Wyeth submitted a BLA to the FDA for Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein). The FDA granted Prevnar 13 Fast Track designation last year, which is designed to facilitate review of products that address serious conditions for which there is an unmet medical need. The submission includes data from 13 Phase III studies involving more than 7,000 infants and young children.

Prevnar 13 is designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease (PD), the leading cause of vaccine-preventable death worldwide. Seven of these serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197) Protein), the current global standard in PD prevention in infants and young children. The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest remaining burden of invasive disease. Both Prevnar 13 and Prevnar use CRM(197), an immunological carrier protein with a 20-year history of use in pediatric vaccines.

“We are pleased that, with this milestone, we are now one step closer to bringing Prevnar 13 to infants and children,” says Emilio Emini, Ph.D., executive vice president, Vaccine R&D, Wyeth. “Prevnar, our currently available vaccine, has both proven clinical efficacy and documented effectiveness, which has resulted in a significant public health impact. Prevnar 13 builds on the scientific foundation of Prevnar and, if approved, will provide coverage for the 13 most prevalent pneumococcal serotypes associated with pneumococcal disease, including serotype 19A, which has emerged as a serious public health threat in the U.S. and around the world.”

To date, the company has submitted applications for 13-valent in more than 40 countries. Prevnar 13 is also being studied in global Phase III trials in adults, with regulatory submissions expected in 2010.