EMA accepts expanded Prevenar indication application
The indication applies to adults and covers 13 serotypes.
The application was based on the positive results of a Community-Acquired Pneumonia Immunization Trial in Adults. The trial found statistically significant reductions in vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive and non-bacteremic CAP, as well as invasive pneumococcal disease in adults aged 65 and older.
"Pneumococcal pneumonia continues to be a serious health problem, causing significant illness and mortality in older adults," Emilio Emini, the senior vice president for vaccine research and development at Pfizer, 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."
The vaccine is currently approved for adults in Europe for the prevention of invasive pneumococcal disease.
Prevenar 13 was originally introduced for use in infants and young children in 2009 in Europe and is now in use in over 120 countries, including the U.S. The treatment is the most widely used pneumococcal conjugate vaccine in the world.