Valneva Advances Chikungunya Vaccine with Regulatory Filings
Valneva Advances IXCHIQ® and Its Use in Adolescents
Strengthening Protection Against Chikungunya
Valneva SE, a leading specialty vaccine company, has recently submitted label extension applications to both the European Medicines Agency (EMA) and Health Canada for its innovative chikungunya vaccine, IXCHIQ®. This move could expand the vaccine's availability to include adolescents aged 12 to 17 years in these regions, which marks a significant step in addressing a pressing public health concern.
These applications not only seek to broaden the age range for vaccination but also include essential data on antibody persistence for up to two years, demonstrating a critical characteristic of IXCHIQ®. Valneva aims to submit similar safety and efficacy data to the U.S. Food and Drug Administration (FDA) within the calendar year, with hopes to secure label extensions across North America.
Significance of IXCHIQ® in Public Health
IXCHIQ® holds the distinction of being the first licensed chikungunya vaccine globally, developed to combat the chikungunya virus, which causes severe flu-like symptoms and long-term joint pain. Currently, the vaccine is approved for adults aged 18 and older in the United States, Europe, and Canada, with expected sales commencing in Canada and Europe by late 2024.
As the world confronts the rise of vector-borne diseases, the need for effective vaccination options becomes increasingly urgent. Valneva’s commitment to expanding IXCHIQ® underlines the ongoing efforts to provide healthcare solutions for individuals, especially those in endemic regions.
Future Plans and Partnership Expansion
In its quest to increase accessibility to IXCHIQ®, Valneva is also in the process of securing marketing authorization in Brazil, anticipating approval in the latter half of the coming year. A critical aspect of their strategy involves a strengthened partnership with The Coalition for Epidemic Preparedness Innovations (CEPI). This partnership is set to offer up to $41.3 million in funding over the next five years, aimed at facilitating broader access to the vaccine in low and middle-income countries, thus reinforcing Valneva's commitment to global health.
Dr. Juan Carlos Jaramillo, Valneva's Chief Medical Officer, emphasizes the urgency of making vaccines available across all age groups. The current increase in chikungunya outbreaks presents significant health risks, making it vital to ensure adolescents and even younger populations have access to IXCHIQ®. Jaramillo notes that diminishing the burden of chikungunya will be critical for endemic regions where healthcare access remains challenging.
Clinical Data Supporting IXCHIQ®
The applications submitted to EMA and Health Canada are anchored in promising Phase 3 clinical trial data regarding adolescent immunity. This evidence indicates that a single dose of IXCHIQ® produces a robust immune response in 99.1% of subjects aged 12 to 17. Furthermore, the vaccine has been well tolerated, alleviating concerns about potential adverse effects.
Health Canada's application further highlights data indicating that the vaccine maintains a significant immune response for 24 months, independent of age. Valneva is also on the cusp of sharing additional data showcasing antibody persistence extending to 36 months, which could further solidify the vaccine's profile.
Understanding Chikungunya Virus
Chikungunya virus (CHIKV) is primarily transmitted through the bites of infected Aedes mosquitoes. Symptoms include high fever, severe joint pain, and various other debilitating effects. The ongoing global spread of chikungunya presents both medical and economic challenges, as outbreaks have been documented in over 110 countries since the virus's resurgence in the early 2000s.
With climate change exacerbating the distribution of mosquito populations, public health organizations, including the WHO, have stressed the importance of addressing chikungunya as a growing public health threat.
About Valneva SE
Valneva SE is at the forefront of vaccine development, focusing on providing solutions for infectious diseases that currently lack adequate therapeutic options. The company's diverse portfolio includes acclaimed vaccines for travelers, alongside its pioneering efforts in developing vaccines against Lyme disease and Zika virus. Valneva’s robust pipeline is supported by growing revenue from its commercial products, enabling it to advance its research and development projects further.
Investor Contact Information
For inquiries regarding investor relations, please reach out to:
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com
Frequently Asked Questions
1. What is IXCHIQ®?
IXCHIQ® is the world’s first licensed chikungunya vaccine aimed at preventing illness caused by the chikungunya virus.
2. Who can currently receive IXCHIQ®?
Currently, IXCHIQ® is approved for individuals 18 years and older in the U.S., Canada, and Europe.
3. What are the expected benefits of the new label extension?
The extension could allow vaccination for adolescents aged 12 to 17, enhancing immunity against chikungunya.
4. What evidence supports the safety of IXCHIQ®?
Clinical trials have shown that IXCHIQ® is well tolerated and induces a strong immune response in the majority of adolescents.
5. How does Valneva plan to expand vaccine access?
Through partnerships and funding, Valneva aims to enhance vaccine availability in lower-income regions and anticipates further studies for expanded use.
About Investors Hangout
Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/
Disclaimer: The content of this article is solely for general informational purposes only; it does not represent legal, financial, or investment advice. Investors Hangout does not offer financial advice; the author is not a licensed financial advisor. Consult a qualified advisor before making any financial or investment decisions based on this article. The author's interpretation of publicly available data shapes the opinions presented here; as a result, they should not be taken as advice to purchase, sell, or hold any securities mentioned or any other investments. The author does not guarantee the accuracy, completeness, or timeliness of any material, providing it "as is." Information and market conditions may change; past performance is not indicative of future outcomes. If any of the material offered here is inaccurate, please contact us for corrections.
Related Articles
- Biocomposites Strengthens Market Position with Acquisition
- Political Scientist Frank Biermann Honored with Environmental Award
- Nokia Partners with iSAT Africa to Boost Rural Connectivity
- Explore Exciting Summer Travel Options with Novaturas Group
- Wipro Limited Partners with Poppulo to Boost Communications
- Unitas Protocol Unveils Second Phase with Insurance and Tokens
- AutoRek Partners with Capgemini to Enhance Financial Solutions
- EDF Concludes Tender Offer for Hybrid Notes with Key Results
- Taiwan Stock Market Sees Positive Performance with Key Gains
- tpay Redefines Mobile Payments with New Brand Identity
Recent Articles
- Box, Inc. Announces $400 Million Offering of Convertible Notes
- TAS Logistyka Expands Warehouse Operations at CTPark Warsaw
- Microsoft Advocates for Transparency in AI Chip Exports
- Fortune Celebrates Groundbreaking Inaugural LGBTQ+ Leaders List
- Celebrating LGBTQ+ Executive Leadership in Global Business
- Airbnb Shares Surge: What Investors Need to Know Now
- Exploring AppLovin's Recent Stock Surge and Future Prospects
- Gold Price Rally: Insights on Market Trends and Futures
- Anticipation Builds for Central Bank Decisions Affecting Markets
- Challenges Faced by 23andMe Board Amid Acquisition Talks
- Innovative Insights from OKX Ventures at Singapore Event
- Awaysis Capital Successfully Executes Leases for Major Assets
- Awaysis Capital Advances with New Leasing Agreements
- Zaid Aloul Steps Up as Chief Commercial Officer at GTN
- Unifor and GM Engage in Productive Contract Negotiations
- Meta's Antitrust Challenges in the EU Over Advertising Practices
- Innovative DOTphin Initiative Connects Digital Art and Ecology
- Insights from Jeff Ren: The Future of CeFi and DeFi
- CI Financial Secures $325 Million Debenture Financing Deal
- Disability:IN Offers Essential Guide for EU Inclusion Standards
- Elon Musk Critiques FAA's Handling of SpaceX Fines Compared to Boeing
- Display.io Unveils Innovative Ad Formats for Content Monetization
- L.A. Libros Festival: A Celebration of Latinx Culture and Arts
- Tupperware Bankruptcy Filing Highlights Struggles in a Changing Market
- Tupperware Brands Launches Chapter 11 Bankruptcy Process
- Boeing and Union Representatives Reignite Negotiations Soon
- Figure Markets Expands Global Footprint with 8% Yield Opportunity
- Starbucks Faces Leadership Shake-Up with CEO Departure
- Dovid Oved Retreat Center's Generous Support for Firefighters
- Tupperware Reimagines Its Future with Chapter 11 Process
- Saxena White Advocates for Investors in Walgreens Class Action
- Trump's Reflections on Biden and Harris' Support After Attack
- Analyzing Mohamed El-Erian's Insights on Fed's Rate Decisions
- Investors Seek Justice in WEBTOON Entertainment Securities Case
- Patriot Battery Metals Inc. Shareholder Meeting Outcomes
- Patriot Battery Metals Achieves Landmark AGM Voting Success
- Wormhole Strengthens Security with Google Cloud Partnership
- Runergy Showcases Innovative Solar Solutions at Major Event
- HONGQI Showcases Luxury Vehicles at Global Summit Event
- Microsoft Warns of Russian Cyber Threats to Harris-Walz Campaign
- Negotiations Between Unifor and GM Reach Critical Deadline
- Top Stocks Making Headlines: Intuitive Machines and More
- Nippon Steel's Acquisition Delayed: What It Means for U.S. Industry
- Foton Motor Partners with ZF Group for Hybrid Vehicle Innovation
- Runergy Showcases Innovative Solar Solutions at Major Expo
- Asian Markets Hold Steady as Fed Rate Decisions Loom
- Unveiling the Future of HR: Key Insights from 2024 Study
- inHearing Technology Enhances Offerings with Intricon Acquisition
- Impact of Japan's Leadership Race on Bank of Japan's Interest Rates
- Dollar Fluctuates as Asian Markets React to Fed Decisions