FDA approves Pfizer’s Prevnar 13 to prevent pneumococcal disease in older children, adolescents
Published on January 28, 2013 at 1:26 AM
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the expansion of the company's pneumococcal conjugate vaccine, Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group, Prevnar 13 is administered as a one-time dose to patients who have never received Prevnar 13.
"As a global leader in pneumococcal disease prevention, extending the impact of Prevnar 13 to older children and adolescents aged 6 through 17 years is a reflection of our dedication to improving public health worldwide," said Susan Silbermann, president, vaccines, Pfizer. "We continue to work tirelessly to make this vaccine available to people at risk for invasive pneumococcal disease."
The FDA approval followed submission and review of a Phase 3, open-label trial of Prevnar 13 in 592 older children and adolescents, including those with asthma. The study met all endpoints, demonstrating immunogenicity and establishing a safety profile in children aged 6 years through 17 years consistent with the safety profile established in previous trials in infants and young children.