Valneva Updates FDA on IXCHIQ® Vaccine Approval for Seniors
Valneva SE, a notable company in the vaccine sector, has made a significant announcement regarding its chikungunya vaccine, IXCHIQ®. The U.S. Food and Drug Administration (FDA) has officially lifted its recommended pause on the administration of IXCHIQ® to elderly individuals aged 60 and above. This decision comes after a thorough review by the FDA, as well as previous endorsements from the European Medicines Agency (EMA), which had similarly advised the lifting of temporary restrictions.
Safety and Prescribing Information Updates
The FDA's approval also aligns with enhancements to the vaccine’s prescribing information (PI), which now includes critical insights regarding serious adverse events observed primarily among older adults with multiple underlying health issues. This update arises from a mass vaccination initiative conducted in response to a chikungunya outbreak in La Réunion.
Understanding Chikungunya Virus
Chikungunya virus (CHIKV) is an infectious disease transmitted by Aedes mosquitoes, manifesting symptoms like fever, severe joint pain, headache, fatigue, and rash. The joint pain can be particularly debilitating, often lasting from weeks to even years. Since its rapid spread beginning in 2004, CHIKV has been reported in over 110 countries, with millions of cases recorded, particularly in the Americas. The economic and healthcare challenges posed by this disease are considerable and are expected to escalate due to climate change, which facilitates the spread of mosquito vectors.
The Importance of IXCHIQ® Vaccine
IXCHIQ® is specifically recommended for individuals over 18 years of age who are at heightened risk of exposure to CHIKV. The FDA advises that the vaccine should be administered judiciously, considering the potential risks versus benefits, particularly for travelers where exposure risk remains low. Additionally, IXCHIQ® is contraindicated in individuals with compromised immune systems.
Ongoing Research and Trials
Furthermore, Valneva is engaged in ongoing research efforts, aiming to potentially extend the IXCHIQ® vaccine’s label to adolescent populations and gather more data on vaccine persistence. This would be a significant step forward, broadening the scope of vaccine availability and enhancing overall public health protection against CHIKV.
About Valneva SE
Valneva SE strives to address unmet medical needs through the development, manufacturing, and commercialization of vaccines. The firm has a proven track record in advancing multiple vaccines from early research to final approvals, with three proprietary travel vaccines currently on the market. Their efforts are directed towards advancing pipeline candidates, including the only Lyme disease vaccine in advanced development, alongside other potential vaccines against Zika virus and Shigella.
Media and Investor Relations
For more information, Valneva's media and investor relations can be contacted as follows:
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
Frequently Asked Questions
What is IXCHIQ® used for?
IXCHIQ® is used to prevent chikungunya disease caused by the chikungunya virus in individuals at high risk of exposure.
Who can receive the IXCHIQ® vaccine?
The vaccine is recommended for individuals aged 18 and older, especially those at increased risk, with careful consideration for elderly individuals.
What updates were made to the prescribing information?
The prescribing information now includes reports of serious adverse events, specifically among older adults with chronic health conditions.
Has the FDA lifted restrictions on younger individuals?
The current FDA updates focus on older adults. Ongoing research may lead to recommendations for younger populations in the future.
How can I contact Valneva for more information?
Media and investors can contact Laetitia Bachelot-Fontaine or Joshua Drumm via the provided email addresses linked to Valneva.
