Post-Authorization Activity Table (PAAT) for Spikevax Bivalent (Original / Omicron BA.4/5)
Updated:
The following table describes post-authorization activity for Spikevax Bivalent (Original / Omicron BA.4/5), a product which contains the medicinal ingredients elasomeran and davesomeran. 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 that are found in PAATs.
For additional information about the drug submission process, refer to the Management of Drug Submissions and Applications Guidance.
Drug Identification Number (DIN):
- DIN 02532352 - 0.05 mg/mL elasomeran and 0.05 mg/mL davesomeran, dispersion, intramuscular administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| NDS # 278413 | 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 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 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 Control # 274416 | 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 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 # 273342 | 2023-03-15 | Review completed 2023-06-26 | 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 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 # 272448 | 2023-02-15 | 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 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 Bivalent (Original / Omicron BA.4/5) to reflect the accumulation of safety data and information gained in the post-market setting for this vaccine. |
| NC # 274520 | 2023-04-19 | Issued NOL 2023-06-07 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to extend the shelf-life of the drug product from 9 months to 12 months. The submission was reviewed and considered acceptable, and an NOL was issued. |
| PBRER # 272847 | 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 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. |
| NC # 272602 | 2023-02-21 | Issued NOL 2023-05-24 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) for a change to a drug substance manufacturing facility. The submission was reviewed and considered acceptable, and an NOL was issued. |
| SNDS # 273747 | 2023-03-29 | Issued NOC (subject to terms and conditions) 2023-05-18 | Submission filed as a Level I – Supplement for the use of Spikevax Bivalent (Original / Omicron BA.4/5) in individuals 6 to 17 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. |
| NC # 271206 | 2023-01-09 | Issued NOL 2023-04-14 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to transfer quality control testing activities to a new facility. The submission was reviewed and considered acceptable, and an NOL was issued. |
| Monthly safety report Control # 271453 | 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 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 # 270689 | 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 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. |
| Drug product (DIN 02532352) market notification | Not applicable | Date of first sale: 2022-11-25 |
The manufacturer notified Health Canada of the date of first sale pursuant to C.01.014.3 of the Food and Drug Regulations. |
| Health Professional Risk Communication | Not applicable | Posted 2022-11-18 |
Health Professional Risk Communication posted (Spikevax Bivalent [Original / Omicron BA.4/5] [elasomeran/davesomeran] COVID-19 Vaccine with English-only Vial and Carton Labels), containing information on labelling, packaging, product safety, and supply for health professionals. |
| NDS # 267589 | 2022-09-12 | Issued NOC (subject to terms and conditions) 2022-11-03 |
NOC issued for New Drug Submission. Terms and conditions were imposed on the authorization. |