Post-Authorization Activity Table (PAAT) for Nuvaxovid
Updated: 2024-07-19
The following table describes post-authorization activity for Nuvaxovid, a product which contains the medicinal ingredient severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant 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 found in Post-Authorization Activity Tables (PAATs).
For additional information about the drug submission process, refer to the Guidance Document: The Management of Drug Submissions and Applications.
Drug Identification Number (DIN):
- DIN 02525364 - 5 mcg/0.5 mL SARS-CoV-2 recombinant spike protein, suspension, intramuscular administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| NC # 284002 | 2024-02-21 | Issued NOL 2023-06-03 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) regarding a change in the reference standard for the drug substance. The submission was reviewed and considered acceptable, and an NOL was issued. |
| DIN 02525364 cancelled (post market) | Not applicable | Discontinuation date: 2024-02-29 | The manufacturer notified Health Canada that sale of the drug has been discontinued post market. Health Canada cancelled the DIN(s) pursuant to section C.01.014.6(1)(a) of the Food and Drug Regulations. |
| PBRER # 278381 | 2023-08-18 | Review completed 20234-01-22 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #3 for the period 2022-12-20 to 2023-06-19. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events in the next PBRER for Nuvaxovid XBB.1.5. |
| SNDS # 275840 | 2023-05-31 | Issued NOC 2023-11-16 | Submission filed as a Level I – Supplement for a new 2-vial pack presentation for the 5-dose vial drug product. The submission was reviewed and considered acceptable, and an NOC was issued. |
| SNDS # 273313 | 2023-03-15 | Cancellation Letter Received 2023-11-09 | Submission filed as a Level I – Supplement for the expansion of the indication to include a booster dose regimen for adolescent patients 12-17 years of age and to update the PM with new safety and efficacy data. In addition, data were provided from studies 2019nCoV-301, -302, and -501 as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. A Summary of Cancellation was published. |
| SNDS # 273625 | 2023-03-24 | Issued NOC 2023-07-18 | Submission filed as a Level I – Supplement for a new 5-dose vial presentation. The data were reviewed and considered acceptable, and an NOC was issued. |
| PBRER # 272740 | 2023-02-27 | Review completed 2023-07-24 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #2 for the period 2022-06-20 to 2022-12-19. The information was reviewed and found acceptable. No further action was required. |
|
Amended Terms and Conditions |
Not applicable |
Terms and conditions amended post authorization |
Health Canada updated the Risk Management Plan Terms and Conditions for Nuvaxovid to reflect the accumulation of safety data and information gained in the post-market setting for this vaccine. |
| SNDS # 270288 | 2022-12-01 | Issued NOC 2023-04-12 | Submission filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations as a Level I – Supplement to add French language text to the inner and outer labels. The submission was reviewed and considered acceptable, and an NOC was issued. |
| NC # 272826 | 2023-03-01 | Issued NOL 2023-04-03 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to extend the shelf life of the drug substance. The submission was reviewed and considered acceptable, and an NOL was issued. |
| NC # 273204 | 2023-03-09 | Issued NOL 2023-03-28 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to change the specifications used to release the drug product and to extend the shelf life of the drug product from 9 to 12 months. The submission was reviewed and considered acceptable, and an NOL was issued. |
| NC # 272045 | 2023-02-06 | Issued NOL 2023-03-24 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to extend the shelf-life of a drug substance intermediate. The submission was reviewed and considered acceptable, and an NOL was issued. |
| NC # 272247 | 2023-02-09 | Issued NOL 2023-03-16 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to extend the in-use shelf life of the drug product from 6 to 12 hours when stored at 2oC to 8oC. The submission was reviewed and considered acceptable, and an NOL was issued. |
| NC # 272286 | 2023-02-09 | Issued NOL 2023-03-13 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to change the qualification protocol for the interim reference standard. The submission was reviewed and considered acceptable, and an NOL was issued. |
| SNDS # 268946 | 2022-10-21 | Issued NOC 2023-03-09 | Submission filed as a Level I – Supplement for a scale-up of the drug substance manufacturing process. The data were reviewed and considered acceptable, and an NOC was issued. |
| SNDS # 271559 | 2023-01-20 | Cancellation Letter Received 2023-02-01 |
Submission filed as a Level I – Supplement to change the stability protocol of the drug substance. The changes were not in scope of an SNDS but were considered to be Level II and III changes. The sponsor cancelled the submission administratively. |
| Bi-monthly safety report Control # 270486 | 2022-12-09 | Review completed 2023-02-17 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Bi-monthly safety report for the period 2022-09-01 to 2022-11-15. The sponsor was asked to continue with the standard monitoring. |
| SNDS # 268596 | 2022-10-12 | Issued NOC 2023-02-02 |
Submission filed as a Level II – Supplement (Safety) to update the PM with safety information related to anaphylaxis, myocarditis, pericarditis, and hypoesthesia/paraesthesia. 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. |
| PBRER # 267302 | 2022-08-25 | Review completed 2023-01-19 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #1 for the period 2021-12-20 to 2022-06-19. The information was reviewed and found acceptable. No further action was required. |
| Monthly safety report Control # 268712 | 2022-10-14 | Review completed 2023-01-03 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #8 for the period 2022-09-01 to 2022-09-30. The sponsor was asked to continue with the standard monitoring. |
| SNDS # 265342 | 2022-06-21 | Issued NOC 2022-12-06 |
Submission filed as a Level I – Supplement to seek authorization for the use of Nuvaxovid in adolescents 12 to 17 years of age. The submission was reviewed and considered acceptable, and an NOC was issued. A Regulatory Decision Summary was published. |
| Monthly safety report Control # 267901 | 2022-09-15 | Review completed 2022-12-05 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #7 for the period 2022-08-01 to 2022-08-31. The sponsor was asked to continue with the standard monitoring. |
| SNDS # 266285 | 2022-08-05 | Issued NOC (subject to terms and conditions) 2022-11-17 |
Submission filed as a Level I – Supplement to seek authorization for a booster dose of Nuvaxovid. 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 # 266986 | 2022-08-15 | Review completed 2022-11-15 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #6 for the period 2022-07-01 to 2022-07-31. The sponsor was asked to continue with the standard monitoring. |
| Post-Market Information Request Review Control # 255370 | 2022-10-07 | Review completed 2022-11-09 |
Request filed regarding transitioning monthly summary safety reports to bi-monthly summary safety reports. Health Canada agreed that the sponsor will submit a bi-monthly summary safety report for one cycle, then submit 6-month PBRERs as described in the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. |
| NC # 267838 | 2022-09-13 | Issued NOL 2022-10-24 |
Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) regarding a change in the reference standard for the drug substance. The submission was reviewed and considered acceptable, and an NOL was issued. |
| SNDS # 268098 | 2022-09-23 | Cancellation Letter Received 2022-10-06 |
Submission filed as a Level II – Supplement (Safety) to update the PM. The proposed revisions exceeded the scope of a Labelling SNDS. The submission was therefore cancelled administratively by the sponsor so as to be filed as a Clinical SNDS. |
| NC # 265872 | 2022-07-11 | Issued NOL 2022-09-14 |
Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to change the primary container closure system for the drug substance, to extend the shelf life of the drug substance, and to change the supplier of an adjuvant. The submission was reviewed and considered acceptable, and an NOL was issued. |
| Amended Terms and Conditions Control # 255370 | Not applicable | Terms and conditions amended post authorization 2022-09-14 |
Health Canada imposed a new Term and Condition to the authorization of Nuvaxovid. Monthly safety reports are to continue to be submitted. |
| Monthly safety report Control # 266288 |
2022-07-22 | Review completed 2022-08-12 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #5 for the period 2022-06-01 to 2022-06-30. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| SNDS # 265228 | 2022-06-16 | Issued NOC 2022-08-12 |
Submission filed as a Level I – Supplement to make updates to the manufacturing process of the drug substance. The information was reviewed and considered acceptable. An NOC was issued. |
| Monthly safety report Control # 265205 |
2022-06-15 | Review completed 2022-07-14 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #4 for the period 2022-05-01 to 2022-05-31. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| NC # 264027 | 2022-05-11 | Issued NOL 2022-07-04 |
Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to extend the shelf lives of the drug substance and the adjuvant. The submission was reviewed and considered acceptable, and an NOL was issue. |
| Monthly safety report Control # 264258 |
2022-05-13 | Review completed 2022-06-15 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #3 for the period 2022-04-01 to 2022-04-30. The sponsor was asked to provide updated assessments for the ongoing monitoring of safety events. |
| Monthly safety report Control # 263401 |
2022-04-14 | Review completed 2022-05-26 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #2 for the period 2022-03-01 to 2022-03-31. The sponsor was asked to continue with the standard monitoring. |
| Monthly safety report Control # 262392 |
2022-03-15 | Review completed 2022-04-01 |
Information filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. Monthly safety report #1 for the period 2021-12-20 to 2022-02-28. The sponsor was asked to continue with the standard monitoring. |
| Drug product (DIN 02525364) market notification | Not applicable | Date of first sale: 2022-03-31 |
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 2022-02-23 |
Health Product Risk Communication posted (Distribution of Nuvaxovid with English-only Vial and Carton Labels), containing information about labelling, product safety and supply for healthcare professionals. |
| NDS # 255370 | 2021-08-27 | Issued NOC (subject to terms and conditions) 2022-02-17 |
NOC issued for New Drug Submission. Terms and conditions were imposed on the authorization. |
| Application # 248761 | 2021-01-29 | 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. |