Chikungunya virus vaccine (Valneva)

The recommendation from the FDA and CDC comes after the latter agency’s Advisory Committee on Immunization Practices (ACIP) recommended in April that the vaccine carry a precaution when used in adults ages 65 and older. On the heels of similar moves in France and the European Union, U.S. health authorities are calling for a pause in the use of Valneva’s chikungunya vaccine in older adults.The FDA and the Centers for Disease Control and Prevention (CDC) are recommending a pause in the use of the single-dose shot, dubbed Ixchiq, in U.S. individuals age 60 and older as investigations into serious adverse event (SAE) reports play out on both sides of the Atlantic.The recommendation from the FDA and CDC comes after the latter agency’s Advisory Committee on Immunization Practices (ACIP) recommended in April that the vaccine carry a precaution when used in adults ages 65 and older, Valneva noted in a Monday press release.Additionally, the European Medicines Agency (EMA) last week rolled out its own Ixchiq restriction in older adults, as well as in people with compromised immune systems.The EMA—which unveiled its vaccine pause roughly one week after a similar move by French health authorities—has kicked off a safety review of Ixchiq following reports of 17 serious adverse events, including two deaths, in vaccine recipients between the ages of 62 and 89.“As highlighted by FDA/CDC, adverse events may not be causally related to vaccination, yet thorough evaluation of these cases is critical to ensure the safe use of Ixchiq, of which over 40,000 doses are estimated to have been utilized to date, worldwide,” Valneva said in its latest release on the U.S. pause recommendation.The company added that it’s working closely with global health authorities and expects formal reviews of post-marketing safety reports in all regions where Ixchiq is approved.  Just last month, Ixchiq scored marketing authorization in Brazil, marking the shot’s first approval in a country where chikungunya is endemic. Besides the U.S., Brazil and Europe, Ixchiq is also approved in Canada.Valneva stressed that it’s committed to safety and working closely with regulatory bodies to provide “timely information about all known SAEs.” Most of the safety flags have cropped up in elderly people with underlying medical conditions, the company explained.Despite potential safety concerns, Valneva is sticking by its vaccine, which became the first ever approved for the chikungunya virus when it won an FDA nod in November 2023. Ixchiq was specifically approved for adults who are at increased risk of exposure to the virus, which is carried by mosquitoes in tropical regions around the world.

Saint Herblain (France), May, 12 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Association (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), in a joint communication to the medical community, have recommended a pause in the use of Valneva’s single-dose live attenuated chikungunya vaccine IXCHIQ® in elderly individuals while ongoing investigations into reported serious adverse events (SAEs) are completed. This update follows an earlier recommendation from the U.S. Advisory Committee on Immunization Practices (ACIP) to include a precaution related to the use of IXCHIQ® in persons aged 65 and over and a similar decision by the European Medicines Agency (EMA) to temporarily suspend the use of the vaccine for individuals over 65 years old pending investigation. Valneva is committed to upholding the highest safety standards and has engaged proactively with health authorities in all territories where IXCHIQ® is licensed to provide timely information about all known SAEs, most of which have been reported to the Vaccine Adverse Event Reporting System (VAERS) and have been in elderly individuals with significant underlying medical conditions and/or co-medications. As highlighted by FDA/CDC, adverse events may not be causally related to vaccination, yet thorough evaluation of these cases is critical to ensure the safe use of IXCHIQ®, of which over 40,000 doses are estimated to have been utilized to date, worldwide. Valneva is working with the health authorities and anticipates formal reviews of the post-marketing safety reports in all territories where IXCHIQ® is approved. The Company will provide further updates as these evaluations are concluded. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said: “We reiterate our support for the precautionary measures that have been taken as well as our commitment to continue monitoring all reported serious adverse events, particularly from the active chikungunya vaccination campaign in La Réunion, as there have not been any further SAEs reported outside of this public vaccination effort to combat this ongoing outbreak. We will continue engaging proactively with the global regulatory authorities while these important investigations continue over the coming months”. The Company continues to see a positive risk-benefit in the vast majority of people with potential exposure to the disease. The FDA and CDC maintain their recommendations for use of IXCHIQ® foin individuals aged 18 to 60 years. The EMA continues to recommend IXCHIQ® for individuals aged 12 to 64 years. Additionally, France’s national public health agency, the Haute Autorité de Santé (HAS), continues to vaccinate people aged 18 to 64 years of age in its campaign to combat the current chikungunya outbreak in La Réunion. About ChikungunyaChikungunya 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 years1. 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 Americas2. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas3 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.4 About Valneva SEWe 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.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 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. Media and Investor Relations Contacts Laetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 7099laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D.VP Global Investor RelationsM +001 917 815 4520joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory 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 or new adverse events, 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 https://jvi-asm-org.libproxy1.nus.edu.sg/content/jvi/88/20/11644.full.pdf 2 https://cmr-asm-org.libproxy1.nus.edu.sg/content/31/1/e00104-163 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 2023.4 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int) Attachment 2025_05_12_FDA_CDC_Update_PR_EN_Final