FLUZONE

What it is

Fluzone High-Dose Quadrivalent is an inactivated quadrivalent influenza vaccine, split virion. It contains 240 micrograms of influenza virus haemagglutinin per 0.7 mL dose in the recommended ratio of 60 micrograms of each of four strains: A/Victoria/4897/2022 (H1N1)pdm09-like strain, A/Croatia/10136RV/2023 (H3N2)-like strain, B/Austria/1359417/2021-like strain, and B/Phuket/3073/2013-like strain. Fluzone High-Dose Quadrivalent is prepared from influenza viruses propagated in embryonated chicken eggs and inactivated with formaldehyde, then chemically disrupted to produce a split virus. Fluzone High-Dose Quadrivalent is presented in prefilled syringes that are not made with natural rubber latex.

Approved indications —

Active immunisation for the prevention of influenza disease in persons 60 years of age and older.

Dosing overview

The recommended dosage of Fluzone High-Dose Quadrivalent is one dose of 0.7 mL, administered annually, in persons 60 years of age and older. Administration should be carried out by intramuscular route, preferably in the deltoid muscle.

Key safety warnings

Prior to any vaccine injection, all known precautions should be taken to prevent hypersensitivity reactions, including a review of the individual's prior vaccination history with respect to possible hypersensitivity to the vaccine or similar vaccines. Appropriate medical treatment and supervision should always be readily available in the event of severe allergic reaction or anaphylactic reaction following administration. Individuals with egg allergy of any severity may be vaccinated. Individuals who report having had a severe allergic reaction or anaphylaxis to egg should have the influenza vaccine administered in an inpatient or outpatient medical setting, and vaccine administration should be supervised by a healthcare provider who is able to manage severe allergic reactions. Recurrence of Guillain-Barré syndrome has been temporally associated with the administration of influenza vaccine. If Guillain-Barré syndrome has occurred within six weeks of any previous influenza vaccination, the decision to give Fluzone High-Dose Quadrivalent should be based on careful consideration of the potential benefits and risks. The immunogenicity of Fluzone High-Dose Quadrivalent may be reduced by immunosuppressive treatment or in individuals with immune deficiency syndromes. In such cases it is recommended to postpone the vaccination until after the immunosuppressive treatment or resolution of the immunosuppressive condition, if feasible. Vaccination of individuals with chronic immunodeficiencies is recommended even though the antibody response may be limited. Because any intramuscular injection can cause an injection-site haematoma in individuals with any bleeding disorder such as haemophilia or thrombocytopaenia, or in individuals on anticoagulant therapy, intramuscular injections with Fluzone High-Dose Quadrivalent should not be administered to such individuals unless the potential benefits outweigh the risk of administration. If the decision is made to administer the 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.

Contraindications

Fluzone High-Dose Quadrivalent is contraindicated in anyone with a history of severe allergic reaction after previous administration of any influenza vaccine or to any component of the vaccine.

Regulatory history

Fluzone High-Dose Quadrivalent was first listed on the ARTG on 31 July 2020. The TGA approved Fluzone High-Dose Quadrivalent on 30 July 2020 for active immunisation for the prevention of influenza disease. The vaccine is specifically indicated for use in persons 65 years of age and older and was designed to enhance immune responses through higher haemagglutinin antigen content, aiming to reduce disease burden in a population known for lower protective immunity from standard vaccines.