Post-Authorization Activity Table (PAAT) for Covifenz
The following table describes post-authorization activity for Covifenz, a product which contains the medicinal ingredient virus-like particles (VLPs) of SARS-CoV-2 spike protein. 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 02521326 - 3.75 mcg/0.5 mL virus-like particles (VLPs) of SARS-COV-2 spike protein, emulsion, intramuscular administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| DIN 02521326 cancelled (pre market) | Not applicable | Discontinuation date: 2023-03-31 | The manufacturer notified Health Canada that sale of the drug has been discontinued pre market. Health Canada cancelled the DIN(s) pursuant to section C.01.014.6(1)(a) of the Food and Drug Regulations. |
| SNDS # 267448 | 2022-08-30 | Issued NOC 2023-03-30 | Submission filed as a Level I – Supplement to expand the indication to include use in the elderly ≥65 years of age. The submission was reviewed and considered acceptable, and an NOC was issued. A Regulatory Decision Summary was published. |
| NC # 270218 | 2022-11-30 | Issued NOL 2023-02-06 |
Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) for a change in the drug substance manufacturing process. The submission was reviewed and considered acceptable, and an NOL was issued. |
| Monthly safety report Control # 264095 |
2022-05-09 | Review completed 2022-05-31 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #2 for the period 2022-03-27 to 2022-04-26. No post-market data is available as the vaccine has not yet been marketed or distributed. The sponsor was asked to pause the submission of the monthly safety report until the vaccine is marketed or distributed. |
| Monthly safety report Control # 263180 |
2022-04-07 | Review completed 2022-05-04 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #1 for the period 2022-02-24 to 2022-03-26. No safety information was presented in the report as the vaccine has not yet been marketed or distributed. The current safety data are consistent with the labelled safety profile of Covifenz. |
| NDS # 254598 | 2021-08-09 | Issued NOC (subject to terms and conditions) 2022-02-24 |
NOC issued for New Drug Submission. Terms and conditions were imposed on the authorization. |
| Application # 251784 | 2021-04-19 | Closed 2021-09-16 |
Application closed with expiry of Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. |