Post-Authorization Activity Table (PAAT) for Comirnaty Original & Omicron BA.4/BA.5
Updated: 2024-03-22
The following table describes post-authorization activity for Comirnaty Original & Omicron BA.4/BA.5, a product which contains the medicinal ingredients tozinameran and famtozinameran. 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 02531461 – 15 mcg/0.3 mL tozinameran and 15 mcg/0.3 mL famtozinameran, suspension, intramuscular administration
- DIN 02533197 – 5 mcg/0.2 mL tozinameran and 5 mcg/0.2 mL famtozinameran, suspension, intramuscular administration
- DIN 02541025 – 1.5 mcg/0.2 mL tozinameran and 1.5 mcg/0.2 mL famtozinameran, suspension, intramuscular administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| Post-Market Information Request Review Control #280076 | 2023-10-18 | Review completed 2024-01-31 | With this submission, the sponsor provided the final clinical study report for BNT162-01, C4591030, and WI255886, post-authorization safety studies indicated in the European Union RMP. Information filed as requested by Health Canada following the review of the RMP (control # 267502). The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine. |
| Post-Market Information Request Review Control #279479 | 2023-09-26 | Review completed 2024-01-28 | With this submission, the sponsor provided the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee Assessment Report to support the termination of study C4591011. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine. |
| PSUR # 278595 | 2023-08-28 | Review completed 2024-01-28 | Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Six-month PSUR #5 for the period 2022-12-19 to 2023-06-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 276731 | 2023-06-29 | Issued NOC 2023-12-08 | Submission filed as a Level I – Supplement as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Canadian-specific bilingual label mock-ups were submitted. The submission was reviewed and considered acceptable, and an NOC was issued. |
| Post-Market Information Request Review Control #267502 | 2023-08-04 | Review completed 2023-11-07 | With this submission, the sponsor provided the final clinical study report for WI235284, a post-authorization safety study indicated in the European Union RMP. Information filed as requested by Health Canada following the review of the RMP (control # 267502). The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine. |
| Post-Market Information Request Review Control #267502 | 2023-07-20 | Review completed 2023-11-07 | With this submission, the sponsor provided the final clinical study report for C4591014, a post-authorization safety study indicated in the European Union RMP. Information filed as requested by Health Canada following the review of the RMP (control # 267502). The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine. |
| PSUR # 273315 | 2023-03-14 | Review completed 2023-09-25 | Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Six-month PSUR for the period 2022-06-19 to 2022-12-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 274791 | 2023-04-28 | Issued NOC 2023-09-13 | Submission filed as a Level II – Supplement (Safety) as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Interim data was filed for study C4591031. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Adverse Reactions and Clinical Trials sections of the PM. An NOC was issued. |
| SNDS # 275559 | 2023-05-24 | Issued NOC (subject to terms and conditions) 2023-08-31 | Submission filed as a Level I – Supplement to seek authorization for use of Comirnaty Original & Omicron BA.4/BA.5 as a 3-dose primary series in individuals 6 months through 4 years of age. The submission was reviewed and considered acceptable, and an NOC was issued. Terms and conditions were imposed on the authorization. A new DIN (02541025) was issued. A Regulatory Decision Summary was published. |
| NC # 274625 | 2023-04-24 | Issued NOL 2023-07-31 | 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. |
|
Monthly safety report |
2023-05-16 |
Review completed |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report for the period 2023-03-16 to 2023-04-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 274363 |
2023-04-14 | Review completed 2023-07-06 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report for the period 2023-02-16 to 2023-03-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 274152 | 2023-04-06 | Issued NOC (subject to terms and conditions) 2023-07-06 | Submission filed as a Level I – Supplement for the use of Comirnaty Original & Omicron BA.4/BA.5 in a 10 mcg (5 through 11 years old) and 30 mcg (in >12 years old) dose as a 2-dose primary series. The submission was reviewed and considered acceptable, and an NOC was issued. Issued NOC (subject to terms and conditions). A Regulatory Decision Summary was published. |
|
Amended Terms and Conditions |
Not applicable |
Terms and conditions amended post authorization |
Health Canada updated the Risk Management Plan Terms and Conditions for Comirnaty Original & Omicron BA.4/BA.5 to reflect the accumulation of safety data and information gained in the post-market setting for this vaccine. |
| Monthly safety report Control # 273366 | 2023-03-16 | Review completed 2023-04-28 | Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report for the period 2023-01-16 to 2023-02-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
|
Risk Management Plan update Control # 267502 |
2022-12-20 | Review completed 2023-04-24 | The updated Core (European Union [EU]) Risk Management Plan (RMP) version 9.0 was filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The review concluded that the RMP is acceptable at this time. |
| Monthly safety report Control # 273314 | 2023-03-14 | Review completed 2023-04-17 | Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report for the period 2022-12-16 to 2023-01-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 237208 | 2023-03-10 | Review completed 2023-04-17 | Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report for the period 2022-11-16 to 2022-12-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 273207 | 2023-03-10 | Review completed 2023-04-17 | Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report for the period 2022-10-16 to 2022-11-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 271449 | 2023-01-16 | Issued NOC 2023-04-04 | Submission filed as a Level I – Supplement to add a single-dose vial presentation, and to add a filling line for the drug product. The information was reviewed and considered acceptable. An NOC was issued. |
| Monthly safety report Control # 273197 | 2022-11-15 | Review completed 2023-03-02 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report for the period 2022-09-16 to 2022-10-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 270982 | 2022-12-23 | Issued NOC 2023-02-22 |
Submission filed as a Level I – Supplement to add a manufacturing site for the production of the drug product, add a new drug product testing site, and change the drug product manufacturing process. The data were reviewed and considered acceptable, and an NOC was issued. |
| NC # 271770 | 2023-01-26 | Issued NOL 2023-02-09 |
Submission filed as a Level II (90 day) Notifiable Change to increase the shelf life from 12 months to 18 months. The submission was reviewed and considered acceptable, and an NOL was issued. |
| Drug product (DIN 02533197) market notification | Not applicable | Date of first sale: 2022-12-19 |
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 2022-12-09 |
Health Professional Risk Communication posted (Comirnaty Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age), containing information about labelling, packaging, product safety, and supply for health professionals. |
| SNDS # 268826 | 2022-10-18 | Issued NOC (subject to terms and conditions) 2022-12-09 |
Submission filed as a Level I – Supplement to seek authorization for use of Comirnaty Original & Omicron BA.4/BA.5 in children 5 to <12 years of age. The submission was reviewed and considered acceptable, and an NOC was issued. Terms and conditions were imposed on the authorization. A new DIN (02533197) was issued. A Regulatory Decision Summary was published. |
| Amended Terms and Conditions Control # 267502 | Not applicable | Terms and conditions amended post authorization 2022-12-09 |
Health Canada imposed a new Term and Condition to the authorization of Comirnaty Original & Omicron BA.4/BA.5. Monthly safety reports are to be submitted, unless otherwise determined by Health Canada. |
| Drug product (DIN 02531461) market notification | Not applicable | Date of first sale: 2022-10-11 |
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 2022-10-07 |
Health Professional Risk Communication posted (Comirnaty Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels), containing information about labelling, packaging, product safety, and supply for health professionals. |
| NDS # 267502 | 2022-09-02 | Issued NOC (subject to terms and conditions) 2022-10-07 |
NOC issued for New Drug Submission. Terms and conditions were imposed on the authorization. |