Celldemic

What it is

Celldemic is indicated for active immunisation against the H5 subtype of Influenza A virus in persons from 6 months of age and older. Celldemic is a new cell-based, adjuvanted influenza zoonotic vaccine.

Approved indications

— Active immunisation against the H5 subtype of Influenza A virus in persons from 6 months of age and older.

Key safety warnings

Appropriate medical treatment and supervision should always be readily available in the event of severe allergic reaction or anaphylactic reaction following administration. Each dose may contain traces of formaldehyde, ovalbumin, and octoxinol-9, which are used during vaccine production, and caution should be exercised when the vaccine is administered to individuals with hypersensitivity to any components of the vaccine including manufacturing residuals. Recurrence of Guillain-Barré syndrome (GBS) has been temporally associated with the administration of influenza vaccine, and if GBS has occurred within 6 weeks of any previous influenza vaccination, the decision to give the vaccine 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 thrombocytopaenia, or in individuals on anticoagulant therapy, intramuscular injections should not be administered to such individuals unless the potential benefits outweigh the risk of administration, and if the decision is made to administer it should be given with caution, with steps taken to avoid the risk of haematoma formation following injection. Vaccination should be postponed in case of a moderate or severe acute disease with or without fever; however, a mild disease should not usually be a reason to postpone vaccination.

Contraindications

Celldemic 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

Celldemic was approved by the TGA on 30 May 2025. Celldemic Pre-pandemic Influenza Vaccine H5N1 was first listed on the ARTG on 11 June 2025 under licence category RE.