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PACP Committee Report

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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

Comirnaty

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

Comirnaty

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

Comirnaty

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

Comirnaty

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

Comirnaty

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

Comirnaty

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

Jcovden

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

Jcovden

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

Jcovden

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

Covifenz

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

Spikevax

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

Spikevax

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.

Nuvaxovid

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.

Nuvaxovid

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.

Nuvaxovid

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

Covishield

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.