

Additionally, a regulatory application has also been filed with Health Canada[7]. If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.

About Phase 3 study VLA1553-321

VLA1553-321 is a prospective, double-blinded, multicenter, randomized, placebo-controlled pivotal Phase 3 trial conducted in 754 adolescents aged 12 to 17 years old in Brazil. The VLA1553-321 clinical trial was initiated in January 2022 and Valneva reported enrollment and vaccination completion in February 2023. VLA1553 or placebo was administered as a single intramuscular immunization to participants who were randomized into two study groups at a 2:1 ratio. The primary objective is to evaluate the immunogenicity and safety of the adult dose of VLA1553 28 days following a single vaccination. Secondary objectives of the trial include assessment of safety and immunogenicity up to twelve months following a single vaccination with VLA1553. The study will also provide safety and immunogenicity data in participants previously exposed to chikungunya.

Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04650399).

About Chikungunya

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[8]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[9]. As of July 2022, more than three million cases have been reported in the Americas[10] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

About VLA1553

VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries[11]. It has been designed by deleting a part of the chikungunya virus genome.

Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[12], final lot-to-lot consistency results in May 2022[13] and positive twelve-month persistence data in December 2022[14].

If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[15]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[16], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.

VLA1553 received FDA Fast Track, Breakthrough Therapy designations and Priority Review in 2018, 2021 and 2023, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020.

About Valneva SE

We are a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases. We take a highly specialized and targeted approach to vaccine development by focusing on vaccine solutions addressing unmet medical needs to ensure we can make a difference to peoples’ lives. We apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, and our established vaccine development capabilities, to develop vaccines against diseases which are not yet vaccine-preventable, or for which there are limited effective treatment options. Today, we are leveraging our expertise and capabilities to rapidly advance a broad range of vaccines into and through the clinic, including candidates against the chikungunya virus and Lyme disease.

https://valneva.com/press-release/valneva-reports-positive-initial-phase-3-safety-data-in-adolescents-for-its-single-shot-chikungunya-vaccine-candidate/

VLA1553: 98.9% - PR Chikungunya Vaccine Candidate Phase 3
https://valneva.com/press-release/valneva-announces-publication-of-its-chikungunya-vaccine-candidate-phase-3-data-in-the-lancet/

UPDATE 2-Rebound in travel helps
May 4 (Reuters) - French vaccine maker Valneva reported on Thursday a smaller-than-expected first-quarter loss as sales of travel vaccines Dukoral and Ixiaro improved, propelling its shares 16% up.

Valneva also confirmed its sales outlook for 2023, with revenue expected between 220 million euros and 260 million euros.

"We managed to double our first-quarter vaccine sales year-over-year, keeping us on track to deliver on our full-year sales guidance," Chief Financical Officer Peter Bühler said in a results statement.

After the European Commission dropped nearly all of its orders of 60 million doses of Valneva's COVID-19 vaccine last year, in a move that all but wiped out the shot's value for the company, the French drugmaker, in line with market trends, redirected its focus to the recovering travel industry.

Its Danish peer Bavarian Nordic also said in February it was to acquire a portfolio of travel vaccines from Emergent BioSolutions, as it noted a rebound in travel vaccines.

Valneva said sales for its travel vaccines Dukoral and Ixiaro more than quadrupled year-on-year, benefiting from continued recovery of travel markets and price increases.

It posted a loss of 12.3 million euros ($13.6 million), excluding interest, taxes, depreciation, and amortisation (adjusted EBITDA) in the quarter, compared with a loss of 17.8 million euros analysts forecast in a company-compiled consensus.

The drugmaker's revenue rose over 53% in the quarter to 33.5 million euros, just below analysts' expectations of 34.3 million euros, while research and development expenses fell 32% from a year earlier, driven by lower spending on the company's COVID-19 vaccine.

Valneva said regulatory filings for its Lyme disease vaccine candidate co-developed with Pfizer, are now expected in 2026, a year later than previously announced.

The two companies announced in February that they would stop testing the vaccine in roughly half of U.S. patients in a late-stage study, citing a breach of clinical trial guidelines by a third-party contractor.

($1 = 0.9022 euros) (Reporting by Greta Rosen Fondahn and Laura Lenkiewicz; Editing by Muralikumar Anantharaman and Emelia Sithole-Matarise)

VLA1553: ... to Present on its Chikungunya Vaccine Candidate and Host a Roundtable at the 23rd World Vaccine Congress in Washington D.C.

https://valneva.com/press-release/valneva-to-present-on-its-chikungunya-vaccine-candidate-and-host-a-roundtable-at-the-23rd-world-vaccine-congress-in-washington-d-c/


March 30, 2023

Saint Herblain (France), March 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today it will present on its single-shot chikungunya vaccine candidate, VLA1553, and host a roundtable on Zika vaccines next week at the 23rd World Vaccine Congress in Washington, D.C.

On April 4, 2023, at 11.40am EDT, Valneva’s Chief Medical Officer, Juan Carlos Jaramillo, MD, will host a roundtable discussion on the opportunities and challenges for a Zika vaccine. Valneva successfully developed an inactivated whole-virus Zika vaccine candidate though Phase 1 prior to the COVID-19 pandemic and is currently evaluating potential re-entry into clinical development later this year or early next year.

In addition, on April 5, 2023, at 9.40am EDT, Susanne Eder-Lingelbach, Vice President, Clinical Development at Valneva, will review the clinical results of the Company’s single-shot chikungunya vaccine candidate, for which a regulatory review process is underway with the U.S. Food and Drug Administration (FDA)[1]. If approved, it could become the first vaccine in the world to address the unmet medical need of chikungunya.

Juan Carlos Jaramillo and Valneva’s Chief Executive Officer, Thomas Lingelbach, will be available during the conference for one-on-one meetings. Interested parties may request a meeting at communications@valneva.com.

Valneva will also display a poster on the clinical results of its chikungunya vaccine candidate in the exhibition foyer of the congress and will have a display in the exhibit area at booth #503.

About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 100 countries. It has been designed by deleting a part of the chikungunya virus genome.

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[2]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[3], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.

Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[4], final lot-to-lot consistency results in May 2022[5] and positive twelve-month persistence data in December 2022[6].

VLA1553 received FDA Fast Track, Breakthrough Therapy designations and Priority Review in 2018, 2021 and 2023, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020.

If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.

VLA2001/Covid.19: Clinical and Regulatory Updates
Saint-Herblain (France), March 2, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced additional data from remaining clinical studies and an update on regulatory submissions for its inactivated COVID-19 vaccine, VLA2001. As previously announced, Valneva will not invest in further development of the vaccine, in the absence of a new partnership[1]. It is, however, completing remaining clinical studies and submissions as agreed with regulators.

On February 23, 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the use of VLA2001 in adults 18 to 50 years of age as a booster dose to be given at least seven months following primary vaccination (the second dose) with VLA2001 (homologous booster dose) or with an adenoviral vector COVID-19 vaccine (heterologous booster dose).

Valneva also provided an update on its pivotal Phase 3 Study COV-Compare (VLA2001-301). In this study, neutralizing antibodies on Day 208 (six months after the second dose of the primary vaccination with VLA2001) were non-inferior compared to the active comparator AZD1222, an adenoviral vector vaccine. The fold decline of neutralizing antibodies over six months after a second vaccination with VLA2001 was similar to the active comparator, and less pronounced than for other licensed COVID-19 vaccines[2],[3]. The T-cell response against the spike protein elicited upon vaccination with VLA2001 was in the same range as for the active comparator. Moreover, T-cell reactivity against the nucleocapsid and membrane protein was induced upon vaccination with VLA2001.

Additionally, results from VLA2001-304, a Phase 3 study in older adults, 56 years of age and above, showed that VLA2001 was well tolerated by these participants when administered as a two-dose or three-dose immunization, thus confirming the previously reported favorable safety profile of VLA2001[4]. In this age group, a two-dose vaccination with VLA2001 was inferior in terms of geometric mean titers and seroconversion rates compared to younger adults aged 30 years and above. After two doses, immunogenicity in older adults was at a level which could be correlated with 60-70% vaccine efficacy against ancestral SARS-CoV-2[5]. A third dose of VLA2001 further increased immunogenicity in participants aged 56 years and above to the titers associated with vaccine efficacy of >90% against ancestral SARS-CoV-2[6],[7].

Finally, VLA2001’s shelf life was recently extended to 21 months compared to 18 months previously. The Company will continue to submit data to further extend it.
https://valneva.com/press-release/valneva-provides-clinical-and-regulatory-updates-for-its-covid-19-vaccine-vla2001/

VLA1553: FDA Accepts Priority Review - Valneva’s Chikungunya Vaccine License Application for Priority Review

Saint-Herblain (France), February 20, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has completed a filing review of its Biologics License Application for Valneva’s single-shot chikungunya vaccine candidate VLA1553 and has determined that the application is sufficiently complete to permit a substantive review. The review classification is Priority.

VLA1553 has been assigned a Prescription Drug User Fee Act (PDUFA) review goal date at the end of August 2023, which is the date by which the FDA intends to take action on the application. The FDA’s acknowledgement of filing does not mean that a license will be granted, nor does it represent any evaluation of the adequacy of the data submitted.

About Chikungunya

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat. As of July 2022, there were more than 3 million reported cases in the Americas[1] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Infection leads to symptomatic disease in up to 97% of humans after three to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. It is estimated that over three quarters of the world’s population live in areas at-risk of CHIKV transmission[2]. High risk areas of infection are places where chikungunya virus-carrying mosquitos are currently endemic, including the Americas, parts of Africa, and Southeast Asia.
https://valneva.com/press-release/fda-accepts-valnevas-chikungunya-vaccine-license-application-for-priority-review/

VLA15: Pfizer and Valneva Issue Update on Phase 3

New York & Saint-Herblain (France), February 17, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announce that Pfizer, as the study sponsor, has decided to discontinue a significant percentage of participants in the U.S. who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15. These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event.

GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. These standards are designed to put participants’ interests first and ensure high scientific integrity. Once Pfizer learned of potential violations of GCP, it conducted a thorough review of the operations and data collection at the clinical trial sites run by the third party and followed standard operating safeguards to determine the correct course of action.

The clinical trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites. The companies intend to work with regulatory authorities, and as previously announced,1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

Participants are being notified and Pfizer has also notified the FDA, other regulatory agencies and the independent Institutional Review Board for this study.

Integrity of data collected in clinical trials is critical to provide evidence and confidence in a potential vaccine or medicine’s safety and efficacy. Pfizer and Valneva are committed to collecting robust data needed for potential regulatory submission of VLA15. While VLA15 is still under investigation, to date the companies have been encouraged by the data from the Phase 2 clinical studies, which demonstrated strong immunogenicity and acceptable safety and tolerability profiles.2-4

About VLA15
VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.5,6 The program was granted Fast Track designation by the U.S. FDA in July 2017.7

About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks.8 It is considered the most common vector-borne illness in the Northern Hemisphere.9 While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the United States and 130,000 people in Europe.10,11 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system.12 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.10

https://valneva.com/press-release/pfizer-and-valneva-issue-update-on-phase-3-clinical-trial-evaluating-lyme-disease-vaccine-candidate-vla15/

VLA1553: Valneva Completes Enrollment for Adolescent Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate


February 14, 2023

Saint-Herblain (France), February 14, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it completed enrollment and vaccination for a Phase 3 trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553. First results of the trial are expected mid-2023.

Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the VLA1553-321 adolescent trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the Food and Drugs Administration (FDA) in the United States (U.S).

Valneva completed rolling submission of the Biologics License Application (BLA) to the U.S. FDA for approval of VLA1553 in persons aged 18 years and above in December 2022[1]. If BLA filing is accepted and approved, VLA1553 could become the first chikungunya vaccine to be marketed in the U.S. Valneva reported final pivotal Phase 3 data for VLA1553 in March 2022[2] and final lot-to-lot consistency results in May 2022[3]. The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination[4].

The VLA1553-321 adolescent trial is also expected to support licensure of the vaccine in Europe and Brazil, which would be the first potential approval for use in endemic populations.

Conducted in collaboration between Instituto Butantan and Valneva, VLA1553-321 is a double-blinded, multi-center, randomized and placebo-controlled Phase 3 trial. 754 adolescents aged 12 to 17 years were vaccinated following randomization at a 2:1 ratio to receive either VLA1553 or placebo. The primary objective of the trial is to evaluate safety and immunogenicity 28 days following a single vaccination with VLA1553. Participants will be evaluated for the primary endpoint and followed up to twelve months. The study will also provide the first systematic safety and immunogenicity data in participants previously exposed to chikungunya.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “Recruitment completion in this study is an important milestone for the overall program. We reported compelling pivotal Phase 3 results in adults and in the elderly, and we are now looking forward to obtaining results in adolescents later this year. Chikungunya virus is a major, growing public health threat which has already impacted over 100 countries and affected millions worldwide, yet no vaccine or specific treatment is currently available to prevent this debilitating disease.”

Dr. Esper Georges Kallas, President of Instituto Butantan, which will develop, manufacture and market VLA1553 in Low- and Middle-Income Countries, commented, “the achievement of this goal is a major milestone to expand the vaccine indication in adolescents. Based on a single-dose schedule, the VLA1553 chikungunya vaccine could become a key tool to prevent the chikungunya disease in endemics areas and fight the disease-induced public health burden.”

Dr. Melanie Saville, Director of Vaccine Research & Development at CEPI, which provided funding for this study, added, “Millions of people have been affected by chikungunya and, today, over a billion people live in areas where chikungunya outbreaks occur. The progress Valneva has made to date brings the world one step closer towards a safe and effective vaccine against this debilitating disease, for which there is currently no specific treatment nor vaccine licenced for human use. Data from this Phase 3 study will help to ensure that the people most affected by this virus can benefit from this product and help regulators assess this important vaccine candidate.”

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[5]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[6], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.

Brazil had an exponential increase of chikungunya cases in 2021 in comparison to 2020, according to data from the Brazilian Vigilance Health Secretary (SVS). At the beginning of December 2021, 90,147 chikungunya cases had been registered compared to 78,808 over the same period in the previous year. The three states that most registered cases of the disease were Pernambuco (29,700 cases), São Paulo (18,100 cases) and Paraíba (9,000 cases), respectively. In 2021, São Paulo which is the most populous state in the country, went from 468 cases to 18,156 cases compared to 20207.

https://valneva.com/press-release/valneva-completes-enrollment-for-adolescent-phase-3-trial-of-single-shot-chikungunya-vaccine-candidate/?lang=en

Merck admits defeat in race with Valneva to get first chikungunya vaccine to market

https://www.fiercebiotech.com/deals/merck-admits-defeat-race-valneva-get-first-chikungunya-vaccine-market

VLA1553: BLA Submission completed / U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate

Saint-Herblain (France), December 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has completed rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its single-shot chikungunya vaccine candidate, VLA1553. Valneva is seeking approval of its investigational chikungunya vaccine in persons aged 18 years and above.

This BLA application follows final pivotal Phase 3 data reported in March 2022[1] and final lot-to-lot consistency results reported in May 2022[2]. A clinical study of VLA1553 in adolescents is ongoing in Brazil[3], which may support future regulatory submissions in this group if VLA1553 is initially approved in adults. The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination[4].

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “The completion of our BLA submission is extremely important as it takes us a step closer to potentially bringing a preventative solution to fight this debilitating disease. Chikungunya is a major public health threat transmitted to humans by infected mosquitoes, and no vaccine or specific treatments for the disease are currently available. If the FDA approves the submission, our goal is to provide a tool to help curtail this growing, unmet medical need.”

The FDA will now review the filing for acceptance, determine priority review eligibility and the action date which it targets to complete its evaluation. The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA1553 in Europe in the second half of 2023.

About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[5]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 100 countries. As of July 2022, more than three million cases have been reported in the Americas[6] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 100 countries. It has been designed by deleting a part of the chikungunya virus genome.

Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[7] and final lot-to-lot consistency results in May 2022[8].

If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[9]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[10], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program.

Valneva to Conduct Investor Meetings during the J.P. Morgan Healthcare Conference and Oddo BHF Forum

December 21, 2022

Saint-Herblain (France), December 21, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team including Thomas Lingelbach, CEO and Peter Bühler, CFO will hold investor meetings during the 41st Annual J.P. Morgan Healthcare Conference, January 9 – 12, 2023 in San Francisco and the Oddo BHF Forum, January 5 – 6, 2023 in Lyon France.

Valneva’s CEO and CFO will notably discuss the Company’s current vaccine pipeline and commercial products as well as highlight Valneva’s core near- and mid-term value drivers, including its Lyme disease vaccine candidate VLA15 (Phase 3, partnered with Pfizer) and its single shot chikungunya virus vaccine candidate VLA1553 (rolling submission of biologics license application underway).

To schedule a 1on1 investor meeting with Valneva, institutional investors and analysts can contact Valneva’s investor relations department at investors@valneva.com.

VLA15: There were no safety concerns observed in this six-month observational follow up
December 1, 2022

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Higher antibody levels were observed in the three-dose vaccination schedule versus the two-dose vaccination schedule, further validating the use of this schedule in the ongoing Phase 3 study
There were no safety concerns observed in this six-month observational follow up

New York & Saint-Herblain (France), December 1, 2022 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today reported antibody persistence data six months after the completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule with their Lyme disease vaccine candidate, VLA15 in both children and adults. This is the first time antibody persistence data are reported in pediatric populations for this vaccine candidate.

Following positive immunogenicity and safety data for Phase 2 study VLA15-221 in April 2022[1], Valneva and Pfizer evaluated the persistence of antibodies six months after the Month 0-2-6 and the Month 0-6 vaccination schedule with VLA15 in healthy adults and pediatric participants (5 to 65 years of age). Data were collected in 96 healthy adults and 81 pediatric participants (5-17 years of age) for the Month 0-2-6 vaccination schedule and in 84 healthy adults and 78 pediatric participants (5-17 years of age) for the Month 0-6 schedule.

As observed in previous clinical studies with VLA15, antibody levels declined over time in all study groups but remained above baseline, confirming their persistence six months after completion of both vaccination schedules. Overall, antibody levels remained higher with the three-dose vaccination schedule compared to the two-dose schedule. Geometric mean fold rise (GMFRs) compared to baseline were 1.9-fold for Serotype 1 (ST1) to 3.2-fold Serotype 2 (ST2) across all age groups in the Month 0-2-6 vaccination schedule. The highest GMFRs were reported in the 5 to 11 years old age group, with GMFR levels at 2.8-fold (ST1) to 6.6-fold (ST2).

These results further validate the use of the three-dose vaccination schedule which is also included in the Phase 3 protocols for all participants.

No vaccine-related serious adverse events (SAEs) and no safety concerns were observed in this six-month observational follow up.

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are pleased with these antibody persistence data that further validate the use of the three-dose vaccination schedule in our ongoing Phase 3 study and the acceptable safety and tolerability profiles of our vaccine candidate. Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere, and each new report of positive data takes us a step closer to potentially bringing this vaccine to both adults and children who could benefit from it.”

Earlier this year, Pfizer and Valneva initiated a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of VLA15[2]. Approximately 6,000 participants 5 years of age and older will receive three doses of VLA15 180 µg or saline placebo as a primary vaccination series followed by one booster dose of VLA15 or saline placebo (1:1 ratio). Enrollment is ongoing in Europe and the United States and expected to be completed in the second quarter of 2023. To learn more, visit www.pfizerclinicaltrials.com/nct05477524. To achieve the required pediatric safety database, Pfizer and Valneva are planning to initiate a complementary Phase 3 clinical study in early December 2022 to collect additional VLA15 safety data in participants 5 to 17 years of age.

“Rates of Lyme disease continue to increase globally, underscoring the importance of a vaccine that may help protect both adults and children,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer of Vaccine Research & Development at Pfizer. “These six-month antibody persistence data are encouraging, and we hope that the data generated from the Phase 3 studies will further support the positive evidence for VLA15 to date.”

Pending successful completion of the Phase 3 studies, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.

About VLA15
VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4 The terms of the collaboration agreement include a $25 million milestone payment made to Valneva upon Pfizer’s initiation of the Phase 3 study. The program was granted Fast Track designation by the U.S. FDA in July 2017.5

About Clinical Study VLA15-221
VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It is the first clinical study with VLA15 which enrolled a pediatric population (5-17 years old).

585 healthy participants received VLA15 at two different immunization schedules (month 0-2-6 [N=190] or month 0-6 [N=187]) or three doses of placebo (month 0-2-6 [N=208]). Vaccine recipients received VLA15 at a dose of 180 µg, which was selected based on data generated in the two previous Phase 2 studies. The main safety and immunogenicity readout was performed one month after the primary vaccination series. A subset of participants will receive a booster dose of VLA15 or placebo at month 18 (booster phase) and will be followed for three additional years to monitor antibody persistence.

VLA15 is tested as an alum-adjuvanted formulation and administered intramuscularly. The study is being conducted at U.S. sites located in areas where Lyme disease is endemic and has enrolled both volunteers with a cleared past infection with Borrelia burgdorferi as well as Borrelia burgdorferi-naïve volunteers.

About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks.6 It is considered the most common vector-borne illness in the Northern Hemisphere.7 While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the United States and 130,000 people in Europe.8,9 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system.9 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.8

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

VALNEVA Investor Day in New York City

Saint-Herblain (France), November 29, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it will host an in-person investor day in New York City to discuss the Company’s current vaccine pipeline, commercial products, and future directions from 10:00 AM to 12:00 PM ET on Tuesday, December 6, 2022. The event will also be webcast live and archived on the Company’s website.

Valneva’s Chief Executive Officer Thomas Lingelbach, Chief Financial Officer Peter Bühler, and other members of the Company’s senior leadership team will highlight Valneva’s core near- and mid-term value drivers: its Lyme disease vaccine candidate VLA15 (Phase 3, partnered with Pfizer), which is the only Lyme vaccine program in advanced clinical development worldwide, and its single shot chikungunya virus vaccine candidate VLA1553, for which pre-commercial and market access preparations are ongoing as rolling submission of a biologics license application (BLA) is currently underway. Valneva will also provide an update on its existing commercial business and select pre-clinical development programs, followed by a financial overview.

A live Q and A session will follow the formal presentations with opportunity for virtual attendees to participate in the Q and A.

Registration: https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MjE0NQ==

Dipal Patel (GSK) as Chief Commercial Officer

https://valneva.com/press-release/valneva-appoints-dipal-patel-as-chief-commercial-officer/

Saint-Herblain (France), November 17, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the appointment of Dipal Patel as Chief Commercial Officer (CCO) and Management Board member. With this newly created role, Valneva strengthens its management team with a recognized commercial industry leader as the Company advances its chikungunya vaccine candidate towards potential market entry in 2023.

Ms. Patel is an established commercial leader with over 23 years of experience in the pharmaceutical sector covering commercial strategy, execution, market access and lifecycle management. Over her career, she has held roles of increasing responsibilities across multiple countries including the United States, Australia, Belgium, Singapore, Thailand, and the European and emerging markets regions. Since 2019, Ms. Patel has been Global Commercial Head of GSK’s shingles vaccine (Shingrix®), leading a global cross-functional team establishing it as a global brand with significant worldwide expansion.

Thomas Lingelbach, Chief Executive Officer of Valneva, said, “Dipal’s addition to our team represents an important and timely step forward in strengthening Valneva’s commercial and strategic leadership. As the travel industry recovers, Dipal will ensure we are further growing our commercial business and preparing the best market access and launch for our chikungunya vaccine candidate. We are excited to leverage the wealth of knowledge, expertise, and insights she brings, and we look forward to her contributions to the growth and strategic development of the Company.”

Ms. Patel, newly appointed Chief Commercial Officer of Valneva, stated, “The last few years have put an increasing focus on the importance of vaccine preventable diseases. I am excited to be part of an organization with a strong [url]vision to address some of the highest unmet medical needs in infectious diseases. I look forward to working with my new team to drive Valneva’s growth and excel in the upcoming launch and commercialization of our chikungunya vaccine candidate.”

Total nine-month revenues of €249.9 million, a ~ 3.5-fold increase compared to 2021

https://www.globenewswire.com/en/news-release/2022/11/10/2552664/0/en/Valneva-Reports-Nine-Month-2022-Results-and-Provides-Corporate-Updates.html

VLA1553: Presenting Single-Shot Chikungunya Vaccine Candidate at Leading Scientific Conferences

October 10, 2022

Valneva initiated rolling submission with the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for licensure of its single-shot chikungunya vaccine candidate in individuals aged 18 years and above in August 2022.

This BLA submission follows final pivotal Phase 3 data reported in March 2022[1] and final lot-to-lot consistency results reported in May 2022[2]. A clinical study of VLA1553 in adolescents is ongoing in Brazil[3], which may support future regulatory submissions in this group if VLA1553 is approved in adults.

The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA1553 in Europe in the first half of 2023.

Saint-Herblain (France), October 10, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA),
a specialty vaccine company, announces today it will present on its single-shot chikungunya vaccine candidate at several leading scientific conferences during the fourth quarter of 2022.

At the World Vaccine Congress Europe in Barcelona, Valneva will present
“One step closer to a chikungunya vaccine: update on Valneva’s live-attenuated vaccine candidate,”
on October 13, 2022 at 2:45pm CEST. The Company will also have a display in the
exhibit area at booth #46 for the duration of the Congress, from October 11 through 14, 2022.

On October 27, 2022 at 10:30am ICT, Valneva will present
“Progress of Clinical Development of a Live-Attenuated Single Shot Chikungunya Vaccine Candidate” as part of the
Vaccines for Tropical Diseases symposium at the 20th International Congress for Tropical Medicine and Malaria (ICTMM2020) in Bangkok.

Valneva will also present on the Phase 3 clinical development of its single-shot chikungunya
vaccine candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 2022 Annual Meeting,
taking place October 30 through November 3, 2022 in Seattle.
The Company will present an abstract on November 1, 2022 at 10:15am PST during an in-person scientific session.

At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) European Congress taking
place November 6 through 9, 2022 in Vienna and online, two posters will be presented:
“Burden of Illness and Paucity of Treatment of the Mosquito-Borne Chikungunya Virus (CHIKV)” and
“The Economic Burden of the Globally Spreading Chikungunya Virus: A Systematic and Targeted Review.”

Finally, the Company will present at the Joint International Tropical Medicine Meeting (JITMM) 2022 in
Bangkok from December 7 through 9, 2022.
Presentations will be made by Valneva’s senior scientific leadership, including Juan Carlos Jaramillo, MD,
Chief Medical Officer of Valneva; Katrin Dubischar, VP Program Director – Chikungunya Vaccine; and Susanne Eder-Lingelbach, VP Clinical Development, among others.

Guidance for mRNA/Florida.NOT for 18-39 years old ...

https://content.govdelivery.com/accounts/FLDOH/bulletins/3312697

Guidance for mRNA COVID-19 Vaccines
October 7, 2022
https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-doc.pdf

ref
https://web.archive.org/web/20221007232657/https://content.govdelivery.com/accounts/FLDOH/bulletins/3312697

https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-doc.pdf

CDC study on rMNA (Pfizer-BioNTech+Moderna)
https://www.cdc.gov/

https://www.bmj.com/content/379/bmj-2022-072141

Participants 893?461 adults (≥18 years) admitted to one of 261 hospitals or to one of 272 emergency department
or 119 urgent care centers for covid-like illness tested for SARS-CoV-2.

Main outcome measures The main outcome was waning of vaccine effectiveness with
BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccine during the omicron and delta periods,
and the period before delta was dominant using logistic regression conditioned on
calendar week and geographic area while adjusting for age, race, ethnicity, local virus circulation,
immunocompromised status, and likelihood of being vaccinated.

Results 45?903 people admitted to hospital with covid-19 (cases) were compared with
213?103 people with covid-like illness who tested negative for SARS-CoV-2 (controls),
and 103?287 people admitted to emergency department or urgent care with covid-19 (cases)
were compared with 531?168 people with covid-like illness who tested negative for SARS-CoV-2.

In the omicron period, vaccine effectiveness against covid-19 requiring admission
to hospital was 89% (95% confidence interval 88% to 90%) within two months after dose 3
but waned to 66% (63% to 68%) by four to five months.
Vaccine effectiveness of three doses against emergency department or urgent care visits
was 83% (82% to 84%) initially but waned to 46% (44% to 49%) by four to five months.
Waning was evident in all subgroups, including young adults and individuals who
were not immunocompromised; although waning was morein people who were
immunocompromised.
Vaccine effectiveness increased among most groups after a fourth dose in whom this booster was recommended.

Conclusions Effectiveness of mRNA vaccines against moderate and severe covid-19 waned with time after vaccination.

_______________________
"The results confirm the low efficacy of basic immunization with the two U.S.-approved mRNA
vaccines from Pfizer/Biontech and Moderna. Protection against hospitalization was
only 73 percent in the first two months after the second dose (versus 96 percent in the delta wave).
The weak protective effect of basic immunization continues to wane over time: After six to eight months,
the protective effect against hospitalization was only 48 percent,
and after more than 14 months, it was just 19 percent," reported the "Deutsches Ärzteblatt."

____ OT
https://www.medrxiv.org/content/10.1101/2022.07.05.22277189v1.full
https://www.cell.com/iscience/fulltext/S2589-0042(22)01119-1

Closing of Upsized €102.9 Million Global Offering
October 4, 2022

The financing was led by US healthcare specialist Deep Track Capital and also included existing shareholders such as French state-owned bank Bpifrance.
Proceeds to be primarily used to continue to advance both the Company’s Phase 3 Lyme disease and chikungunya vaccine candidates towards marketing approval and to progress preclinical assets.

Saint Herblain (France), October 4, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announced today the closing of its previously announced global offering to specified categories of investors of an aggregate 21,000,000 new ordinary shares, consisting of a public offering of 375,000 American Depositary Shares (“ADSs”), each representing two ordinary shares, in the United States at an offering price of $9.51 per ADS (the “U.S. Offering”), and a concurrent private placement of 20,250,000 ordinary shares in Europe (including France) and other countries outside of the United States at the corresponding offering price of €4.90 per ordinary share (the “European Private Placement”, and, together with the U.S. Offering, the “Global Offering”). Aggregate gross proceeds of the Global Offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately €102.9 million ($99.9 million).

Valneva’s ordinary shares are listed on Euronext Paris under the symbol “VLA” and its ADSs are listed on the Nasdaq Global Select Market under the symbol “VALN”.

Goldman Sachs, Jefferies, Guggenheim Securities and Bryan, Garnier & Co. acted as joint bookrunners for the Global Offering.

The Company has filed a shelf registration statement on Form F-3 relating to the ADSs and ordinary shares sold in the Global Offering with the U.S. Securities and Exchange Commission (“SEC”) on August 12, 2022, which was declared effective on August 19, 2022. The offering was made by means of a prospectus and copies of the prospectus relating to and describing the terms of the Global Offering may be obtained from Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: prospectus-ny@ny.email.gs.com or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at +1 877 821 7388 or by email at Prospectus_Department@Jefferies.com.

Application was made to list the new ordinary shares issued pursuant to the Global Offering on Euronext Paris pursuant to a listing prospectus (the “Listing Prospectus”) which was approved by the Autorité des Marchés Financiers (“AMF”) on September 30, 2022 under number 22-405. The Listing Prospectus comprises (i) the 2021 universal registration document filed with the AMF on March 23, 2022 (document d’enregistrement universel 2021) under number D. 22-0140 (the “2021 URD”), as completed by an amendment to the 2021 universal registration document filed with the AMF on September 30, 2022 under number D. 22-0140-A01 (the “Amendment”) and (ii) a securities note (Note d’opération) (the “Securities Note”), including (iii) a summary of the prospectus. Copies of the Company’s 2021 URD, as amended, is available free of charge on the Company’s website. The Listing Prospectus has been published on the Company’s website and on the AMF’s website (www.amf-france.org).

VAL2001: 2022-SEP-26: Update on its COVID-19 2nd GEN Activities

Saint-Herblain (France), September 26, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced a further update on its COVID-19 vaccine activities.

The Company had previously communicated that it would invest in further
development of a potential second-generation COVID-19 vaccine only if it received
the necessary funding or commitments to such funding during the third quarter of
2022[1]. The Company is in active discussions with a prospective partner for
potentially funding the development of a second-generation COVID-19 vaccine.
These ongoing discussions may continue for several months and may not lead to an
agreement.

In parallel, Valneva is continuing discussions with various governments and has
initiated regulatory processes with additional regulatory authorities, with the aim to
deploy remaining inventory into international markets in the next twelve months. The
Company also expects to report additional clinical data in the fourth quarter of 2022,
notably heterologous booster data, which may potentially support the positioning of its
inventory.

Thomas Lingelbach, Valneva’s Chief Executive Officer, commented, “As we are near the end of the third quarter 2022, we are engaged in active discussions that are likely to continue into the coming months. We therefore plan to continue exploring these potential funding opportunities and will provide future updates if and when we enter into an agreement for further development of our COVID-19 vaccine program.”

PreHevbri®: Valneva and VBI Vaccines Announce European Partnership for Marketing and Distribution of PreHevbri®


September 8, 2022

SAINT-HERBLAIN, France and CAMBRIDGE, Mass. (September 8, 2022) – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (Valneva) and VBI Vaccines Inc. (Nasdaq: VBIV) (VBI) today announced a partnership in select European markets for the marketing and distribution of PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)], the only 3-antigen hepatitis B vaccine approved in Europe.

Under the terms of the agreement, specialty vaccine company Valneva will promote and distribute PreHevbri throughout select European countries, which initially include the United Kingdom, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands. Valneva and VBI expect PreHevbri to be available in these countries in early 2023.

Thomas Lingelbach, President and CEO of Valneva, commented: “We welcome this partnership with VBI which underlines Valneva’s expertise in vaccine commercialization. Among the past years, we have continued to develop our third-party vaccine marketing and distribution activities further, notably with the signing of a distribution agreement with Bavarian Nordic in 2020, and we are extremely pleased to add VBI’s Hepatitis B vaccine to this portfolio today. Our objective is to continue leveraging our commercial infrastructure to combat as many infectious diseases as we can.”

Jeff Baxter, President and CEO of VBI, commented: “This partnership is a significant milestone for PreHevbri, enabling us to hit the ground running in Europe. Valneva has substantial local knowledge, experience, and relationships in each of these European countries where we expect to launch, which will be of critical value as we work, collectively, to provide broad access to this differentiated 3-antigen HBV vaccine in Europe. Strategically, VBI and Valneva are two companies aligned by a shared mission to reduce the burden of infectious disease, and this new collaboration will build upon that meaningful synergy.”

PreHevbri was approved by the European Commission (EC) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) in the second quarter of 2022 for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults.

About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

About PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)]
PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the European Union/European Economic Area, the United Kingdom, the United States, and Israel. The brand names for this vaccine are: PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac® (Israel).

Full European Summary of Product Characteristics for PreHevbri are available from the EMA website at www.ema.europa.eu.

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

U.S. Indication
PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)
Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio. Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio. PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free). To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov. Please see Full Prescribing Information.

About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to commercialize three vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and the chikungunya virus.

Valneva Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, its manufacturing and commercialization capabilities, and estimates for future performance. 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 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 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.

About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

Website Home: http://www.vbivaccines.com/

News and Resources: http://www.vbivaccines.com/news-and-resources/

Investors: http://www.vbivaccines.com/investors/

VBI Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com

Valneva Contacts
Laëtitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
Phone: +33 (0)6 4516 7099
Email: laetitia.bachelot-fontaine@valneva.com

Joshua Drumm, Ph.D.
VP Global Investor Relations
Phone: +1 917 815 4520
Email: joshua.drumm@valneva.com

VLA2001. The Lancet Infectious Diseases - Phase 3 Data

September 6, 2022

Saint-Herblain (France), September 6, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that The Lancet Infectious Diseases (“The Lancet ID”), a peer-reviewed medical journal, has published the Company’s pivotal Phase 3 clinical data for its inactivated, whole-virus COVID-19 vaccine, VLA2001.

The paper, entitled “Immunogenicity and safety of an inactivated whole-virus COVID-19 vaccine (VLA2001) compared with the adenoviral vector vaccine ChAdOx1 in adults in the UK (COV-COMPARE): interim analysis of a randomised, controlled, phase 3, immunobridging trial” provides a detailed analysis of the Phase 3 results, showing that VLA2001 demonstrated superior neutralizing antibody titer levels versus the comparator vaccine, as well as broad T-cell responses against the S- (spike), M- (membrane), and N- (neucleocapsid) proteins, and a significantly better tolerability profile versus the comparator vaccine. It can be accessed via the following link: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00502-3/fulltext.

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This Lancet publication is a strong scientific and developmental validation of the work that has been accomplished at Valneva. We are pleased that more detailed results on our inactivated COVID-19 vaccine are now available to the scientific and broader public health communities.”
https://www.thelancet.com/journals/laninf/home

Valneva reported positive topline Phase 3 results for VLA2001 in October 2021[1].

In August 2022, the World Health Organization issued recommendations for use of Valneva’s inactivated COVID-19 vaccine[2].

The Company published safety and immunogenicity data from the Phase 1/2 trial of VLA2001 in the Journal of Infection[3] in June 2022.

https://valneva.com/press-release/valneva-announces-publication-of-its-covid-19-vaccine-phase-3-data-in-the-lancet-infectious-diseases/

VLA2001: Heterologous Booster

Saint-Herblain (France), August 29, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 results for its inactivated, adjuvanted COVID-19 vaccine VLA2001. Additional readouts from the Company’s pivotal VLA2001-301 “Cov-Compare” trial showed persistent immunogenicity and first positive heterologous booster results following primary vaccination with ChAdOx1-S (AstraZeneca).

The Company previously reported immunogenicity data at Day 43 post primary vaccination[1] and has now evaluated immunogenicity in VLA2001-301 trial participants approximately two months following primary immunization (“Day 71”), as part of the prespecified analysis of secondary endpoints. At Day 71, neutralizing antibody titers induced by VLA2001 were non-inferior to ChAdOx1-S: VLA2001 GMT was 444.0 (95% CI: 414.0, 476.2), ChAdOx1-S GMT was 411.8 (95% CI: 389.7, 435.0). Seroconversion rates remained constant at Day 71 (above 92% in both treatment groups). Additionally, T-cell responses analyzed in a sub-set of the 3,560 trial participants followed for approximately six months after primary vaccination (“Day 208”) showed that VLA2001 induced broad antigen-specific IFN-gamma producing T-cells reactive against the S-protein, as well as the N- and M-proteins up to Day 208. The safety profile of VLA2001 continues to be favorable and the vaccine was well tolerated up to Day 208.

The occurrence of COVID-19 cases (exploratory endpoint) was similar between the VLA2001 and ChAdOx1-S groups, supporting earlier findings[2]. There were no severe COVID-19 cases up to Day 208 in the direct comparative groups (above 30 years of age), which may suggest that both vaccines provided similar protection against severe COVID-19 disease caused by the circulating variant(s) (predominantly Delta). There was one severe COVID-19 case in the 18-29 years of age cohort (n=1040 participants) in a participant with a BMI >40 and history of asthma.

A total of 958 participants from the VLA2001-301 trial received a single dose of VLA2001 approximately eight months after priming with either VLA2001 or ChAdOx1-S (AstraZeneca) to evaluate the booster effect in both homologous and heterologous (“mix and match”) settings. Previously, VLA2001 showed an excellent immune response after a third dose administered seven to eight months in participants who received VLA2001 as a primary vaccination in a Phase 1/2 study[3].

In both the homologous and heterologous setting, VLA2001 was able to boost immunity to higher neutralizing antibody titers than following priming, and to levels reported to be highly efficacious (90%) against SARS-CoV-2[4]. Neutralizing antibody titers following a VLA2001 booster dose administered approximately eight months after primary vaccination were between 3-fold (heterologous) to 28-fold (homologous) higher compared to pre-boost levels, in line with previous VLA2001 Phase 1/2 homologous booster results[5]. A booster dose of VLA2001 was well tolerated by both VLA2001- and ChAdOx1-S-primed participants. The tolerability profile of a booster dose with VLA2001 was similar to the favorable profile observed after the first and second vaccination with VLA2001 in the Phase 1/2 and initial Phase 3 trial results.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We are pleased to report the first positive heterologous booster results for VLA2001, which successfully boosted immunity in participants primed with AstraZeneca’s ChAdOx1-S. This complements the positive homologous booster data we’ve generated in our Phase 1/2 and this Phase 3. We believe the robust immunogenicity and safety profile of our differentiated whole virus, inactivated vaccine remains compelling, and we look forward to providing further booster and durability results from ongoing studies with the hope of maximizing the potential for our vaccine to make a meaningful impact on public health.”

The Company’s dedicated heterologous booster trial of VLA2001, VLA2001-307, which aims to provide booster data following primary vaccination with an mRNA vaccine or natural infection caused by COVID-19, remains ongoing with results expected in Q4 2022. If positive, we believe these data from VLA2001-307, combined with these initial heterologous booster results from VLA2001-301, may support potential use of VLA2001 as a heterologous booster, subject to applicable regulatory and national scientific recommendations and approvals.

About Phase 3 Cov-Compare Study VLA2001-301
Cov-Compare is a randomized, observer-blind, controlled, comparative immunogenicity study in 4012 adults for which Valneva has reported meeting all primary endpoints including superiority with regards to GMT of neutralizing antibodies at two weeks after the second dose of VLA2001 compared to ChAdOx1-S (AstraZeneca). Participants have been followed up for safety and immunogenicity up to Month 6. As part of the trial’s booster extension, 958 participants have received a third vaccination approximately eight months after priming with either VLA2001 or ChAdOx1-S. Participants who had already received a licensed COVID-19 vaccine outside of the study or had a COVID-19 infection prior to the booster dose have not been included in the immunogenicity analysis of the booster response. Participants who did not receive a VLA2001 booster vaccination will continue with their scheduled Month 12 follow up visit, and participants who received a booster dose will be followed up to six months after booster dose administration.

VAL2001: 2022-AUG-23 - PR Valneva/WHO Recommendations Inactivated COVID-19 Vaccine

August 23, 2022

Saint-Herblain (France), August 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, confirms today that the World Health Organization (WHO) has issued recommendations for use of the Company’s inactivated COVID-19 vaccine.

WHO’s interim recommendations for use of the Valneva VLA2001 vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) on its August 11, 2022 extraordinary meeting and published in its background document.[1]

WHO’s interim recommendations also include a recommendation for a booster dose of VLA2001 four to six months after completion of the primary series and note that a booster dose of VLA2001 following primary vaccination with ChAdOx1-S (AstraZeneca) can be considered.

WHO may further update its interim recommendations to include additional uses of Valneva’s COVID-19 vaccine as new data are made available.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We are pleased that WHO has issued guidance on the use of Valneva’s inactivated COVID-19 vaccine and believe that this guidance may support others in evaluating the potential of our vaccine to make a meaningful impact on public health. We look forward to working with WHO as they review VLA2001 for prequalification and to continuing our existing discussions with governments who are considering VLA2001 for their vaccine portfolios.”

Valneva currently has agreements to supply VLA2001 to certain EU Member States[2] and the Kingdom of Bahrain[3]. Valneva is retaining inventory for potential additional supply to these EU Member States should demand increase. In parallel, the Company is continuing discussions with various other governments around the world, with the aim to deploy approximately eight to ten million doses of remaining inventory into international markets in the next six to twelve months. In light of current order levels and existing inventories, Valneva has suspended manufacturing of the vaccine.[4]

VLA2001: WHO recommendations 18-AUG-2022

These WHO interim recommendations for use of the Valneva VLA2001 vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) on its 11 August 2022 extraordinary meeting and the evidence summary included in the background document and annexes referenced below.

https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE-recommendation-Valneva-VLA2001

VLA1553: Start Rolling Submission FDA Biologics Lic. Appl. for Single-Shot Chikungunya

https://valneva.com/press-release/valneva-initiates-rolling-submission-of-fda-biologics-license-application-for-its-single-shot-chikungunya-vaccine-candidate/

August 18, 2022

Saint-Herblain (France), August 18, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has initiated rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the Company’s single-shot chikungunya vaccine candidate in persons aged 18 years and above.

This BLA submission follows final pivotal Phase 3 data reported in March 2022[1] and final lot-to-lot consistency results reported in May 2022[2]. A clinical study of VLA1553 in adolescents is ongoing in Brazil[3], which may support future regulatory submissions in this group if VLA1553 is approved in adults.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “This is an extremely important milestone for our VLA1553 program and we are very proud to be the first company worldwide that has begun submission of a BLA for a chikungunya vaccine candidate. Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease. We will continue to work assiduously to bring VLA1553 to market as soon as possible.”

Valneva is currently targeting the end of 2022 for completion of the BLA submission. Once all portions of the application have been submitted and if the filing is accepted, the FDA will determine priority review eligibility and the action date which the FDA will target to complete its evaluation.

This rolling BLA submission is part of the accelerated approval pathway agreed upon with the FDA in 2020[4]. The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA1553 in Europe in the first half of 2023.

About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[5]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 100 countries. As of July 2022, more than three million cases have been reported in the Americas[6] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 120 countries. It has been designed by deleting a part of the chikungunya virus genome.

Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[7] and final lot-to-lot consistency results in May 2022[8].

If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[9]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[10], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program.

IXIARO® Supply Contract with U.S. Department of Defense

Saint Herblain (France), August 18, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that the U.S. Department of Defense (DoD) has decided not to exercise the second option year of the contract[1] to supply Valneva’s Japanese encephalitis (JE) vaccine IXIARO®.

Due to the past and ongoing impact of the COVID-19 pandemic on its operations, the DoD considers its existing IXIARO® supply levels sufficient to meet current needs. The DoD has communicated an interest in negotiating a new supply contract in 2023, once inventory returns to standard levels. The Company expects no impact on its 2022 financial guidance as a result of this decision and will continue deliveries of IXIARO® pursuant to the terms of the first option year, which the DoD exercised with amended terms[2], through the fourth quarter of 2022. The DoD has relied on IXIARO® since 2010 to help protect personnel who are deployed to JE endemic areas, for whom JE vaccination is recommended.

The total minimum value of the existing supply contract was approximately $118 million, assuming the exercise of the second option year, which had a minimum value of approximately $36 million for 250,000 doses.

Thomas Lingelbach, President and Chief Executive Officer of Valneva, commented: “We thank the DoD for their partnership and look forward to further contract negotiations in the future. In parallel, we continue to see significant recovery in the private travel market for IXIARO®, which more than tripled in the first half of this year compared to the first half of 2021.”

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.
https://valneva.com/press-release/valneva-provides-update-on-ixiaro-supply-contract-with-u-s-department-of-defense/

Valneva Reports H1 2022 Results and Provides Corporate Updates

https://valneva.com/press-release/valneva-reports-h1-2022-results-and-provides-corporate-updates/

August 11, 2022

Excellent progress on late-stage clinical programs

Lyme Disease Vaccine Candidate VLA15

Phase 3 study initiated in August 2022[1]
Further positive Phase 2 results reported, including first pediatric data[2]

Single-Shot Chikungunya Vaccine Candidate VLA1553

Initiation of rolling submission for Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) imminent
Final positive pivotal Phase 3 results reported[3]
Final positive lot-to-lot consistency Phase 3 results reported[4]

Four marketing authorizations granted for inactivated COVID-19 vaccine

First Standard Marketing Authorization granted in Europe by the European Medicines Agency (EMA)[5]
Conditional Marketing Authorization granted in the United Kingdom (UK) by the Medicines and Healthcare products Regulatory Agency (MHRA)[6] and Emergency Use Authorizations granted in the Kingdom of Bahrain[7] and the United Arab Emirates (UAE)[8]

H1 revenue and cash

Total revenue of €93.2 million in the first half of 2022 compared to €47.5 million in the first half of 2021
Includes product sales of €33.3 million (vs €31.8 million in the first half of 2021) with first COVID-19 vaccine sales of €3.8 million
€59.9 million of other revenues (vs €15.7 million in the first half of 2021)
Cash position of €336.2 million as of June 30, 2022
Includes €90.5 ($95) million of proceeds from Pfizer’s investment in Valneva via an equity subscription agreement[9]

Updated FY 2022 Financial Guidance

Valneva expects total revenues to reach €340 million to €360 million in 2022 noting the continued recovery of travel vaccine sales, the revenue recognition linked to the EC and UK supply contracts and the recently revised Advance Purchase Agreement (APA) with the European Commission for the Company’s COVID-19 vaccine.
Product sales of the Company’s travel vaccine franchise are expected to reach €70 million to €80 million while COVID-19 product sales are expected to reach €30 million to €40 million.
Other Revenues are expected to reach approximately €240 million and will be mainly COVID-19 related. Other non-COVID-19 related revenues will be negative in 2022 due to the increased refund liability linked to the amendment of the VLA15 collaboration and license agreement with Pfizer. COVID-19 related Other Revenues will have no cash impact in 2022 and relate to revenues recognized in relation to the UK and EC Advance Purchase Agreements.
Valneva expects R&D expenses of €120 million to €135 million in 2022. The Company will continue investing in progressing its two leading, late-stage investigational vaccines against Lyme disease and chikungunya in the second half of 2022. Valneva will invest in further development of its current or any potential second-generation COVID-19 vaccine only if it receives the necessary funding or commitments to such funding during the third quarter of 2022. The Company also remains committed to further expanding its R&D pipeline, including through the advancement of some of the Company´s pre-clinical candidates towards clinical entry.

VAL15: “With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,”

August 8, 2022

Approximately 6,000 participants 5 years of age and older will be enrolled in Lyme disease-endemic regions in Europe and the U.S.

New York & Saint-Herblain (France), August 8, 2022 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced the initiation of a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15.

“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial.”

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are extremely pleased to reach this important milestone in the development of VLA15. Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere. We look forward to further investigating the VLA15 candidate in Phase 3, which will take us a step closer to potentially bringing this vaccine to both adults and children who would benefit from it.”

The randomized, placebo-controlled, Phase 3 VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older. The study is being conducted at up to 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States. Participants will receive three doses of VLA15 180 µg or saline placebo as a primary vaccination series followed by one booster dose of VLA15 or saline placebo (1:1 ratio).

Data from the Phase 2 studies continue to demonstrate strong immunogenicity in adults as well as in children, with acceptable safety and tolerability profiles in both study populations.1,2 Pending successful completion of the Phase 3 study, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.

As per the terms of the collaboration agreement between Pfizer and Valneva, Pfizer will make a $25 million milestone payment to Valneva upon initiation of the Phase 3 study.

VAL15: FOCUS-Climate change puts Lyme disease in focus for France's Valneva
By Natalie Grover
https://finance.yahoo.com/news/focus-climate-change-puts-lyme-060000185.html

LONDON, Aug 8 (Reuters) - With climate change spurring more cases of tick-borne Lyme disease, drugmaker Valneva is betting big on a vaccine as it looks beyond disappointing sales of its COVID shot.

Although Valneva secured European Union and British regulatory approval, both walked away from contracts worth more than a billion dollars combined, wiping nearly 40% off the value of Valneva's share price in the past six months.

The French firm had touted its COVID-19 vaccine as a traditional alternative for people who had refused shots based on newer messeneger RNA (mRNA) technology, which teach cells how to make a protein that will trigger an immune response.

But unlike the fierce competition with major international drugmakers such as Pfizer, Moderna and AstraZeneca to roll out vaccines to tackle the coronavirus pandemic, there are no established rivals for either Lyme disease or Chikungunya.

As climate change leads to longer summers and milder winters in many parts of the world, including Europe and North America, infections which spread through so-called vectors, such as ticks and mosquitoes, are escalating https://www.ecdc.europa.eu/en/climate-change/climate-change-europe/vector-borne-diseases, according to the European Centre for Disease Prevention and Control.

Valneva Chief Executive Thomas Lingelbach said there has been a significant increase in the prevalence of disease-causing vectors. "Global warming is certainly a key - if not the driving force," he told Reuters in an interview.

The company, based in Saint-Herblain on the outskirts of Nantes in south-west France, is preparing to start a late-stage human trial for its experimental vaccine against Lyme disease and will soon submit its vaccine against Chikungunya for U.S. approval after a successful late-stage study.

The Lyme disease vaccine trial will start in the coming weeks, involving at least 5,000 people over the age of five.

Lyme disease is usually caused by poppyseed-sized ticks which carry the bacteria. While most bites do not lead to an infection and not every person infected has a characteristic rash, some find out later they have the disease.

But by this point, standard antibiotic treatment can become ineffective and if untreated, some patients can go on to develop serious complications, including brain inflammation.

Chikungunya is spread through the bite of an infected mosquito, largely in the developing world including Africa, Asia and the Indian subcontinent.

While rarely fatal, the viral disease is characterised by intense muscle and joint pain that can last months or years.

If approved, Valneva aims to sell its Chikungunya shot as a travel vaccine in the developed world, and to populations in low- and middle-income countries. Rx Securities analyst Samir Devani expects it to generate peak sales of $250 million.

Valenva expects that, if successful, the Lyme disease vaccine, known as VLA15, will generate annual global sales of $1 billion, given burgeoning tick populations, rising infection rates and the incidence of long-term complications.

That could prove transformative for Valneva, which generated 350 million euros in revenue last year.

'HUGE OPPORTUNITY'

The COVID-19 pandemic and recent outbreaks of monkeypox outside Africa, where it is endemic, have shored up interest in vaccines for infectious diseases among drugmakers and investors.

Endemic diseases which are either chronic or prone to acute periodic outbreaks are a major public health challenge for the developing world and a "huge opportunity" for vaccine makers, David Pinniger, healthcare fund manager at Polar Capital, said.

This is reflected in the fund's portfolio, which includes shares in Valneva, AstraZeneca and Bavarian Nordic , which makes the main approved monkeypox vaccine.

In June, Valneva was given a major boost when Pfizer bought an 8.1% stake for 90.5 million euros ($92 million), to co-develop the Lyme disease vaccine.

Valneva's VLA15 is not the first Lyme disease vaccine to be developed. SmithKline Beecham, which later became GSK, secured U.S. approval for its LYMErix shot in 1998.

But challenges including a lukewarm recommendation from a key U.S. advisory committee, unfounded safety concerns and growing anti-vaccine sentiment, led to paltry sales.

The vaccine generated just $5 million in 2001 and it was withdrawn from the market a year later.

Valneva and Pfizer are banking on how much things have since changed, with infection rates now at half a million cases in Europe and the United States each year.

The hope is that VLA15 could help people who live in rural areas and other places where ticks are endemic, Lingelbach said.

VLA15 is designed to attack multiple strains of bacteria, rather than just one as was the case with LYMErix.

There is also a greater scientific understanding of Lyme disease, while celebrities including Justin Bieber and Amy Schumer have made their struggles with it public.

"Their word carries some weight," Sam Telford, a professor at Tufts University who helped run the LYMErix clinical trial, said.