Pfizer (PFE) Receives EC Approval for Expanded Prevenar 13 Indication
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Pfizer, Inc. (NYSE: PFE) announced hat 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.
“Prevenar 13 has been administered to millions of infants and young children around the world and helps protect against the often fatal effects of pneumococcal disease,” said Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer. “As the global leader in pneumococcal disease prevention, Pfizer continues to study the use of this life-saving vaccine across all ages.”
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 6 to 17 years consistent with the safety profile established in previous trials in infants and young children.
“Children and adolescents aged 6 to 17 with underlying medical conditions have an increased risk of pneumococcal disease,” said Luis Jodar, Ph.D., vice president, Vaccines Global Medicines Development Group, Pfizer. “Pfizer will continue working with health authorities worldwide in an effort to provide access to Prevenar 13 to those at risk of disease.”
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“Prevenar 13 has been administered to millions of infants and young children around the world and helps protect against the often fatal effects of pneumococcal disease,” said Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer. “As the global leader in pneumococcal disease prevention, Pfizer continues to study the use of this life-saving vaccine across all ages.”
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 6 to 17 years consistent with the safety profile established in previous trials in infants and young children.
“Children and adolescents aged 6 to 17 with underlying medical conditions have an increased risk of pneumococcal disease,” said Luis Jodar, Ph.D., vice president, Vaccines Global Medicines Development Group, Pfizer. “Pfizer will continue working with health authorities worldwide in an effort to provide access to Prevenar 13 to those at risk of disease.”
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