FluQuadri

What it is

FluQuadri is an inactivated quadrivalent influenza vaccine prepared from influenza viruses propagated in embryonated chicken eggs. The virus is chemically disrupted using a non-ionic surfactant, octoxinol-9 (Triton® X-100), producing a split virus. FluQuadri contains 60 micrograms of haemagglutinin per 0.5 mL dose in the recommended ratio of 15 micrograms of haemagglutinin of each of the four influenza strains. Neither antibiotics nor preservative are used during manufacture. FluQuadri is presented in prefilled syringes that are not made with natural rubber latex.

Approved indications

— Active immunisation against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. — Use in adults and children 6 months and older.

Dosing overview

Adults and children 6 months of age and older receive a 0.5 mL dose. For children who have not been adequately primed based on influenza vaccination history, a second dose should be administered approximately 4 weeks apart. Administration should be carried out by the intramuscular route.

Key safety warnings

Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration of the vaccine, especially for individuals who have a known allergy to egg protein. Patients with a history of Guillain-Barré Syndrome with an onset related in time to influenza vaccination may be at increased risk of again developing the syndrome. If Guillain-Barré Syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give FluQuadri should be based on careful consideration of the potential benefits and risks. Because any intramuscular injection can cause an injection-site haematoma in individuals with any bleeding disorder such as haemophilia or thrombocytopenia, or in individuals on anticoagulant therapy, intramuscular injections with FluQuadri should not be administered to such individuals unless the potential benefits outweigh the risk of administration. If the decision is made to administer any product by intramuscular injection to such individuals, it should be given with caution, with steps taken to avoid the risk of haematoma formation following injection. Syncope (fainting) has been reported following vaccination with FluQuadri. Procedures should be in place to prevent falling injury and manage syncopal reactions. Antibody responses to FluQuadri are lower in individuals 65 years of age and older than in younger adults. Adults aged 65 years and older are strongly recommended to receive either high-dose or adjuvanted influenza vaccine every year.

Contraindications

FluQuadri should not be administered to anyone with a known systemic hypersensitivity reaction, such as anaphylaxis, after previous administration of any influenza vaccine or to any component of the vaccine. Vaccination should be postponed in case of moderate or severe acute or febrile disease with or without fever, but a mild disease with low-grade fever is usually not a reason to postpone vaccination.

PBS listing

FluQuadri 60 micrograms in 0.5 mL suspension for injection is registered on the ARTG. The vaccine is listed on the National Immunisation Program for prevention of seasonal influenza in patients aged 65 years and over, at-risk children aged 6 months and older, and healthy children aged 6 months to less than 5 years.

Regulatory history

FluQuadri received initial ARTG registration on 2 December 2014. The Pharmaceutical Benefits Scheme Advice Committee recommended the vaccine in March 2018 for prevention of seasonal influenza in patients aged 65 years or older, finding it cost-effective on a cost-minimisation basis. In November 2019, the Committee recommended extending the National Immunisation Program listing to include at-risk children aged 6 months and older and healthy children aged 6 months to less than 5 years on a cost-minimisation basis. In November 2021, the Committee extended its recommendation for the 65 years and over listing for a further 12 months.