TYPHIM Vi (Salmonella typhi Vi Capsular Polysaccharide Vaccine) - Voluntary Recall of Vi Polysaccharide Typhoid Vaccine Batches with Potentially Lower than Expected Antigen Content - For the Public

Starting date:

October 4, 2012

Posting date:

October 4, 2012

Type of communication:

Public Communication

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-15083

This is duplicated text of a letter from Sanofi Pasteur Limited. 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 TYPHIM Vi (Salmonella typhi Vi Capsular Polysaccharide Vaccine)

October 4, 2012

Subject: Voluntary Recall of Sanofi Pasteur Vi polysaccharide typhoid vaccine, TYPHIM Vi^® batches with potentially lower than expected antigen content

Sanofi Pasteur, the vaccines division of Sanofi, has announced that it is voluntarily recalling several batches of its typhoid fever vaccine, TYPHIM Vi^®, due to concerns that the doses may not provide the intended protection against the disease.

There is no safety concern for individuals who have received a TYPHIM Vi^® vaccine dose from a recalled batch. The doses were identified as potentially having less antigen, the substance that stimulates the immune system to produce antibodies against the disease.

• There is no safety concern for individuals who have received a TYPHIM Vi^® vaccine dose from a recalled batch.
• Individuals who received a TYPHIM Vi^® vaccination from a recalled batch may have received less than the intended amount of antigen. Sanofi Pasteur does not recommend revaccination earlier than otherwise indicated.
• TYPHIM Vi^® vaccines from batches not impacted by the recall can be administered.
• The recall may lead to a typhoid vaccine shortage.

TYPHIM Vi^® is indicated for active immunization against S. typhi, the organism which causes typhoid fever, in individuals two years of age or older.

Vaccination against typhoid fever does not preclude the recommendation to avoid exposure to potentially contaminated food and drink, and all hygienic recommendations must be carefully maintained.

In Canada, there are two other suppliers of typhoid vaccines. There is no published efficacy or immunogenicity data of an oral attenuated S. typhi vaccine in people initially vaccinated with a Vi polysaccharide vaccine.

In all cases, Sanofi Pasteur recommends that the decision to vaccinate and re-vaccinate an individual is taken when the benefit of vaccination outweighs the risk of non-vaccination according to the level of exposure to typhoid fever.

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-marketing adverse events are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse events for vaccines in patients receiving TYPHIM Vi^® should be reported to Sanofi Pasteur Limited or the Public Health Agency of Canada at the following addresses:

Sanofi Pasteur Limited

Pharmacovigilance Department

1755 Steeles Avenue West, Toronto, Ontario, Canada M2R 3T4

Tel: 1-888-621-1146 or Fax: 416-667-2435

How to report a suspected Adverse Event following Immunization:

Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form.

The Adverse Events Following Immunization Reporting Form and Guidelines can be found on the Public Health Agency of Canada Web site or in the Canadian Compendium of Pharmaceuticals and Specialties.

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

original signed by

Antigona Tomovici, MD

Director, Medical Affairs