Latest news with #JuanCarlosJaramillo
Yahoo
07-05-2025
- Health
- Yahoo
Valneva Provides Update Following European Medicines Agency Announcement on Use of IXCHIQ® in Elderly
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said: 'We are deeply concerned by the reports of adverse events experienced by elderly individuals. Valneva remains committed to upholding the highest safety standards and respects the precautionary measures taken by authorities as investigations continue. The Company will continue to monitor all reported serious adverse events and fully cooperate with health authorities while also actively exploring a potential update to the product's indication.' On April 25, 2025, within the framework of the ongoing vaccination campaign initiated in La Réunion at the beginning of April prioritizing people aged 65 and older with comorbidities 3 , France's national public health agency, the Haute Autorité de Santé (HAS), suspended its recommendation for use of the vaccine in that age range pending further investigation. The vaccination campaign is maintained for people aged 18 to 64 years of age. 4 Valneva previously reported on changes to recommendations for use of IXCHIQ ® in the U.S. 1 and France 2 . On April 16, 2025, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recommended a precaution related to the use of Valneva's chikungunya vaccine IXCHIQ ® in persons aged 65 and over. Additionally, EMA highlighted that the exact cause of these serious adverse events and their relationship with the vaccine have not yet been determined and is reminding healthcare professionals that IXCHIQ ® must not be given to people whose immune system is weakened because of disease or medical treatments, as stated in IXCHIQ ® 's Summary of Product Characteristics (SmPC). The decision was taken following a plenary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) on May 5, 2025 and is based on reports of 17 SAEs worldwide (including two deaths) in elderly people with significant underlying medical conditions and/or co-medications. To date, over 40,000 doses of IXCHIQ ® have been used worldwide. Saint Herblain (France), May, 07 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has started a review of Valneva's single-dose live attenuated chikungunya vaccine IXCHIQ ® based on reports of serious adverse events (SAEs) in elderly people. As a temporary measure, while this review is ongoing, EMA has suspended the use of the vaccine for individuals over 65 years old. EMA has maintained current recommendations for IXCHIQ ® for people from 12 to 64 years of age. Story Continues The Company continues to see a positive risk-benefit in the vast majority of people with potential exposure to 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 years5. 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 Americas6. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas7 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.8 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. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at Media and Investor Relations Contacts Laetitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)6 4516 7099 Joshua Drumm, Ph.D. VP Global Investor Relations M +001 917 815 4520 Forward-Looking Statements This 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 Provides Update on ACIP Recommendation for its Chikungunya Vaccine IXCHIQ® Among U.S. Travelers 2 Valneva Provides Update on Recommendation for Use of Its Chikungunya Vaccine by French Authorities 3 Valneva Responds to French Government's Call for Vaccine Supply of IXCHIQ® against Chikungunya Outbreak in La Réunion 4 Valneva Provides Update on Recommendation for Use of Its Chikungunya Vaccine by French Authorities 5 6 7 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. 8 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas ( Attachment
Yahoo
18-04-2025
- Health
- Yahoo
Valneva Provides Update on ACIP Recommendation for its Chikungunya Vaccine IXCHIQ® Among U.S. Travelers
Saint Herblain (France), April 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that during its regular meeting on April 16, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) updated its recommendation for use of Valneva's single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV). ACIP maintained its current recommendation for 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 aged ≥18 years traveling or taking up residence in a country or territory without an outbreak but with elevated risk for U.S. travelers if planning travel for an extended period of time e.g., six months or more. The ACIP also voted to recommend a precaution related to the use of IXCHIQ® in persons aged ≥65 years. This precaution is a response to an ongoing investigation by the CDC of six cases of serious adverse events (SAEs), including five hospitalizations, among persons aged 67-86 years after vaccination with IXCHIQ®. These SAEs were reported through the Vaccine Adverse Event Reporting System (VAERS), which is intended to be an early warning system to identify potential safety issues but generally cannot determine if adverse events are caused by a vaccine. All of the individuals who were hospitalized had pre-existing comorbidities, and ACIP concluded that while plausible, no causal association with IXCHIQ® could be determined for all cases and that further investigation is warranted. ACIP also noted that for individuals aged ≥65 years, vaccination with IXCHIQ® might be indicated in certain higher-risk settings (e.g., outbreak), given the known risks for severe chikungunya disease and hospitalization in this age group. For example, earlier this month Valneva supplied 40,000 doses of IXCHIQ® to France's Island of La Réunion where the local public health agency, the Agence Régionale de Santé (ARS), is prioritizing vaccination of adults aged 65 and over, especially those with comorbidities, to protect residents during the ongoing chikungunya outbreak. Valneva recently received confirmation from ARS for an order of 50,000 additional doses of IXCHIQ® as part of its ongoing effort to manage this outbreak. To date, Valneva has supplied approximately 80,000 doses of IXCHIQ® in the United States, Canada and Europe. No further SAEs have been reported since January 2025 globally, and Valneva has not identified any safety signal concerns that are inconsistent with the U.S. product label through its ongoing post-marketing safety monitoring, including its periodic safety reports and routine signal detection activities, which are shared with the U.S. Food and Drug Administration (FDA). Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, 'Valneva is committed to the highest standards of safety, and the safety profile of IXCHIQ® remains unchanged and positive. We respect the ACIP recommendation and agree on the importance of continuing the stringent safety surveillance protocols that are in place. We encourage providers to assess the benefit/risk of vaccination based on the individual's medical history and upcoming travel, in line with the current recommendation.' The recommendation from ACIP is pending final approval by the Director of the CDC and the U.S. Department of Health and Human Services. 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 years1. 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 Americas2. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas3 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.4 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 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 Media and Investor Relations Contacts Laetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 Joshua Drumm, Global Investor RelationsM +001 917 815 Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to potential product sales 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, 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 2 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 2023.4 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas ( Attachment 2025_04_18_ACIP_PR_EN_FinalSign in to access your portfolio
Yahoo
16-04-2025
- Health
- Yahoo
Valneva Receives First Marketing Authorization for IXCHIQ® in a Chikungunya Endemic Country
Saint Herblain (France), April 14, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to its single-dose vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The ANVISA decision marks the world's first approval of a chikungunya vaccine in an endemic country. Part of Valneva's endemic country strategy, this endeavor is supported by the Coalition for Epidemic Preparedness Innovations (CEPI)1, with co-funding from the European Union (EU), and Instituto Butantan2 to support broader access to a chikungunya vaccine in low-and-middle-income countries (LMICs). IXCHIQ® is the world's first licensed chikungunya vaccine available to address this significant unmet medical need. In addition to Brazil, IXCHIQ® is approved for the prevention of disease caused by the chikungunya virus in people aged 12 years and older in the EU, and in people aged 18 years and older in the United States (U.S.)3, Canada4 and the United Kingdom (U.K.)5. Label extension applications to adolescents were submitted in the U.S., Canada and the U.K. This important approval primarily enables initiation of large-scale clinical trials of IXCHIQ® in Brazil, including the committed Phase 4 clinical trials supporting IXCHIQ®'s approval by the U.S. Food and Drug Administration (FDA) and the European Commission to generate additional data on vaccine effectiveness. CEPI is providing funding support to these trials. ANVISA continues to review VLA1555, the chikungunya vaccine candidate which, if approved, will be locally manufactured and distributed by Instituto Butantan pursuant to its collaboration with Valneva. Potential approval is anticipated in mid-2025. Instituto Butantan is committed to providing a locally manufactured vaccine at an affordable price in Latin America and selected LMICs. Valneva and Instituto Butantan are working together to ensure fast access to its chikungunya vaccines for the Brazilian market and other countries in the region as quickly as possible. The Americas saw nearly 300,000 chikungunya cases and 300 deaths attributed to the virus between January and July 2023, totaling more than 720,000 cases since 20206. Brazil has reported the highest number of cases, with over 1 million total between January 2019 and July 20246. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, 'This approval marks a crucial milestone toward making our chikungunya vaccine available to LMICs where the disease is endemic. The ongoing outbreak in Brazil underscores the fact that containing chikungunya is an international public health priority. Our vaccine is particularly well suited for LMICs, where vaccine access is often limited, due to its ability to induce a robust, long-lasting antibody response in both younger and older adults with a single vaccination. We would like to thank our partners CEPI and Instituto Butantan for helping us address this urgent medical need by accelerating further access to our highly differentiated vaccine.' Dr. Esper Kallás, Director of Instituto Butantan added, 'The approval of the chikungunya vaccine is a great victory for Brazil, where over 150,000 people suffer from the disease every year. It is an honor for Butantan to be able to contribute to ensuring that this vaccine reaches the population that needs it the most.' Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), commented, 'As we confront the ongoing challenges posed by chikungunya, today marks a significant step forward in our collective efforts to expand access to an important vaccine to not only benefit the travelers' market but also populations in need in outbreak-affected countries, like Brazil. ANVISA's marketing authorization of the vaccine offers new hope in the fight against the debilitating disease and allows us to make headway in our goal to protect the tens of thousands in the country who suffer from chikungunya each year. Brazil's approval is testament to the power of collaboration, innovation and determination and should help set the world up for additional approvals in other endemic regions in the near future.' Supported by CEPI and the EU's Horizon program, Valneva remains focused on expanding the vaccine's access in LMICs. In December 2024, Valneva announced a new partnership with the Serum Institute of India (SII), the world's largest manufacturer of vaccines by number of doses, enabling supply of the vaccine in Asia7. Additionally, as part of the CEPI and EU support, Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, for which it reported positive results in January 2025. The trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the fourth quarter of 2025, with the objective to extend the product label to this age group. Valneva is also expected to evaluate the vaccine in pregnant women in countries affected by chikungunya outbreaks, like Brazil8. 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 years9. 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 Americas10. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas11 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.12 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 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 Instituto Butantan Instituto Butantan is the main producer of immunobiological products and vaccines in Brazil. Instituto Butantan carries out scientific missions domestically and abroad through the Pan American Health Organization, the World Health Organization, UNICEF and the United Nations. The Institute is an affiliate of the São Paulo State Secretariat of Health and cooperates with the Brazilian Ministry of Health for the improvement of overall health in Brazil. It acts in partnership with various universities and entities such as the Bill & Melinda Gates Foundation for the achievement of its institutional objectives. For more information please visit the Institute website at or contact the press office at (+55 11) 2627-9606 / 9428 or email to imprensa@ 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. Media and Investor Relations Contacts Valneva Laetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 Joshua Drumm, Global Investor RelationsM +001 917 815 CEPIpress@ +44 7387 055214 Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to business partnerships and the progress, timing, results and completion of technology transfer and regulatory approvals in additional markets. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as 'could,' 'should,' 'may,' 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'aims,' 'targets,' or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 CEPI awards up to US$23.4 million to Valneva for late-stage development of a single-dose chikungunya vaccine - Valneva2 Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries - Valneva3 Valneva Announces U.S. FDA Approval of World's First Chikungunya Vaccine, IXCHIQ® - Valneva4 Valneva Announces Health Canada Approval of the World's First Chikungunya Vaccine, IXCHIQ® - Valneva5 Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ® - Valneva6Vaccines on the table as chikungunya outbreak intensifies in India - BlueDot7 Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India - Valneva8 CEPI expands partnership with Valneva with $41.3 million to support broader access to world's first Chikungunya vaccine | CEPI9 10 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 2023.12 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas ( Attachment 2025_04_14_ANVISA_Approval_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.
Telegraph
25-03-2025
- Health
- Telegraph
Vaccines rushed to French island amid major Chikungunya outbreak
Tens of thousands of jabs have been rushed to France's Réunion Island to fight a major outbreak of Chikungunya that has killed two people and put dozens in hospital. Nearly three thousand cases of the mosquito-borne virus, which causes debilitating joint pain, were reported in the first week of March alone, bringing the total to 8,750 since the disease began spreading in August last year. It is the worst outbreak of Chikungunya on the island – a part of France located in the Indian Ocean – since 2005, when about a third of the population were infected, killing 225. In an effort to contain the spiralling infections, Valneva, a French biotech company, responded to a French government request and sent 40,000 doses of its Chikungunya vaccine to the overseas territory. Juan Carlos Jaramillo, Valneva's chief medical officer, said it has 'the capacity to supply more [vaccine] doses' and is 'working closely' with regional officials to prevent the virus from spreading internationally. 'Chikungunya outbreaks spread rapidly, so it is crucial to vaccinate as many people as possible to help contain the virus,' he said in a statement. The vaccine will be rolled out on Réunion Island from the start of April, according to the European Centres of Disease Control (ECDC). The vaccine drive will target the most vulnerable, including those who are over 65, people working in vector control and anyone with severe co-morbidities over the age of 18. A team of 150 health workers has been deployed to carry out daily fumigation operations and an emergency epidemic response has been activated on the island, according to the local authorities. In 2023, the Valneva vaccine, known as Ixchiq, became the first chikungunya jab to gain regulatory approval by the US Food and Drugs Administration (FDA). While the vaccine is highly effective at preventing infection, there are currently no specific antibody treatments for Chikungunya. The disease is rarely fatal but causes similar symptoms to dengue and Zika virus – including fever, swelling, headaches, fatigue and rashes. Like dengue and Zika, Chikungunya is spread by the Aedes mosquito. It gets its name from a word in the Kimakonde language spoken in southern Tanzania which means 'to become contorted' and describes the stooped appearance of those afflicted with it. The number of cases on Réunion Island has 'increased sharply' in recent weeks, according to the ECDC. Most of them are concentrated in the south of the island, particularly in the Le Tampon region. Local media reported last week that an 86-year-old and a 96-year-old had died from the virus, adding that one of the victims had underlying health conditions. At least 24 people have required treatment in hospital. Chikungunya is seen as an emerging global health threat, as warming global temperatures allow mosquitoes to thrive in new areas and spread the infection further than the subtropical regions it is usually found. The outbreak comes less than a month after Réunion was ravaged by the strongest cyclone in 30 years. Three people were killed by the tropical storm. Prof Lance Turtle, an infectious diseases expert at the University of Liverpool, said 'time will tell if there is a definitive link' between the two events, but said it was 'plausible'. 'We don't fully understand what drives chikungunya outbreaks, but climate and temperature can influence this,' he told The Telegraph. 'If there was lots of standing fresh water left over after the cyclone, which is likely, then mosquito populations can increase and that can help drive an outbreak.'
