EU expands approval of Prevenar 13 for Pneumonia in adults-Pfizer

The European Commission approved an expanded indication for the use of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), from Pfizer, 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 older.

Pfizer conducted the CAPiTA study as part of its regulatory commitments to global regulatory authorities. The results have been submitted to the U.S. Food and Drug Administration and regulatory agencies in other major markets, including Australia and Canada, for inclusion in the product’s labeling.

Comment: With this approval for Prevenar 13, it is now indicated in the EU for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 years of age and the elderly. Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including the United States and Japan. It is the most widely used pneumococcal conjugate vaccine (PCV) in the world, and more than 750 million doses of Prevenar 7-valent/Prevenar 13 have been distributed worldwide. In addition, Prevenar 13 is approved for use in adults 50 years of age and older in more than 90 countries, and is also approved in the United States, European Union (EU) and other countries for use in older children and adolescents aged 6 to 17 years.