Regulatory Decision Summary for CHADOX1-S [RECOMBINANT] (VAXZEVRIA)
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: CHADOX1-S [RECOMBINANT] (VAXZEVRIA)
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
March 31, 2022
What was the purpose of this submission?
The purpose of the submission was the addition of a booster dose of 0.5 mL administered at least 6 months after the second dose, in individuals who previously received a 2-dose primary vaccination course with VAXZEVRIA.
What did the company submit to support its submission?
The company submitted clinical supporting data in addition to labelling components.
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 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 or through enrollment in clinical trials.
Additional information
*Proposed Brand Name:
Vaxzevria
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| VAXZEVRIA | 02510847 | ASTRAZENECA CANADA INC | CHADOX1-S [RECOMBINANT] 50000000000 VP / 0.5 ML |