Valneva Provides Update on Recommendations for Use of IXCHIQ® in the United Kingdom
MWN-AI** Summary
Valneva SE, a specialty vaccine company, recently updated its recommendations for the use of its chikungunya vaccine IXCHIQ® in the UK. This update comes from the UK’s Commission on Human Medicines (CHM), which conducted a thorough review of the vaccine's benefits and risks. The revised prescribing information now includes restrictions for individuals over 60 and those with specific health conditions, alongside guidance on the timing of the vaccination prior to travel.
The Medicine and Healthcare products Regulatory Agency (MHRA) confirmed that the benefit-risk profile for IXCHIQ® remains favorable for individuals aged 18 to 59 who are at risk of chikungunya infection, provided they do not have any contraindicated medical conditions. This update follows a temporary suspension of the vaccine's use in older adults after reports of serious adverse events (SAEs) emerged during an outbreak vaccination campaign in La Réunion, France.
Chikungunya, a mosquito-borne disease characterized by debilitating joint pain and fever, has increasingly spread to over 110 countries since its resurgence in 2004. The World Health Organization (WHO) has flagged it as a major public health issue, with significant medical and economic burdens, especially as climate change continues to affect the geographical spread of mosquito vectors.
Valneva, focused on developing and commercializing vaccines for infectious diseases, is dedicated to maintaining high safety standards. The company actively monitors the post-marketing safety data for IXCHIQ® and collaborates with health authorities to adjust recommendations as necessary. This reflects Valneva's commitment to addressing unmet medical needs through targeted vaccine solutions.
MWN-AI** Analysis
Valneva SE's recent update regarding IXCHIQ®, its chikungunya vaccine, introduces both potential growth opportunities and risks for investors. With the UK's Commission on Human Medicines revising recommendations that limit the vaccine's use in those over 60 and individuals with certain health conditions, it is clear that Valneva is committed to prioritizing safety while navigating regulatory challenges.
The favorable benefit-risk assessment for individuals aged 18-59 is a positive sign for Valneva, strengthening its position in a crucial segment of the population at risk for chikungunya. This vaccine could play a significant role as global travel resumes, particularly to endemic regions, thereby expanding the potential market for Valneva. In light of the WHO identifying chikungunya as a major public health concern, the demand for preventive solutions will likely increase.
However, the restrictions could impact revenue projections, particularly if the market for older populations is sidelined. Investors should closely monitor how these new guidelines affect vaccination uptake in the UK and other targeted markets. Given the company's robust pipeline, including promising candidates for Lyme disease and Zika, potential revenue diversification mitigates some risks associated with IXCHIQ®.
Valneva's commitment to safety and ongoing collaboration with health authorities, especially after reported serious adverse events during an outbreak, indicates a proactive approach to risk management. This foresight may bolster investor confidence despite current pressures.
In conclusion, while Valneva's immediate prospects may be tempered by regulatory constraints on IXCHIQ®, the company's overall growth trajectory remains strong, driven by its innovative vaccine portfolio and the rising global health challenges posed by infectious diseases. Investors should consider Valneva as a strategically positioned entity in the specialty vaccine landscape, yet remain cognizant of the associated risks.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Lyon (France), February 13, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that following a review of the benefits and risks of the Company’s single?dose chikungunya vaccine, IXCHIQ®, the United Kingdom’s (UK) Commission on Human Medicines (CHM) has updated its recommendations for use of the vaccine.
The updated Prescribing Information (PI) will reflect these recommendations, which now include a restriction for individuals over 60 years of age, for people with specified health conditions, as well as timing of vaccination prior to travel. For further details please refer to this Link.
The MHRA confirmed that the benefit–risk profile of IXCHIQ® remains favorable for individuals aged 18 to 59 years who are at risk of chikungunya infection and do not have the contraindicated underlying medical conditions.
The update follows MHRA’s temporary suspension on the use of IXCHIQ® in older individuals1, which was based on reports of serious adverse events (SAEs), mainly in elderly people with significant underlying medical conditions during an outbreak vaccination campaign on the French island of La Reunion.
Valneva is committed to upholding the highest safety standards and will continue monitoring post marketing safety data of IXCHIQ® and work in a collaborative way with all relevant authorities to potentially further update recommendations and restrictions of use, if justified.
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 now 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 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 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.
| Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)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 |
Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect 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.
[2] Reemergence of Chikungunya Virus
[3] Vaccine and Therapeutic Options To Control Chikungunya Virus
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FAQ**
How does the updated prescribing information for IXCHIQ® impact Valneva SE INRLF's market position in the vaccine landscape, particularly regarding the restrictions for individuals over 60 and those with specific health conditions?
What strategies is Valneva SE INRLF implementing to address the safety concerns raised by the MHRA about IXCHIQ®, especially after reports of serious adverse events in elderly individuals during the vaccination campaign?
In light of the growing chikungunya cases and the World Health Organization’s emphasis on it as a public health concern, what measures is Valneva SE INRLF taking to leverage its vaccine pipeline for future business growth?
With climate change affecting the geographical spread of chikungunya, how is Valneva SE INRLF planning to adapt its vaccine development strategies to meet the evolving public health challenges associated with this disease?
**MWN-AI FAQ is based on asking OpenAI questions about Valneva SE (OTC: INRLF).
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