Regulatory Decision Summary for VidPrevtyn Beta
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 Beta)
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
January 25, 2023
What was the purpose of this submission?
The purpose of this submission was to seek authorization of VidPrevtyn Beta for use as a booster for active immunisation to prevent COVID-19 in individuals older than 18 years of age who have previously received an mRNA or adenoviral vector COVID-19 vaccine.
What did the company submit to supports its submission?
The sponsor submitted quality, clinical and non-clinical data packages, as well as labelling information and a post-market Risk Management Plan.
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 in screening pending additional data from the sponsor. 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.