(Reuters) - Pfizer Inc on Tuesday said the European Commission has approved expanding the use of Prevenar 13, its pneumococcal conjugate vaccine, to older children and adolescents 6 to 17 years old.
The vaccine protects against the potentially fatal effects of pneumococcal disease, a group of illnesses caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus.
Children in this age group who have not previously received Prevenar 13 may receive a single dose of the vaccine, Pfizer said.
The European Commission’s decision to approve this expanded indication followed submission and review of a Phase 3 trial of Prevenar 13 in 592 healthy children and adolescents, including those with underlying medical conditions such as asthma.
Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries.
It is not indicated for the prevention of pneumococcal pneumonia in the pediatric population in the United States.
The vaccine is approved for use in adults 50 years of age and older in more than 80 countries.
Reporting By Debra Sherman; Editing by Theodore d'Afflisio