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Health professional risk communication

IXIARO Japanese Encephalitis Vaccine (inactivated, adsorbed) - Recall of Lot JEV09L37C - For the Public

Starting date:
March 8, 2011
Posting date:
March 16, 2011
Type of communication:
Public Communication
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Audience:
General Public
Identification number:
RA-15924

This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on IXIARO Japanese Encephalitis Vaccine (inactivated, adsorbed)

March 8, 2011

Subject: Important information regarding IXIARO® Japanese Encephalitis vaccine (inactivated, adsorbed), Lot JEV09L37C

Intercell AG and Novartis Pharmaceuticals Canada Inc. (Novartis), in consultation with Health Canada, are advising people who were vaccinated with one or both doses of lot JEV09L37C of IXIARO® after December 23, 2010, that this specific lot may not provide full protection against Japanese Encephalitis. Therefore, lot JEV09L37C IXIARO® is being recalled in Canada.

  • Individuals who were vaccinated with a Japanese Encephalitis vaccine after December 23rd, 2010, should check if they were vaccinated with IXIARO® Lot JEV09L37C.
  • If so, they should return to their Health Care Professional to be re-vaccinated, if they are still at risk of exposure to Japanese Encephalitis.

Novartis' Japanese Encephalitis vaccine, IXIARO® (inactivated, adsorbed) Lot JEV09L37C is being recalled in Canada (DIN 02333279, UPC Code 0 63601 18546 0), because this specific lot may not produce the desired protection against Japanese Encephalitis in individuals who were vaccinated with one or both doses after December 23, 2010.

There is no evidence of a safety concern with this lot. No other lots of IXIARO® are affected by this recall. New supply is available and free replacement product is available up to April 30, 2011. Please contact your health care professional if you were vaccinated with Japanese Encephalitis vaccine after December 23, 2010.

IXIARO® is manufactured by Intercell AG and distributed in Canada by Novartis. Intercell AG and Novartis reiterate their commitment to the delivery of quality pharmaceutical products.

Managing marketed health product-related adverse events depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse events are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse events for vaccines in patients receiving IXIARO® should be reported to Novartis or the Public Health Agency of Canada at the following addresses:

Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.,
Dorval, QC H9S 1A9
e-mail address: drug.safety@novartis.com

Public Health Agency of Canada
Vaccine Safety Section
130 Colonnade Road,
Address Locator: 6502A
Ottawa, ON K1A OK9
Telephone: 1-866-844-0018
Fax: 1-866-844-5931
E-mail: caefi@phac-aspc.gc.ca

How to report a suspected Adverse Event following Immunization:
If a patient experiences an adverse event following immunization, please complete the Adverse Events Following Immunization (AEFI) Form and send it to the local health department in your province or territory. The list of contacts is also provided below.

If you have any questions or have difficulties contacting your local health department, please contact the Vaccine Safety Section at the Public Health Agency of Canada at:
Telephone: 613-954-5590, 1-866-844-0018
Fax: 613-954-9874; 1-866-844-5931

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at MedEffect Canada
  • Call toll-free at 1-866-234-2345
  • Complete a Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffectTM Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:
Biologics and Genetic Therapies Directorate (BGTD)
E-mail: BGTD_ORA_Enquiries@hc-sc.gc.ca
Telephone: 613-957-1722

If you have any questions regarding this important information, please contact your Health Care Professional or Novartis Customer Relations at 1-800-465-2244. For medical inquiries, please contact Novartis Medical Information at 1-800-363-8883.

A copy of this Public Communication and Health Care Professional Recall letter are available on the Novartis Web Site and the Health Canada Web Site.

Sincerely,

original signed by

Kerstin Westritschnig, M.D.
Medical Officer
Intercell AG

Jean-Marie Leclerc, M.D., FRCP(C)
Chief Scientific Officer and Senior Vice-President
Clinical and Regulatory Affairs
Novartis Pharmaceuticals Canada Inc.

IXIARO® is a registered trademark.

Provincial/Territorial Contacts for Adverse Events Following Immunization Form

Alberta
Alberta Health and Wellness
Community Health Branch
Immunization Program
10025 Jasper Ave NW
PO Box 1360
Edmonton, AB T5J 2N3
Phone: 780-415-2824
Web site: Alberta Health

British Columbia
BC Centre for Disease Control
Epidemiology Services
655 West 12th Avenue
Vancouver, BC, V5Z 4R4
Phone: 604-707-2517
Fax: 604-707-2516
Web site: British Columbia Centre for Disease Control

Manitoba
Manitoba Health & Healthy Living
Communicable Disease Control Branch
4th Floor-300 Carlton Street
Winnipeg, MB R3B 3M9
Phone: 204-788-6737 Fax: 204-948-3044
Web site: Manitoba Health ([NJS_FILE:0dc0b352-a169-4c77-9f52-0d1c27d30a51:f3b8b6cf-a8c9-4fd7-a9bf-5127bf8920ba])

New Brunswick
Office of the Chief Medical Officer of Health
P.O. Box 5100, Carleton Place
Fredericton, NB E3B 5G8
Phone: 506-453-2323
Web site: New Brunswick Health

Newfoundland and Labrador
Public Health
Dept. of Health and Community Services
PO Box 8700
St. John's NL A1B 4J6
Phone: 709-729-5019; 709-729-0115
Fax: 709-729-0730
Web site: Newfoundland and Labrador Public Health

Nova Scotia
Nova Scotia Health Promotion and Protection
Summit Place, 6th Floor
1601 Lower Water Street, P.O. Box 487
Halifax, NS B3J 2R7
Phone: 902-424-8160
Fax: 902-424-0550
Web site: Nova Scotia Health

Northwest Territories
Office of the Chief Medical Health Officer
Dept. of Health and Social Services
Box 1320
Yellowknife, NT X1A 2L9
Phone: 867-920-8646
Fax: 867-873-0442
Web site: Northwest Territories Dept. of Health and Social Services

Nunavut
Office of the Chief Medical Health Officer
Dept. of Health and Social Services
Box 1000, Station 1000
Iqaluit, Nunavut, X0A 0H0
Phone: 867-975-5700
Fax: 867-979-3190

Ontario
Direct all forms to your local public health unit.
Contact information for each health unit can be found on the following web page: Ontario Health
Phone: PHD Info line 1-866-532-3161
TTY: 1-800-387-5559

Prince Edward Island
Office of Chief Health Officer
Department of Health
Box 2000
Charlottetown, PEI C1A 7N8
Tel: 902-368-4996
Fax: 902-620-3354
Web site: Prince Edward Island Health

Quebec
Phone: Call Info Santé in your region
Web site: Quebec Health

Saskatchewan
Saskatchewan Health
Population Health Branch
3475 Albert Street
Regina, SK S4S 6X6
Phone: 1-800-667-7766
Web site: Saskatchewan Health

Yukon
Vaccine Program Manager
Yukon Territorial Government
Health & Social Services
# 2 Hospital Road
Whitehorse, YT Y1A 3H8
Phone: (867) 667-8330
Web site: Yukon Health and Social Services