FDA approves expanded indication for Prevenar 13 to prevent pneumonia in adults-Pfizer

Pfizer Inc. announced that the European Commission approved an expanded indication for the use of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s landmark Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease (IPD) in adults aged 65 and old.

This study is one of the largest double-blind, randomized, placebo-controlled vaccine efficacy trials ever conducted in older adults. The CAPiTA study achieved its primary and secondary objectives. It involved approximately 85,000 subjects aged 65 years and older and was conducted by Julius Clinical, an academic research organization affiliated with the University Medical Center Utrecht (UMCU) in the Netherlands.