Post-Authorization Activity Table (PAAT) for Spikevax Bivalent
Updated: 2024-05-17
The following table describes post-authorization activity for Spikevax Bivalent, a product which contains the medicinal ingredients elasomeran and imelasomeran. 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 - 02530252 - 0.05 mg/mL elasomeran and 0.05 mg/mL imelasomeran, dispersion, intramuscular administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| PBRER # 278579 | 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 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. |
| DIN 02530252 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 DIN pursuant to section C.01.014.6(1)(a) of the Food and Drug Regulations. |
| NDS # 278389 | 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 # 274400 | 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 # 273353 | 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 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 # 272456 | 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 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 to reflect the accumulation of safety data and information gained in the post-market setting for this vaccine. |
| PBRER # 272831 | 2023-03-02 | 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. |
| Monthly safety report Control # 271447 | 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 # 270694 | 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. |
| SNDS # 269428 | 2022-11-04 | Issued NOC (subject to terms and conditions) 2023-02-17 |
Submission filed as a Level I – Supplement to seek authorization for an extension of the age indication for a booster dose of an mRNA-based vaccine formulation Spikevax Bivalent, containing two components (Original SARS-CoV2 mRNA vaccine Spikevax, and Omicron BA.1) in a 50 mcg dose for adolescents 12 to 17 years of age and a 25 mcg dose for children 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. |
| Monthly safety report Control # 269720 | 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 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. |
| Monthly safety report Control # 268784 | 2022-10-17 | 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 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. |
| Drug product (DIN 02530252) market notification | Not applicable | Date of first sale: 2022-09-12 |
The manufacturer notified Health Canada of the date of first sale pursuant to C.01.014.3 of the Food and Drug Regulations. |
| Health Product Risk Communication | Not applicable | Posted 2022-09-02 |
Health Product Risk Communication posted (Distribution of Spikevax Bivalent [elasomeran/imelasomeran] COVID-19 Vaccine with English-only Vial and Carton Labels), containing important information about labelling, packaging and product safety for healthcare professionals. |
| NDS # 265656 | 2022-06-30 | Issued NOC (subject to terms and conditions) 2022-09-01 |
NOC issued for New Drug Submission. Terms and conditions were imposed on the authorization. |