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Pfizer Submits Applications to FDA and EMA for Use of its Pneumococcal Conjugate Vaccine, Prevnar 13®, in Adults 50 and Older
Date:12/22/2010

NEW YORK, Dec. 22, 2010 /PRNewswire/ -- Pfizer Inc (NYSE: PFE) today announced that it has submitted supplemental applications to both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expand the use of Prevnar 13®* (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) to adults 50 years of age and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine.

(Logo: http://photos.prnewswire.com/prnh/20100416/PFIZERLOGO)

The FDA is targeting a review cycle of 10 months from the application's submission date, resulting in an expected action date in October 2011, subject to the FDA's acceptance of the application. The EMA will follow the centralized procedure for review of Pfizer's application.  

"We are pleased to be another step closer to potentially bringing Prevnar 13 to adults aged 50 and older," says Emilio Emini, PhD, chief scientific officer, Vaccine Research, Pfizer. "These milestones are further examples of the company's commitment to help prevent pneumococcal disease through vaccination and to improve health and well-being at every stage of life."  

Prevnar 13, which is based on the scientific foundation of Prevnar®** (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), was approved for use in infants and young children in Europe in December 2009 and in the United States in February 2010. Like Prevnar, Prevnar 13 uses conjugate technology that has been shown to confer a high antibody response in infants and toddlers.

In the United States, Pfizer is seeking approval from the FDA to market Prevnar 13 for the active immunization of adults 50 years of age and older for the prevention of pneumococcal disease (including pneumonia and invasi
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SOURCE Pfizer Inc.
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