Pfizer Gets Expanded Prevnar 13 Label in EU

Pfizer has received approval from the EC for updates to the Summary of Product Characteristics (SmPC) for pneumococcal conjugate vaccine Prevenar 13 (sold as Prevnar 13 in the U.S.). The updated label now includes information describing the use of the vaccine in preterm infants, children and adolescents with sickle cell disease who were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine, and adults with human immunodeficiency virus (HIV) infection who were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine.

The decision to approve the SmPC for Prevenar 13 followed the EMA’s review of data submitted by Pfizer from several studies assessing immunogenicity and safety of vaccination with Prevenar 13 in these three risk groups. These data are under review by the FDA.

Prevenar 13 received an expanded indication in the EU in July 2013 to include adults aged 18 to 49 years for active immunization for the prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae (S. pneumoniae).