Valneva’s IXCHIQ loses UK marketing authorization
Valneva expects the UK revocation to have only minimal overall sales impact and no product-recall expense.
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Form Type
6-K
Rhea-AI Filing Summary
Valneva SE (VALN) announced that the UK Medicines and Healthcare products Regulatory Agency revoked IXCHIQ’s UK marketing authorization after the Commission on Human Medicines’ further benefit-risk assessment for travelers. Valneva said the decision followed a review of previous safety data and was not associated with a newly identified safety signal; the revocation does not affect the vaccine’s licenses in the EU, Canada, Brazil or other territories where it is marketed.
Valneva expects no expense related to product recall and only minimal impact on overall sales revenue, citing low traveler sales, several months without active UK distribution and no product remaining on the UK market. It will not appeal, citing the decision’s immaterial financial and commercial impact and its strategic focus on expanding access in endemic territories. In Brazil’s pilot vaccination strategy, more than 61,000 people aged 18–59 had been vaccinated without new safety concerns identified; approximately 187,000 IXCHIQ doses had been administered globally.
Key Figures
People vaccinated in Brazil: More than 61,000 people
Age range vaccinated in Brazil: 18–59 years
IXCHIQ doses administered globally: Approximately 187,000 doses
+2 more
5 metrics
People vaccinated in Brazil
More than 61,000 people
Pilot vaccination strategy; no new safety concerns identified
Age range vaccinated in Brazil
18–59 years
People vaccinated to date in the pilot vaccination strategy
IXCHIQ doses administered globally
Approximately 187,000 doses
Reported to date
Countries where chikungunya has been identified
Over 110 countries
Across Asia, Africa, Europe and the Americas
Reported chikungunya cases in the Americas
More than 3.7 million cases
Between 2013 and 2023
Key Terms
marketing authorization, benefit-risk assessment, post-marketing evidence, pilot vaccination strategy, +1 more
5 terms
marketing authorization regulatory
"the UK marketing authorization for IXCHIQ® has been revoked"
An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.
benefit-risk assessment regulatory
"following a further benefit-risk assessment of IXCHIQ® for travelers"
post-marketing evidence medical
"the emerging post-marketing evidence"
pilot vaccination strategy medical
"the ongoing pilot vaccination strategy (PVS) in Brazil"
endemic territories medical
"expanding access to IXCHIQ® in endemic territories"
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What happened to VALN’s IXCHIQ authorization in the UK?
The UK Medicines and Healthcare products Regulatory Agency revoked IXCHIQ’s UK marketing authorization after the Commission on Human Medicines conducted a further benefit-risk assessment for travelers. Valneva said the decision followed a review of previous safety data and was not associated with a newly identified safety signal.
Does the UK decision affect IXCHIQ licenses in other countries?
Valneva said the UK revocation does not affect IXCHIQ product licenses in the EU, Canada, Brazil or other territories where it is marketed. The European Medicines Agency and Health Canada recently maintained their marketing authorizations with updated product information.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: October 7, 2026
Commission File Number: 001-40377
Valneva SE
(Translation of registrant's name into English)
Îlot Saint-Joseph, Bureaux Convergence
12ter Quai Perrache
69002 Lyon, France
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
On October 7, 2026, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1. The information contained in this Form 6-K is hereby incorporated by reference into the registrant's registration Statement on Form F-3 (File No. 333-268071).
Exhibit | |||||
Exhibit 99.1 | Press release dated October 7, 2026 | ||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Valneva SE (Registrant) | ||||||||||||||||||||
Date: October 7, 2026 | /s/ Thomas Lingelbach | |||||||||||||||||||
Thomas Lingelbach | ||||||||||||||||||||
Chief Executive Officer and President | ||||||||||||||||||||
VALNEVA SE
Îlot Saint-Joseph, Bureaux Convergence, Bât. A,
12 ter Quai Perrache
69002 Lyon, France
Valneva Provides Update on IXCHIQ® in the United Kingdom
Lyon (France), October 07, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that, following a further benefit-risk assessment of IXCHIQ® for travelers by the United Kingdom’s (UK) Commission on Human Medicines (CHM), the UK marketing authorization for IXCHIQ® has been revoked by the Medicines and Healthcare products Regulatory Agency (MHRA). The decision was based on a review of previous safety data and was not associated with any newly identified safety signal. It does not affect the product licenses for IXCHIQ® in the EU, Canada, Brazil, or other territories where IXCHIQ® is currently marketed.
IXCHIQ® was launched in the UK in mid-2025. Due to low sales amongst travelers, Valneva has not actively distributed IXCHIQ® in the UK for several months. As no product currently remains on the UK market, Valneva expects no expense related to product recall and only minimal impact on its overall sales revenue going forward.
Valneva considers the benefit-risk profile of IXCHIQ® favorable when used in accordance with the approved indication, contraindications, warnings and precautions. This is further supported by the emerging post-marketing evidence, including the ongoing pilot vaccination strategy (PVS)1 in Brazil, where more than 61,000 people aged 18-59 years have been vaccinated to date with no new safety concerns identified. Similar safety reviews were concluded recently by the European Medicines Agency (EMA) and by Health Canada, which maintained the marketing authorizations for IXCHIQ®, with updated product information. To date, approximately 187,000 doses of IXCHIQ® have been administered globally.
While the Company disagrees with CHM’s and MHRA’s conclusion, Valneva has decided not to appeal the decision, given its immaterial financial and commercial impact, and in line with the Company’s strategic focus on expanding access to IXCHIQ® in endemic territories, where the risk of chikungunya virus infection is highest.
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 years2. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has been identified in over 110 countries in Asia, Africa, Europe and the Americas3. 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
1 https://valneva.com/press-release/valneva-and-instituto-butantan-announce-initiation-of-a-pilot-vaccination-campaign-in-brazil-with-single-shot-chikungunya-vaccine-ixchiq/
2 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf
3 https://cmr.asm.org/content/31/1/e00104-16
October 07, 2026 VALNEVA SE
to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem4.
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.
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 other global public health threats. More information is available at www.valneva.com.
Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP, Global Communications and European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelotfontaine@valneva.com | Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com | ||||||||||
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in France. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements with respect to: the impact of the UK MHRA revocation of the UK marketing authorization for IXCHIQ® on Valneva's business, financial condition, and results of operations; Valneva's expectations regarding the financial and commercial impact of the MHRA's decision and its decision not to appeal; the continued validity and status of IXCHIQ®'s product licenses and marketing authorizations in the EU, Canada, Brazil, and other territories where IXCHIQ® is currently marketed; and Valneva's assessment of the benefit-risk profile of IXCHIQ® and the outcome of related or future regulatory reviews, including by other health authorities. These forward-looking statements are based on Valneva’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements
4 https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON448
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involves risks and uncertainties that could cause Valneva’s business, strategy, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: Valneva’s success in the commercialization of its commercial products; uncertainties and delays involved in the development and manufacture of vaccines; the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including tariffs and other trade policies and uncertainty related to such policies; the conflicts in Ukraine, Iran and the Middle East; fluctuations in inflation and uncertain credit and financial markets and their resulting impacts on Valneva’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Valneva’s ability to realize the benefits of its collaboration and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; the impact of the global and European credit crisis; the ability to obtain or maintain patent or other proprietary intellectual property protection and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled “Risk Factors” in Valneva’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) and the Autorité des marchés financiers (“AMF”) on March 18, 2026, and in other filings made with the SEC and AMF from time to time. Valneva is providing this information as of the date of this press release and expressly 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, except as required by law.
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