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PREVNAR 20™ Indications and Usage (pneumococcal 20-valent conjugate vaccine)

1 INDICATIONS AND USAGE

Prevnar 20 is a vaccine indicated for active immunization for the prevention of pneumonia and invasive 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.

This indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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