Pfizer announced that the European Commission has approved expanding the use of the company’s pneumococcal conjugate vaccine, Prevenar 13, 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. 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.
- Pharmaceuticals & Drug Trials
- pneumococcal conjugate vaccine
- the European Commission