Post-Authorization Activity Table (PAAT) for Jcovden (previously the Janssen COVID-19 Vaccine)

Health Canada conducted a third ad-hoc review of available data on the risk of thrombosis with thrombocytopenia syndrome (TTS) with viral vector vaccines Jcvoden and Vaxzevria. The sponsors were requested to submit all available data to Health Canada for review. The information was assessed, and Health Canada will continue to monitor the safety of these vaccines.

Submission filed as a Level I – Supplement to seek authorization for a booster dose of Jcovden, following primary vaccination with an mRNA COVID-19 vaccine in subjects 18 years of age and older. The submission was reviewed and considered acceptable, and an NOC was issued. A Regulatory Decision Summary was published.

Submission filed as a Level II – Supplement (Safety) to update the PM with pooled analyses of safety data from studies COV1001, COV1002, COV2001, COV3001, and COV3009. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Adverse Reactions section of the PM. An NOC was issued.

Submission filed as a Level II – Supplement (Safety) to update the PM with new safety information related to facial paralysis. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Adverse Reactions section of the PM, and corresponding changes were made to Part III: Patient Medication Information. An NOC was issued.

Submission filed as a Level II – Supplement (Safety) to update the PM. The changes were in response to an Advisement Letter issued by Health Canada dated 2022-06-06, requesting revisions related to small-vessel vasculitis with cutaneous manifestation. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Adverse Reactions section of the PM. An NOC was issued.

Submission filed in response to commitments made as per the Food and Drug Regulations. PBRER #2 for the period 2021-08-25 to 2022-02-24. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

Submission filed as a Level II – Supplement to change the brand name from the Janssen COVID-19 Vaccine to Jcvoden, and to introduce Canadian-specific labels. The information was reviewed and considered acceptable. An NOC was issued. Terms and conditions were imposed on the authorization.

Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to transfer quality control testing activities between sites. The submission was reviewed and considered acceptable, and an NOL was issued.

Health Canada reviewed information under a memorandum issued by the United States Food and Drug Administration based on an updated analysis of reported cases of thrombosis with thrombocytopenia syndrome. Health Canada issued a letter to the sponsor requesting further information. The response was reviewed, and 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 extend the shelf life from 6 to 11 months and to update the release specifications for the drug substance and drug product. 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. Bi-monthly safety report #1 for the period 2021-11-01 to 2022-01-15. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

Submission filed as a Level I – Supplement to seek authorization for a booster dose of the Janssen COVID-19 Vaccine. The submission was reviewed and considered acceptable, and an NOC was issued. A Regulatory Decision Summary was published.

The updated Core (European Union [EU]) Risk Management Plan (RMP) version 4.0 and Canadian Addendum version 3.0 dated December 2021 were filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The review concluded that the RMP and Canadian Addendum are acceptable at this time. The current post-market safety data are consistent with the labelled safety profile of the Janssen COVID-19 Vaccine.

Health Canada imposed a new Term and Condition to the authorization of the Janssen COVID-19 Vaccine. Health Canada considered the Term and Condition of bi-monthly safety reports closed. This Term and Condition has been replaced with the requirement to submit Periodic Safety Update Reports / Periodic Benefit Risk Evaluation Reports every 6 months.

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. A Regulatory Decision Summary was published. DIN 02513153 was issued.

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 Product Monograph was updated to include information related to Guillain-Barré syndrome, capillary leak syndrome and other adverse drug reactions. Changes were made to the Contraindications, 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.

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 2021-06-01 to 2021-06-30 as well as other post-market safety data. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events.

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 thrombosis and thrombocytopenia in the Warnings and Precautions and Post-Market Adverse Reactions 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 the use of carton and vial labels approved in the United States) 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 #3 for the period 2021-05-01 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 thrombosis as an important potential risk.

Health Canada started a safety review for Janssen COVID-19 Vaccine, in response to case reports from the United States of thrombosis (blood clots) in combination with thrombocytopenia (low blood platelets).