On Jul. 12, 2016, Pfizer announced that Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received U.S. Food and Drug Administration (FDA) approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older, for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes.

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. This is in addition to recommendations set forth by ACIP in 2014 for adults 65 years and older.

The FDA’s decision to approve the label expansion followed the submission and review of data from an open-label, Phase 3 trial of Prevnar 13 in adults who were not previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine (PPSV23). The study, which was published in Vaccine in October 2015, compared the immunogenicity, safety, and tolerability of Prevnar 13 in adults age 18 to 49 years with adults age 60 to 64, for whom Prevnar 13 was already approved.