Panvax

What it is

Panvax H5N8 pre-pandemic is a pandemic influenza vaccine (split virion, inactivated) suspension for injection containing influenza virus haemagglutinin as the active ingredient. The vaccine is a purified, inactivated, monovalent, split virion vaccine containing antigen of the A/Astrakhan/3212/2020 (H5N8)-like virus at 30 microgram HA per 0.5 mL dose. Panvax H5N8 pre-pandemic vaccine is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. The virus is harvested from the eggs, purified, inactivated with beta-propiolactone and disrupted with sodium taurodeoxycholate to produce split virion particles which are further purified prior to formulation with aluminium phosphate adjuvant.

Approved indications

— Active immunisation in persons from 6 months of age, to prevent influenza disease caused by the influenza A virus.

Dosing overview

Two 0.5 mL doses, 21 days apart. The vaccine should be administered by intramuscular injection.

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. Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues such as eggs, chicken protein, neomycin or polymyxin B sulfate. Antibody response in patients with endogenous or iatrogenic immunosuppression may be diminished. If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection. Influenza vaccines may impair the metabolism of warfarin, theophylline, phenytoin, phenobarbitone and carbamazepine by the hepatic P450 system, though results from studies have shown conflicting evidence or found no evidence of an interaction, with variable degree of interaction and time after vaccination, and the interaction may be idiosyncratic.

Contraindications

History of an anaphylactic (life-threatening) reaction to any of the constituents or trace residues (such as eggs and chicken protein) of this vaccine. However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.

Regulatory history

Panvax H5N8 pre-pandemic (ARTG 421511) was first listed on 2023-10-06.