Pfizer Inc. (NYSE: PFE) announced today 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.
“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.”About Prevenar 13 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 worldwide. It is the most widely used pneumococcal conjugate vaccine, with more than 500 million doses of Prevenar/Prevenar 13 having been distributed worldwide. Currently, Prevenar 13 is included as part of a national or regional immunization program in more than 60 countries, helping to protect more than 30 million children per year against invasive pneumococcal disease. Prevenar 13 offers the broadest serotype coverage of any currently available pneumococcal conjugate vaccine for prevention of pneumococcal disease including invasive pneumococcal disease, pneumonia and otitis media. The 13 pneumococcal serotypes in Prevenar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are among the most prevalent invasive-disease-causing strains in children worldwide.