Wyeth Submits European Marketing Authorization Application For 13-Valent Vaccine For The Prevention Of Pneumococcal Disease In Infants

Main Category: Immune System / Vaccines
Also Included In: Infectious Diseases / Bacteria / Viruses;  Regulatory Affairs / Drug Approvals
Article Date: 03 Dec 2008 - 8:00 PST

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Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for approval to market its investigational 13-valent pneumococcal conjugate vaccine (PCV13) for infants and young children. Wyeth is seeking an indication for the prevention of pneumococcal disease (PD) caused by the 13 serotypes included in the investigational vaccine in infants and children from two months to five years of age. The review of the MAA will be coordinated by the EMEA for all 27 countries in the European Union, as well as Norway, Iceland and Liechtenstein.

PCV13 includes the 13 most prevalent pneumococcal serotypes associated with serious PD. Seven of these (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevenar™ (Pneumococcal saccharide conjugated vaccine, adsorbed) - 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 burden of remaining invasive disease. Both Prevenar (also known as PCV7) and PCV13 use CRM197 - an immunological carrier protein with a 20-year history of use in pediatric vaccines...

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