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World Health Organization Grants Prequalification to Prevenar 13*, Pfizer's 13-valent Pneumococcal Conjugate Vaccine for Infants and Young Children
Date:8/23/2010

by 13 strains of Streptococcus 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 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for strains 1, 3, 5, 6A, 7F, and 19A.

Indication for Prevenar 13* in Most Countries Outside the United States

Prevenar 13 is indicated for the prevention of invasive disease, pneumonia, and otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children from 6 weeks to 5 years of age.

Additional Information About Prevenar 13*

Prevenar 13 has been approved for use in infants and young children in more than 60 countries, to date. In addition, regulatory filings for Prevenar 13 for pediatric use are in advanced stages of review in various countries.

Prevenar 13, built on the scientific foundation of Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), includes the 7 serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevenar plus 6 additional serotypes (1, 3, 5, 6A, 7F, and 19A). Together, these 13 serotypes represent the most prevalent invasive disease-causing serotypes in young children worldwide. Prevenar 13 is the only pneumococcal conjugate vaccine indicated for the prevention of invasive disease caused by serotypes 3, 6A, and 19A. Both Prevenar and Prevenar 13 use CRM197 – a carrier protein that has been used in various approved pediatric conjugate vaccines for more than 20 years.

Pneumococcal Disease

According to the World Health Organization, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than five. Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacter
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SOURCE Pfizer Inc.
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