ARTG Entry

VAXNEUVANCE

ARTG entry for VAXNEUVANCE (Pneumococcal purified capsular polysaccharides, Diphtheria CRM197 protein), ARTG 350791 — Product Information, dosage form,…

What it is

Vaxneuvance is a pneumococcal 15-valent conjugate vaccine (CRM197 protein), adsorbed, supplied as a 0.5 mL suspension for intramuscular injection in a pre-filled syringe.

Approved indications

— Prevention of pneumococcal disease in paediatric populations.

Key safety warnings

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Administration of pneumococcal conjugate vaccines should be postponed in individuals suffering from acute moderate or severe febrile illness. Pneumococcal conjugate vaccines should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration. Pneumococcal conjugate vaccines will not protect against Streptococcus pneumoniae serotypes other than those included in the vaccine nor other micro-organisms that cause invasive disease, pneumonia, or otitis media. As with any vaccine, a pneumococcal conjugate vaccine may not protect all individuals receiving the vaccine from pneumococcal disease.

Contraindications

Hypersensitivity to the active substances or to any of the excipients, or to diphtheria toxoid, and allergic reaction or anaphylactic reaction following prior administration of pneumococcal polysaccharide conjugate vaccine.

PBS listing

Vaxneuvance was recommended by PBAC in March 2023 for prevention of pneumococcal disease in paediatric populations, but the item was withdrawn in November 2024.

Regulatory history

Vaxneuvance was first listed on the ARTG on 17 January 2022. The product received a positive PBAC recommendation in March 2023 for prevention of pneumococcal disease in various paediatric populations, but this item was subsequently withdrawn in November 2024.

TGA Public Summary — ARTG 350791