FLUCELVAX

What it is

Flucelvax is a trivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures), suspension for injection containing Influenza virus haemagglutinin as active ingredient. It is a purified, inactivated, subunit influenza vaccine. Each 0.5 mL dose contains influenza virus surface antigens (haemagglutinin and neuraminidase) for the 2026 influenza season: A/Missouri/11/2025 (H1N1)pdm09-like virus 15 micrograms haemagglutinin, A/Sydney/1359/2024 (H3N2)-like virus 15 micrograms haemagglutinin, and B/Austria/1359417/2021-like virus 15 micrograms haemagglutinin. The antigens are propagated in Madin Darby Canine Kidney (MDCK) cells. Flucelvax does not contain egg proteins as eggs are not used in the manufacturing process.

Approved indications

— Prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine, in adults and children 6 months of age and older.

Dosing overview

Children aged 6 months to less than 9 years receive one or two 0.5 mL doses; if two doses are given, they must be administered at least 4 weeks apart. Children aged 9 to less than 18 years receive one 0.5 mL dose. Adults aged 18 years and older receive one 0.5 mL dose. Flucelvax should be administered by intramuscular injection only.

Key safety warnings

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration of the vaccine. Immunisation should be postponed in patients with febrile illness until the fever is resolved. In immunocompromised patients the antibody response may be lower, and a protective immune response may not be elicited in all vaccine recipients. If Guillain-Barré syndrome has occurred within 6 weeks of previous influenza vaccination, the decision to give Flucelvax should be based on careful consideration of the potential benefits and risks.

Contraindications

Flucelvax is contraindicated in individuals with known severe allergic reactions (such as anaphylaxis) to any component of the vaccine or a previous dose of any influenza vaccine.

PBS listing

Flucelvax was recommended by PBAC in March 2024 for prevention of influenza in patients aged 6 months and older.

Regulatory history

Flucelvax (trivalent formulation) was first listed on the ARTG on 10 July 2025. The PBAC recommended the medicine in March 2024 for the prevention of influenza in patients aged 6 months and older.