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Indications

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) is indicated for active immunization for the prevention of invasive disease and pneumonia 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.

This indication for the prevention of pneumonia caused by S. pneumoniae is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

CAPVAXIVE is indicated for active immunization for the prevention

CAPVAXIVE is indicated for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B,

Select Safety Information

Do not administer CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine, including diphtheria toxoid.

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.

The most commonly reported (>10%) solicited adverse reactions in individuals 18 to 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%).

The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).

Vaccination with CAPVAXIVE may not protect all vaccine recipients.

Before administering CAPVAXIVE, please read the accompanying Prescribing Information. The Patient Information also is available.

Do not administer CAPVAXIVE to individuals with a history of a severe

Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine, including diphtheria toxoid.

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.