July 10 2013 | By Márcio Barra
Pfizer’s Prevenar 13, a pneumococcal conjugate vaccine already in use in infants, young children and adolescents between ages of 6 weeks and 17 years and adults of 50 years and over, received approval today by European Comission to be used in a wider age group – adults aged 18 to 49 years for active immunization for the prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae.
The European Commission’s decision to approve this label expansion for Prevenar 13 followed the submission and review of data from an open-label Phase 3 trial of the vaccine in healthy adults aged 18 to 49 years. The study showed that Prevenar 13 is at least as immunogenic in this age group as it is in adults 60 to 64 years of age, as measured one month after vaccination. Moreover, Prevenar 13 showed a favorable safety profile and was generally well tolerated.
This makes Prevenar 13, already one of Pfizer’s biggest franchises – $3.72 billion in 2012 revenue, Pfizer’s fourth-biggest seller – the only pneumococcal vaccine in the EU that offers protection against invasive disease from infancy through adulthood.
Prevenar 13, or Prevnar 13 in the US, is used to prevent infections from 13 strains of the Streptococcus pneumoniae bacterium. The vaccine originally was part of Wyeth’s vaccine portfolio, becoming property of Pfizer when it bought Wyeth in 2009.