Aujemflu (influenza virus haemagglutinin)
Aujemflu is approved for active immunisation against influenza in persons 50 years of age and older. Aujemflu Trivalent influenza vaccine contains the active ingredient influenza virus haemagglutinin.
Aujemflu is an adjuvanted, cell-based vaccine approved to help prevent certain types of influenza or ‘flu’. Australian healthcare professionals can give the vaccine to people aged 50 years and older.
Influenza is a respiratory infection caused by the flu virus. It is very contagious. It usually spreads from one person to another by small droplets from coughs and sneezes. The virus enters the nose or throat and may spread to the lungs. Influenza infection can lead to serious illness.
Aujemflu, given as an intramuscular (IM) injection, helps prevent infection from the influenza virus and control the spread of the disease. As influenza strains can change every year, previous influenza vaccinations provide limited protection against new strains. Subsequently, updated flu vaccines are recommended each year to help lower the risk of catching the ‘flu’, especially for people at a higher risk due to age or certain medical conditions.
Aujemflu is an adjuvanted, cell-based influenza vaccine that contains 3 inactive strains (trivalent) of the influenza virus; 2 influenza A subtypes and one influenza B type. Inactivated vaccines are a type of vaccine where the viruses have been killed or are ‘inactive’ and therefore cannot spread or cause disease.
Aujemflu works by triggering your body to produce an immune response against the 3 types of influenza virus strains included in the vaccine. After vaccination, the body recognises haemagglutinin and neuraminidase – proteins found on the surface of the influenza viruses - and produces specific antibodies in the blood that help fight the virus. It usually takes 2-3 weeks after vaccination to develop protection against influenza.
The adjuvant in Aujemflu, called MF59, boosts the body’s protection by increasing the strength, breadth and persistence of the immune response over the course of the influenza season, compared with non-adjuvanted influenza vaccines. Most people who receive the vaccine will produce enough antibodies against the influenza virus included in the vaccine. However, as with all vaccines, 100% protection cannot be guaranteed.
Aujemflu only protects against the influenza strains used to make the vaccine. It does not protect against other influenza strains or other infections that can cause flu-like symptoms, such as the common cold.
The effectiveness and safety of Aujemflu were assessed in one main clinical study and 3 supporting studies using the comparable aQIVc vaccine whose manufacturing process is the same, and composition is similar, to Aujemflu.
The main study, Study V201_03, was a Phase 3, global multicentre study conducted during the 2023 – 2024 Northern Hemisphere influenza season. Almost 7,700 participants aged 50 years and older received either:
- aQIVc (similar to Aujemflu),
- adjuvanted Quadrivalent Influenza Vaccine (aQIV) or
- quadrivalent recombinant seasonal influenza vaccine (QIVr).
Immunogenicity, the medicines’ ability to effectively produce an immune response, and safety were assessed 28 days post-vaccination, by measuring antibody levels in the blood, and through participant reporting of serious and non-serious adverse events (side effects or unexpected outcomes). Immune response persistence and serious adverse events were also assessed for one year after vaccination in a subset of participants.
Three Phase 2 supporting studies also tested the safety and effectiveness of aQIVc, in adults over 50 years of age.
Key findings from clinical studies
- The study vaccine, aQIVc, induced an immune response that was superior to the responses induced by aQIV 28 days after vaccination in adults 50 years of age and older.
- The immunogenicity results for aQIVc were similar for high-risk subjects compared with the healthy study population.
- Participants who received the study vaccine, aQIVc, had higher antibody levels in their blood at one-year post-vaccination compared to those who received aQIV for the 3 types of flu included in the vaccine.
- The Phase 2 studies demonstrated the addition of the MF59 adjuvant to the cell-based non-adjuvanted influenza vaccine improved the immune response in subjects 50 years of age and older.
- In the clinical studies, all vaccine formulations were well-tolerated, with no safety concerns identified.
- Common, mild to moderate side effects included local reactions at the injection site including redness, pain or swelling, feeling tired, headaches, muscle or joint pain, nausea and fever.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Aujemflu and the medicine can be registered in Australia.
More detailed information on why the TGA approved Aujemflu will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
Australian CMIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
Australian PIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
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