Health Canada Approves 13-Valent Pneumococcal Vaccine
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Health Canada Approves 13-Valent Pneumococcal Vaccine

OTTAWA, Ontario -- December 22, 2009 -- Health Canada has approved a pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein [Prevnar 13] for children aged 6 weeks through 5 years for active immunisation against invasive pneumococcal disease.

The 13-valent vaccine is designed to provide the broadest coverage of any pneumococcal conjugate vaccine. The new vaccine includes strains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F -- responsible for the greatest remaining burden of invasive disease in young children worldwide.

In early 2009, Health Canada granted Priority Review status to the vaccine, 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.

Health Canada’s approval of was based on a clinical trial program of 13 core phase 3 studies involving more than 7,000 children. Data from the phase 3 studies support the safety and immunogenicity of the 13-valent vaccine for the prevention of pneumococcal disease in infants and young children.

Data indicate that the 13-valent vaccine has a safety profile similar to that of the 7-valent vaccine (Prevnar) and can be administered with all routine paediatric vaccines studied.

SOURCE: Pfizer Canada Inc.

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