Valneva Reports Positive Phase 2 Results for IXCHIQ® Chikungunya Vaccine in Children, Supporting Future Phase 3 Trials
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 10 2025
0mins
Should l Buy VALN?
Source: Globenewswire
- Safety and Tolerability: Valneva's IXCHIQ® vaccine demonstrated excellent tolerability in 304 children aged one to eleven, with no safety concerns identified, ensuring a smooth transition to future Phase 3 trials.
- Antibody Persistence: Twelve months post-vaccination, the full dose group exhibited significantly higher antibody levels than the half dose group, with a 94.7% seroresponse rate indicating the vaccine's efficacy in children, thereby enhancing the company's competitive position in the vaccine market.
- Clinical Trial Support: The trial, partially funded by CEPI, yielded results consistent with previous six-month data, further validating the selection of the full dose and laying the groundwork for future pediatric vaccination efforts.
- Global Health Impact: Given the severe chikungunya outbreaks in countries like Brazil and India, Valneva's vaccine is poised to provide long-term protection in low- and middle-income countries, addressing the urgent global demand for vaccines.
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Analyst Views on VALN
Wall Street analysts forecast VALN stock price to rise
2 Analyst Rating
1 Buy
1 Hold
0 Sell
Moderate Buy
Current: 10.020
Low
7.55
Averages
10.28
High
13.00
Current: 10.020
Low
7.55
Averages
10.28
High
13.00
About VALN
Valneva SE is a France-based company that specializes in the development, manufacture and commercialization of vaccines to protect people from infectious diseases through preventative medicine. The Company's portfolio includes two commercial vaccines for travelers: IXIARO/JESPECT, for the prevention of Japanese Encephalitis, and DUKORAL, which is indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by Enterotoxigenic escherichia coli (ETEC). The Company has also vaccines in development, including candidates against Lyme disease, COVID-19 and chikungunya. Its technologies and services segment cooperates with various pharmaceutical companies using its platform: EB66 vaccine production cell line and IC31 adjuvant. The Company is focused on research and development (R&D) programs, as well as holds investment in product candidates and commercial products.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Valneva Updates Ixchiq Vaccine Recommendations in the UK
- Vaccine Usage Restrictions: Valneva's Ixchiq vaccine has updated usage recommendations in the UK due to reports of serious adverse events associated with the single-dose shot, leading to restrictions for individuals over 60, which may impact market acceptance of the vaccine.
- Target Population Adjustment: The UK's Commission on Human Medicines suggests that Ixchiq still offers a favorable benefit-risk profile for individuals aged 18-59 without contraindications, indicating a positive outlook for the vaccine's application among younger demographics.
- Safety Review Impact: Following reports of very rare but fatal reactions, the commission temporarily suspended the use of the vaccine in individuals aged 65 and older in June, potentially limiting Valneva's sales in the senior market segment.
- FDA Authorization Changes: Although the FDA approved Ixchiq as the world's first chikungunya vaccine in 2023, it suspended its authorization last August due to safety concerns, highlighting the regulatory challenges faced by the vaccine in the market.
See More
UK Updates IXCHIQ Vaccine Usage Recommendations
- Vaccine Usage Update: The UK's Commission on Human Medicines (CHM) has updated its recommendations for Valneva SE's single-dose chikungunya vaccine IXCHIQ®, now including restrictions for individuals over 60 years, ensuring the safety and efficacy of the vaccine's use.
- Risk Assessment Findings: While usage for those over 60 is restricted, the MHRA confirms that the benefit-risk profile of IXCHIQ® remains favorable for individuals aged 18 to 59, highlighting the vaccine's significance in younger populations.
- Safety Monitoring Commitment: Valneva is committed to ongoing monitoring of post-marketing safety data for IXCHIQ® and will collaborate with relevant authorities to ensure timely updates to vaccine usage recommendations in response to potential safety concerns.
- Public Health Impact: The chikungunya virus has caused over 3.7 million cases globally, and with the impact of climate change, the spread of this virus is expected to intensify, making Valneva's vaccine development crucial for public health.
See More
Valneva and Brazil Launch Pilot Chikungunya Vaccine Program
- Pilot Program Launch: Valneva and Instituto Butantan have initiated a pilot vaccination strategy for the IXCHIQ® vaccine, aiming to evaluate its effectiveness and safety in real-world settings, with plans to vaccinate over 500,000 adults aged 18 to 59.
- Vaccine Coverage Goals: The program targets a vaccine coverage rate of 20% to 40% across ten strategically selected municipalities, addressing public health needs as outlined by the Brazilian Ministry of Health to mitigate chikungunya transmission.
- Global Health Commitment: Valneva's Chief Medical Officer emphasized that this initiative underscores the company's commitment to global preparedness against chikungunya threats, with expectations to generate critical real-world data that reinforces the vaccine's public health value.
- Technology Transfer and Collaboration: Valneva signed a technology transfer agreement with Butantan in 2021, ensuring the vaccine's development and commercialization in Latin America, highlighting the strong collaboration between the two entities in addressing public health challenges.
See More
Valneva Withdraws Ixchiq Vaccine Applications Amid FDA Hold
- Application Withdrawal: Valneva SE has voluntarily withdrawn its Biologics License Application (BLA) and Investigational New Drug (IND) application for the Ixchiq vaccine in the U.S. following the FDA's suspension of the license in August 2025 due to four reports of serious adverse events (SAEs) resembling chikungunya illness.
- Clinical Hold: The FDA has placed the IND for Ixchiq on clinical hold pending an investigation into a newly reported foreign SAE, resulting in no active clinical studies vaccinating participants, which significantly impacts the company's vaccine rollout strategy.
- Safety Assessment: Valneva is actively seeking additional information to further characterize the case related to Ixchiq vaccination, as the case may be plausibly linked to the vaccine, although causality has not been established, potentially affecting public confidence and market acceptance of the vaccine.
- Future Plans: Despite these challenges, Valneva intends to continue discussions with health authorities in all territories where Ixchiq is licensed and plans to advance post-marketing clinical activities, while also looking forward to submitting a Biologics License Application for the Lyme disease vaccine candidate VLA15 in collaboration with Pfizer in 2026.
See More
Valneva SE Withdraws Chikungunya Vaccine Applications, Shares Drop 7.7%
- Vaccine Withdrawal: Valneva SE has withdrawn its BLA and IND applications for the IXCHIQ Chikungunya vaccine due to an FDA suspension and review of new serious adverse events, leading to a 7.7% drop in pre-market trading to $9.29, indicating market concerns over its product prospects.
- Market Decline: U.S. stock futures are broadly lower, with Dow futures falling around 700 points, reflecting investor caution regarding economic outlook, which may impact overall market sentiment and exacerbate volatility in other stocks.
- Other Stock Movements: Shares of Rezolve AI PLC and POET Technologies Inc fell 15% and 11.2% respectively in pre-market trading, indicating widespread investor apprehension towards tech stocks, potentially prompting a reassessment of risk appetite.
- Tesla Update: Tesla's stock fell 2.7% to $425.75 in pre-market trading, despite CEO Elon Musk confirming that vehicles equipped with the AI4 chip will achieve unsupervised autonomous driving, suggesting insufficient market confidence in the electric vehicle sector.
See More
Valneva SE Withdraws IXCHIQ Vaccine Applications Following FDA License Suspension
- Application Withdrawal: Valneva SE has voluntarily withdrawn its biologics license and IND applications for the IXCHIQ vaccine in the U.S. following the FDA's suspension of the vaccine's license in August 2025, indicating significant regulatory hurdles for the company.
- Clinical Trials Halted: Currently, no clinical studies for IXCHIQ are actively recruiting participants due to the FDA placing the IND on clinical hold, which disrupts the company's research and development timeline.
- Adverse Event Investigation: The FDA is investigating a serious adverse event plausibly related to IXCHIQ vaccination that occurred outside the U.S., involving a young adult who received three vaccines, which may undermine market confidence in the vaccine's safety.
- Commitment to Safety: Valneva emphasizes its commitment to the highest safety standards and continues proactive engagement with health authorities, asserting that IXCHIQ's benefit-risk profile remains favorable for individuals in endemic regions despite the current challenges.
See More
Valneva Updates Ixchiq Vaccine Recommendations in the UK
- Vaccine Usage Restrictions: Valneva's Ixchiq vaccine has updated usage recommendations in the UK due to reports of serious adverse events associated with the single-dose shot, leading to restrictions for individuals over 60, which may impact market acceptance of the vaccine.
- Target Population Adjustment: The UK's Commission on Human Medicines suggests that Ixchiq still offers a favorable benefit-risk profile for individuals aged 18-59 without contraindications, indicating a positive outlook for the vaccine's application among younger demographics.
- Safety Review Impact: Following reports of very rare but fatal reactions, the commission temporarily suspended the use of the vaccine in individuals aged 65 and older in June, potentially limiting Valneva's sales in the senior market segment.
- FDA Authorization Changes: Although the FDA approved Ixchiq as the world's first chikungunya vaccine in 2023, it suspended its authorization last August due to safety concerns, highlighting the regulatory challenges faced by the vaccine in the market.
See More
UK Updates IXCHIQ Vaccine Usage Recommendations
- Vaccine Usage Update: The UK's Commission on Human Medicines (CHM) has updated its recommendations for Valneva SE's single-dose chikungunya vaccine IXCHIQ®, now including restrictions for individuals over 60 years, ensuring the safety and efficacy of the vaccine's use.
- Risk Assessment Findings: While usage for those over 60 is restricted, the MHRA confirms that the benefit-risk profile of IXCHIQ® remains favorable for individuals aged 18 to 59, highlighting the vaccine's significance in younger populations.
- Safety Monitoring Commitment: Valneva is committed to ongoing monitoring of post-marketing safety data for IXCHIQ® and will collaborate with relevant authorities to ensure timely updates to vaccine usage recommendations in response to potential safety concerns.
- Public Health Impact: The chikungunya virus has caused over 3.7 million cases globally, and with the impact of climate change, the spread of this virus is expected to intensify, making Valneva's vaccine development crucial for public health.
See More
Valneva and Brazil Launch Pilot Chikungunya Vaccine Program
- Pilot Program Launch: Valneva and Instituto Butantan have initiated a pilot vaccination strategy for the IXCHIQ® vaccine, aiming to evaluate its effectiveness and safety in real-world settings, with plans to vaccinate over 500,000 adults aged 18 to 59.
- Vaccine Coverage Goals: The program targets a vaccine coverage rate of 20% to 40% across ten strategically selected municipalities, addressing public health needs as outlined by the Brazilian Ministry of Health to mitigate chikungunya transmission.
- Global Health Commitment: Valneva's Chief Medical Officer emphasized that this initiative underscores the company's commitment to global preparedness against chikungunya threats, with expectations to generate critical real-world data that reinforces the vaccine's public health value.
- Technology Transfer and Collaboration: Valneva signed a technology transfer agreement with Butantan in 2021, ensuring the vaccine's development and commercialization in Latin America, highlighting the strong collaboration between the two entities in addressing public health challenges.
See More
Valneva Withdraws Ixchiq Vaccine Applications Amid FDA Hold
- Application Withdrawal: Valneva SE has voluntarily withdrawn its Biologics License Application (BLA) and Investigational New Drug (IND) application for the Ixchiq vaccine in the U.S. following the FDA's suspension of the license in August 2025 due to four reports of serious adverse events (SAEs) resembling chikungunya illness.
- Clinical Hold: The FDA has placed the IND for Ixchiq on clinical hold pending an investigation into a newly reported foreign SAE, resulting in no active clinical studies vaccinating participants, which significantly impacts the company's vaccine rollout strategy.
- Safety Assessment: Valneva is actively seeking additional information to further characterize the case related to Ixchiq vaccination, as the case may be plausibly linked to the vaccine, although causality has not been established, potentially affecting public confidence and market acceptance of the vaccine.
- Future Plans: Despite these challenges, Valneva intends to continue discussions with health authorities in all territories where Ixchiq is licensed and plans to advance post-marketing clinical activities, while also looking forward to submitting a Biologics License Application for the Lyme disease vaccine candidate VLA15 in collaboration with Pfizer in 2026.
See More
Valneva SE Withdraws Chikungunya Vaccine Applications, Shares Drop 7.7%
- Vaccine Withdrawal: Valneva SE has withdrawn its BLA and IND applications for the IXCHIQ Chikungunya vaccine due to an FDA suspension and review of new serious adverse events, leading to a 7.7% drop in pre-market trading to $9.29, indicating market concerns over its product prospects.
- Market Decline: U.S. stock futures are broadly lower, with Dow futures falling around 700 points, reflecting investor caution regarding economic outlook, which may impact overall market sentiment and exacerbate volatility in other stocks.
- Other Stock Movements: Shares of Rezolve AI PLC and POET Technologies Inc fell 15% and 11.2% respectively in pre-market trading, indicating widespread investor apprehension towards tech stocks, potentially prompting a reassessment of risk appetite.
- Tesla Update: Tesla's stock fell 2.7% to $425.75 in pre-market trading, despite CEO Elon Musk confirming that vehicles equipped with the AI4 chip will achieve unsupervised autonomous driving, suggesting insufficient market confidence in the electric vehicle sector.
See More
Valneva SE Withdraws IXCHIQ Vaccine Applications Following FDA License Suspension
- Application Withdrawal: Valneva SE has voluntarily withdrawn its biologics license and IND applications for the IXCHIQ vaccine in the U.S. following the FDA's suspension of the vaccine's license in August 2025, indicating significant regulatory hurdles for the company.
- Clinical Trials Halted: Currently, no clinical studies for IXCHIQ are actively recruiting participants due to the FDA placing the IND on clinical hold, which disrupts the company's research and development timeline.
- Adverse Event Investigation: The FDA is investigating a serious adverse event plausibly related to IXCHIQ vaccination that occurred outside the U.S., involving a young adult who received three vaccines, which may undermine market confidence in the vaccine's safety.
- Commitment to Safety: Valneva emphasizes its commitment to the highest safety standards and continues proactive engagement with health authorities, asserting that IXCHIQ's benefit-risk profile remains favorable for individuals in endemic regions despite the current challenges.
See More
