Pfizer receives EU approval for new Prevenar 13 indication

Pfizer has received European Commission approval for an expanded indication for its vaccine Prevenar 13.

The product has been approved for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older, based on data from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) study.

Prevenar 13's summary of product characteristics have also been updated to include efficacy data from CAPiTA, which demonstrated the vaccine's ability to deliver statistically significant reductions in initial episodes of vaccine-type pneumococcal community-acquired pneumonia.

The results from this trial have also been submitted to the US Food and Drug Administration and regulatory agencies in other major markets, including Australia and Canada, for inclusion in the product's labelling.

Rene Reinert, vice-president of Pfizer's vaccines medical and scientific affairs business in Europe, said: "We welcome the approval of this new indication for Prevenar 13 in the EU, which will enable healthcare professionals to help adults reduce their risk of pneumococcal pneumonia caused by the 13 serotypes in the vaccine."

This comes after the firm announced new clinical data last month showing the safety and efficacy of its drug Elelyso in the treatment of paediatric patients with type 1 Gaucher disease.