Valneva Moves Forward with IXCHIQ® for Adolescents
Boosting Protection Against Chikungunya
Valneva SE, a prominent vaccine company, has recently submitted applications to extend the label of its innovative chikungunya vaccine, IXCHIQ®, to both the European Medicines Agency (EMA) and Health Canada. This could make the vaccine available for adolescents aged 12 to 17 in these regions, marking an important advancement in a crucial public health issue.
These applications aim not just to widen the vaccine's age range, but they also include vital data showing that antibody levels last for up to two years, highlighting a key feature of IXCHIQ®. Valneva plans to deliver similar safety and efficacy data to the U.S. Food and Drug Administration (FDA) within this calendar year, hoping to gain label extensions throughout North America.
The Importance of IXCHIQ® for Public Health
As the first licensed chikungunya vaccine worldwide, IXCHIQ® was developed to fight the chikungunya virus, which induces severe flu-like symptoms and persistent joint pain. Currently, the vaccine is approved for adults aged 18 and older in the U.S., Europe, and Canada, with sales expected to begin in these regions by late 2024.
With vector-borne diseases on the rise globally, the availability of effective vaccination options is becoming increasingly essential. Valneva’s aim to expand IXCHIQ® reflects ongoing efforts to offer healthcare solutions, particularly for people in endemic areas.
Plans for the Future and Partnerships
To enhance access to IXCHIQ®, Valneva is actively pursuing marketing authorization in Brazil, where approval is anticipated in the latter half of next year. A significant aspect of their strategy includes strengthening their partnership with The Coalition for Epidemic Preparedness Innovations (CEPI). This partnership plans to provide up to $41.3 million in funding over the next five years, aimed at improving vaccine access in low and middle-income countries. This reinforces Valneva's commitment to global health.
Dr. Juan Carlos Jaramillo, Valneva's Chief Medical Officer, stresses the importance of ensuring that vaccines are made available to all age groups. As chikungunya outbreaks increase, the health risks escalate, making it crucial for adolescents and younger populations to have access to IXCHIQ®. Jaramillo emphasizes that alleviating chikungunya's burden is especially important in endemic areas where healthcare access can be limited.
Clinical Evidence Supporting IXCHIQ®
The applications submitted to EMA and Health Canada are based on encouraging Phase 3 clinical trial data that highlights adolescent immunity. This data shows that a single dose of IXCHIQ® generates a strong immune response in 99.1% of participants aged 12 to 17. Moreover, the vaccine has been well tolerated, which eases concerns about possible side effects.
The application to Health Canada further emphasizes that the vaccine maintains a significant immune response for 24 months, regardless of age. Valneva is also nearing the point of releasing additional data that demonstrates antibody persistence extending up to 36 months, potentially solidifying the vaccine's positive profile.
Understanding the Chikungunya Virus
The chikungunya virus (CHIKV) is primarily spread through bites from infected Aedes mosquitoes. It can cause high fever, severe joint pain, and other debilitating symptoms. The virus's ongoing global spread presents both medical and economic challenges, with outbreaks recorded in over 110 countries since its resurgence in the early 2000s.
Public health organizations, including the WHO, have highlighted the need to address chikungunya as a growing public health threat, particularly as climate change continues to spread mosquito populations.
About Valneva SE
Valneva SE is a leader in vaccine development, dedicated to providing solutions for infectious diseases that currently lack effective treatments. Their diverse portfolio includes well-known vaccines for travelers and ongoing efforts to create vaccines against Lyme disease and the Zika virus. Valneva’s growing commercial revenues empower them to further advance their research and development initiatives.
Contact Information for Investors
For any inquiries related to investor relations, please contact:
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 first licensed vaccine designed to prevent illness caused by the chikungunya virus.
2. Who can currently receive IXCHIQ®?
IXCHIQ® is currently available for individuals aged 18 years and older in the United States, Canada, and Europe.
3. What are the expected benefits of the new label extension?
The label extension could allow for vaccination in adolescents aged 12 to 17, enhancing their immunity against chikungunya.
4. What evidence supports the safety of IXCHIQ®?
Clinical trials have demonstrated that IXCHIQ® is well tolerated and produces a strong immune response in most adolescents.
5. How does Valneva plan to expand vaccine access?
Valneva intends to improve vaccine availability in lower-income regions through partnerships and funding, along with future studies for broader use.
