Aventis Pasteur

--URGENT VACCINE RECALL--

Voluntary Recall of Single Dose Menomune® - A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined (see Vaccine Recall Reply Form)

October 22, 2002

Dear Health Care Provider:

Aventis Pasteur Limited is notifying all customers who may have single dose Menomune® - A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined) that there has been a failure in the vaccine’s stability testing in the USA for some lots of single dose Menomune® - A/C/Y/W-135 that indicates a potential for reduced protection from disease caused by serogroup A. This test result relates to serogroup A in the single dose vials. There is evidence to indicate that serogroups C, Y, W-135 in the single dose vials, and that the ten dose vials of Menomune® - A/C/Y/W-135 are NOT affected.

As a precautionary measure, Aventis Pasteur Limited is conducting a voluntary recall of all in-date single dose vials of Menomune® - A/C/Y/W-135 in Canada. The list of the recalled lots can be found in the attached Medical Statement/Reimmunization Guidelines. DO NOT USE THESE LOTS. Please return all recalled lots immediately to Aventis Pasteur Limited. We strongly recommend that you follow the procedures outlined in this recall letter and in the attached Vaccine Recall Reply Form.

We will provide a credit to your account for all in-date single dose vials of Menomune® - A/C/Y/W-135 returned and cover the costs of shipping the material back to Aventis Pasteur Limited via Canada Post. Healthcare providers can apply to Aventis Pasteur Customer Service for reimbursement for reimmunizing at local Medicare rates. Please submit your invoice to us.

For additional information, please see the attached Medical Statement/Reimmunization Guidelines.

This voluntary recall is being conducted with the approval of Health Canada. Their recommendations for management of persons receiving Menomune® - A/C/Y/W-135 will be posted as a Travel Health Advisory at www.hc-sc.gc.ca/pphb-dgspsp/tmp-pmv/prof_e.html.

Please accept our apologies for any inconvenience we may have caused. You are a valued customer of Aventis Pasteur Limited and we greatly appreciate your cooperation. Should you have any questions, please call Aventis Pasteur Limited’s Customer Service at 416-667-2611 or toll free at 1-800-268-4171.

Sincerely,

original signed by

Stan Gillis
Director, Customer Service

Aventis Pasteur Limited • Connaught Campus • 1755 Steeles Avenue West • Toronto, Ontario, Canada M2R 3T4 • www.aventis.com Telephone +1 416-667-2701 • Fax +1 416-667-0313

Aventis Pasteur

October 22, 2002

Medical Statement/Reimmunization Guidelines
for the Voluntary Recall of Single Dose Vials of Menomune® -A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined)

Aventis Pasteur recently completed a routine 12-month stability testing of Menomune®-A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined) in single dose vials. The potency test result for some lots in the US for serogroup A failed the specification for this test. This result indicates a potential for reduced protection against disease caused by serogroup A. There is evidence to indicate that serogroups C, Y, W-135 in the single dose vials, and that the ten dose vials of Menomune® - A/C/Y/W-135 are NOT affected.

Aventis Pasteur Limited initiated the voluntary recall of all in-date single dose Menomune®-A/C/Y/W-135 as a precautionary measure because single dose vials of Menomune®-A/C/Y/W-135 may fail potency standards for serogroup A before the expiration date. The vaccine met specifications at the time of release and it is our assessment that the vaccine was potent for at least six months after labelling. This assessment is based on a recent clinical trial using a related lot of Menomune®-A/C/Y/W-135, administered to adults four to six months after labelling, that demonstrated protection against serogroup A. Therefore, it is likely that those who received vaccine from one of the affected lots prior to six months after labelling are protected against serogroup A and would not require revaccination. A list of the affected lots distributed in Canada with the relevant six-month dates is at the end of this Statement.

The risk of contracting meningococcal disease caused by serogroup A is extremely low in North America. There have been only two reported cases in Canada during the past five years.

Serogroup A is responsible for epidemic and endemic meningococcal disease in the African “meningitis belt,” which includes parts of Benin, Burkina Faso, Cameroon (northern), Chad, Cote D’Ivoire, Eritrea (western), Ethiopia, Ghana, Gambia, Guinea, Guinea Bissau, Mali, Niger, Nigeria (northern), Senegal and Sudan. However, epidemics have occurred in the last decade outside the meningitis belt in Angola, Burundi, Central African Republic, Democratic Republic of the Congo, Kenya, Malawi, Mozambique, Rwanda, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.

To date this year, based on international public health reports, meningitis A outbreaks have been reported in Burundi, Chad, Ethiopia, Ghana, Mali, Niger, Somalia, Sudan, Tanzania and Togo. Outbreaks have also occurred in association with the annual Hajj pilgrimage in Saudi Arabia. ¹ Periodically, epidemic serogroup A meningococcal disease occurs in other regions of the world. ² Information about geographic regions where serogroup A meningococcal disease is present can be found at Health Canada’s Travel Medicine Program, News from International Public Health Authorities, www.TravelHealth.gc.ca, or www.cdc.gov/travel

As a precautionary measure, revaccination for protection against serogroup A disease should be considered for those persons who received vaccine from any lot being recalled that was already over six months past the date of its labelling at the time of administration and who have laboratory or industrial exposure to serogroup A or who travel to certain parts of the world where there is an increased risk of exposure to serogroup A. The theoretical risk of immunologic hyporesponsiveness due to repeated immunization must be weighed against the benefits of reimmunizing someone who will be at high risk for exposure to serogroup A disease. A minimum of two weeks between doses of meningococcal vaccine has been recommended by Health Canada unless the person is at immediate high risk.

If reimmunization is indicated, Aventis Pasteur’s bivalent Meningococcal Polysaccharide Vaccine Groups A/C will be provided free of charge by Aventis Pasteur upon request through Customer Service at (416) 667-2611 or 1-800-268-4171.

Health care providers are asked to include this notice in patient files for reference to determine if revaccination is needed for travel in the future.

This voluntary recall is being conducted with the approval of Health Canada. Their recommendations for management of persons receiving Menomune®-A/C/Y/W-135 will be posted as a Travel Health Advisory at www.hc-sc.gc.ca/pphb-dgspsp/tmp-pmv/prof_e.html

Following is a list of the affected lots with the relevant six month dates referred to above.

    *NOTE: Six Month Date -- if a dose from a specified lot was given
    on or after this date, consider reimmunization with bivalent
    Meningococcal Polysaccharide Vaccine Groups A/C, if the person
    is or will be travelling to or working in, an area where serogroup A
    meningococcal disease is endemic, or outbreaks have been reported
    OR if the person has or will have laboratory or industrial exposure
    to serogroup A meningococcal bacteria.

original signed by

Pierre Lavigne, M.D.
Director, Medical Affairs

¹ Health Canada’s Travel Medicine Program, http://www.hc-sc.gc.ca/pphb-dgspsp/tmp-pmv/men_e.html
² Communicable Disease Surveillance and Response (CSR), WHO: April 20, 2000.

Aventis Pasteur Limited • Connaught Campus • 1755 Steeles Avenue West • Toronto, Ontario, Canada M2R 3T4 • www.aventis.com Telephone +1 416-667-2701 • Fax +1 416-667-0313