PACP Committee Report
If you have any questions or comments regarding the accessibility of this publication, please contact us at accessible@parl.gc.ca.
APPENDIX B: SUPPLEMENTAL INFORMATIONFROM HEALTH CANADA
In response to a request at the hearing for additional information, the department provided the following response in a letter to the Committee.
Approval Timeline of Covid-19 Vaccines Authorized by Health Canada
Health Canada has been working diligently to review and approve COVID-19 vaccines in an expedited manner while ensuring their safety and efficacy. The Department has approved several COVID-19 vaccines, including those developed by AstraZeneca, BioNTech (Pfizer), Medicago, Janssen, Novavax, and Moderna. Additionally, the Department continues to monitor the safety and efficacy of COVID-19 vaccines after they are approved to ensure their long-term safety and effectiveness.
The review and approval of COVID-19 vaccines can be a complex and iterative process, and review times vary depending on several factors, including the type of vaccine, the stage of development, and the quality and timing of the data from clinical trials submitted to Health Canada. Furthermore, clinical trials conducted in the later stages of the pandemic generally tended to take longer given the additional time needed to recruit study participants. The table below (Table 1: List of COVID-19 vaccines authorized by Health Canada) outlines the information requested from the Committee organized by sponsor and the date by which an application was received by Health Canada.
More specifically on Medicago’s COVID-19 vaccine submission, the initial request through Health Canada’s temporary interim order (IO) pathway was filed on April 19, 2021, indicating that additional scientific data would only become available in September 2021.
Medicago was able to continue with their submission and provided the final data once it became available on December 15, 2021, which included clinical study reports for the phase 3 trial, the draft product monograph, and draft risk management plan. Health Canada was then able to complete its review and a Notice of Compliance for the product was issued on February 24, 2022.
Table 1—List of COVID-19 vaccines authorized by Health Canada
Authorization holder |
Brand name, proper name or common name |
Date filed |
Date of authorization or expanded indication |
Total Duration in days |
Authorization or expanded indication |
|
AstraZeneca Canada Inc |
Vaxzevria ChAdOx1-S (recombinant) solution for injection |
2020-10-01 |
2021-02-26 |
148 |
Vaccine for adults 18 and over authorized under an Interim Order |
|
AstraZeneca Canada Inc |
Vaxzevria ChAdOx1-S (recombinant) solution for injection |
2021-06-14 |
2021-11-19 |
158 |
Vaccine for adults 18 and over authorized under the Food and Drug Regulations. |
|
BioNTech Manufacturing GmbH |
Tozinameran (mRNA vaccine, BNT162b2) suspension for injection |
2020-10-09 |
2020-12-09 |
61 |
Vaccine for adults 16 and over authorized under an Interim Order |
|
BioNTech Manufacturing GmbH |
Comirnaty Tozinameran (mRNA vaccine, BNT162b2) suspension for injection |
2021-04-16 |
2021-05-05 |
19 |
Pediatric indication (ages 12–15 years) authorized under an Interim Order |
|
BioNTech Manufacturing GmbH |
Tozinameran (mRNA vaccine, BNT162b2) suspension for injection |
2021-06-10 |
2021-09-16 |
98 |
Vaccine for adults 12 and over authorized under the Food and Drug Regulations. |
|
BioNTech Manufacturing GmbH |
Tozinameran (mRNA vaccine, BNT162b2) suspension for injection |
2021-10-01 |
2021-11-09 |
39 |
First booster dose 18 and over authorized under the Food and Drug Regulations. |
|
BioNTech Manufacturing GmbH |
Tozinameran (mRNA vaccine, BNT162b2) suspension for injection |
2021-10-18 |
2021-11-19 |
32 |
Pediatric indication (ages 5–11 years) authorized under the Food and Drug Regulations. |
|
BioNTech Manufacturing GmbH |
Tozinameran (mRNA vaccine, BNT162b2) suspension for injection |
2021-02-23 |
2022-06-01 |
463 |
First booster dose (ages 16–17 years) authorized under the Food and Drug Regulations. |
|
BioNTech Manufacturing GmbH |
Tozinameran (mRNA vaccine, BNT162b2) suspension for injection |
2022-05-27 |
2022-08-19 |
84 |
First booster dose (ages 5–11 years) authorized under the Food and Drug Regulations. |
|
BioNTech Manufacturing GmbH |
Comirnaty Tozinameran (mRNA vaccine, BNT162b2) suspension for injection |
2022-06-23 |
2022-09-09 |
78 |
Pediatric indication (ages 6 months-5 years) authorized under the Food and Drug Regulations. |
|
BioNTech Manufacturing GmbH |
Comirnaty Original/Omicron BA.1 Tozinameran, riltozinameran suspension for injection |
2022-07-22 |
2022-10-21 |
91 |
Bivalent booster (ages 12 years and over) authorized under the Food and Drug Regulations. |
|
BioNTech Manufacturing GmbH |
Comirnaty Original & Omicron BA.4/BA.5 Tozinameran, famtozinameran suspension for injection |
2022-09-02 |
2022-10-07 |
35 |
Bivalent booster (ages 12 years and over) authorized under the Food and Drug Regulations. |
|
BioNTech Manufacturing GmbH |
Comirnaty Original & Omicron BA.4/BA.5 Tozinameran, famtozinameran suspension for injection |
2022-10-18 |
2022-12-09 |
52 |
Bivalent booster (ages 5–11 years) authorized under the Food and Drug Regulations. |
|
Janssen Inc |
AD26.COV2.S (recombinant) suspension for injection |
2020-11-30 |
2021-03-05 |
95 |
Vaccine for adults 18 and over authorized under an Interim Order |
|
Janssen Inc |
AD26.COV2.S (recombinant) suspension for injection |
2021-06-14 |
2021-11-23 |
162 |
Vaccine for adults 18 and over authorized under the Food and Drug Regulations. |
|
Janssen Inc |
AD26.COV2.S (recombinant) suspension for injection |
2021-12-17 |
2022-05-11 |
145 |
First booster dose authorized under the Food and Drug Regulations. |
|
Medicago Inc |
Virus-like particles (VLP) of SARS- CoV-2 spike protein emulsion for injection |
2021-08-09* |
2022-02-24 |
199 |
Vaccine for adults 18 and over authorized under the Food and Drug Regulations. |
|
ModernaTX, Inc |
Spikevax Elasomeran suspension for injection |
2020-10-12 |
2020-12-23 |
72 |
Vaccine for adults 18 and over authorized under an Interim Order |
|
ModernaTX, Inc |
Spikevax Elasomeran suspension for injection |
2021-06-04 |
2021-08-27 |
84 |
Pediatric indication (ages 12–17 years) authorized under an Interim Order |
|
ModernaTX, Inc |
Spikevax Elasomeran suspension for injection |
2021-06-15 |
2021-09-16 |
93 |
Vaccine for adults 12 and over authorized under the Food and Drug Regulations. |
|
ModernaTX, Inc |
Elasomeran suspension for injection |
2021-10-06 |
2021-11-12 |
37 |
First booster dose (ages 18 years and older) authorized under the Food and Drug Regulations. |
|
ModernaTX, Inc |
Elasomeran suspension for injection |
2021-11-16 |
2022-03-17 |
121 |
Pediatric indication (ages 6–11 years) authorized under the Food and Drug Regulations. |
|
ModernaTX, Inc |
Spikevax Elasomeran suspension for injection |
2022-03-16 |
2023-01-12 |
302 |
First booster dose (ages 12–17 years) authorized under the Food and Drug Regulations. |
|
ModernaTX, Inc |
Spikevax Elasomeran suspension for injection |
2022-04-29 |
2022-07-14 |
76 |
Pediatric indication (ages 6 months–5 years) authorized under the Food and Drug Regulations. |
|
ModernaTX, Inc |
Spikevax Bivalent Elasomeran, imelasomeran dispersion for injection |
2022-06-30 |
2022-09-01 |
63 |
Bivalent booster (ages 18 years and over) authorized under the Food and Drug Regulations. |
|
ModernaTX, Inc |
Spikevax Bivalent (Original / Omicron BA.4/5) Elasomeran, davesomeran dispersion for injection |
2022-09-12 |
2022-11-03 |
52 |
Bivalent booster (ages 18 years and over) authorized under the Food and Drug Regulations. |
|
Novavax Inc. |
SARS-CoV-2 recombinant spike protein suspension for injection |
2021-08-27* |
2022-02-17 |
174 |
Vaccine for adults 18 and over authorized under the Food and Drug Regulations. |
|
Novavax Inc. |
SARS-CoV-2 recombinant spike protein suspension for injection |
2022-06-21 |
2022-12-06 |
168 |
Adolescent dose (ages 12–17 years) authorized under the Food and Drug Regulations. |
|
Novavax Inc. |
SARS-CoV-2 recombinant spike protein suspension for injection |
2022-08-05 |
2022-11-17 |
104 |
First booster dose authorized under the Food and Drug Regulations. |
|
Verity Pharmaceuticals Inc/Serum Institute of India |
ChAdOx1-S (recombinant) solution for injection |
2021-01-23 |
2021-02-26 (expired 2021‑09-16) |
34 |
Vaccine for adults 18 and over authorized under an Interim Order |
|
*Note: On the Auditor General of Canada’s Report 9 on COVID-19 Vaccines, Exhibit 9.1—Health Canada expedited its processes for vaccine authorization during the COVID-19 pandemic, the dates listed in the exhibit represent the filing dates made by Novavax and Medicago under the Interim Order (IO). These submissions were not approved under the IO, and are thus not represented in this table, which only lists submissions that were approved.