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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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

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

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.