Valneva's IXCHIQ® Vaccine Use Update for Elderly in the U.S.
Valneva Updates on IXCHIQ® Vaccine Use for Elderly Population
Valneva SE (NASDAQ: VALN; Euronext Paris: VLA), a noted specialty vaccine company, has made important announcements regarding the administration of its single-dose live attenuated chikungunya vaccine, IXCHIQ®. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have jointly recommended a pause in the use of this vaccine in elderly individuals, as investigations into serious adverse events (SAEs) are actively underway.
Understanding the Pause Recommendation
This recent update has come following an earlier recommendation from the U.S. Advisory Committee on Immunization Practices (ACIP), which highlighted a precautionary measure specifically addressing the use of IXCHIQ® in individuals aged 65 or above. Similarly, the European Medicines Agency (EMA) has also temporarily suspended the vaccine's use for the same demographic while investigations are ongoing.
Valneva's Commitment to Safety
Valneva is taking proactive steps to ensure maximum safety standards in all regions where IXCHIQ® is authorized. The company has engaged with health authorities to share timely updates about all known SAEs. Most of these reports, which largely involve elderly individuals with pre-existing health conditions, have been filed with the Vaccine Adverse Event Reporting System (VAERS).
Evaluating Risks and Benefits
Despite the pause in use for older adults, it’s important to note that the FDA and CDC maintain their recommendations for administering IXCHIQ® to individuals aged 18 to 60 years. Valneva believes that the overall risk-benefit ratio remains positive for most individuals exposed to the chikungunya virus.
Chikungunya and Public Health Measures
The chikungunya virus is transmitted through infected Aedes mosquitoes, causing symptoms such as fever, severe joint pain, and rash. The joint pain can be particularly debilitating and may last for weeks or even years. The emergence of chikungunya as a global health concern has prompted significant public health campaigns to mitigate outbreaks effectively. Valneva continues to support vaccination efforts targeted at individuals aged 12 to 64 years, particularly in ongoing campaigns to combat outbreaks.
Valneva's Vaccination Pipeline
Valneva SE is deeply engaged in developing a broad range of vaccines addressing critical public health needs. The company has advanced several vaccine candidates from early research to approvals, with a particular focus on unique and effective solutions. This includes ongoing partnerships, such as with Pfizer for the only Lyme disease vaccine candidate currently in advanced clinical development.
Fostering Regulatory Collaboration
As highlighted by Valneva's Chief Medical Officer, Dr. Juan Carlos Jaramillo, the company remains committed to monitoring SAEs continuously, particularly from the chikungunya vaccination campaigns in regions like La Réunion. Ongoing engagement with global health authorities will ensure thorough evaluations are conducted during the investigation period.
Looking Forward
While challenges exist, Valneva views the eventual outcome of the investigations positively and is dedicated to transparency throughout this process. By evaluating the reported data diligently and communicating findings promptly, the company aims to ensure public trust and safety in its vaccination programs.
Frequently Asked Questions
What led to the recommendation pause for IXCHIQ® in the elderly?
The pause was recommended due to reported serious adverse events in elderly individuals, prompting investigations by the FDA and CDC.
Is IXCHIQ® still recommended for younger age groups?
Yes, the FDA and CDC still endorse the use of IXCHIQ® for individuals aged 18 to 60 years.
What health risks are associated with chikungunya?
Chikungunya can cause severe joint pain, fever, headache, and fatigue, with joint pain potentially lasting for years.
How is Valneva ensuring vaccine safety?
Valneva is actively reporting adverse events and collaborating with health authorities to monitor the safety of IXCHIQ®.
What is Valneva's focus in developing vaccines?
Valneva focuses on creating specialized vaccines for infectious diseases with unmet medical needs, including partnerships for innovative vaccine candidates.
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