Regulatory Decision Summary for Afluria Tetra

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:


Medicinal ingredient(s):

Quadrivalent Inactivated Influenza Vaccine (Split Virion)

Therapeutic area:

Active Immunizing Agent

Type of submission:

New Drug Submission (NDS)

Control number:

What was the purpose of this submission?


The intent of this New Drug Submission (NDS) was to seek market authorisation of Afluria Tetra, a quadrivalent inactivated vaccine (QIV). The approved indication for Afluria Tetra is active immunization of adults and children aged 5 years or older for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine.


Why was the decision issued?


Afluria Tetra was evaluated in two clinical trials in subjects 5 years of age and older.

In adults aged ≥18 years in Study QIV 01, Afluria Tetra (quadrivalent, QIV) showed non-inferior immunogenicity for matched vaccine strains to trivalent formulations of Afluria (trivalent, TIV). Additionally, the immune responses were superior for Afluria QIV to the results for the alternate (non-included) influenza B strains for the TIV comparators. There were no efficacy studies for Afluria QIV. However, it is anticipated that the clinical efficacy of Afluria QIV will be similar to that demonstrated for Afluria TIV. In a study in adults 18 to <65 years of age, the efficacy of Afluria TIV for the prevention of laboratory-confirmed infection due to vaccine-matched strains was 60%.

In children and adolescents 5 to <18 years of age in Study QIV 02, Afluria QIV showed non-inferior immunogenicity to the comparator QIV (Fluarix Tetra). Although Fluarix Tetra is not approved in Canada, it is similar to an approved vaccine (FluLaval Tetra), in terms of immunogenicity and safety profiles. In addition, efficacy data are available for the comparator (Fluarix Tetra) and FluLaval Tetra in children, with efficacy against laboratory-confirmed influenza ranging from 50% to 63%. It is anticipated that the clinical efficacy of Afluria QIV would be similar to that observed for the comparator QIV in children.

Study results showed that the safety profile of Afluria Tetra was similar to the comparator vaccines. Afluria Tetra has a clinically acceptable safety and tolerability profile in subjects 5 years and older.

Overall, given the efficacy (as inferred from the immunogenicity data for Afluria Tetra) against a potentially serious and life-threatening disease, it is reasonable to conclude that the benefits of Afluria Tetra outweigh known and expected risks in subjects 5 years and older.


Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.