Pfizer has obtained FDA approval for the expanded use of Prevnar 13, pneumococcal conjugate vaccine, in children and adults between six to 17 years of age who are new to the vaccine.
The single dose Pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein] will provide protection from invasive disease caused by 13 Streptococcus pneumoniae serotypes.
Pfizer vaccine president Susan Silbermann said, "We continue to work tirelessly to make this vaccine available to people at risk for invasive pneumococcal disease."
The FDA approval was based on positive data from Prevnar 13 Phase 3, open-label study conducted in 592 older children and adolescents.
The study which met all the endpoints established significant immunogenicity and safety profile of the vaccine.
