Wyeth’s Pneumococcal Vax Gets Fast Track

Wyeth’s investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers has been granted Fast Track designation by the FDA. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD) and otitis media caused by serotypes included in the vaccine. The vaccine includes six new serotypes in addition to the seven serotypes included in Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), also known as PCV7.
   
Fast Track designation is designed to facilitate review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need. Wyeth plans to submit the BLA on a rolling basis and expects the application to be completed in 1Q09.
   
The 13-valent pneumococcal conjugate vaccine is being studied in Phase III global trials in both infants and adults.