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Pfizer Inc Wins EU Approval To Expand Use Of Prevenar To Children


Tuesday, 8 Jan 2013 07:00am EST 

Pfizer Inc announced that the European Commission has approved expanding the use of the Company's pneumococcal conjugate vaccine, Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), to older children and adolescents aged 6 to 17 years for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by vaccine-type Streptococcus pneumoniae . Children in this age group who have not previously received Prevenar 13 may receive a single dose of the vaccine. The European Commission's decision to approve this expanded indication followed submission and review of a Phase 3, open-label trial of Prevenar 13 in 592 healthy children and adolescents, including those with underlying medical conditions such as asthma (17.4% of the study population). The study met all endpoints, demonstrating immunogenicity and establishing a safety profile in children and adolescents aged six to 17 years consistent with the safety profile established in previous trials in infants and young children. Pneumococcal Disease (PD) is a group of illnesses caused by the bacterium Streptococcus pneumoniae ( S. pneumoniae ), also known as pneumococcus. 

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