Valneva Updates IXCHIQ® Vaccine Guidelines for Seniors Age 65+
Valneva Updates IXCHIQ® Vaccine Guidelines for Seniors Age 65+
Valneva SE (NASDAQ: VALN; Euronext Paris: VLA), a renowned specialty vaccine company, has made significant strides in its ongoing commitment to public health. As of now, the European Medicines Agency (EMA) has initiated a review of the chikungunya vaccine, IXCHIQ®, after receiving reports concerning adverse events in elderly individuals. This decision marks a step toward enhancing safety protocols, particularly for adults aged 65 and above.
Current Status of IXCHIQ® Vaccine
In response to preliminary safety concerns, the EMA has decided to temporarily suspend the use of IXCHIQ® for individuals over 65 years old. This action was revealed following a plenary meeting by the Pharmacovigilance Risk Assessment Committee (PRAC), which took place on May 5, 2025. This review stems from reports of 17 serious adverse events worldwide relating to the vaccine, which included two fatalities among elderly patients with notable pre-existing medical conditions.
Previous Recommendations
Valneva continues to actively engage with regulatory authorities, as they had previously adjusted recommendations regarding IXCHIQ® for various demographics. For instance, just earlier this month, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) advised caution when using IXCHIQ® for people aged 65 and older. These measures reflect a careful balancing of potential benefits against the risks identified.
EMA Focus on Safety
Importantly, the EMA has clarified that while these adverse events require further investigation, the direct cause and relationship to the vaccine have yet to be conclusively established. They have reiterated to healthcare providers that IXCHIQ® should not be administered to individuals with compromised immune systems due to existing health conditions or treatments.
Statements from Valneva’s Leadership
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, expressed the company’s concern regarding these reports: “We are deeply concerned by the reports of adverse events experienced by elderly individuals. Valneva remains committed to upholding the highest safety standards and respects the precautionary measures taken by authorities as investigations continue.” This perspective underscores Valneva’s priority on safety while looking to maintain its strong risk-benefit profile for the majority of those at risk of chikungunya.
Insights on Chikungunya Virus
The chikungunya virus (CHIKV) is primarily transmitted through infected mosquitos, leading to numerous debilitating symptoms including fever and severe joint pain. The occurrence of chikungunya has seen a significant rise since 2004, affecting millions globally. In fact, the disease has been reported in over 110 countries. With the spread of climate-related factors influencing mosquito population dynamics, the World Health Organization (WHO) categorizes chikungunya as a pressing global health issue.
Valneva’s Commitment to Vaccine Development
Valneva has established itself as a key player in the vaccine industry. The company focuses on developing and commercializing innovative vaccines that meet critical health needs. Currently, Valneva is advancing multiple candidates through its pipeline including the only Lyme disease vaccine in advanced clinical stages and solutions for diseases like Shigella and Zika virus. Their dedication is fueled by ongoing revenues from their existing commercial portfolio which supports the comprehensive development of future vaccines.
Conclusion
In light of current developments, the EMA’s review of IXCHIQ® for the elderly reflects a proactive stance in addressing safety concerns. Valneva SE assures the public that it is maintaining open communication with health authorities and emphasizing rigorous safety protocols across its operations. As the investigation continues, the health and safety of vaccinated populations remain a priority, demonstrating the company's longstanding commitment to public health.
Frequently Asked Questions
What triggered the EMA's review of IXCHIQ®?
The EMA initiated the review based on reports of serious adverse events, including two fatalities in patients aged 65 and over who had pre-existing conditions.
How does the EMA's decision impact elderly patients?
The EMA has temporarily suspended the use of IXCHIQ® in individuals over 65 while the review is ongoing, prioritizing patient safety.
What is chikungunya, and how is it transmitted?
Chikungunya is a mosquito-borne viral disease characterized by severe joint and muscle pain, transmitted mainly by Aedes mosquitoes.
What is Valneva's response to the adverse events reported?
Valneva is cooperating with health authorities, ensuring their commitment to highest safety standards and monitoring potential adverse events closely.
What other vaccines does Valneva offer?
Valneva develops various vaccines, including those for Lyme disease, Shigella, and Zika virus, focusing on significant global health threats.
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