Post-Authorization Activity Table (PAAT) for Comirnaty Original & Omicron BA.4/BA.5

Updated:

2023-05-26

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 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 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

Post-Authorization Activity Table (PAAT)

Activity/submission type, control number Date submitted Decision and date Summary of activities
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.