Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants an...( - Candidate vaccine designed to prote...),Health

- Candidate vaccine designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease -

COLLEGEVILLE, Pa., March 31 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Prevnar 13(TM), Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein). Last year, the FDA granted Prevnar 13 Fast Track designation, which is designed to facilitate review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.

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(R), 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 Research and Development, Wyeth Pharmaceuticals. "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
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