Pfizer files for further expanded Prevenar 13 label in the EU; with more submissions to come
This article was originally published in Scrip
Executive Summary
Pfizer has reported that top-line data show that its pneumococcal vaccine, Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), met its primary objective in a Phase III study. The findings support a recent regulatory submission to expand the indication of Prevenar 13 in the European Union to include adults between 18 and 49 years old, and will be used to support similar planned submissions in other countries around the world in the future, the company said.