Saint Herblain (France), August 7, 2025 – Valneva se (Nasdaq: Valn; Euronext Paris: VLA), a company specializing in vaccines, announced today the lifting of the temporary judgment of the American health agency Food and Drug Administration (FDA) on the use of IXCHIQ® (Living vaccine attenuated) in people aged 60 and over as well as its agreement on updating the characteristics of the product. IXCHIQ® It remains indicated in the United States for the prevention of the disease caused by the chikungunya virus (Chikv) in people aged 18 and over with increased risk of exposure to Chikv.
The FDA decision follows the announcement of the European Medicines Agency (EMA) in July1 Recommending the lifting of temporary restrictions in the elderly following the completion of a complete review of the vaccine by the Committee for the Risk Assessment in Matcovigilance of the EMA (PRAC).
The characteristics of the product have been updated in order to take into account several serious side effects reported in the elderly suffering from multiple chronic diseases, following a vaccination campaign in the meeting aimed at responding to a severe chikungunya epidemic.
The FDA noted that for most American travelers, the risk of exposure to the chikungunya virus is low and that, therefore, the product is not advised for most of them. IXCHIQ® should only be administered in the event of a significant risk of infection by chikungunya and only after an in -depth examination of profits and risks. It is reminded to health professionals that IXCHIQ® is contraindicated in people whose immune system is weakened by an immunosuppressive disease or treatment, as already indicated in the product characteristics of Ixchiq® in the United States, Europe and other territories.
In addition, the “Warnings and precautions” section of the product has been extended to reflect the profile of the side effects observed, especially in people over the age of 65 and the elderly suffering from one or more chronic diseases.
FDA journals currently underway on the expansion of Ixchiq’s potential indication® Adolescents and the inclusion of additional data on the persistence of antibodies continue to progress.
About chikungunya
The chikungunya virus (chikv) is a viral disease transmitted by mosquitoes, which is spread through infected Aedes mosquitoes. It causes fever, strong joint and muscle pain, headache, nausea, fatigue and rashes. Joint pain is often disabling and can persist for weeks, or even years2.
In 2004, the disease began to spread quickly, causing large -scale epidemics worldwide. Since the reappearance of the virus, the Chikv has been identified in more than 110 countries in Asia, Africa, Europe and America3. Between 2013 and 2023, more than 3.7 million cases were identified on the American continent4 And the economic impact of the disease is considered extremely important. The medical and economic impact of the disease should continue to increase since the vectors of the virus are constantly extending their territory. As such, the World Health Organization (WHO) stressed that chikungunya constituted a major risk to public health5.
About Valneva is
Valneva is a company specializing in the development, production and marketing of prophylactic vaccines against infectious diseases generating important medical needs. Valneva has a highly specialized and targeted approach and uses its expertise in different vaccination methods to develop vaccines against diseases for which they do not yet exist vaccines or for which existing solutions can be improved.
The company has solid R&D experience having increased several vaccines from the first stages of research until they are placing on the market. Valneva is currently selling three trip vaccines.
The income from the growing commercial activity of the company contribute to the continuous advancement of its portfolio of vaccines. This includes the only candidate for Lyme disease vaccine in advanced clinical development phase, under partnership with Pfizer, the most advanced tetravalent vaccine in the world against shigellosis as well as candidates against the Zika virus and other global public health threats. Further information is available on the site www.valneva.com.
| Investor and media contacts Valneva Laetitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)6 4516 7099 [email protected] |
Joshua Drumm, Ph.D. |
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This press release contains certain prospective declarations relating to Valneva’s activity, in particular with regard to advancement, calendar, results and completion of research, development and clinical trials of candidate products, regulatory approval of candidate products and the revision of existing products. In addition, even if the real results or the development of Valneva comply with the prospective statements contained in this press release, these results or evolutions of Valneva may not be representative of the future. In some cases, you can identify prospective statements by terms like “could,” should “expect,” anticipate, ““ anticipate, ”“ believes, ”“ To the intention, ”“ esteem ”“ targeting, ”“ target, ”or similar words. These prospective statements are largely based on Valneva’s current expectations on the date of this press release and are subject to a certain number of known and unknown risks and uncertainties as well as other factors that could make real results, yield or real achievements differ considerably from future results, future performance or achievements, expressed or undernoled by these statements Prospective. In particular, Valneva’s expectations could be affected by, among other things, uncertainties linked to the development and manufacture of vaccines, unexpected clinical test results, unexpected regulatory actions or delays, competition in general, monetary fluctuations, the impact of the global and European credit crisis, to the ability to obtain or keep a patent or any other intellectual property protection, cancellation of existing contracts, the occurrence of one or the other of these events that can considerably affect the activity, the financial situation, the Valneva’s outlook and operating results. Given these risks and uncertainties, there can be no assurance that the prospective statements formulated in this press release will actually be made. Valneva provides the information contained in this press release on the date and declines any intention or obligation to update or publicly revise any prospective statement, whether due to new information, future events or for other reasons.
1 Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted | European Medicines Agency (EMA)
2 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf
3 https://cmr.asm.org/content/31/1/e00104-16
4 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.
5 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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