Volume 29-23
1 December 2003

[Table of Contents]

MENOMUNE^TM MENINGOCOCCAL VACCINE UPDATE

Health Canada's recommendations in consultation with the National Advisory Committee on Immunization (NACI) and the National Committee to Advise on Tropical Medicine and Travel (CATMAT)

Aventis Pasteur Limited withdrew single-dose vials of Menomune^TM (quadrivalent polysaccharide meningococcal vaccine) in November 2002 because of findings of reduced stability of the serogroup A component of the vaccine. Subsequent investigation by the company has revealed that the findings were due to a testing problem rather than a vaccine stability problem. The testing methods have been modified accordingly. The Biologics and Radiopharmaceuticals Evaluation Centre, Health Canada, has reviewed the data from Aventis Pasteur Limited and concurs with the company's results. Therefore, Menomune^TM vaccine single-dose vials now meet product specifications and will be reintroduced to the Canadian market. 

In a statement published in CCDR on 15 November, 2002, entitled "Management of People Who Have Received Menomune^TM Meningococcal Vaccine since 16 May, 2001"⁽¹⁾, re-immunization recommendations were developed (www.phac-aspc.gc.ca/publicat/ccdr-rmtc/02vol28/dr2822ea.html). As a result of the new findings, people who received a dose of vaccine from the affected lots of Menomune^TM no longer need to be considered for re-immunization. It should be presumed that these people are appropriately immunized. People who were re-immunized with a second dose should expect no ill effects. 

For further information from Aventis Pasteur Limited regarding the Menomune^TM vaccine, please contact the Vaccine Information Service at 1-888-621-1146. Additional contacts at Health Canada are as follows: 

Quarantine, Travel and Migration Health
Office of Public Health Security
Centre for Emergency Preparedness and Response
Public Health Agency of Canada
Health Canada
Telephone: (613) 952-5212 

Division of Respiratory Section
Immunization and Respiratory Infections
Centre for Infectious Disease Prevention and Control
Public Health Agency of Canada
Health Canada
Telephone: (613) 946-2075 

Blood Products and Vaccines
Submission Management Division
Centre for Policy and Regulatory Affairs
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
Telephone: (613) 952-3604 

Reference 

1. Health Canada. Management of people who have received Menomune^TMmeningococcal vaccine since 16 May, 2001. CCDR 2002;28:181-82.

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