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Vaxneuvance
Published
Product name
Vaxneuvance
Active ingredient
Pneumococcal 15-valent conjugate vaccine (CRM197 Protein)
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Vaxneuvance (pneumococcal 15-valent conjugate vaccine (CRM197 protein)) was approved for the following therapeutic use:
Vaxneuvance is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) in adults 18 years of age and older.
Vaxneuvance may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine .
The use of Vaxneuvance should be guided by official recommendations.
How this medicine works
Vaxneuvance contains serotype specific pneumococcal capsular polysaccharides each of which is conjugated to a carrier protein (CRM197), and elicits antibodies that enhance opsonisation, phagocytosis, and killing of pneumococci to protect against pneumococcal disease. Vaxneuvance is also expected to elicit a T cell dependent immune response. Carrier protein specific helper T cells support specificity, functionality and maturation of serotype specific B cells. Immune responses following natural exposure to S. pneumoniae or following pneumococcal vaccination can be determined through the measurements of opsonophagocytic activity (OPA) and immunoglobulin G (IgG) responses. OPA represents functional antibodies capable of opsonising pneumococcal capsular polysaccharides for presentation to phagocytic cells for engulfment and subsequent killing and are considered an important immunologic surrogate measure of protection against pneumococcal disease in adults. OPA titres are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. A validated multiplexed opsonophagocytic assay (MOPA) was used to measure serotype specific OPA titres for each of the 15 serotypes contained in Vaxneuvance.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing),nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Vaxneuvance was considered favourable for the therapeutic use approved.