Pfizer has reported that FDA’s 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]). Prevnar 13 vaccine is aimed at the prevention of invasive pneumococcal disease in infants and young children.
The company is seeking an indication for active immunisation 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.
Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar 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 US Serotype 19A is the most common serotype in the US.
The Advisory Committee’s votes in support of Prevnar 13 were based on a review of the data from 13 core Phase III studies involving more than 7,000 children. The Advisory Committee’s discussion included consideration of the multiple immunogenicity endpoints in the trials.
Emilio Emini, chief scientific officer of vaccine research at Pfizer, said: “Pfizer is very pleased with the outcome of the Advisory Committee’s votes on the safety and effectiveness of Prevnar 13. We look forward to working with the FDA to obtain approval for this important vaccine.”