Afluria Quad

What it is

Afluria Quad is an inactivated quadrivalent influenza vaccine (split virion) suspension for injection, containing influenza virus haemagglutinin as active ingredient. It is a purified, inactivated, split virion (split virus) vaccine. Each 0.5 mL dose contains 15 micrograms haemagglutinin for each of four influenza virus strains: A/Victoria/4897/2022 (H1N1)pdm09-like virus, A/Croatia/10136RV/2023 (H3N2)-like virus, B/Austria/1359417/2021-like virus, and B/Phuket/3073/2013-like virus. The vaccine is prepared from virus grown in the allantoic cavity of embryonated eggs, purified by zonal centrifugation, inactivated by propiolactone and disrupted by sodium taurodeoxycholate.

Approved indications

— Prevention of influenza caused by influenza virus, Types A and B contained in the vaccine, in persons aged 5 years and over.

Dosing overview

For children aged 5 to less than 9 years, the dose is 0.5 mL, with either one or two doses depending on previous vaccination history. Previously unvaccinated children in this age group should be given two doses at least four weeks apart. For children and adolescents aged 9 to less than 18 years, and for adults aged 18 years and over, the dose is 0.5 mL as a single dose. Immunisation should be undertaken in anticipation of seasonal outbreaks of influenza.

Key safety warnings

Appropriate medical treatment and supervision should always be available to manage the rare event of an anaphylactic reaction following administration of the vaccine, and adrenaline should always be ready for immediate use whenever any injection is given. Persons with a history of anaphylaxis to egg should be vaccinated only in medical facilities with staff experienced in recognising and treating anaphylaxis. Immunisation should be postponed in patients with acute febrile illness until the fever is resolved. In immunocompromised patients the antibody response may be lower. If Guillain-Barré syndrome has occurred within 6 weeks of previous influenza vaccination, the decision to give Afluria Quad vaccine should be based on careful consideration of the potential benefits and risks. In adults aged 18 to less than 65 years, the most commonly reported injection-site adverse reaction is pain (≥ 40 per cent), and the most common systemic adverse events are myalgia and headache (≥ 20 per cent). In children aged 5 to less than 18 years, the most common injection site reactions are pain (51.4 per cent), redness (17.1 per cent), and induration/swelling (13.8 per cent); the most common solicited systemic adverse events are headache (15.5 per cent) and myalgia (13.1 per cent).

Contraindications

Afluria Quad vaccine is contraindicated in children less than 5 years of age because the safety and efficacy in this age group has not been evaluated. Afluria Quad vaccine is contraindicated in individuals who have previously experienced anaphylaxis following a dose of any influenza vaccine, or anaphylaxis following exposure to any component of the vaccine, excluding egg protein.

Regulatory history

Afluria Quad was first listed on the ARTG on 22 July 2016 (ARTG 262428) as an inactivated quadrivalent influenza vaccine in a pre-filled syringe with attached needle. A needle-free variant (ARTG 294907) was first listed on 9 January 2018. On 1 February 2018, the TGA approved the extension of indications for Afluria Quad to include paediatric use for persons aged 5 years and over. In November 2017, the PBAC recommended an amendment to the PBS listing to allow quadrivalent influenza vaccine to be used for the prevention of influenza in individuals aged 6 months and older.