CAPVAXIVE

What it is

CAPVAXIVE is a pneumococcal 21-valent conjugate vaccine containing 84 micrograms of pneumococcal purified capsular polysaccharide antigen (4 micrograms each of polysaccharide serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, deOAc15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) conjugated to approximately 65 mcg of diphtheria CRM 197 protein. CAPVAXIVE is available in 0.5 mL single-dose prefilled syringes.

Approved indications

— Prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults 18 years of age and older.

Dosing overview

CAPVAXIVE is administered as a 0.5 mL dose intramuscularly as one single dose in adults. For individuals previously vaccinated with one or more doses of other pneumococcal vaccines, a single dose of CAPVAXIVE should be administered, with the dosing interval after the last dose of the prior pneumococcal vaccine guided by official recommendations.

Key safety warnings

Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of CAPVAXIVE. No safety and immunogenicity data are available for CAPVAXIVE in immunocompromised individuals; based on experience with pneumococcal vaccines, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE. The safety and effectiveness of CAPVAXIVE in children younger than 18 years of age have not been established. This medicinal product is subject to additional monitoring in Australia, which will allow quick identification of new safety information.

Contraindications

CAPVAXIVE is contraindicated in individuals with a history of a severe allergic reaction (such as anaphylaxis) to the active substances, diphtheria toxoid or to any of the excipients.

Regulatory history

CAPVAXIVE was approved by the TGA on 2025-01-30. The vaccine was first listed on the Australian Register of Therapeutic Goods (ARTG 429290) on 2025-02-05.