Post-Authorization Activity Table (PAAT) for Vaxzevria (previously the AstraZeneca COVID-19 Vaccine)
Updated: 2024-05-17
The following table describes post-authorization activity for Vaxzevria (previously the AstraZeneca COVID-19 Vaccine), a product which contains the medicinal ingredient ChAdOx1‑S (recombinant). For more information on the type of information found in PAATs, please refer to the Frequently Asked Questions: Summary Basis of Decision (SBD) Project: Phase II and to the List of abbreviations found in Post-Authorization Activity Tables (PAATs).
For additional information about the drug submission process, refer to the Guidance Document: The Management of Drug Submissions and Applications.
Drug Identification Number (DIN):
- DIN 02510847 - 5 x 1010 virus particles/0.5 mL ChAdOx1‑S (recombinant), 10‑dose vial, solution, intramuscular administration
- DIN 02511444 - 5 x 1010 virus particles/0.5 mL ChAdOx1‑S (recombinant), 8‑dose vial, solution, intramuscular administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| PBRER Control # 278841 | 2023-09-05 | Review completed 2024-03-28 | Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #5 for the period 2022-12-29 to 2023-06-28. The information was reviewed and no further action was required. |
| DIN 02510847 cancelled (post market) | Not applicable | Discontinuation date: 2023-12-19 | The manufacturer notified Health Canada that sale of the drug has been discontinued post market. Health Canada cancelled the DIN pursuant to section C.01.014.6(1)(a) of the Food and Drug Regulations. |
|
Risk Management Plan update |
2023-09-08 | Review completed 2023-10-20 | The updated Risk Management Plan (RMP) Canadian Addendum versions 6.2 and 6.3 were filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The review concluded that the Canadian Addenda are acceptable at this time. The current post-market safety data are consistent with the labelled safety profile of Vaxzevria. |
| Risk Management Plan update Control # 272970 |
2023-02-28 | Review completed 2023-08-11 | The updated Core (European Union [EU]) Risk Management Plan (RMP) version 8 and Canadian Addendum version 6.1 were filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The review concluded that the RMP and Canadian Addendum are acceptable at this time. The current post-market safety data are consistent with the labelled safety profile of Vaxzevria. |
| DIN 02510847 reported as dormant | Not applicable | 2023-07-27 | The manufacturer reported the DIN as dormant as per section C.01.014.71 and subsection C.01.014.5(1)(a)(ii) of the Food and Drug Regulations. |
| PBRER Control # 272971 | 2023-02-28 | Review completed 2023-06-27 | Information filed as per as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #4 for the period 2022-06-29 to 2022-12-28. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Amended Terms and Conditions Control # 253700 | Not applicable | Review completed 2023-05-29 | Health Canada updated the Risk Management Plan Terms and Conditions for Vaxzevria to reflect the accumulation of safety data and information gained in the post-market setting for this vaccine. |
| Post-Market Information Request Review Control # 265358 | 2022-09-08 | Review completed 2023-03-10 |
Health Canada conducted a third ad-hoc review of available data on the risk of thrombosis with thrombocytopenia syndrome (TTS) with viral vector vaccines Jcvoden and Vaxzevria. The sponsors were requested to submit all available data to Health Canada for review. The information was assessed, and Health Canada will continue to monitor the safety of these vaccines. |
| PBRER Control # 267684 | 2022-09-06 | Review completed 2023-01-24 |
Information filed as per as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #3 for the period 2021-12-29 to 2022-06-28. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 267545 | 2022-09-02 | Issued NOC 2022-12-14 |
Submission filed as a Level II – Supplement (Safety) to update the PM with new safety information related to tinnitus and cutaneous vasculitis, and migrate it to the 2020 format. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Adverse Reactions section of the PM, and corresponding changes were made to Part III: Patient Medication Information. An NOC was issued. |
| PBRER Control # 262073 | 2022-03-04 | Review completed 2022-06-29 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Six-month PBRER #2 for the period 2021-06-29 to 2021-12-28. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| NC # 261920 | 2022-03-01 | Issued NOL 2022-05-09 |
Submission filed as a Level II (90 day) Notifiable Change to add a new assay for the release of the drug substance and drug product. The submission was reviewed and considered acceptable, and an NOL was issued. |
| SNDS # 261469 | 2022-02-11 | Issued NOC 2022-05-05 |
Submission filed as a Level II – Supplement (Safety) to update the Product Monograph (PM). The PM was updated to reflect new information on thrombosis and thrombocytopenia, and thrombosis without thrombocytopenia. Changes were made to the Warnings and Precautions and Patient Medication Information sections of the PM. The submission was reviewed and considered acceptable, and an NOC was issued. |
| Risk Management Plan update Control # 261469 |
2022-02-11 | Review completed 2022-05-05 |
The updated Core (European Union [EU]) Risk Management Plan (RMP) version 7.0 and Canadian Addendum version 5.2 were filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The review concluded that the RMP and Canadian Addendum are acceptable at this time. The current post-market safety data are consistent with the labelled safety profile of Vaxzevria. |
| SNDS # 259446 | 2021-12-10 | Cancellation Letter Received 2022-03-31 |
Submission filed as a Level I – Supplement to seek authorization for a booster dose of Vaxzevria. A Summary of Cancellation was published. |
| Bi-monthly safety report Control # 261476 | 2022-02-14 | Review completed 2022-04-08 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Bi-monthly safety report #3 for the period 2021-12-01 to 2022-01-31. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| NC # 262361 | 2022-03-14 | Issued NOL 2022-03-21 |
Submission filed as a Level II (90 day) Notifiable Change to add new working host cell banks. The submission was reviewed and considered acceptable, and an NOL was issued. |
| Post-Market Information Request Review Control # 259117, 259118 | 2021-12-07 | Review completed 2022-03-11 |
Health Canada requested that the sponsor submit their plan to address the impact of the new variant of concern (Omicron) on the effectiveness and on any associated safety issues of their COVID-19 vaccine. In addition, the sponsor was requested to submit any detailed analyses of the effectiveness of the vaccine against the new variant. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine. |
| Amended Terms and Conditions Control # 253700 | Not applicable | Terms and conditions amended post authorization 2022-02-28 |
Health Canada imposed a new Term and Condition to the authorization of Vaxzevria. The sponsor is required to submit Periodic Safety Update Reports / Periodic Benefit Risk Evaluation Reports every 6 months. Health Canada considered the Term and Condition of bi-monthly safety reports closed. |
| Bi-monthly safety report Control # 259636 | 2021-12-15 | Review completed 2022-02-18 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Bi-monthly safety report #2 for the period 2021-10-01 to 2021-11-30. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Bi-monthly safety report Control # 257622 | 2021-10-15 | Review completed 2021-12-10 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Bi-monthly safety report #1 for the period 2021-08-01 to 2021-09-30. The sponsor was asked to commit to conducting cumulative reviews of ongoing monitoring of safety events and to provide an update to the Risk Management Plan. |
| NDS # 253700 | 2021-06-14 | Issued NOC (subject to terms and conditions) 2021-11-19 |
NOC issued for New Drug Submission. The submission was reviewed and considered acceptable, and an NOC was issued. Terms and conditions were imposed on the authorization. A Regulatory Decision Summary was published. DIN 02510847 was issued. DIN 02511444 was not transitioned to the Food and Drug Regulations when the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 expired. |
| Public advisory | Not applicable | Posted 2021-11-09 |
Public Advisory posted (Health Canada is updating the labels of the Janssen and Vaxzevria [AstraZeneca] COVID-19 vaccines), containing important information about product safety for the general public. |
| Amendment # 255966 | 2021-08-20 | Authorization amended 2021-09-15 |
An application submitted to amend the authorization in respect of this drug (relating to a change in product name from the AstraZeneca COVID-19 Vaccine to Vaxzevria) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Risk Management Plan update Control # 256225 |
2021-08-31 | Review completed 2021-09-15 |
The updated Core (European Union) Risk Management Plan (RMP) version 4 and Canadian Addendum version 4 succession 4 were filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. The review concluded that the RMP is acceptable at this time. The current post-market safety data are consistent with the labelled safety profile of the AstraZeneca COVID-19 Vaccine. |
| Monthly safety report Control # 255663 |
2021-08-15 | Review completed 2021-09-14 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Monthly safety report #7 for the period 2021-06-29 to 2021-07-31. The sponsor was asked to commit to conducting cumulative reviews of ongoing monitoring of safety events. |
| Periodic Benefit-Risk Evaluation Report Control # 256224 |
2021-08-31 | Review completed 2021-09-14 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Six-month Periodic Benefit-Risk Evaluation Report (PBRER) #1 for the period 2020-12-29 to 2021-06-28. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 254485 |
2021-07-15 | Review completed 2021-08-14 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Monthly safety report #6 for the period 2021-06-01 to 2021-06-28. The sponsor was asked to commit to conducting cumulative reviews of ongoing monitoring of safety events. |
| Risk Management Plan update Control # 254799 |
2021-07-15 | Review completed 2021-08-13 |
Updated Core (European Union) Risk Management Plan (RMP) and Canadian Addendum filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). The review concluded that the RMP is acceptable at this time. The safety concerns identified and their corresponding pharmacovigilance and risk minimization activities may be updated in a timely manner as more data becomes available in the clinical trial programs and in the real world use setting. The sponsor was requested to update the RMP to expand on the important potential risk of nervous system disorders including Guillain-Barré syndrome. |
| Amendment # 254869 | 2021-07-19 | Authorization amended 2021-08-13 |
An application submitted to amend the authorization in respect of this drug (relating to a Product Monograph update) has been reviewed and it has been determined that the changes are acceptable. The Product Monograph was updated to include information related to Guillain-Barré syndrome; changes were made to the Warnings and Precautions, Post-Market Adverse Reactions and Patient Medication Information sections. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Amendment # 254400 | 2021-07-05 | Authorization amended 2021-07-22 |
An application submitted to amend the authorization in respect of this drug (relating to an update to the manufacturing process and a new testing site for the drug substance and drug product) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Monthly safety report Control # 253385 |
2021-06-15 | Review completed 2021-07-08 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Monthly safety report #5 for the period 2021-05-01 to 2021-05-31. The sponsor was asked to update the Product Monograph to reflect the risk of Guillain-Barré syndrome and to submit an updated Risk Management Plan to include thrombocytopenia as an important potential risk. |
| Risk Management Plan update Control # 252882 |
2021-06-11 | Review completed 2021-07-07 |
Canadian Addendum to European Union Risk Management Plan Version 4 succession 2 filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). The review concluded that the RMP is acceptable at this time. The safety concerns identified and their corresponding pharmacovigilance and risk minimization activities may be updated in a timely manner as more data becomes available in the clinical trial programs and in the real world use setting. The sponsor was requested to update the RMP to align with the revised Product Monograph and risk minimization measures for the important identified risk of thrombosis in combination with thrombocytopenia and the important potential risk of thrombosis. |
| Dear Healthcare Professional Letter | Not applicable | Posted 2021-06-29 |
Dear Healthcare Professional Letter posted (AstraZeneca COVID-19 Vaccine and Covishield: Risk of Capillary Leak Syndrome), containing important information for healthcare professionals. |
| Amendment # 252495 | 2021-05-07 | Authorization amended 2021-06-29 |
An application submitted to amend the authorization in respect of this drug (relating to a Product Monograph update) has been reviewed and it has been determined that the changes are acceptable. The Product Monograph was updated to include information related to capillary leak syndrome, thrombosis and thrombotic events; changes were made to the Warnings and Precautions, Post-Market Adverse Reactions and Non-Clinical Toxicology sections. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Amendment # 254063 | 2021-06-23 | Authorization amended 2021-06-25 |
An application submitted to amend the authorization in respect of this drug (relating to an alternative test for the drug substance) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Amendment # 253383 | 2021-06-03 | Authorization amended 2021-06-22 |
An application submitted to amend the authorization in respect of this drug (relating to a new manufacturing and testing site for the drug product) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Amendment # 252545 | 2021-05-10 | Authorization amended 2021-06-09 |
An application submitted to amend the authorization in respect of this drug (relating to a new reference standard and alternative testing sites for the drug substance and drug product) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Monthly safety report Control # 252386 |
2021-05-14 | Review completed 2021-06-07 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Monthly safety report #4 for the period 2021-04-01 to 2021-04-30 as well as other post-market safety data. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Amendment # 253087 | 2021-05-26 | Authorization amended 2021-06-02 |
An application submitted to amend the authorization in respect of this drug (relating to an alternative testing site for the drug product) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Amendment # 253134 | 2021-05-27 | Authorization amended 2021-05-28 |
An application submitted to amend the authorization in respect of this drug (relating to the extension of the shelf life of two lots from 6 to 7 months) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Risk Management Plan update Control # 251571 |
2021-04-28 | Review completed 2021-05-19 |
Updated Core (European Union) Risk Management Plan (RMP) and Canadian Addendum filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). The review concluded that the RMP is acceptable at this time. The safety concerns identified and their corresponding pharmacovigilance and risk minimization activities may be updated in a timely manner as more data becomes available in the clinical trial programs and in the real world use setting. The sponsor was requested to submit an updated RMP to add one important potential risk and additional risk minimization measures to adequately reflect the information on thrombosis with thrombocytopenia syndrome. |
| Amendment # 251908 | 2021-04-22 | Authorization amended 2021-05-09 |
An application submitted to amend the authorization in respect of this drug (relating to a new manufacturing site for the drug substance) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Monthly safety report Control # 251336 |
2021-04-15 | Review completed 2021-05-06 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Monthly safety report #3 for the period 2021-03-01 to 2021-03-31. The current post-market safety data are consistent with the labelled safety profile of the AstraZeneca COVID-19 Vaccine. |
| Amendment # 251802 | 2021-04-20 | Authorization amended 2021-04-23 |
An application submitted to amend the authorization in respect of this drug (relating to a Product Monograph update) has been reviewed and it has been determined that the changes are acceptable. The Product Monograph was updated to include information related to thrombocytopenia and coagulation disorders in the Contraindications, Warnings and Precautions, Post-Market Adverse Reactions, and Patient Medication Information sections. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Risk Management Plan update Control # 251008 |
2021-04-08 | Review completed 2021-04-21 |
Updated Core (European Union) Risk Management Plan (RMP) and Canadian Addendum filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). The review concluded that the RMP is acceptable at this time. The safety concerns identified and their corresponding pharmacovigilance and risk minimization activities may be updated in a timely manner as more data becomes available in the clinical trial programs and in the real world use setting. |
| Risk Management Plan update Control # 250447 |
2021-03-17 | Review completed 2021-04-21 |
Updated Core (European Union) Risk Management Plan (RMP) and Canadian Addendum filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). The review concluded that the RMP is acceptable at this time. The safety concerns identified and their corresponding pharmacovigilance and risk minimization activities may be updated in a timely manner as more data becomes available in the clinical trial programs and in the real world use setting. |
| Summary Safety Review posted | Not applicable | Posted 2021-04-19 |
Summary Safety Review posted for the AstraZeneca COVID-19 Vaccine (Assessing the Potential Risk of Thrombosis in combination with Thrombocytopenia). |
| New safety review started by Health Canada | Not applicable | Started between 2021-03-01 |
Health Canada started a safety review for the AstraZeneca COVID-19 Vaccine, in response to case reports of thrombosis (blood clots) in combination with thrombocytopenia (low blood platelets). |
| Advisory | Not applicable | Published 2021-04-14 |
Advisory posted (Health Canada provides update on the AstraZeneca and Covishield COVID-19 vaccines), containing important information for the general public, healthcare professionals and hospitals. |
| Amendment # 251532 | 2021-04-09 | Authorization amended 2021-04-14 |
An application submitted to amend the authorization in respect of this drug has been reviewed and it has been determined that the changes are acceptable. A literature review and additional safety data were submitted. The Product Monograph and Healthcare Professional and Public Guides were updated to include information related to thrombosis with thrombocytopenia. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Monthly safety report Control # 250447 |
2021-03-15 | Review completed 2021-04-07 |
Information filed as per the terms and conditions imposed on the authorization issued under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order). Monthly safety report #2 for the period 2021-02-01 to 2021-02-28. The current post-market safety data are consistent with the labelled safety profile of the AstraZeneca COVID-19 Vaccine. |
| Amendment # 250727 Amended terms and conditions |
Not applicable | Terms and conditions amended post authorization 2021-04-06 |
One of the terms and conditions imposed on the authorization of the AstraZeneca COVID-19 Vaccine was amended. An extension was granted to provide a complete response to Term #1 issued 2021-03-29. |
| Dear Healthcare Professional Letter | Not applicable | Published 2021-04-01 |
Dear Healthcare Professional Letter posted (Important Safety Information on the Importation of AstraZeneca COVID-19 Vaccine with English-only Vial and Carton Labels [US-Labelled Supply]), containing important information for healthcare professionals. |
| Drug product (DIN 02510847) market notification | Not applicable | Date of first sale 2021-04-01 |
The manufacturer notified Health Canada of the date of first sale in accordance with section 8 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. |
| Amendment # 250891 | 2021-03-23 | Authorization amended 2021-03-31 |
An application submitted to amend the authorization in respect of this drug (relating to new manufacturing sites for the drug substance and drug product) has been reviewed and it has been determined that the changes are acceptable. The authorization under the Interim Order has been amended to permit these changes. Additional terms and conditions were imposed on this authorization when it was amended to permit this change, to ascertain the continued quality of the drug substance and drug product manufactured at the new sites. |
| Amendment # 250727 Additional terms and conditions |
Not applicable | Terms and conditions imposed post authorization 2021-03-29 |
Additional terms and conditions were imposed on the authorization of the AstraZeneca COVID-19 Vaccine. The information requested by Health Canada will support the ongoing evaluation of recent reports of rare thrombotic events with thrombocytopenia, and allow Health Canada to determine whether additional risk mitigation measures are needed. |
| Dear Healthcare Professional Letter | Not applicable | Published 2021-03-24 |
Dear Healthcare Professional Letter posted (Important Safety Information on AstraZeneca COVID-19 Vaccine and Covishield: Risk of Thrombosis and Thrombocytopenia), containing important safety information for healthcare professionals. |
| Amendment # 250727 | 2021-03-22 | Authorization amended 2021-03-24 |
An application submitted to amend the authorization in respect of this drug has been reviewed and it has been determined that the changes are acceptable. The changes were in response to an Advisement Letter issued by Health Canada, dated 2021-03-20, requesting a labelling update as per new evidence and information reviewed to address the signs and symptoms of thromboembolism and/or thrombocytopenia. The Product Monograph was updated to include information related to thrombocytopenia and coagulation disorders in the Warnings and Precautions, Adverse Reactions, Post-Market Adverse Reactions, and Patient Medication Information sections. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Amendment # 250447 | 2021-03-15 | Authorization amended 2021-03-24 |
An application submitted to amend the authorization in respect of this drug has been reviewed and it has been determined that the changes are acceptable. The Product Monograph was updated to include information related to hypersensitivity including anaphylaxis as well as information related to administration, a pregnancy exposure registry, and adverse reactions. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Advisement Letter | Not applicable | Issued 2021-03-20 |
Health Canada issued an Advisement Letter, requesting a labelling update as per new evidence and information reviewed to address the signs and symptoms of thromboembolism and/or thrombocytopenia. |
| Amendment # 250081 | 2021-03-04 | Authorization amended 2021-03-12 |
An application submitted to amend the authorization in respect of this drug has been reviewed and it has been determined that the changes are acceptable. The Product Monograph and other documents were updated to include reference to Covishield. The authorization under the Interim Order has been amended to permit these changes. The authorization in respect of this drug (so amended) continues to be subject to terms and conditions that pertain to matters other than these changes. No additional terms and conditions were imposed when the authorization was amended to reflect these changes. |
| Advisory | Not applicable | Published 2021-03-11 |
Advisory posted (Adverse events in Europe following immunization with the AstraZeneca COVID-19 Vaccine), containing important information for the general public. |
| Dear Healthcare Professional Letter | Not applicable | Published 2021-03-01 |
Dear Healthcare Professional Letter posted (Authorization of the AstraZeneca COVID-19 Vaccine with English-only Vial and Carton Labels), containing important information about supply and product safety for healthcare professionals. |
| Application # 244627 | 2020-10-01 | Authorized (with terms and conditions) 2021-02-26 |
Authorized with terms and conditions under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 |