Template for Public Communications - Vaccines

Revised Date: 2012-07-27

Also available in French: Modèle de communication au public - Vaccins

Public Communication - Health Canada Endorsed Important Safety Information on [Vaccines]

[Sponsor logo]

[Date (mm/dd/yyyy)]

[Version Number]

[Salutation]

Subject: Association of [insert Brand Name (generic name)] with [insert specific adverse event]

[Paragraph 1- Description of health risk]

• [Key message 1 - Describe the health risk]
• [Key message 2 - State what people can do about the health risk]
• [Key message 3 - Provide any other important information]
• [Key message 4 - Optional]

[Paragraph(s) including additional detailed instructions on how to use the new safety or therapeutic effectiveness information]

[Paragraph(s) describing risk management measures]

[Paragraph including adverse event reporting instructions. The following statement should be included:]

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 [specific adverse event] or other serious or unexpected adverse events for vaccines in patients receiving [brand name] should be reported to [name of sponsor] or the Public Health Agency of Canada at the following addresses:

[Name and address of sponsor in Canada]

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, 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

<Closing>

Original signed by

<Name>

References:

1. ...
2. ...
3. ...

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: www.albertahealthservices.ca/

British Columbia
British Columbia Centre for Disease Control
Epidemiology Services
655 West 12^th Avenue
Vancouver, BC V5Z 4R4
Phone: 604-707-2517
Fax: 604-707-2515
Web site: www.bccdc.ca

Manitoba
Manitoba Department of Health
Communicable Disease Control Branch
4^th Floor-300 Carlton Street
Winnipeg, MB R3B 3M9
Phone: 204-788-6737
Fax: 204-948-3044
Web site: http://www.gov.mb.ca/health/publichealth/cdc/docs/aefi_form.pdf

New Brunswick
Communicable Disease Control (CDC) Branch
Office of the Chief Medical Officer of Health
Department of Health
2^nd Floor HSBC Place, 520 King Street
P.O. Box 5100
Fredericton, NB E3B 5G8
Main CDC Office Number: 506-444-3044Office of the Chief Medical Officer of Health
Web site: http://www2.gnb.ca/content/gnb/en/departments/ocmoh.html

Newfoundland and Labrador
Public Health
Department of Health and Community Services
P.O. Box 8700
St. John's NL A1B 4J6
Phone: 709-729-5019, 709-729-0115
Fax: 709-729-0730
Web site: http://www.health.gov.nl.ca/health/publichealth/cdc/immunizations.html

Nova Scotia
Department of Health and Wellness
Summit Place, 6^th Floor
1601 Lower Water Street
P.O. Box 487
Halifax, NS B3J 2R7
Phone: 902-424-8160
Fax: 902-424-0550
Web site: http://www.gov.ns.ca/hpp/cdpc/

Northwest Territories
Office of the Chief Medical Health Officer
Department of Health and Social Services
P.O. Box 1320
Yellowknife, NT X1A 2L9
Phone: 867-920-8646
Fax: 867-873-0442
Web site: http://www.hlthss.gov.nt.ca/default.htm

Nunavut
Office of the Chief Medical Health Officer
Department of Health and Social Services
P.O. Box 1000, Station 1000
Iqaluit, NU 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: http://www.health.gov.on.ca/english/public/contact/phu/phuloc_mn.html
Phone: PHD Info line 1-866-532-3161
TTY: 1-800-387-5559

Prince Edward Island
Office of Chief Health Officer
Department of Health and Wellness
P.O. Box 2000
Charlottetown, PEI C1A 7N8
Tel:  902-368-4996
Fax:  902-620-3354
Web site: http://www.gov.pe.ca/health/index.php3

Quebec
Phone: Call Info Santé in your region
Web site: http://www.msss.gouv.qc.ca/sujets/santepub/vaccination/index.php?accueil_en

Saskatchewan
Saskatchewan Ministry of Health
Population Health Branch
3475 Albert Street
Regina, SK S4S 6X6
Phone: 1-800-667-7766
Web site: http://www.health.gov.sk.ca/

Yukon
Vaccine Program Manager
Yukon Territorial Government
Health & Social Services
#2 Hospital Road
Whitehorse, YT Y1A 3H8
Phone:(867) 667-8330
Web site: http://www.hss.gov.yk.ca