Pfizer receives European approval to expand use of Prevenar 13 to older chlidren

theflyonthewall.com

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.

View Comments (0)

Recommended for You