🇨🇦 IXCHIQ (chikungunya vaccine, live, attenuated) and the Risk of Serious Adverse Reactions in Medically Frail Individuals 65 Years of Age and Older

Hazard/Reason: Post-marketing data suggest that individuals 65 years of age and older who are medically frail with multiple chronic medical conditions may be at an increased risk of serious and life-threatening adverse reactions following recent vaccination with IXCHIQ.   Audience Healthcare professionals, including physicians, pharmacists, and nurses specializing in travel or tropical medicine.   Key messages Individuals 65 years of age and older who are medically frail with multiple chronic medical conditions may be at an increased risk of serious and life-threatening adverse reactions following recent vaccination with IXCHIQ.   Healthcare professionals are advised to: Carefully weigh the potential risks and benefits when considering IXCHIQ vaccination in individuals 65 years of age and older. Instruct vaccinated individuals to promptly seek medical attention if they experience symptoms suggestive of severe reactogenicity or severe chikungunya-like adverse reactions following vaccination.    The Canadian Product Monograph for IXCHIQ has been updated to reflect this safety information.   Background IXCHIQ is a live, attenuated vaccine, indicated for active immunization to prevent disease caused by the chikungunya virus in individuals 12 years of age and older, administered as a single dose. In the post-market setting, serious adverse reactions following vaccination with IXCHIQ were most commonly reported in medically frail individuals with advanced chronic diseases, adults 65 years of age and older (especially those 75 years of age and older), and those at high risk of having an undiagnosed immunocompromised condition (e.g., occult cancer or immunosenescence). Severe reactogenicity or chikungunya-like adverse reactions in medically frail individuals with chronic diseases may lead to a deterioration of overall health. Complications can include malaise and decreased appetite, exacerbation of pre-existing diseases, confusional state, encephalopathy, or encephalitis, leading to falls, hospitalization, and death.   Information for consumers IXCHIQ is a vaccine used to help protect against the chikungunya virus in people 12 years of age and older.  Information collected after IXCHIQ was approved suggests that people 65 years of age and older who are medically frail and have several long-term health conditions may have a higher risk of serious side effects after recently receiving the vaccine. Some people may experience severe side effects or symptoms similar to chikungunya after vaccination. These reactions can make a person feel generally unwell, reduce appetite, worsen existing health conditions, or cause confusion or changes in brain function, including brain inflammation, which can lead to falls, hospitalisation, or death. Patients should seek medical attention immediately if they develop severe symptoms after vaccination. They should consult with their healthcare professional if they have any questions or concerns about the information contained within this communication.   Information for healthcare professionals Healthcare professionals are advised to: Carefully weigh the potential risks and benefits when considering IXCHIQ vaccination in individuals 65 years of age and older. The decision to vaccinate should be based on an individualized risk–benefit assessment, taking into account the patient’s overall health status and their risk of exposure to the chikungunya virus.   Instruct vaccinated individuals to promptly seek medical attention if they experience symptoms suggestive of severe reactogenicity or severe chikungunya-like adverse reactions following vaccination.   Action taken by Health Canada Health Canada, in collaboration with Valneva Canada Inc., has updated the Canadian Product Monograph for IXCHIQ to include this new information. Health Canada is communicating this important safety information to healthcare professionals and

This page links to official sources. Verify model/lot/batch details in the official notice.