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Fluad Quad

Published
Product name
Fluad Quad
Active ingredient
Inactivated quadrivalent influenza vaccine (surface antigen)
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for

Fluad Quad (inactivated quadrivalent influenza vaccine (surface antigen)) was approved for the following therapeutic use:

Active immunisation against influenza in persons 65 years of age and older.

How this medicine works

Fluad Quad provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine. Fluad Quad has been shown to evoke antibody responses to the viral surface glycoproteins, haemagglutinin and neuraminidase. These antibodies provide protection against clinical illness in a high proportion of vaccine recipients. The antibody response to Fluad Quad is similar to Fluad which is increased when compared to the response to vaccines without adjuvant, and is most pronounced for A/H3N2 influenza antigens. This increased response is even more pronounced in subjects 65 years of age and older. The inclusion of the second B strain in Fluad Quad also provides additional benefit compared to Fluad. The adjuvant MF59 broadens the overall immune response allowing the vaccine to offer greater protection against heterologous strains of the virus. This may be important when there is a mismatch between the virus strains included in the vaccine and the strains circulating in the community. The antibody response is increased when compared to the response to non adjuvanted inactivated influenza vaccine. This increased response is seen particularly in elderly subjects with low pre-immunisation titres and/or with underlying diseases (diabetes, cardiovascular and respiratory diseases) who are at increased risk of complications of influenza infection.

Why the TGA approved or did not approve this medicine

The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Fluad Quad was considered favourable for the therapeutic use approved.