Pfizer applies for EU approval of new Prevenar 13 indication

Pfizer has applied to the European Medicines Agency for approval of its vaccine product Prevenar 13 in a new indication.

The company is seeking to expand the label of the pneumococcal polysaccharide conjugate vaccine to include the prevention of pneumonia in adults caused by the 13 pneumococcal serotypes contained in the vaccine.

Data from the landmark Community-Acquired Pneumonia Immunisation Trial in Adults showed the product can deliver statistically significant reductions in vaccine-type pneumococcal community-acquired pneumonia (CAP) – including non-invasive/non-bacteremic CAP – and invasive pneumococcal disease in adults aged 65 and older.

Prevenar 13 was first approved in Europe in December 2009 for the prevention of invasive pneumococcal disease.

Dr Emilio Emini, 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."

Since hospitalisations due to pneumococcal pneumonia represent a growing burden on public health systems due to ageing populations, there could be strong demand for Prevenar 13 in this new indication.