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# FDA Approves Expanded Indication for Prevnar 13
- URL: https://www.fdaweb.com/fda-approves-expanded-indication-for-prevnar-13/
- Published: 2016-07-13T12:00:00.000Z
- Updated: 2026-09-14T21:14:04.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136174

FDA has approved a Pfizer BLA supplement for Prevnar 13 (pneumococcal 13-valent conjugate vaccine \[diphtheria CRM197 protein\]) for an expanded age indication to include adults 18 through 49 years of age for active immunization for preventing pneumonia and invasive disease caused by 13 *Streptococcus pneumoniae* serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Previously, the indication was for adults 50 years and older. “The expanded age indication now more closely aligns with the 2012 U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practices (ACIP) recommendations for adults 19 years of age and older with immunocompromising conditions (e.g., HIV, chronic renal failure, cancer), functional or anatomic asplenia (e.g., sickle cell disease), cerebral spinal fluid leak, and Cochlear implants,” the company says.