Valneva Submits Adolescent Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to UK MHRA

Saint Herblain (France), March 31, 2025 – Valneva SE (NASDAQ:VALN, 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 www.valneva.com.

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 CEPI.net. 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

[email protected]

+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 Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ® - Valneva

2 Valneva Receives EMA's Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ^® - Valneva

3 Valneva Announces U.S. FDA Approval of World's First Chikungunya Vaccine, IXCHIQ^® - Valneva

4 Valneva Receives Marketing Authorization in Europe for the World's First Chikungunya Vaccine, IXCHIQ^® - Valneva

5 Valneva Announces Health Canada Approval of the World's First Chikungunya Vaccine, IXCHIQ^® - Valneva

6 Valneva Responds to French Government's Call for Vaccine Supply of IXCHIQ® against Chikungunya Outbreak in La Réunion - Valneva

7 Valneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine - Valneva

8 Valneva Reports High Sustained Immune Response in Adolescents One Year After Single Vaccination with its Chikungunya Vaccine - Valneva

9 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World's First Chikungunya Vaccine - Valneva

10 Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India - Valneva

11 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf

12 https://cmr.asm.org/content/31/1/e00104-16

13 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.

14 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int)

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