Pfizer Obtains Health Canada Approval For Prevnar 13

Pfizer Canada has reported that 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.

The company said that Prevnar 13 is designed to provide the 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 remaining burden of invasive disease in young children worldwide.

Reportedly, the Health Canada’s approval of Prevnar 13 was based on a clinical trial program of 13 core phase III studies involving more than 7,000 children. Data from phase III clinical trials support the safety and immunogenicity of Prevnar 13 for the prevention of pneumococcal disease in infants and young children. Data indicated that Prevnar 13 has a safety profile similar to that of Prevnar (7-valent) and can be administered with all routine pediatric vaccines studied.

Jim Kellner, head of department of pediatrics for the University of Calgary, said: “The approval of Prevnar 13 is a step forward in supporting the health of children in Canada. 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.”