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.

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