Regulatory Decision Summary for Fluad Quad
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: Fluad Quad
Medicinal ingredient(s):
Haemagglutinin-Strain A (H3N2)
Haemagglutinin-Strain B (Victoria)
Haemagglutinin-Strain B (Yamagata)
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
November 17, 2020
What was the purpose of this submission?
The purpose of this New Drug Submission was to seek market authorization for Fluad Quad, a quadrivalent adjuvanted inactivated influenza vaccine, for active immunization against influenza disease caused by subtypes contained in the vaccine. The proposed indication was for children aged ≥6 months to <72 months and for adults aged ≥65 years.
What did the company submit to support its submission?
The Sponsor submitted quality, non-clinical, clinical, and labelling components.
For the pediatric indication, the Sponsor submitted one Phase III trial comparing clinical efficacy, immunogenicity and safety of Fluad Quad with non-adjuvanted inactivated influenza vaccines in children aged ≥6 months to <72 months. Additional data from revaccination studies with Fluad Quad and clinical studies of Fluad were also provided as supporting information.
For the geriatric indication, the Sponsor submitted two pivotal studies. One Phase III trial compared clinical efficacy, immunogenicity and safety of Fluad Quad vs a non-influenza vaccine. A second Phase III clinical trial compared immunogenicity and safety of Fluad Quad vs Fluad in adults ≥65 years of age. Additional data from clinical studies and published data for Fluad in adults ≥65 years of age were also provided as supporting information.
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 the submission without prejudice to refile at a later date.
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 or in clinical trials.
Additional information
*Proposed Brand Name:
Fluad Quad