FDA grants priority review to Prevnar 13

COLLEGEVILLE, Pa. The Food and Drug Administration has granted priority review to Wyeth Pharmaceuticals’ application for the pneumococcal vaccine Prevnar 13 (diphtheria CRM[197] protein).

The company submitted the application for the vaccine, a 13-valent conjugate vaccine, on March 31.

Wyeth said it is seeking approval for Prevnar 13 for the prevention of invasive pneumococcal disease and otitis media caused by the 13 serotypes in the vaccine in children ages 2 months to 5 years. Prevnar 13 includes six serotypes in addition to the seven in the earlier version of Prevnar.

“Since its launch in 2000, our seven-valent pneumococcal vaccine, Prevnar, has significantly reduced the incidence of pneumococcal disease among infants and young children in the United States,” Wyeth Pharmaceuticals EVP vaccine research and development Emilio Emini said. “Recently, however, disease due to pneumococcal serotypes not found in Prevnar, particularly serotype 19A, have increased in prevalence in many regions of the world and are a significant public health concern.”