FDA Expands Use of Prevnar 13 Pneumonia Vaccine

Label now includes adults 18 through 48 years of age

Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein], Pfizer) has received 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 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is the only pneumococcal vaccine approved across the lifespan.

With the FDA’s decision, Prevnar 13 is now approved for:

  • Adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 S. pneumoniae strains in the vaccine
  • Children 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive disease caused by 13 S. pneumoniae strains in the vaccine

According to Pfizer, the expanded age indication now more closely aligns with the 2012 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., human immunodeficiency virus [HIV] infection, chronic renal failure, and cancer), functional or anatomic asplenia (e.g., sickle cell disease), cerebral spinal fluid leak, and cochlear implants. This is in addition to recommendations issued by the ACIP in 2014 for adults 65 years of age 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 18 to 49 years of age with that in adults 60 to 64 years of age, for whom Prevnar 13 was already approved.

S. pneumoniae, also known as pneumococcus, is the most common bacterial cause of community-acquired pneumonia. Pneumococcal pneumonia can be classified as noninvasive when bacteria cause infection in the lungs but are not detected in the blood concurrently, or invasive when bacteria also enter the bloodstream (bacteremic pneumonia) or another normally sterile site in the body. While noninvasive forms of pneumococcal disease are typically more common, the invasive types of disease are generally more severe.

Prevenar 13 is the most widely used pneumococcal conjugate vaccine in the world and is included in the pediatric national immunization programs in 102 countries.

Source: Pfizer; July 12, 2016.