NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) 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 older.
Streptococcus pneumoniae, also known as pneumococcus, is the most common bacterial cause of community-acquired pneumonia. Pneumococcal pneumonia is one of the leading causes of death and hospitalization worldwide.
Pfizer conducted the CAPiTA study (Community-Acquired Pneumonia Immunization Trial in Adults) 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.
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