Pfizer Inc (NYSE:PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children. The Company is seeking an indication for active immunization of infants and toddlers for the prevention of invasive disease (including sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema) and otitis media caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes. The FDA will consider the Advisory Committee’s votes and discussion in its review of the Biologic License Application (BLA) for Prevnar 13, which has an action date of December 30, 2009.
Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A) associated with the majority of remaining invasive pneumococcal disease in infants and young children in the U.S. Serotype 19A is the most common serotype in the U.S. Prevnar®, the standard in pneumococcal disease prevention for infants and young children, was first introduced in the U.S. in 2000.
“Pfizer is very pleased with the outcome of the Advisory Committee’s votes on the safety and effectiveness of Prevnar 13,” says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. “We look forward to working with the FDA to obtain approval for this important vaccine.”