Product Dossier
VAXIGRIP
Product Dossier for VAXIGRIP (Influenza virus haemagglutinin, Sanofi-Aventis). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Sanofi-Aventis
- Active ingredient: Influenza virus haemagglutinin
- Therapeutic area: Infectious Disease
- Related brand: Audenz
- Related brand: Celldemic
- Related brand: INFLUVAC
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
Vaxigrip is an inactivated trivalent influenza vaccine, split virion, formulated to contain three influenza strains: A/Missouri/11/2025 (H1N1)pdm09-like strain, A/Singapore/GP20238/2024 (H3N2)-like strain, and B/Austria/1359417/2021-like strain, each at 15 micrograms haemagglutinin per 0.5 mL dose. The strains are propagated in fertilised hens' eggs from healthy chicken flocks and conform to annual requirements of the Australian Influenza Vaccine Committee and World Health Organisation recommendations for the 2026 season. The vaccine is supplied as a suspension for injection in a pre-filled syringe.
Approved indications Vaxigrip is indicated for:
— Active immunisation of adults, including pregnant women, for the prevention of influenza disease caused by the two influenza A virus subtypes and the one influenza B virus type contained in the vaccine. — Active immunisation of children from 6 months of age and older for the prevention of influenza disease caused by the two influenza A virus subtypes and the one influenza B virus type contained in the vaccine. — Passive protection of infants from birth to less than 6 months of age following vaccination of pregnant women.
Dosing overview
Individuals from 9 years of age receive a single 0.5 mL injection. Children from 6 months to 8 years of age receive either two 0.5 mL injections at least one month apart if not previously vaccinated, or a single 0.5 mL injection if previously vaccinated. For infants younger than 6 months of age, a single 0.5 mL injection given to pregnant women may provide passive protection. Given antigenic variation in circulating influenza viruses and the duration of immunity provided by the vaccine, annual vaccination at the beginning of the risk period is recommended.
Key safety warnings
Vaxigrip should under no circumstances be administered intravenously. Individuals with egg allergy, including a history of anaphylaxis, can be safely vaccinated with influenza vaccines, with guidance available in the current Immunisation Handbook. Patients with a history of Guillain-Barré Syndrome may be at increased risk of developing the syndrome again, and if GBS has occurred within 6 weeks of previous influenza vaccination, the decision to give Vaxigrip should be based on careful consideration of potential benefits and risks. If Vaxigrip is administered to immunocompromised individuals, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy, they may have a reduced immune response to vaccination, with current recommendations available in the Immunisation Handbook. The vaccine should be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following intramuscular administration. Vaccination with Vaxigrip may not protect 100% of recipients, and influenza vaccines are not effective against all possible strains, with protection limited to strains from which the vaccine is prepared or to closely related strains.
Contraindications
Vaxigrip should not be given to individuals with a history of severe allergic reaction to any component of the vaccine or after previous administration of Vaxigrip or a vaccine containing the same components. Vaccination should be postponed in case of moderate or severe febrile or acute disease.
Regulatory history
Vaxigrip was first listed on the ARTG on 2025-11-05 as an inactivated trivalent influenza vaccine suspension for injection. The TGA approved Vaxigrip Tetra, a related quadrivalent formulation, for registration on 15 May 2019, with indication for active immunisation of adults and children from 6 months of age and older for prevention of influenza disease. In November 2017, the PBAC recommended a change to the PBS listing to allow quadrivalent influenza vaccine to be used for prevention of influenza in individuals aged 6 months and older.