We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Flucelvax Quad
Published
Product name
Flucelvax Quad
Active ingredient
Quadrivalent influenza vaccine (surface antigen, inactivated)
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Flucelvax Quad (quadrivalent influenza vaccine, surface antigen, inactivated) was approved for the following therapeutic use:
For the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine. The vaccine is indicated for use in adults and children 9 years of age and older.
For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.
How this medicine works
Influenza illness and its complications follow infection with influenza viruses. Global surveillance and analysis of influenza virus isolates permits identification of yearly antigenic variants. Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus. In some human studies, antibody titres of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects. Antibody against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.Annual revaccination with current influenza vaccines is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus may change from year to year.
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 Flucelvax Quad was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- 341450, 319093
- 341450, 319093