Regulatory Decision Summary for Covaxin (Health Canada)
Summary
This Health Canada Regulatory Decision Summary covers a New Drug Submission for Covaxin, filed 2022-02-14 under control number 254518. It states that no decision was issued: the company cancelled its submission on August 26, 2022. The submission sought authorization to prevent COVID-19 in people 18 and older and relied on a Phase 3 study whose efficacy analysis was based on 130 symptomatic cases. Health Canada says its review was nearing completion and it had identified deficiencies in the data that would have precluded approval, and that the sponsor chose to re-file later with more data. It expects no impact on patients using the Special Access Programme.
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Full text
Regulatory Decision Summary for Covaxin Review decision The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision. Product type: Drug Summary of Cancellation: COVAXIN (Whole virion, inactivated corona virus) Medicinal ingredient(s): Whole virion, inactivated corona virus Therapeutic area: Vaccines, for human use Type of submission: New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV) Control number: 254518 Overview Decision issued No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued. Date of cancellation August 26, 2022 What was the purpose of this submission? The submission is to seek authorization of Covaxin for the prevention of Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older. What did the company submit to support its submission? The sponsor submitted quality, pre-clinical and clinical components. The pivotal clinical safety and efficacy information were collected from a Phase 3 study (BBIL/BBV152-C/2020) (NCT04641481). The phase 3 study compared two doses of BBV152 (or Covaxin) to placebo to evaluate the efficacy, safety, and immunogenicity of the vaccine in adults ≥ 18 years of age. The primary efficacy endpoint analyses were based on the accrual of 130 virologically-confirmed (RT-PCR positive) symptomatic cases of COVID-19 post Dose 2 (+14 days). The data from 16,973 subjects in India were included in the per-protocol analysis. What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation? At the time of the cancellation, the review of the submission was nearing completion. Health Canada had identified some deficiencies in the data that would have precluded issuing an approval. The sponsor chose to cancel their submission in order to re-file at a later date with additional data. What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials? There is no expected impact for patients using SAP. Requests for special access to Covaxin will continue to be considered on a case-by-case basis. For more information about the Special Access Programme refer to the programme's web site: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas Additional information *Proposed Brand Name: Covaxin Date of decision: 2022-08-26 Manufacturer: Vaccigen Ltd. Drug Identification Numbers issued: - N/A Prescription status: Date filed: 2022-02-14 Contact: Office of Regulatory Affairs - Biologic and Radiopharmaceutical Drugs Directorate (ORA-BRDD) Date modified: 2026-10-15
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