Post-Authorization Activity Table (PAAT) for Spikevax (previously COVID-19 Vaccine Moderna)
Updated: 2024-05-17
The following table describes post-authorization activity for Spikevax (previously COVID-19 Vaccine Moderna), a product which contains the medicinal ingredient elasomeran or mRNA-1273 SARS-CoV-2. 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 02510014 - 100 mcg/0.5 mL elasomeran, dispersion, intramuscular administration
- DIN 02527685 - 50 mcg/0.25 mL elasomeran, dispersion, intramuscular administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| PBRER # 278580 | 2023-08-25 | Review completed 2024-04-05 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #5 for the period 2022-12-18 to 2023-06-17. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events in the next PBRER for Spikevax XBB.1.5. |
| DINs 02510014, 02527685 cancelled (post market) | Not applicable | Discontinuation date: 2024-01-19 | The manufacturer notified Health Canada that sale of the drug has been discontinued post market. Health Canada cancelled the DINs pursuant to section C.01.014.6(1)(a) of the Food and Drug Regulations. |
| NDS # 278419 | 2023-08-21 | Issued NOC 2023-10-04 | Submission filed to transfer ownership of the drug product from ModernaTX, Inc. to Moderna Biopharma Canada Corporation. An NOC was issued. |
|
Monthly safety report |
2023-06-15 | Review completed 2023-09-26 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #23 for the period 2023-04-18 to 2023-05-17. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
|
Monthly safety report |
2023-05-15 | Review completed 2023-09-20 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #22 for the period 2023-03-18 to 2023-04-17. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
|
Monthly safety report |
2023-04-17 | Review completed 2023-06-29 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #21 for the period 2023-02-18 to 2023-03-17. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 273354 |
2023-03-16 | Review completed 2023-06-29 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #20 for the period 2023-01-18 to 2023-02-17. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 272453 |
2023-02-16 | Review completed 2023-06-15 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #19 for the period 2022-12-18 to 2023-01-17. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
|
Amended Terms and Conditions |
Not applicable |
Terms and conditions amended post authorization |
Health Canada updated the Risk Management Plan Terms and Conditions for Spikevax to reflect the accumulation of safety data and information gained in the post-market setting for this vaccine. |
| PBRER # 272833 | 2023-03-01 | Review completed 2023-06-02 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #4 for the period 2022-06-19 to 2022-12-17. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Post-Market Information Request Review Control # 271477 | 2023-01-17 | Review completed 2023-04-27 | Health Canada conducted an ad-hoc review of available data on heavy menstrual bleeding following vaccination. Health Canada requested that the sponsor submit an updated review on this issue in the next PSUR/PBRER. Health Canada will continue to monitor the safety and effectiveness of this vaccine. |
| Monthly safety report Control # 271450 | 2023-01-16 | Review completed 2023-03-13 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #18 for the period 2022-11-19 to 2022-12-17. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 270693 | 2022-12-15 | Review completed 2023-02-27 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #17 for the period 2022-10-19 to 2022-11-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| PBRER # 267341 | 2022-08-29 | Review completed 2023-01-31 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #3 for the period 2022-01-01 to 2022-06-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 269717 | 2022-11-15 | Review completed 2023-01-24 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #16 for the period 2022-09-19 to 2022-10-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Post-Market Information Request Review Control # 270676 | 2022-12-14 | Review completed 2023-01-20 |
Information filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Interim reports for ongoing study P901. The sponsor was asked to continue to provide updated assessments for the ongoing monitoring of safety studies. |
| Post-Market Information Request Review Control # 269195 | 2022-10-31 | Review completed 2023-01-20 |
Information filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Interim reports for ongoing study P911. The sponsor was asked to continue to provide updated assessments for the ongoing monitoring of safety studies. |
| Post-Market Information Request Review Control # 269193 | 2022-10-31 | Review completed 2023-01-20 |
Information filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Interim reports for ongoing study P903. The sponsor was asked to continue to provide updated assessments for the ongoing monitoring of safety studies. |
| SNDS # 262408 | 2022-03-16 | Issued NOC (subject to terms and conditions) 2023-01-12 |
Submission filed as a Level I – Supplement to extend the use of a 50 µg dose booster of Spikevax currently approved for adults 18 years and older to adolescents (12 to <18 years) to prevent COVID-19 caused by SARS-CoV-2. 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. |
| Monthly safety report Control # 268787 | 2022-10-18 | Review completed 2022-12-08 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #15 for the period 2022-08-19 to 2022-09-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Post-Market Information Request Review Control # 268287 | 2022-09-29 | Review completed 2022-11-25 |
Information filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Interim reports for ongoing study P905. The sponsor was asked to continue to provide updated assessments for the ongoing monitoring of safety studies. |
| Post-Market Information Request Review Control # 268276 | 2022-09-29 | Review completed 2022-11-25 |
Information filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Interim reports for ongoing study P904. The sponsor was asked to continue to provide updated assessments for the ongoing monitoring of safety studies. |
| Monthly safety report Control # 267920 | 2022-09-15 | Review completed 2022-11-25 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #14 for the period 2022-07-19 to 2022-08-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 267010 |
2022-08-16 | Review completed 2022-10-04 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #13 for the period 2022-06-16 to 2022-07-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Bi-monthly safety report Control # 266110 |
2022-07-15 | Review completed 2022-09-21 |
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 2022-04-16 to 2022-06-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 262952 | 2022-04-01 | Cancellation Letter Received 2022-09-16 |
Submission filed as a Level I – Supplement for a new indication: as subsequent booster doses in individuals 50 years of age and older who have received a primary series and a first booster dose of any Health Canada-approved COVID-19 vaccine at least 3 months after receipt of a first booster dose. A Summary of Cancellation was published. |
| Post-Market Information Request Review Control # 263842 | 2022-04-29 | Review completed 2022-08-10 |
Information filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Interim reports for ongoing studies P903 and P904. The sponsor was asked to continue to provide updated assessments for the ongoing monitoring of safety studies. |
| SNDS # 263775 | 2022-04-29 | Issued NOC (subject to terms and conditions) 2022-07-14 |
Submission filed as a Level I – Supplement to seek authorization for use of Spikevax in children 6 months to 5 years of age. 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. |
| Drug product (DIN 02527685) market notification | Not applicable | Date of first sale: 2022-07-14 |
The manufacturer notified Health Canada of the date of first sale pursuant to C.01.014.3 of the Food and Drug Regulations. |
| Bi-monthly safety report Control # 264306 |
2022-05-16 | Review completed 2022-07-13 |
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 2022-02-16 to 2022-04-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| PSUR # 262232 | 2022-03-10 | Review completed 2022-07-11 |
Submission filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PSUR #2 for the period 2021-07-01 to 2021-12-31. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Post-Market Information Request Review Control # 262954 | 2022-04-01 | Review completed 2022-07-05 |
Health Canada conducted an ad-hoc review of available data on pregnancy- and breastfeeding-related outcomes. Health Canada requested that the sponsor submit interim and final reports, and regular summaries of post-authorization safety studies, and to continue to submit any detailed analyses. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine. |
| Health Product Risk Communication | Not applicable | Posted 2022-06-06 |
Health Product Risk Communication posted (Distribution of a New Presentation of Spikevax [elasomeran] COVID-19 Vaccine [0.10 mg/mL in 2.5 mL multidose vial] with English-only Vial and Carton Labels), containing information on labelling, packaging, and product safety for healthcare professionals. |
| SNDS # 263161 | 2022-04-07 | Issued NOC (subject to terms and conditions) 2022-06-01 |
Submission filed as a Level I – Supplement for a new presentation and updates to the Product Monograph. The submission was reviewed and considered acceptable, and an NOC was issued. Terms and conditions were imposed on the authorization. A new DIN (02527685) was issued for the new presentation. |
| Bi-monthly safety report Control # 262189, 262409, 262953 |
2022-03-09 | Review completed 2022-05-31 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Bi-monthly safety report #1 for the period 2022-01-01 to 2022-02-15, and interim reports for ongoing studies P901 and P904. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 262273 | 2022-03-11 | Issued NOC 2022-05-16 |
Submission filed as a Level I – Supplement to submit Canadian-specific bilingual labelling for Spikevax. The submission was reviewed and considered acceptable, and an NOC was issued. |
| NC # 262494 | 2022-03-18 | Issued NOL 2022-05-06 |
Submission filed as a Level II (90 day) Notifiable Change for changes related to the manufacture of the drug substance. The submission was reviewed and considered acceptable, and an NOL was issued. |
| Amended Terms and Conditions Control # 252733 | Not applicable | Terms and conditions amended post authorization 2022-04-20 |
Health Canada imposed a new Term and Condition to the authorization of Spikevax. The Term and Condition of monthly safety reports is considered closed and has been replaced with the requirement to submit bi-monthly safety reports. In addition, the sponsor is required to submit Periodic Safety Update Reports / Periodic Benefit Risk Evaluation Reports every 6 months. |
| Risk Management Plan Control # 259827 | 2021-12-21 | Review completed 2022-04-12 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations, and included the pharmacovigilance plan for the booster indication approved with SNDS # 257293. The submission was reviewed and considered acceptable. The current post-market safety data are consistent with the labelled safety profile of Spikevax. |
| Monthly safety report Control # 260469 |
2022-01-18 | Review completed 2022-04-06 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #12 for the period 2021-12-01 to 2021-12-31, as well as interim reports for ongoing studies P901, P902 and P903. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| NC # 261785 | 2022-02-25 | Issued NOL 2022-03-22 |
Submission filed as a Level II (90 day) Notifiable Change to update the release specifications for the drug substance and drug product. The submission was reviewed and considered acceptable, and an NOL was issued. |
| Post-Market Information Request Review Control # 257574 | 2021-10-13 | Review completed 2022-03-18 |
Health Canada requested that the sponsor submit an updated cumulative review of events of myocarditis and/or pericarditis. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine. The current post-market safety data are consistent with the labelled safety profile of Spikevax. |
| NC # 261086 | 2022-02-03 | Issued NOL 2022-03-17 |
Submission filed as a Level II (90 day) Notifiable Change to make changes to reference standards used in the release of the drug substance and drug product. The submission was reviewed and considered acceptable, and an NOL was issued. |
| SNDS # 258658 | 2021-11-16 | Issued NOC (subject to terms and conditions) 2022-03-17 |
Submission filed as a Level I – Supplement to seek authorization for use of Spikevax in individuals 6 to 11 years of age. 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. |
| Post-Market Information Request Review Control # 259122, 259123 | 2021-12-06 | 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. |
| Monthly safety report Control # 259638 |
2021-12-16 | Review completed 2022-02-18 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #11 for the period 2021-11-01 to 2021-11-30. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 258708 |
2021-11-17 | Review completed 2022-01-21 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #10 for the period 2021-10-01 to 2021-10-31. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Health Product Risk Communication | Not applicable | Posted 2022-01-11 |
Health Product Risk Communication posted (Shelf Life Extension for the Spikevax [elasomeran] COVID-19 Vaccine with Printed Expiry Dates on Vial and Carton Labels), containing information on labelling, packaging, product safety and supply for healthcare professionals. |
| NC # 259289 | 2021-12-06 | Issued NOL 2021-12-23 |
Submission filed as a Level II (90 day) Notifiable Change to extend the shelf life from 7 to 9 months. The submission was reviewed and considered acceptable, and an NOL was issued. |
| Risk Management Plan Control # 257655 |
2021-10-15 | Review completed 2021-12-20 |
An update to the European Union (EU) Risk Management Plan (RMP) version 2.3 filed to include information about ongoing safety data, and the adolescent indication. The review concluded that the update is acceptable at this time. |
| Monthly safety report Control # 257655 |
2021-10-15 | Review completed 2021-12-07 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #9 for the period 2021-09-01 to 2021-09-30. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 256687 |
2021-09-16 | Review completed 2021-12-07 |
Submission filed in response to commitments made 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 #8 for the period 2021-08-01 to 2021-08-31. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 257293 | 2021-10-06 | Issued NOC (subject to terms and conditions) 2021-11-12 |
Submission filed as a Level I – Supplement to seek authorization for a booster dose of Spikevax. 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. |
| Health Product Risk Communication | Not applicable | Posted 2021-11-10 |
Health Product Risk Communication posted (Distribution of Spikevax [elasomeran] COVID-19 Vaccine with English-only Vial and Carton Labels), containing important information about supply for healthcare professionals. |
| PSUR # 256785 | 2021-09-20 | Review completed 2021-11-04 |
Submission filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PSUR #1 for the period 2020-12-18 to 2021-06-30. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Updated Health Product Risk Communication | Not applicable | Posted 2021-10-29 |
Health Product Risk Communication updated (Importation of COVID-19 Vaccine Moderna with up to 15 Doses per Vial and English-only Vial and Carton Labels [US-Labelled Supply]), containing important information about labelling, safety, packaging and supply for healthcare professionals. |
| NC # 257706 | 2021-10-19 | Issued NOL 2021-10-29 |
Submission filed as a Level II (90 day) Notifiable Change to extend the shelf life of 13 lots from 7 to 9 months. The submission was reviewed and considered acceptable, and an NOL was issued. |
| Drug product (DIN 02510014) market notification | Not applicable | Date of first sale 2021-09-30 |
The manufacturer notified Health Canada of the date of first sale pursuant to C.01.014.3 of the Food and Drug Regulations. |
| NDS # 252733 | 2021-05-15 | Issued NOC (subject to terms and conditions) 2021-09-16 |
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. Product name changed from COVID-19 Vaccine Moderna to Spikevax. Regulatory Decision Summary published. DIN 02510014 was issued. |
| Monthly safety report Control # 255696 |
2021-08-15 | Review completed 2021-09-15 |
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 2021-07-01 to 2021-07-31. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Amendment # 255935 | 2021-08-25 | Authorization amended 2021-09-03 |
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 changes were in response to an Advisement Letter issued by Health Canada, requesting the sponsor update the Product Monograph to include information related to facial paralysis (Bell's palsy) in the 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 # 253430 | 2021-06-04 | Authorization amended 2021-08-27 |
An application submitted to amend the authorization in respect of this drug (relating to relating to an expansion of the currently-approved indication to children 12 to 17 years of age) 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. An updated Risk Management Plan was submitted and approved. The current post-market safety data are consistent with the labelled safety profile of the COVID-19 Vaccine Moderna. A Summary of the rationale for authorization for use in relation to the COVID-19 pandemic was published. Additional terms and conditions were imposed on this authorization when it was amended to permit this change, to ascertain the continued safe use of the product. |
| Monthly safety report Control # 254480 |
2021-07-15 | Review completed 2021-08-17 |
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 2021-06-30. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Amendment # 253863 | 2021-06-17 | Authorization amended 2021-08-16 |
An application submitted to amend the authorization in respect of this drug (relating to changes to the manufacturing process 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 # 253474 | 2021-06-08 | Authorization amended 2021-08-04 |
An application submitted to amend the authorization in respect of this drug (relating to a new manufacturing 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 # 254062 | 2021-06-23 | Authorization amended 2021-07-21 |
An application submitted to amend the authorization in respect of this drug (relating to an increase in manufacturing scale of 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 # 253365 |
2021-06-17 | 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 provide updated assessments for the ongoing monitoring of safety events. |
| Advisory | Not applicable | Posted 2021-06-30 |
Advisory posted (Health Canada updates Pfizer-BioNTech and Moderna COVID-19 vaccine labels to include information on myocarditis and pericarditis), containing safety information for the general public. |
| Amendment # 254172 | 2021-06-28 | Authorization amended 2021-06-30 |
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 changes were in response to an Advisement Letter issued by Health Canada to manufacturers of COVID-19 mRNA vaccines, requesting they update labelling with respect to new safety information concerning myocarditis and pericarditis. 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 # 253864 | 2021-06-18 | Authorization amended 2021-06-23 |
An application submitted to amend the authorization in respect of this drug (authorizing a limited supply from the United States) 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. |
| Dear Healthcare Professional Letter | Not applicable | Posted 2021-06-14 |
Dear Healthcare Professional Letter posted (Importation of COVID-19 Vaccine Moderna with up to 15 Doses per Vial and English-only Vial and Carton Labels [US-Labelled Supply]), containing information on supply, labelling and packaging for healthcare professionals. |
| Amendment # 253433 | 2021-06-07 | Authorization amended 2021-06-11 |
An application submitted to amend the authorization in respect of this drug (authorizing a limited supply from the United States) 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 Control # 253384 | 2021-06-03 | Review completed 2021-06-10 |
An administrative update to the European Union (EU) Risk Management Plan (RMP) version 1.2 was filed. The review concluded that the update is acceptable at this time. |
| Amendment # 251607 | 2021-04-13 | Authorization amended 2021-06-09 |
An application submitted to amend the authorization in respect of this drug (relating to updates to the Product Monograph and storage conditions) has been reviewed and it has been determined that the changes are acceptable. The in-use time for filled syringes and punctured vials was extended from 6 to 24 hours, and room temperature storage of unpunctured vials was extended from 12 to 24 hours. 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 # 252740 |
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. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Amendment # 252738 | 2021-05-17 | Authorization amended 2021-05-31 |
An application submitted to amend the authorization in respect of this drug (relating to new manufacturing sites 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 # 250291 | 2021-03-08 | Authorization amended 2021-05-17 |
An application submitted to amend the authorization in respect of this drug (relating to alternative quality control 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 # 251801 |
2021-04-15 | Review completed 2021-05-07 |
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 #3 for the period 2021-02-18 to 2021-03-31. The current post-market safety data are consistent with the labelled safety profile of COVID-19 Vaccine Moderna. |
| Monthly safety report Control # 250475 |
2021-03-16 | Review completed 2021-04-27 |
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 2021-01-18 to 2021-02-17. The current post-market safety data are consistent with the labelled safety profile of COVID-19 Vaccine Moderna. |
| Amendment # 251731 | 2021-04-16 | Authorization amended 2021-04-23 |
An application submitted to amend the authorization in respect of this drug (relating to an alternative container closure system) 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 # 251635 | 2021-04-13 | Authorization amended 2021-04-23 |
An application submitted to amend the authorization in respect of this drug (relating to a new source of a raw material) 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 # 250173 | 2021-03-05 | Authorization amended 2021-03-19 |
An application submitted to amend the authorization in respect of this drug (relating to manufacturing process changes 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. |
| Amendment # 249696 | 2021-02-09 | Authorization amended 2021-03-10 |
An application submitted to amend the authorization in respect of this drug (relating to a Canadian-specific label) 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 # 249434 |
2021-02-15 | Review completed 2021-03-02 |
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 #1 for the period 2020-12-18 to 2021-01-17. The current post-market safety data are consistent with the labelled safety profile of COVID-19 Vaccine Moderna. |
| Amendment # 249865 | 2021-02-26 | Authorization amended 2021-02-27 |
An application submitted to amend the authorization in respect of this drug (relating to a new source of a raw material) 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 # 249649 | 2021-01-25 | Authorization amended 2021-02-27 |
An application submitted to amend the authorization in respect of this drug (relating to a new source of a raw material) 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. |
| Dear Healthcare Professional Letter | Not applicable | Posted 2021-02-22 |
Dear Healthcare Professional Letter posted (Updated English-only Global Vial and Carton Labels and Post-Market Adverse Reaction Information), containing important information about supply, label update, and product safety for healthcare professionals. |
| Amendment # 248159 | 2021-01-11 | Authorization amended 2021-02-19 |
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 with new safety information identified during pharmacovigilance activities. Anaphylaxis has now been reported through vaccine surveillance programs during mass vaccination. In addition, the brand name has been revised from Moderna COVID-19 Vaccine to COVID-19 Vaccine Moderna. 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 Control # 248156 | 2021-01-25 | Review completed 2021-02-17 |
The updated Core (European Union [EU]) Risk Management Plan (RMP) and Canadian Addendum 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 of the Core EU RMP in conjunction with the Canadian Addendum is acceptable at this time. The safety concerns 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. |
| Drug product (DIN 02510014) market notification | Not applicable | Date of first sale: 2020-12-23 |
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. |
| Dear Healthcare Professional Letter | Not applicable | Posted 2020-12-23 |
Dear Healthcare Professional Letter posted (Authorization of the Moderna COVID-19 Vaccine with English-only Vial and Carton Labels), containing important information about supply and product safety for healthcare professionals. |
| Application # 244946 | 2020-10-12 | Authorized (with terms and conditions) 2020-12-23 |
Authorized with terms and conditions under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 |