Pfizer announced that the FDA has approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) for use in vaccine-naïve children and adolescents aged 6–17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine.
The FDA approval was based on 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 6–17 years consistent with the safety profile established in previous trials in infants and young children.
Prevnar 13 is already approved for the prevention of invasive disease caused by 13 S. pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in children 6 weeks through 5 years of age, and in children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains (4, 6B, 9V, 14, 18C, 19F, and 23F). Prevnar 13 is also approved for use in adults >50 years old for immunization against pneumonia and invasive disease caused by S. pneumoniae due to serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
For more information, call (800) 505-4426 or visit www.prevnar13.com