The FDA has approved Wyeth’s Prevnar 13 (pneumococcal 13-valent conjugate vaccine) for the prevention of invasive pneumococcal disease and otitis media in children 6 weeks through 5 years of age. Prevnar 13 extends the protection of Prevnar (pneumococcal 7-valent conjugate vaccine) to include an additional six serotypes of Streptococcus pneumoniae and is also indicated for the prevention of otitis media caused by the seven serotypes shared with Prevnar.
This approval was based on data from a randomized, multicenter, immunogenicity study. Prevnar 13 post-vaccination antibody response comparisons to Prevnar were comparable to those shown to be protective in Prevnar.
Prevnar 13 is expected to be available in single-dose, pre-filled syringes in mid-March 2010.
For more information call (800) 934-5556 or visit www.wyeth.com.