Latest news with #ValnevaSE
Yahoo
11-06-2025
- Health
- Yahoo
How close are we to getting a vaccine for Lyme disease?
Diana Moser has, to the best of her knowledge, not contracted Lyme disease, a welcome status quo that might be credited to the tick-repellant clothing she wears in the yard of her East LaHave, N.S., home, or to the insect spray she squirts on herself, or to just plain-old luck. Or, it's possible the good fortune is due to what some are hoping is a "game changer" in the fight against the disease, which is caused by tick-borne bacteria and, if left untreated, can lead to severe heart, joint and nervous system symptoms. Moser is one of dozens of people in Nova Scotia, and more than 9,000 in the eastern United States, Eastern Canada and parts of Europe, who are taking part in clinical trials for a vaccine against Lyme infection. "I think it's incredibly important to have," she said of a vaccine, noting she knows at least four people who have contracted Lyme disease, including one who has had it multiple times. "It's such a tricky disease, like when you get Lyme, so many things can happen. It causes joint pain, it causes inflammation. It really affects your system in a deep and abiding way." There were more than 27,000 cases of Lyme disease recorded in Canada between 2009 and 2024, the majority of those in the last four years. Actual infection rates are higher, however, because cases go undetected or unreported, according to the federal government. In the United States, over 89,000 cases were reported in 2023 to the Centers for Disease Control. In one study, researchers used insurance claims data to estimate that nearly half a million people a year may be diagnosed and treated for Lyme disease. The vaccine furthest along the research pipeline is the collaboration between multinational pharmaceutical giant Pfizer and European vaccine company Valneva SE, with Phase 3 clinical trials scheduled to run to the end of December. WATCH | How close are we to getting a vaccine for Lyme disease?: A Pfizer spokesperson said if trials are successful the company could potentially apply in 2026 to the U.S. Food and Drug Administration and the European Medicines Agency for approvals to market the vaccine. There is no timeline for a similar application to Health Canada. The clinical trials have targeted areas where Lyme disease is endemic. Participants were chosen for their increased risk, including landscapers in tick-infested areas, people who do a lot of hiking or gardening, or who have dogs that routinely come home with ticks attached. Like all participants, Moser doesn't know if she has been injected with a course of the real vaccine and a booster, or simply been given a placebo, although she hopes to learn which it is once the trials end. Some, but not all, blacklegged ticks carry Borrelia burgdorferi, the bacteria that causes Lyme disease. The ticks are tiny, living in woods, shrubs and long grass, attaching themselves to humans or animals that brush past the vegetation and then feeding on their blood. When they bite, some of their stomach contents, including the bacteria, are eventually discharged into the bloodstream. In most cases, the tick must be attached for at least 24 hours before a person is infected. The Pfizer-Valneva vaccine prompts the human body to create antibodies to a protein on Borrelia burgdorferi, according to Dr. Joanne Langley, a pediatrician with the Canadian Center for Vaccinology, a Halifax-based group helping conduct the clinical trials in Nova Scotia. Ideally, if a Borrelia burgdorferi-carrying tick latches on to the skin, the vaccinated immune system will recognize the bacteria and attack and clear it, preventing Lyme disease, Langley said. "It could be really a game changer for how we try to deal with Lyme infection," she said in an interview, adding that half of people who contract the disease don't even remember being bitten by a tick. "It would be really great if we could be a little more carefree in the woods and just walking around our environment." Found widely in the eastern United States, the first colony of blacklegged ticks in Canada was discovered in the 1970s in an Ontario provincial park on Lake Erie. It has since become established in six provinces. In Nova Scotia, which has some of the highest tick numbers, populations are growing both in rural and urban areas, according to the provincial government. What has perplexed some people who ritually pick ticks off their pets or who have been infected with Lyme is why it has taken so long to develop a vaccine, especially given Lyme vaccines for dogs have been available for years. A Lyme vaccine for humans did hit the market in 1998, but was pulled in 2002 by the company that developed it, citing poor sales. Its reputation had been damaged by reports of adverse reactions, even though the FDA didn't find any evidence it was causing harm. Thomas Hart, a microbiologist who studies Lyme disease at Johns Hopkins Bloomberg School of Public Health in Baltimore, said the controversy "just chilled the whole field." "That's part of why we're only now seeing momentum again and bringing the Lyme disease vaccine actually through clinical trials in to market," he said. Hart has not been involved with the Pfizer-Valneva work, but said it's a "real promising vaccine" and it will be a "big deal" if approved. But it's not the only vaccine research. For instance, Hart said, scientists are examining vaccines aimed at deterring ticks from simply feeding on humans, protecting people not just against Lyme disease, but from other tick-borne infections. Another strain of research attacks the problem from an imaginative angle — small food-like pellets coated in vaccine to inoculate, of all things, mice. It's an idea conceived by Dr. Maria Gomes-Solecki, a veterinarian and microbiologist at the University of Tennessee Health Science Center. Mice and ticks, she said, infect each other with Borrelia burgdorferi. Vaccinating mice attempts to break the cycle. That brings down the prevalence in an area of ticks that have the bacteria, which in turn cuts the risk of humans getting Lyme disease. "One strategy alone is not enough to control this disease," she said in an interview. The company US Biologic has been marketing the product for about a year and a half, according to president Chris Przybyszewski. Pellets can tossed using a scoop — at intervals at the sides of trails, for instance — or deployed near homes in small circular "stations." The product is aimed at homeowners, golf courses, summer camps, outdoor athletic facilities and pest-management outfits. The company is also working with governments to deploy it on public lands, he said. The pellets, shaped like acorns, don't provide any nutritional value and don't attract other animals, Przybyszewski said. But the mice will eat them, he said, and research shows they can cut the rate of infected ticks in an area by 75 per cent. There are plans to eventually bring the product to Canada, he said, with US Biologic likely to begin seeking approval this year or next. "I think it's just incredibly important that we pay more attention to this kind of concept, really focusing on products and programs that can make a difference and really create a new way of stopping infectious diseases," he said. For Colin Chase, a participant in the Pfizer-Valneva vaccine clinical trials, ticks are a fact of life, both as someone with a deep love of the woods, and as a volunteer search and rescuer who routinely clambers through dense Nova Scotia forests. Searchers take the full range of precautions, he said, examining each other for the tiny creatures, stripping down before they go inside their homes and throwing their clothes in the dryer and then the washer. Many have a favoured anti-tick spray they swear by. But even with those efforts, ticks can still sneak in and become embedded on the skin. If a vaccine is safe and effective, Chase said, why wouldn't someone take advantage? "Because otherwise the alternative is, 'Oh, I'm not going to go in the woods. I'm going to disconnect myself from the natural environment.' And there's so much beauty in the woods," he said. MORE TOP STORIES
Yahoo
05-06-2025
- Business
- Yahoo
Valneva Reports Positive Six-Month Antibody Persistence and Safety Phase 2 Results in Children for its Single-Shot Chikungunya Vaccine IXCHIQ®
IXCHIQ® was well tolerated by children aged one to eleven years regardless of the dose or previous chikungunya infection (CHIKV) Antibody levels remained high after six months in both dose groups, although more robust with the full dose Six-month data confirm full dose selection for pivotal Phase 3 trial Saint-Herblain (France), June 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the first quarter of 2026, with the objective of extending the product label to this age group. Trial VLA1553-221's six-month results were in line with the initial data the Company reported for this trial in January 20251. A full dose (licensed IXCHIQ® formulation and presentation) elicited a more robust immune response in children aged one to eleven years at Day 15 and Day 180 post vaccination compared to a half dose. Overall, the immunological response profile was in line with what was previously observed in adults and adolescents234567. The strong immune response was confirmed in CHIKV-naïve children with a 96.5% seroresponse rate (full dose) at Day 180. VLA1553 was well tolerated in children aged one to eleven years regardless of the dose or previous CHIKV infection. No safety concerns were identified. The comparability of the VLA1553 doses tested in terms of safety and tolerability, along with the more pronounced immune response of the full dose observed for all age groups tested in children up to Day 180 post-vaccination, support the selection of the full dose for use in this population. Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, 'The six months persistence and safety data in children are aligned with the robust antibody response and safety profile we reported in adolescents after a single vaccination. Considering the significant risk chikungunya poses to individuals living in or traveling to endemic areas, it's crucial to ensure that the vaccine is accessible to people of all ages and capable of potentially offering long-term protection from a single shot. This is especially important in Low- and Middle-Income countries (LMICs) where access to vaccines is often limited.' Brazil has reported the highest number of chikungunya cases worldwide, with over one million cases between January 2019 and July 20248, followed by India with 370,000 cases during the same period. This number is rapidly increasing due to the current outbreak in the Indian states of Maharashtra and Telangana, for which the U.S. Centers for Disease Control and Prevention (CDC) issued a travel notice after identifying higher-than-expected numbers of chikungunya cases in returning travelers9. Additionally, two outbreaks are ongoing on the French islands of La Reunion and Mayotte10. About ChikungunyaChikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years11. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas12. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas13 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.14 About Phase 2 Trial VLA1553-221 VLA1553-221 is a multi-center, randomized, observer-blinded, dose response Phase 2 clinical trial in 304 healthy children aged one to eleven years. The trial is performed at three trial sites in the Dominican Republic and 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. Participants were randomized 2:2:1 to receive either a full dose (licensed IXCHIQ® formulation and presentation) or a half dose of the vaccine, or an active control (Nimenrix). Additional information, including a detailed description of the trial design, eligibility criteria and investigator sites, is available at (Identifier: NCT06106581). About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first and only chikungunya vaccine, as well as certain third-party from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at About CEPICEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organizations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI's pandemic-beating five-year plan for 2022-2026 is the '100 Days Mission' to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Learn more at Follow us on X (@CEPIvaccines), LinkedIn and Facebook. About Horizon EuropeHorizon Europe — #HorizonEU — is the European Union's flagship Research and Innovation programme, part of the EU-long-term Multiannual Financial Framework (MFF) with a budget of €95,5 billion to spend over a seven-year period (2021-2027). Under Horizon Europe, health research will be supported with the aim to find new ways to keep people healthy, prevent diseases, develop better diagnostics and more effective therapies, use personalised medicine approaches to improve healthcare and wellbeing, and take up innovative health technologies, such as digital ones. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 Joshua Drumm, Global Investor RelationsM +001 917 815 Forward-Looking StatementsThis press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory review of existing products. 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 or new adverse events, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Valneva Reports Positive Phase 2 Results in Children for its Chikungunya Vaccine and Announces Phase 3 Dose Decision - Valneva2 Valneva Announces Positive Phase 3 Pivotal Results for its Single-Shot Chikungunya Vaccine Candidate - Valneva3 Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate - Valneva4 Lancet Paper: Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate - Valneva6 Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate - Valneva7 Lancet Paper: 12 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). Last accessed 01 Aug 2023.14 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas ( Attachment 2025_06_05_VLA1553-221_6M_Persistence_Data_PR_EN_FinalError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
26-05-2025
- Business
- Yahoo
Valneva to Participate at U.S. and European Investor Conferences in June
Saint-Herblain (France), May 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2025. Key topics for discussion include Valneva's commercial stage vaccines and its differentiated portfolio of vaccine candidates, including VLA15, the world's leading Lyme disease vaccine candidate. VLA15 is partnered with Pfizer and currently being evaluated in a pivotal Phase 3 trial for which the Company expects first data at the end of 2025. Institutional investors who would like to meet 1on1 with management at any of the below conferences are asked to submit a request to their representative at the respective bank. Jefferies Global Healthcare Conference Format Fireside chat and investor meetingsDate/ time June 5, 2025, 11:40am ETWebcast Link. A replay of the webcast will also be available in the 'Investor' section of the Valneva New York Goldman Sachs 46th Annual Global Healthcare Conference: Format Fireside chat and investor meetingsDate/ time June 9, 2025, 1:20pm ET Location Miami, FL Oddo BHF Nextcap Forum: Format Investor meetings onlyDate/ time June 12, 2025Location Virtual BNP Paribas SMID Cap Conference: Format Investor meetings onlyDate/ time June 18, 2025Location Paris, France 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 from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP, Global Communications and European Investor RelationsM +33 (0)6 4516 Joshua Drumm, Global Investor Relations M +001 917 815 Forward-Looking StatementsThis press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory review of existing products. 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 or new adverse events, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Attachment 2025_05_26_VLA_June_2025_Conferences_PR_EN_Final
Associated Press
31-03-2025
- Health
- Associated Press
Valneva Submits Adolescent Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to UK MHRA
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) to potentially expand the use of its chikungunya vaccine, IXCHIQ®, currently approved in adults1, to adolescents aged 12 to 17 years in the UK. This submission follows the recent positive opinion of the European Medicines Agency (EMA) on extension of IXCHIQ® label to adolescents in the European Union (EU)2. IXCHIQ® is the world's first licensed chikungunya vaccine available to address this significant unmet medical need. It is approved in the U.S.3, Europe4, Canada5 and the UK for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. Chikungunya has become an increasingly pressing public health issue, with outbreaks currently ongoing in India, Brazil and the French Island of La Réunion. Valneva announced last week that it has responded to the French government's call for supply of IXCHIQ® in La Réunion and that it will provide 40,000 doses to the Island's wholesalers, with an option to provide more6. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, 'Given the substantial risk that chikungunya presents to people residing in or traveling to endemic regions, it's imperative to ensure the vaccine is available to all age groups. Broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness, which is currently spreading in areas that were previously unaffected. The long-term durability of the immune response is also extremely important, especially for endemic countries where access to immunization can be difficult.' Valneva is focused on expanding the vaccine's label and access. Label extension applications to adolescent were submitted in Europe, the United-States, Canada and the UK based on positive six-month adolescent Phase 3 data which showed that a single-dose vaccination with IXCHIQ® induces a high and sustained immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated7. Valneva reported further positive Phase 3 data in adolescents earlier this year, which showed a sustained 98.3% sero-response rate one-year after single vaccination with IXCHIQ®8. The Lancet Infectious Diseases, a world leading infectious diseases journal, also published an article showing that the vaccine was well tolerated in adolescents aged 12 to 17 years 28 days after a single injection, regardless of previous chikungunya virus (CHIKV) infection. Additionally, in the third quarter of 2024, the Company expanded its partnership with the Coalition for Epidemic Preparedness (CEPI)9, with support from the EU Horizon Europe program, through a $41.3 million grant to advance broader access to the vaccine in Low- and Middle-Income Countries (LMICs), post-marketing studies and research to support potential label extensions in children, adolescents and pregnant women. Within the framework of this partnership, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII)10, the world's largest manufacturer of vaccines by number of doses, enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs. This new agreement complements the license agreement Valneva signed in 2021 with Instituto Butantan in Brazil for the development, manufacturing and marketing of a local chikungunya vaccine at an affordable price for distribution in Latin American countries and selected LMICs affected by the disease. About Chikungunya Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years11. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas12. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas13 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.14 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, including the world's first chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at About CEPI CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organizations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI's pandemic-beating five-year plan for 2022-2026 is the '100 Days Mission' to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Learn more at Follow us on X (@CEPIvaccines), LinkedIn and Facebook. About Horizon Europe Horizon Europe — #HorizonEU — is the European Union's flagship Research and Innovation programme, part of the EU-long-term Multiannual Financial Framework (MFF) with a budget of €95.5 billion to spend over a seven-year period (2021-2027). Under Horizon Europe, health research will be supported with the aim to find new ways to keep people healthy, prevent diseases, develop better diagnostics and more effective therapies, use personalised medicine approaches to improve healthcare and wellbeing, and take up innovative health technologies, such as digital ones. CEPI Media Contact +44 7387 055214 Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to possible additional sales in an outbreak context, the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as 'could,' 'should,' 'may,' 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'aims,' 'targets,' or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 13 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017).. Last accessed 01 Aug 2023.
