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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

ve disease) caused by the Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine. In the European Union, the Company is seeking marketing authorization for active immunization for the prevention of disease caused by S. pneumoniae in adults aged 50 years and older. Pfizer plans regulatory submissions in additional countries in 2011.

Pfizer's applications to the FDA and EMA are based on six Phase III studies involving approximately 6,000 subjects. Data from the studies are expected to be shared in peer-reviewed forums beginning in 2011.

Pneumococcal Disease

Pneumococcal disease is a group of illnesses caused by the bacterium S. pneumoniae, also known as pneumococcus. It includes invasive infections such as bacteremia, sepsis, and meningitis, as well as non-invasive infections, such as pneumonia and otitis media. Pneumococcal disease is a major cause of illness and death in adults worldwide.

Indication for Prevnar 13 for Pediatric Use in the United States

In the United States, Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the sixth birthday). Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused by 13 serotypes of S. pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is also indicated for the prevention of otitis media (ear infection) caused by seven serotypes of S. pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for serotypes 1, 3, 5, 6A, 7F, and 19A.

Prevnar 13 is not indicated for the prevention of pneumonia in the United States.

Important Safety Information for Prevnar 13 for Pediatric Use in the United States

Prevnar 13 should not be given to anyone with a severe allergic reaction to any component of Prevnar 13, Prevnar, or any diphtheri
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SOURCE Pfizer Inc.
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