Latest news with #HauteAutoritédeSanté
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
Local France
14-04-2025
- Health
- Local France
France launches summer Covid-19 vaccine renewal campaign
On Monday, the French government launched a new Covid-19 booster vaccination campaign aimed at elderly and vulnerable people. The campaign will run until at least June 15th, 2025. It may then be extended into July, if health officials think it necessary. The pre-summer vaccine drive was recommended by France's national health authority, the Haute Autorité de Santé, in a report published in March. Despite the fact that it has now been over five years since the start of the pandemic, the latest variant of the virus is still circulating in France, though at lower levels than in years previous. In its most recent bulletin, Santé Publique France said that there were no immediate public health concerns about Covid-19. However, certain groups are still at risk of developing a severe form of the disease, especially ahead of the busy summer travel season. Advertisement As such, the latest campaign will target: Anyone aged 80 and over; Anyone with weakened immune systems, regardless of their age; people residing in care homes or long-term care units, regardless of their age; and any person at very high risk according to each individual medical situation and as part of a medical decision shared with the care team. Vaccinations can be repeated three months after the last injection or last Covid-19 infection. Residents of nursing homes and long-term care facilities will be able to receive this new injection directly at their facility. For everyone else, the vaccine may be administered by general practitioners or specialists, pharmacists , nurses, midwives, or hospital departments where the person is being treated. Vaccinations against Covid-19 are entirely reimbursed the French public health insurance system, for people who are registered . READ MORE: The different ways you can make a doctor's appointment in France
Yahoo
24-03-2025
- Health
- Yahoo
Valneva Responds to French Government's Call for Vaccine Supply of IXCHIQ® against Chikungunya Outbreak in La Réunion
Saint Herblain (France), March 24, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is responding to the chikungunya outbreak that is rapidly intensifying in France's Island of La Réunion with its vaccine IXCHIQ®. In agreement and with support from the local public health agency, the Agence Régionale de Santé La Réunion, Valneva will provide 40,000 doses starting early April, with an option to provide more, through distribution agreements with the Island's wholesalers. This supply of doses, paid for by the French authorities, is in line with the recommendation of France's national public health agency, the Haute Autorité de Santé (HAS), to prioritize for vaccination adults aged 65 and over, with co-morbidities. IXCHIQ® remains available for purchase in France (mainland and overseas). Chikungunya cases have spiked substantially in La Réunion since early 2025, with 8,600 cases recorded and almost 3,000 new cases during the week of March 3 to 9, 20251. Similar to the 2005-2006 chikungunya outbreak, there is a risk of transmission to mainland France and other French overseas territories. Local authorities of La Réunion have published a Level 4 emergency crisis management plan to contain the outbreak, while the Centers for Disease Control and Prevention (CDC) agency of the United States (U.S.) also issued a travel alert as millions of international travelers visit France's southern resorts and La Réunion Island annually. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, 'Chikungunya outbreaks spread rapidly, so it is crucial to vaccinate as many people as possible to help contain the virus. We have the capacity to supply more doses and will continue working closely with Agence Régionale de Santé La Réunion to manage this outbreak locally and prevent its spread to other regions through international travel." IXCHIQ® is the world's first licensed chikungunya vaccine available to address this significant unmet medical need. It is approved in the United States2, Europe3, Canada4 and the United Kingdom5 for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The European Medicines Agency (EMA) recently adopted a positive opinion recommending authorization of a label extension for IXCHIQ® to individuals 12 years of age and older6. On March 5, 2025, the Haute Autorité de Santé recommended to prioritize for vaccination adults aged 65 and over, especially those with comorbidities, followed by adults aged 18 and over with comorbidities, and vector control workers7. Valneva is focused on expanding the vaccine's label and access. In the third quarter of 2024, the Company expanded its partnership with the Coalition for Epidemic Preparedness (CEPI)8, 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)9, 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 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 years10. 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 Americas11. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas12 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.13 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 tetravalent 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 & European Investor RelationsM +33 (0)6 4516 Joshua Drumm, Global Investor RelationsM +001 917 815 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 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. CEPI Media Contactpress@ +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. 1 Chikungunya à La Réunion : semaine du 3 au 9 mars 2025 | Agence Régionale de Santé La Réunion2 Valneva Announces U.S. FDA Approval of World's First Chikungunya Vaccine, IXCHIQ®3 Valneva Receives Marketing Authorization in Europe for the World's First Chikungunya Vaccine, IXCHIQ®4 Valneva Announces Health Canada Approval of the World's First Chikungunya Vaccine, IXCHIQ®5 Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ®6 Valneva Receives EMA's Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ® - Valneva7 8 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World's First Chikungunya Vaccine - Valneva9 Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India - Valneva10 11 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 2023.13 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas ( Attachment 2025_03_24_IXCHIQ_La Reunion_Outbreak_Response_PR_EN_FinalSign in to access your portfolio
