EMA green lights Pfizer bid to broaden pneumonia vaccine use
- Pfizer is attempting to broaden the use of Prevnar 13 (pneumococcal conjugate vaccine) to include prevention of non-invasive/non-bacterial community-acquired pneumonia (CAP) and invasive pneumococcal disease in adults aged 65 and older.
- Pfizer also recently submitted a supplemental biologics license application (BLA) to the FDA for a similar expansion. A response is expected by September.
- The applications are based on data from the Community-Acquired Pneumonia Immunization Trial in Adults, whose results were positive.
Pneumonia continues to be a serious health problem and leading cause of death for older adults. According to the American Lung Association, pneumococcal pneumonia is the most common cause of bacterial pneumonia acquired outside of hospitals.
Each year, there are 175,000 cases of pneumococcal pneumonia, with a fatality rate of 5% to 7% overall, and much higher in adults over 65. Pfizer senior vice-president of Vaccine Research and Development Emilio Emini said, "The results of the Community-Acquired Pneumonia Trial in Adults study underscore the potential benefits of Prevenar 13 in preventing disease in this age group.”
- Pharmaceutical Business Review Pfizer seeks EMA approval for new indication of Prevenar 13 vaccine