Available information for COMIRNATY - Submission control number 252736
From Health Canada
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Submission information
- Submission control number:
- 252736
- Brand name:
- COMIRNATY
- Manufacturer:
- BIONTECH MANUFACTURING GMBH
- Ingredients:
- TOZINAMERAN
- Health Canada regulatory activity:
- NDS-NAS
- Health Canada regulatory decision:
- NOC
- Health Canada regulatory decision date:
- 2021-09-16
- Health Canada public release date:
- 2022-02-02
Submission archive
Study documents
1.0.7 General Note to Reviewer
2.5 Clinical Overview
2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
2.7.3 Summary of Clinical Efficacy
2.7.4 Summary of Clinical Safety
5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
C4591001 - A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-CoV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
BNT162-01 - A Multi-Site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-19 Using Different Dosing Regimens in Healthy Adults
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