Regulatory Decision Summary for VidPrevtyn
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:
Summary of Cancellation: SARS-CoV-2 prefusion spike delta TM protein, recombinant (*VidPrevtyn)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
February 27, 2023
What was the purpose of this submission?
The purpose of this submission was to seek authorization as primary series for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 18 years of age and older.
What did the company submit to supports its submission?
- Information and data concerning the manufacture and control of the drug substance and drug product were provided.
- The non-clinical content in package 1 consisted of 4 pharmacology studies (CoV2-02-Ms, CoV2 03-MS, CoV2-01-NHP, CoV2-04-NHP, CoV2-02-Hm) and 2 toxicology studies (5003471, 5003591).
- The clinical content consisted of:
- Study VAT00001: Phase 1/2, first-in-human, randomized, parallel group, placebo controlled, modified double-blind (observer-blind), dose-ranging,multi-center study with a Sentinel Safety Cohort and Early Safety Data Review (ESDR);
- Study VAT00002: Phase 2, randomized, modified double-blind, multi-center, dose finding study evaluating the safety, reactogenicity, and immunogenicity of 2 injections of 3 different antigen doses of CoV2 preS dTM-AS03 administered 21 days apart by IM;
Of note, Study VAT00008, the Phase 3 pivotal clinical trial was not submitted, and was pending.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
At the time of the cancellation, the review of the submission was ongoing and no decision or recommendations had been made. The sponsor chose to cancel their submission without prejudice 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 accessing the drug using SAP. In Canada, there are several marketed vaccine products that target COVID-19 disease. All marketed alternatives must be ruled out to be clinically essential under SAP.