Post-Authorization Activity Table (PAAT) for Comirnaty (previously the Pfizer-BioNTech COVID-19 Vaccine)

Updated:

2023-11-17

The following table describes post-authorization activity for Comirnaty (previously the Pfizer-BioNTech COVID-19 Vaccine), a product which contains the medicinal ingredient tozinameran. 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 02509210 - 30 µg/0.3 mL tozinameran, suspension, intramuscular administration
  • DIN 02522454 - 10 μg/0.2 mL tozinameran, suspension, intramuscular administration
  • DIN 02527863 - 30 μg/0.3 mL tozinameran, suspension, intramuscular administration
  • DIN 02530325 - 3 μg/0.2 mL tozinameran, 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 # 277008 2023-07-07 Review completed 2023-10-17 With this submission, the sponsor provided a cumulative review of cases reporting idiopathic inflammatory myopathies/myositis following vaccination with Comirnaty, as requested by Health Canada following the review of PSUR # 3 (control # 267220). The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine.
DIN 02522454 and 02527863 reported as dormant Not applicable 2023-10-11 The manufacturer reported the DINs as dormant as per section C.01.014.71 and subsection C.01.014.5(1)(a)(ii) of the Food and Drug Regulations.
Post-Market Information Request Review Control # 276181 2023-06-09 Review completed 2023-09-25 Further to Health Canada's review of available data on pregnancy- and breastfeeding-related outcomes (control # 266586) the sponsor was requested to submit interim updates and the final report of studies C4591009, C4591010, C4591011, C4591021, and C4591022. With this submission, the sponsor announced study C4591010 had been terminated. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine.
Post-Market Information Request Review Control # 274972 2023-05-03 Review completed 2023-09-25 Further to Health Canada's review of available data on pregnancy- and breastfeeding-related outcomes (control # 266586) the sponsor was requested to submit interim updates and the final report of studies C4591009, C4591010, C4591011, C4591021, and C4591022. With this submission, the sponsor filed an interim safety report for study C4591021. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine.
PSUR # 272720 2023-02-24 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 #4 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.
NC # 274798 2023-04-26 Issued NOL 2023-07-12 Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) for changes in the drug product manufacturing process. The submission was reviewed and considered acceptable, and an NOL was issued.
NC # 274578 2023-04-21 Issued NOL 2023-07-11 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 Control # 275249 2023-05-15 Review completed 2023-07-07 Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report #15 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 # 274326 2023-04-13 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 #14 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.

Amended Terms and Conditions 
Control # 252736

Not applicable

Terms and conditions amended post authorization
2023-06-09

Health Canada updated the Risk Management Plan Terms and Conditions for Comirnaty to reflect the accumulation of safety data and information gained in the post-market setting for this vaccine.
SNDS # 270587 2022-12-13 Issued NOC 2023-05-26 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.
Monthly safety report Control # 273308 2023-03-14 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 #13 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.
Post-Market Information Request Review Control # 271478 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.
Post-Market Information Request Review Control # 272851 2023-03-01 Review completed 2023-04-17 Further to Health Canada's review of available data on pregnancy- and breastfeeding-related outcomes (control # 266586) the sponsor was requested to submit interim updates and the final report of studies C4591009, C4591010, C4591011, C4591021, and C4591022. With this submission, the sponsor filed an interim safety report for studies C4591010, C4591012, and C4591022. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine.
Monthly safety report Control # 272411 2023-02-14 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 #12 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 # 271378 2023-01-13 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 #11 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 # 270690 2022-12-15 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 #10 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.
DIN 02509210 reported as dormant Not applicable 2023-03-24 The manufacturer reported the DIN as dormant as per section C.01.014.71 and subsection C.01.014.5(1)(a)(ii) of the Food and Drug Regulations.
SNDS # 270734 2022-12-16 Issued NOC 2023-03-21 Submission filed as a Level II – Supplement (Safety) to update the PM with information about the risk of dizziness. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Warnings and Precautions, and Adverse Reactions sections of the PM, and corresponding changes were made to Part III: Patient Medication Information. An NOC was issued.
Monthly safety report Control # 269718 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 #9 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.

PSUR # 267220 2022-08-23 Review completed
2023-02-16

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Six-month PSUR #3 for the period 2021-12-19 to 2022-06-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

SNDS # 270460 2022-12-08 Issued NOC
2023-02-01

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.

Amended Terms and Conditions Control # 265483 Not applicable Terms and conditions amended post authorization
2022-12-21

Health Canada imposed a new Term and Condition to the authorization of Comirnaty, DIN 02530325. Monthly safety reports are to be submitted, unless otherwise determined by Health Canada.

NC # 270520 2022-12-09 Issued NOL
2022-12-20

Submission filed as a Level II (90 day) Notifiable Change to increase the shelf life from 12 months to 18 months for the tris-sucrose formulation. The submission was reviewed and considered acceptable, and an NOL was issued.

Monthly safety report Control # 268677 2022-10-13 Review completed
2022-11-29

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report #8 for the period 2022-08-16 to 2022-09-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

Amended Terms and Conditions Control # 252736, 257698, 260067 Not applicable Terms and conditions amended post authorization
2022-11-24

Health Canada imposed a new Term and Condition to the authorization of Comirnaty, DINs 02509210, 02522454, and 02527863. PSURs/PBRERs are to be submitted every 6 months, unless otherwise determined by Health Canada.

Post-Market Information Request Review Control # 268295 2022-10-03 Review completed
2022-11-15

Further to Health Canada's review of available data on pregnancy- and breastfeeding-related outcomes (control # 266586) the sponsor was requested to submit interim updates and the final report of studies C4591009, C4591010, C4591011, C4591021, and C4591022. With this submission, the sponsor filed an interim safety report for study C4591021. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine.

Post-Market Information Request Review Control # 267546 2022-09-02 Review completed
2022-11-15

Further to Health Canada's review of available data on pregnancy- and breastfeeding-related outcomes (control # 266586) the sponsor was requested to submit interim updates and the final report of studies C4591009, C4591010, C4591011, C4591021, and C4591022. With this submission, the sponsor filed an interim safety report for study C4591010. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine.

Post-Market Information Request Review Control # 266586 2022-08-02 Review completed
2022-11-15

Further to Health Canada's review of available data on pregnancy- and breastfeeding-related outcomes (control # 266586) the sponsor was requested to submit interim updates and the final report of studies C4591009, C4591010, C4591011, C4591021, and C4591022. With this submission, the sponsor filed interim safety reports for studies C4591010, C4591021, and C4591022. The information was assessed and Health Canada will continue to monitor the safety and effectiveness of this vaccine.

Monthly safety report
Control # 267735
2022-09-09 Review completed
2022-10-27

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report #7 for the period 2022-07-16 to 2022-08-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

SNDS # 266506 2022-07-29 Issued NOC
2022-10-26

Submission filed as a Level I – Supplement to add an alternate site for the manufacture of the drug substance and testing and release of the drug product. The data were reviewed and considered acceptable, and an NOC was issued.

Monthly safety report
Control # 266827
2022-08-09 Review completed
2022-09-20

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report #6 for the period 2022-06-16 to 2022-07-15.  The sponsor was asked to continue with the standard monitoring.

Drug product (DIN 02530325) market notification Not applicable Date of first sale:
2022-09-15

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
2022-09-09

Health Professional Risk Communication posted (Comirnaty [COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine]: New Presentation for Use in Children Aged 6 Months to Less Than 5 Years with English-only Vial and Carton Labels), containing information about packaging, product safety, and supply for health professionals.

SNDS # 265483 2022-06-23 Issued NOC (subject to terms and conditions)
2022-09-09

Submission filed as a Level I – Supplement to seek authorization for use of Comirnaty 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.

NC # 266658 2022-08-05 Issued NOL
2022-09-06

Submission filed as a Level II (90 day) Notifiable Change to add a new source of an excipient. The submission was reviewed and considered acceptable, and an NOL was issued.

SNDS # 264621 2022-05-27 Issued NOC (subject to terms and conditions)
2022-08-19

Submission filed as a Level I – Supplement to seek authorization for a booster dose of Comirnaty in individuals 5 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 # 266083
2022-07-15 Review completed
2022-08-12

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report #5 for the period 2022-05-16 to 2022-06-15.  The sponsor was asked to continue with the standard monitoring.

Risk Management Plan update
Control # 263358
2022-04-13 Review completed
2022-08-11

The updated Core (European Union [EU]) Risk Management Plan (RMP) version 5.0 was filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The review of the Core EU RMP is acceptable at this time. The current post-market safety data are consistent with the labelled safety profile of Comirnaty.

NC # 265853 2022-07-07 Issued NOL
2022-07-19

Submission filed as a Level II (90 day) Notifiable Change to change the batch size of the tris-sucrose formulation. The submission was reviewed and considered acceptable, and an NOL was issued.

PSUR # 262159 2022-03-07 Review completed
2022-07-14

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Six-month PSUR #2 for the period 2021-06-19 to 2021-12-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

Bi-monthly safety report
Control # 264200
2022-05-12 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 #3 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.

NC # 265637 2022-06-29 Issued NOL
2022-07-12

Submission filed as a Level II (90 day) Notifiable Change to add a new manufacturing site for drug substance starting material. The submission was reviewed and considered acceptable, and an NOL was issued.

NC # 265381 2022-06-21 Issued NOL
2022-07-08

Submission filed as a Level II (90 day) Notifiable Change to add filling lines for the drug product. The submission was reviewed and considered acceptable, and an NOL was issued.

Post-Market Information Request Review Control # 265749 2022-03-14 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.

Monthly safety report
Control # 265062
2022-06-09 Review completed
2022-06-22

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report #4 for the period 2022-04-16 to 2022-05-15. Routine monitoring will continue.

Amended Terms and Conditions Control # 252736 Not applicable Terms and conditions amended post authorization
2022-06-21

Health Canada imposed a new Term and Condition to the authorization of Comirnaty. Canadian-specific bilingual labelling is to be developed for Comirnaty presentations currently marketed in Canada.

Updated Health Product Risk Communication Not applicable Posted
2022-06-10

Updated Health Product Risk Communication posted (Comirnaty [COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine]: New Formulation/Presentation for Use in Individuals 12 Years of Age and Older), containing new safety information for healthcare professionals. The update was published to convey that each presentation of Comirnaty in Canada now has a distinct DIN.

Drug product (DIN 02527863) market notification Not applicable Date of first sale:
2022-06-07

The manufacturer notified Health Canada of the date of first sale pursuant to C.01.014.3 of the Food and Drug Regulations.

New DIN Control # 260067 Not applicable DIN issued
2022-06-07

To avoid potential medication errors, a new DIN (02527863) was issued for the tris-sucrose 30 μg/0.3 mL formulation for individuals 16 years of age and older (grey cap), previously approved in SNDS # 260067.

SNDS # 261729 2022-02-23 Issued NOC (subject to terms and conditions)
2022-06-01

Submission filed as a Level I – Supplement to seek authorization for a booster dose of Comirnaty in individuals 16 and 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.

Bi-monthly safety report
Control # 262301
2022-03-11 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 #2 for the period 2021-12-16 to 2022-02-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

Health Product Risk Communication Not applicable Posted
2022-05-09

Health Product Risk Communication posted (Comirnaty [COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine]: New Formulation/Presentation for Use in Individuals 12 Years of Age and Older), containing new safety information for healthcare professionals.

NC # 262286 2022-03-01 Issued NOL
2022-04-29

Submission filed as a Level II (90 day) Notifiable Change to add a new manufacturing site for drug substance starting material. The submission was reviewed and considered acceptable, and an NOL was issued.

Monthly safety report
Control # 263141
2202-04-06 Review completed
2022-04-28

Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report #3 for the period 2022-02-16 to 2022-03-15. The sponsor was asked to continue with the standard monitoring.

NC # 263158 2022-04-07 Issued NOL
2022-04-25

Submission filed as a Level II (90 day) Notifiable Change to increase the shelf life from 9 months to 12 months for the phosphate-buffered saline formulation. The submission was reviewed and considered acceptable, and an NOL was issued.

NC # 262659 2022-03-23 Issued NOL
2022-04-14

Submission filed as a Level II (90 day) Notifiable Change to increase the shelf life from 9 months to 12 months for the tris-sucrose formulation. The submission was reviewed and considered acceptable, and an NOL was issued.

Bi-monthly safety report
Control # 260378
2022-01-14 Review completed
2022-03-31
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 2021-10-29 to 2021-12-15. The sponsor was asked to continue with the standard monitoring.
NC # 261933 2022-03-01 Issued NOL
2022-03-22
Submission filed as a Level II (90 day) Notifiable Change to add a line for filling of the drug product. The submission was reviewed and considered acceptable, and an NOL was issued.
NC # 261624 2022-02-18 Issued NOL
2022-03-22
Submission filed as a Level II (90 day) Notifiable Change to add a new manufacturing site for drug substance starting material. The submission was reviewed and considered acceptable, and an NOL was issued.
Post-Market Information Request Review Control # 258961 2021-11-23 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 Comirnaty.
Monthly safety report
Control # 261025
2022-02-02 Review completed
2022-03-17
nformation filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report #14 for the period 2021-12-16 to 2022-01-15. The sponsor was asked to continue with the standard monitoring.
SNDS # 261085 2022-02-02 Issued NOC
2022-03-15
Submission filed as a Level I – Supplement for a new manufacturing site for the drug product. The submission was reviewed and considered acceptable, and an NOC was issued.
SNDS # 260067 2022-01-05 Issued NOC
2022-03-15
Submission filed as a Level I – Supplement for a new 2.25 mL fill volume for a previously-approved formulation, and corresponding changes to the Product Monograph. The submission was reviewed and considered acceptable, and an NOC was issued.
Post-Market Information Request Review Control # 259120, 259121 2021-12-08 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.
SNDS # 259675 2022-01-17 Issued NOC
2022-02-18
Submission filed as a Level II – Supplement (Safety). 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 erythema multiforme, hypoesthesia, and paresthesia in the Post-market Adverse Reactions and Patient Medication Information sections. The submission was reviewed and considered acceptable, and an NOC was issued.
NC # 261315 2022-02-09 Issued NOL
2022-02-18
Submission filed as a Level II (90 day) Notifiable Change to update analytical methods for the drug substance and drug product. The submission was reviewed and considered acceptable, and an NOL was issued.
Risk Management Plan update
Control # 259288
2021-12-06 Review completed
2022-02-17
The updated Core (European Union [EU]) Risk Management Plan (RMP) versions 2.6 and 4.0 and Canadian Addendum dated November 2021 were filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The review of the Core EU RMP in conjunction with the Canadian Addendum is acceptable at this time. The current post-market safety data are consistent with the labelled safety profile of Comirnaty.
NC # 260764 2022-01-26 Issued NOL
2022-02-02
Submission filed as a Level II (90 day) Notifiable Change for changes to the drug product manufacturing process. The submission was reviewed and considered acceptable, and an NOL was issued.
NC # 260740 2022-01-25 Issued NOL
2022-02-01
Submission filed as a Level II (90 day) Notifiable Change to add a new source of an excipient. The submission was reviewed and considered acceptable, and an NOL was issued.
NC # 260684 2022-01-24 Issued NOL
2022-02-01
Submission filed as a Level II (90 day) Notifiable Change to add a new source of an excipient. The submission was reviewed and considered acceptable, and an NOL was issued.
Monthly safety report
Control # 259632
2021-12-15 Review completed
2022-01-30
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Abbreviated monthly safety report #12 for the period 2021-10-29 to 2021-11-30. The sponsor was asked to continue with the standard monitoring.
NC # 260191 2022-01-10 Issued NOL
2022-01-26
Submission filed as a Level II (90 day) Notifiable Change to add a line for filling of the drug product. The submission was reviewed and considered acceptable, and an NOL was issued.
NC # 260217 2022-01-11 Issued NOL
2022-01-21
Submission filed as a Level II (90 day) Notifiable Change for changes to the drug product manufacturing process. The submission was reviewed and considered acceptable, and an NOL was issued.
Monthly safety report
Control # 258661
2021-11-16 Review completed
2022-01-21
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #11 for the period 2021-10-01 to 2021-10-28. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.
NC # 259717 2021-12-17 Issued NOL
2022-01-20
Submission filed as a Level II (90 day) Notifiable Change to increase the shelf life from 6 months to 9 months for the pediatric formulation. The submission was reviewed and considered acceptable, and an NOL was issued.
NC # 259910 2021-12-23 Issued NOL
2022-01-14
Submission filed as a Level II (90 day) Notifiable Change to increase the manufacturing scale of the drug substance. The submission was reviewed and considered acceptable, and an NOL was issued.
NC # 259445 2021-12-10 Issued NOL
2022-01-07
Submission filed as a Level II (90 day) Notifiable Change to add a new manufacturing site for drug substance starting material. The submission was reviewed and considered acceptable, and an NOL was issued.
NC # 259276 2021-12-03 Issued NOL
2022-01-04
Submission filed as a Level II (90 day) Notifiable Change to add a line for filling of the drug product. The submission was reviewed and considered acceptable, and an NOL was issued.
NC # 259502 2021-12-13 Issued NOL
2021-12-16
Submission filed as a Level II (90 day) Notifiable Change to add a manufacturing line for the drug substance. The submission was reviewed and considered acceptable, and an NOL was issued.
Monthly safety report
Control # 257656
2021-10-15 Review completed
2021-12-13
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #10 for the period 2021-09-01 to 2021-09-30. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.
Drug product (DIN 02522454) market notification Not applicable Date of first sale:
2021-11-22
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
2021-11-19
Health Product Risk Communication posted (Corminaty [COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine]: New Formulation for Use in Children Aged 5 Years to Less Than 12 Years), important information about safety, packaging and supply for healthcare professionals.
SNDS # 257698 2021-10-18 Issued NOC (subject to terms and conditions)
2021-11-19

Submission filed as a Level I – Supplement to seek authorization for use of Comirnaty in children 5 to less than 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 Regulatory Decision Summary was published. A new DIN (02522454) was issued for the pediatric formulation.

Risk Management Plan update
Control # 257845
2021-10-21 Review completed
2021-11-18
The updated Core (European Union [EU]) Risk Management Plan (RMP) version 3.0 dated October 13, 2021 was filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The review of the Core EU RMP is acceptable at this time. The current post-market safety data are consistent with the labelled safety profile of Comirnaty.
SNDS # 257162 2021-10-01 Issued NOC (subject to terms and conditions)
2021-11-09

Submission filed as a Level I – Supplement to seek authorization for a booster dose of Comirnaty. 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 # 257449 2021-10-08 Issued NOL
2021-10-26
Submission filed as a Level II (90 day) Notifiable Change for changes to the drug product manufacturing process. The submission was reviewed and considered acceptable, and an NOL was issued.
Monthly safety report
Control # 256898
2021-09-15 Review completed
2021-10-26
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 #9 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.
NDS # 252736 2021-06-10 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 the Pfizer-BioNTech COVID-19 Vaccine to Comirnaty. Regulatory Decision Summary published. DIN 02509210 was issued.

Risk Management Plan update
Control # 254230
2021-08-12 Review completed
2021-09-15
The updated Core (European Union [EU]) Risk Management Plan (RMP) version 2.3 and Canadian Addendum dated August 2021 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 current post-market safety data are consistent with the labelled safety profile of the Pfizer-BioNTech COVID-19 Vaccine.
Monthly safety report
Control # 255691
2021-08-15 Review completed
2021-09-13
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 #8 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.
Periodic Safety Update Report
Control # 256093
2021-08-26 Review completed
2021-09-13
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). Six-month Periodic Safety Update Report (PSUR) #1 for the period 2020-12-19 to 2021-06-18. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.
Amendment # 256327 2021-09-02 Authorization amended
2021-09-13
An application submitted to amend the authorization in respect of this drug (relating to changes in the process to manufacture 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 # 254768 2021-07-14 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. Changes were made to the Warnings and Precautions, 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 # 256085 2021-08-25 Authorization amended
2021-08-27
An application submitted to amend the authorization in respect of this drug (relating to an extension of the shelf life for the drug product to 9 months when stored at the intended storage conditions of -90°C to -60°C) 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 # 255910 2021-08-19 Authorization amended
2021-08-26
An application submitted to amend the authorization in respect of this drug (relating to a new source of an excipient) 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 # 255881 2021-08-18 Authorization amended
2021-08-20
An application submitted to amend the authorization in respect of this drug (relating to a new test site 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 # 253362 2021-06-03 Authorization amended
2021-08-19
An application submitted to amend the authorization in respect of this drug (relating to a new formulation suite and additional filling lines 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.
Monthly safety report
Control # 254572
2021-07-15 Review completed
2021-08-15

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 2021-06-01 to 2021-06-30. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

Advisory Not applicable Posted
2021-08-06

Advisory posted (Health Canada updates Pfizer-BioNTech COVID-19 vaccine label to reflect very rare reports of Bell's Palsy), containing information about a product label update for the general public and healthcare professionals.

Amendment # 254781 2021-07-15 Authorization amended
2021-08-06

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 # 255242 2021-07-29 Authorization amended
2021-08-04

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 # 254700 2021-07-23 Authorization amended
2021-08-04

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 # 254773 2021-07-15 Authorization amended
2021-07-23

An application submitted to amend the authorization in respect of this drug (relating to alternative quality control testing sites and changes to the manufacturing processes 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 # 254772 2021-07-15 Authorization amended
2021-07-23

An application submitted to amend the authorization in respect of this drug (relating to a new manufacturing site for the drug substance and drug product, and changes to the drug substance manufacturing process) 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 # 254769 2021-07-14 Authorization amended
2021-07-23

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.

Monthly safety report
Control # 253419
2021-06-15 Review completed
2021-07-12

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 2021-04-30 to 2021-05-31 as well as other post-market safety data. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

Risk Management Plan update
Control # 253040
2021-05-25 Review completed
2021-06-30

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. The sponsor was requested to submit an updated RMP to include depression exacerbation in the pediatric population and myocarditis/pericarditis as important potential risks.

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 # 254161 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 # 253175 2021-05-28 Authorization amended
2021-06-09
An application submitted to amend the authorization in respect of this drug (relating to a new source of an excipient) 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 # 251813
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 #5 for the period 2021-04-01 to 2021-04-30 as well as other post-market safety data. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.
Amendment # 252926 2021-05-20 Authorization amended
2021-05-31
An application submitted to amend the authorization in respect of this drug (relating to a new source of an excipient) 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 # 252391 2021-05-05 Authorization amended
2021-05-31
An application submitted to amend the authorization in respect of this drug (relating to changes in the process to manufacture it) 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 # 252616 2021-05-12 Authorization amended
2021-05-26
An application submitted to amend the authorization in respect of this drug (relating to changes in the process to manufacture it) 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 # 252087 2021-04-27 Authorization amended
2021-05-19
An application submitted to amend the authorization in respect of this drug (relating to new manufacturing sites 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 # 252524 2021-05-10 Authorization amended
2021-05-19
An application submitted to amend the authorization in respect of this drug (relating to an extension of the shelf life of the undiluted drug product to include up to 1 month of storage at 2-8oC) 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 # 251805
2021-04-15 Review completed
2021-05-06
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 2021-03-01 to 2021-03-31. The current post-market safety data are consistent with the labelled safety profile of the Pfizer-BioNTech COVID-19 Vaccine.
Amendment # 251855 2021-04-21 Authorization amended
2021-05-05
An application submitted to amend the authorization in respect of this drug (relating to a new manufacturing site 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 # 251730 2021-04-16 Authorization amended
2021-05-05
An application submitted to amend the authorization in respect of this drug (relating to an expansion of the currently-approved indication to children 12 to 15 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.

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.
Amendment # 251309 2021-04-06 Authorization amended
2021-04-23
An application submitted to amend the authorization in respect of this drug (relating to changes in the process to manufacture it) 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 # 251308 2021-04-06 Authorization amended
2021-04-23
An application submitted to amend the authorization in respect of this drug (relating to a new source of an excipient) 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 # 250059
2021-03-16 Review completed
2021-04-21
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 2021-02-01 to 2021-02-28. The current post-market safety data are consistent with the labelled safety profile of the Pfizer-BioNTech COVID-19 Vaccine.
Amendment # 250010 2021-03-02 Authorization amended
2021-04-01
An application submitted to amend the authorization in respect of this drug (relating to manufacturing process updates 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 # 250082 2021-03-04 Authorization amended
2021-03-10
An application submitted to amend the authorization in respect of this drug (relating to changes in the process to manufacture it) 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
2021-03-08
Dear Healthcare Professional Letter posted (Updated Storage and Transportation Conditions), containing important safety and product safety information for healthcare professionals.
Monthly safety report
Control # 248783
2021-02-13 Review completed
2021-03-05
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 2021-01-01 to 2021-01-31. The current post-market safety data are consistent with the labelled safety profile of the Pfizer-BioNTech COVID-19 Vaccine.
Amendment # 249418 2021-02-12 Authorization amended
2021-03-03
An application submitted to amend the authorization in respect of this drug (relating to a new source of an excipient) 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 # 249850 2021-02-25 Authorization amended
2021-03-03
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 drug product may be stored at -25°C to -15°C for a total of two weeks. The Product Monograph was updated to include post-market hypersensitivity reactions and the results of a completed reproductive and developmental toxicity study. 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 # 247923 2021-01-11 Review completed
2021-02-23
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.
Amendment # 249352 2021-02-10 Authorization amended
2021-02-18
An application submitted to amend the authorization in respect of this drug (relating to changes in the process to manufacture it) 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 # 248561 2021-01-21 Authorization amended
2021-02-12
An application submitted to amend the authorization in respect of this drug (relating to a new source of an excipient) 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.
Advisory Not applicable Posted
2021-02-08
Dear Healthcare Professional Letter posted (Updated dosage and administration and post-market adverse reaction information), containing information about supply, a product label update and important safety information for healthcare professionals.
Amendment # 248628 2021-01-22 Authorization amended
2021-02-08
An application submitted to amend the authorization in respect of this drug (relating to changing the Product Monograph to reflect the vaccine vial content of 6 doses per vial) 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.

Additional terms and conditions were imposed on this authorization when it was amended to permit this change, to ensure safe use of the product.
Amendment # 248272 2021-01-13 Authorization amended
2021-02-08
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. Severe allergic reactions, including anaphylaxis, have now been reported through vaccine surveillance programs during mass vaccination. 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 # 248389
2021-01-15 Review completed
2020-02-01
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 2020-12-01 to 2020-12-31. The current post-market safety data are consistent with the labelled safety profile of the Pfizer-BioNTech COVID-19 Vaccine.
Amendment # 248137 2021-01-08 Authorization amended
2021-01-22
An application submitted to amend the authorization in respect of this drug (relating to a new source of an excipient) 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 # 248059 2021-01-07 Authorization amended
2021-01-22
An application submitted to amend the authorization in respect of this drug (relating to revised specifications within the manufacturing processes 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 # 248078 2021-01-07 Authorization amended
2021-01-19
An application submitted to amend the authorization in respect of this drug (relating to changes in the process to manufacture it) 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.
Drug product (DIN 02509210) market notification Not applicable Date of first sale:
2020-12-14
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.
Advisory Not applicable Posted
2020-12-12
Advisory posted (Health Canada recommendations for people with serious allergies), containing important information about allergies and product safety for healthcare professionals and the general public.
Dear Healthcare Professional Letter Not applicable Posted
2020-12-12
Dear Healthcare Professional Letter posted (Authorization of Pfizer‑BioNTech COVID‑19 Vaccine with English-only Carton and Vial Labels), containing important information about supply and product safety for healthcare professionals.
Application # 244906 2020-10-09 Authorized (with terms and conditions)
2020-12-09
Authorized with terms and conditions under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19