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

Issue

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 Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Report health or safety concerns Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving IXCHIQ should be reported to Valneva Canada Inc. or Health Canada. Valneva Canada Inc. Commercial Operations 3535 Bd Saint-Charles, Suite 600 Kirkland (Montreal), QC H9H 5B9 Tel: 514-630-6999 For Medical Inquiries, to report Adverse Events and Product Complaints: Toll free: 1-855-356-0831 Email: medinfocanada@valneva.com To correct your mailing address or fax number, contact Valneva Canada Inc. You can report any suspected adverse reactions associated with the use of health products to Health Canada by: Calling toll-free at 1-866-234-2345; or Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax. For other health product inquiries related to this communication, contact Health Canada at: Marketed Health Products Directorate E-mail: mhpd-dpsc@hc-sc.gc.ca Telephone: 613-954-6522 Fax: 613-952-7738 Original signed by Dr. Juan Carlos Jaramillo, MD Chief Medical Officer Valneva SE

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