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Wyeth Provides Regulatory Update on Prevnar 13* in the United States
Date:8/11/2009

sible for the greatest remaining burden of invasive disease. Prevnar has been available in the U.S. for more than nine years. It is currently available in 95 countries and more than 235 million doses have been distributed worldwide.

The Prevnar 13 submission is based on a clinical trial program of 13 core Phase 3 studies involving more than 7,000 infants and young children. To date, the company has submitted regulatory applications for Prevnar 13 in more than 50 countries spanning six continents, with filings in additional countries planned. In July, Prevenar 13*, as it is known outside the U.S., was approved in Chile for use in infants and young children.

About Pneumococcal Disease

Pneumococcal disease is complex and describes a group of illnesses all caused by the bacterium Streptococcus pneumoniae. Pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years of age and is estimated to cause up to one million deaths worldwide in children each year.

Pneumococcal disease affects both children and adults, and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media.

Important Safety Information for Prevnar 13*

In clinical studies, the most commonly reported adverse events in children were injection site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. Risks are associated with all vaccines, including Prevnar 13. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. As with any vaccine, Prevnar 13 may not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.

Indication for Prevnar((R))

Prevnar(R) is indicated for act
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SOURCE Wyeth Pharmaceuticals
Copyright©2009 PR Newswire.
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