Expanded indication for Prevenar 13 in Pneumonia-Pfizer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that the indication for Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), from Pfizer, be expanded to include the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults 18 years and older. Prevenar 13 is currently approved in Europe for the prevention of invasive pneumococcal disease (IPD) in the same population. The CHMP’s positive opinion will now be reviewed by the European Commission (EC). The decision on whether to approve Prevenar 13 for this indication will be made by the EC and will be applicable to all European Union member states plus Iceland, Liechtenstein and Norway.

The CHMP opinion was granted following review of the results from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA). The study achieved its primary and secondary objectives. The primary endpoint evaluated the efficacy of Prevenar 13 for the prevention of a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older. Secondary endpoints were the prevention of a first episode of vaccine-type non-invasive/non-bacteremic CAP, and prevention of a first episode of vaccine-type IPD in adults aged 65 and older.