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Prevenar 20
Published
Product name
Prevenar 20
Active ingredient
Pneumococcal purified capsular polysaccharides
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Prevenar 20 (pneumococcal purified capsular polysaccharides) was approved for the following therapeutic use:
Active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.
Prevenar 20 may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine.
Prevenar 20 should be used in accordance with official recommendations.
How this medicine works
Prevenar 20 contains 20 pneumococcal capsular polysaccharides all conjugated to a cross reacting material CRM197 carrier protein, which modifies the immune response to the polysaccharide from a T-cell independent response to a T-cell dependent response. The T-cell dependent response leads to both an enhanced antibody response and generation of memory B-cells, allowing for an anamnestic (booster) response on re-exposure to the bacteria.
Vaccination with Prevenar 20 induces serum antibody production and immunologic memory against the serotypes contained within the vaccine.
Protection against pneumococcal disease is conferred mainly by opsonophagocytic killing of Streptococcus pneumoniae. Prevenar 20 generates functional antibodies as measured by opsonophagocytic activity (OPA). An opsonic antibody titre that is predictive of protection against invasive pneumococcal disease or pneumococcal pneumonia has not been established.
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 Prevenar 20 was considered favourable for the therapeutic use approved.
Sponsor