Authorization of COVISHIELD with English-only Vial and Carton Labels

Starting date:

February 26, 2021

Posting date:

March 1, 2021

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Issue:

Labelling and Packaging, New safety information, Supply

Audience:

Healthcare Professionals

Identification number:

RA-75063

Last updated: 2021-04-17

• Issue
• Who is affected
• Report health or safety concerns
• Related AWRs
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IMPORTANT: Access to Canadian-specific labelling information during the initial distribution of COVISHIELD.

Audience

Healthcare professionals including infectious disease physicians, pharmacists, family physicians, public health officials, nurses and nurse practitioners, and healthcare professionals at the identified points of use.

Verity Pharmaceuticals Inc. (the Canadian importer and distributor) is initially distributing COVISHIELD (COVID-19 Vaccine) doses directly to vaccination locations where administration of the vaccine will occur, as outlined by provincial and territorial governments and public health authorities.

Key messages

• COVISHIELD (manufactured by Serum Institute of India) and AstraZeneca COVID-19 VACCINE (manufactured by AstraZeneca) are ChAdOx1-S recombinant vaccines developed by AstraZeneca and the University of Oxford. Health Canada has reviewed the manufacturing information for these vaccines and found them to be comparable.
• On February 26, 2021, COVISHIELD (DIN 02512947) and AstraZeneca COVID-19 vaccines were authorized in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
• COVISHIELD is indicated for active immunization of individuals 18 years of age and over for the prevention of coronavirus disease 2019 (COVID-19).
• At this time, Verity Pharmaceuticals Inc. is providing vaccine supplies with a global product name and English-only labels on the vials and cartons in Appendix A (see images below) in order to expedite the distribution of COVISHIELD in Canada.
• The brand name COVISHIELD is temporarily accepted for use in Canada due to urgent public health need.
• Healthcare professionals are advised that:
  • Important Canadian-specific information is absent from the COVISHIELD global vial and carton labels (see the Information for healthcare professionals section).
  • The Canadian Product Monograph, which is available in French and English on Health Canada’s Drug Product Database, the federal government’s covid-vaccine.canada.ca website, or at www.covishield-canada.ca, should be referenced for complete product information.
  • The Canadian-specific labelling information including the Product Monograph and training materials can be accessed at www.covishield-canada.ca, or by scanning the QR code in Appendix B (see images below). This information is also available on the federal government’s covid-vaccine.canada.ca website.
  • Verity Pharmaceuticals Inc. has developed Health Canada approved vial and carton labels in French and English in Appendix C (see images below), and has made them available on the www.covishield-canada.ca website. The labels are also available on the federal government’s covid-vaccine.canada.ca website. Verity Pharmaceuticals Inc. has agreed that vaccine supplies with Canadian-specific labelling in French and English will be available as soon as feasible given the need to ensure a rapid global supply of the vaccine.
  • Paper copies of the Canadian Product Monograph and Patient Handout in French and English will be available at the points of use for healthcare professionals and patients.
  • Paper copies of the Health Canada approved vial and carton labels in French and English will also be made available in Appendix C (see images below) for reference by healthcare professionals at the points of use.

    

Issue

COVISHIELD was authorized for use in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. As an extraordinary measure to provide earlier access to vaccine supplies in the context of the global pandemic, Verity Pharmaceuticals Inc. is providing, at this time, vaccine vials and cartons labelled with a global product name and global label information. This label is presented in English-only and is missing some important Canadian-specific information normally found on Health Canada approved labels (see the Information for healthcare professionals section).

Products affected

COVISHIELD, COVID-19 Vaccine (ChAdOx1-S [recombinant])
5 mL solution for intramuscular injection, multiple dose vials.
Each vial contains 10 doses (each dose is 0.5 mL).
DIN: 02512947

Manufacturer: Serum Institute of India Pvt. Ltd.  
Canadian Importer and Distributor: Verity Pharmaceuticals Inc.

Background information

COVISHIELD is indicated for active immunization of individuals 18 years of age and over for the prevention of coronavirus disease 2019 (COVID-19).

Given the public health emergency resulting from the current pandemic, Health Canada has authorized the importation, sale, and advertising of COVISHIELD with vial and carton labels that are in English-only for the initial distribution of the vaccine. This allows earlier access to the vaccine for the Canadian population ahead of the Canadian-labelled product being available, and facilitates the global deployment of this vaccine across many countries given the high demand.

COVISHIELD, with global labels in English-only, is the same as the Health Canada authorized COVISHIELD and should be used in Canada for the same indication and per the same vaccination schedule. COVISHIELD has the same indication and vaccination schedule as the AstraZeneca COVID-19 Vaccine. The Canadian Product Monograph for COVISHIELD, which is approved by Health Canada for the duration of the interim order, and available in French and English, should be used for complete product information. The Product Monograph is available on Health Canada’s Drug Product Database, on the federal government’s covid-vaccine.canada.ca website, or at www.covishield-canada.ca.

Verity Pharmaceuticals Inc. has also developed Health Canada approved vial and carton labels in French and English in Appendix C (see images below), and has made them available on the www.covishield-canada.ca website. The labels are also available on the federal government’s covid-vaccine.canada.ca website.

The use of COVISHIELD is permitted under an interim authorization in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.

Patients should be advised of the nature of the authorization.

Who is affected

Information for healthcare professionals

In order to provide rapid access to COVISHIELD for Canadians, Verity Pharmaceuticals Inc. will provide product vials and cartons labelled in English-only for a limited time period. 

Healthcare professionals are advised that:

• The approved Canadian Product Monograph, which is available in French and English on Health Canada’s Drug Product Database, the federal government’s covid-vaccine.canada.ca website or at www.covishield-canada.ca, should be used for complete product information.
• The following important Canadian-specific information is absent from the COVISHIELD global vial and carton labels:
  • Drug Identification Number (DIN)
  • name and address of the Canadian DIN holder
  • name and address of the Canadian importer and distributor
  • adequate direction for use
  • all corresponding text in French
• The COVISHIELD global vial and/or carton labels include the numbers "(01) 08901213006976", "20017305/0" and "MFG.LIC. NO.:10". These numbers are not applicable to Canada and therefore should be disregarded.
• The COVISHIELD global vial and/or carton labels refer to the global package insert. The global package insert, which is included in the global product carton, is not applicable to Canada and therefore should be disregarded.
• The Canadian-specific information for the globally branded product can be accessed at www.covishield-canada.ca, or by scanning the QR code in Appendix B (see images below). This information is also available on the federal government’s covid-vaccine.canada.ca website.
• Paper copies of the Canadian Product Monograph and Patient Handout will be available at the points of use for this vaccine.
• Verity Pharmaceuticals Inc. has developed Health Canada approved vial and carton labels in French and English in Appendix C (see images below), and has made them available on the www.covishield-canada.ca website. The labels are also available on the federal government’s covid-vaccine.canada.ca website.
• Paper copies of the Health Canada approved vial and carton labels in French and English will also be made available in Appendix C (see images below), for reference by healthcare professionals at the points of use.
• For any medical questions, contact Medical Information at 1-800-977-9778, or online at www.covishield-canada.ca.
• For any other general inquiries, contact Verity Pharmaceuticals Inc. Customer Service at 437-266-2121, or email covishield-publicrelations@veritypharma.com.

Action taken by Health Canada

On September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 to expedite the authorization for the importation, sale, and advertising of drugs used in relation to COVID-19 while taking into consideration urgent public health needs. The Interim Order will expire after one year. Health Canada authorized the use of COVISHIELD under the Interim Order on February 26, 2021, and this vaccine has been added to the "List of authorized drugs, vaccines and expanded indications" for COVID-19.

Health Canada is permitting the use of a global English-only label for a limited period. Health Canada has imposed terms and conditions requiring Verity Pharmaceuticals Inc. to provide vaccine supplies with Canadian-specific labels as soon as possible. Health Canada has made full labelling information available in French and English on the federal government’s covid-vaccine.canada.ca website.

Health Canada has worked with Verity Pharmaceuticals Inc. to prepare this alert for the vaccine, currently named COVISHIELD. This brand name is temporarily accepted for use in Canada due to the urgent public health need for vaccines. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system, as well as through social media channels, including LinkedIn and Twitter.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any serious or unexpected side effects in patients receiving COVISHIELD should be reported to your local Health Unit or Verity Pharmaceuticals Inc.

Verity Pharmaceuticals Inc.
2560 Matheson Blvd. East, Suite 220
Mississauga, ON, Canada, L4W 4Y9
For any medical questions, contact Medical Information at 1-800-977-9778 or submit a form online at www.covishield-canada.ca.

If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory and send it to your local Health Unit.

For other health product inquiries related to this communication, contact Health Canada at:

Biologic and Radiopharmaceutical Drugs Directorate
E-mail: hc.brdd.dgo.enquiries.sc@canada.ca

Original signed by

Howard Glase
CEO
Verity Pharmaceuticals Inc.

Related AWRs

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