Prevnar(R) 13 Provides Broadest Coverage of any Pneumococcal Conjugate Vaccine for Infants and Young Children Against the Threat of Serious Pneumococcal Disease
Following a Priority Review, Health Canada has approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)) for children aged six weeks through five years for active immunization against invasive pneumococcal disease, a bacterial infection that can include meningitis (inflammation of the coverings of the brain and spinal cord), sepsis (bloodstream infection), bacteremic pneumonia, pleural empyema (accumulation of pus in the cavity surrounding the lungs) and bacteremia (bacteria in the blood).
Prevnar 13 is designed to provide the broadest coverage of any pneumococcal conjugate vaccine. The new vaccine includes the seven strains in Prevnar (4, 6B, 9V, 14, 18C, 19F and 23F) as well as six additional strains (1, 3, 5, 6A, 7F and 19A) responsible for the greatest remaining burden of invasive disease in young children worldwide.
"The approval of Prevnar 13 is a significant step forward in supporting the health of children in Canada," says Dr. Jim Kellner, Head of the Department of Pediatrics for the University of Calgary and Clinical Department Head of Pediatrics for the Calgary Zone of Alberta Health Services. "Prevnar 13 provides coverage of the 13 most prevalent disease causing strains of invasive pneumococcal disease, including serotype 19A, which is increasing in prevalence in Canada and other regions of the world and is often antibiotic resistant."
In early 2009, Health Canada granted Priority Review status to Prevnar 13, which is only granted to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating illnesses or for conditions where there is no existing drug on the Canadian market with the same profile or where the new product represents a significant improvement in the benefit/risk profile over existing products.