New Vaccine for Pneumococcal Disease Receives Priority Approval From Health Canada

Prevnar(R) 13 Provides Broadest Coverage of any Pneumococcal Conjugate Vaccine for Infants and Young Children Against the Threat of Serious Pneumococcal Disease

KIRKLAND, QC, Dec. 22 /CNW/ - 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.

Pneumococcal disease is the number one vaccine-preventable cause of death worldwide in children younger than five years of age.(1) In Canada, the pneumococcal vaccination program has significantly reduced vaccine-preventable strains of Streptococcus pneumoniae (S. pneumoniae), the bacterium that causes pneumococcal disease. However, specific antibiotic-resistant strains like 19A are a growing concern. In fact, 19A is one of the most prevalent strains causing serious pneumococcal disease today.

"Pneumococcal vaccination was not available when my daughter Lauren was born," says Nicole Nayman, mother of two. "If a vaccine like Prevnar 13 had been available, Lauren might not have contracted pneumococcal meningitis at the age of 19 months, which has led her to be profoundly deaf in both ears. This is why I encourage parents to speak to their physician about their child's vaccination program and ensure that they are receiving the best possible protection."

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

The recommended immunization schedule for Prevnar 13 in Canada is at ages two, four, six and 12 to 15 months, and the vaccine can be administered at the same time as other regularly administered childhood vaccines.

ABOUT PNEUMOCOCCAL DISEASE

According to the World Health Organization (WHO), pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than five years and is estimated to cause up to one million deaths worldwide in children each year.(2)

Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae.(3) Pneumococcal disease includes invasive infections such as bacteremia, sepsis and meningitis, as well as pneumonia and acute otitis media.(4)

ABOUT PREVNAR (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein))

To date, Pfizer has submitted regulatory applications for Prevnar 13 for use in infants and young children in 60 countries spanning six continents and has already been approved in four countries, including Canada. In addition, the vaccine is being studied in global Phase III clinical trials in adults, with regulatory submissions expected in 2010.

Prevnar (7-valent) was first approved in Canada in 2001 and is the only National Advisory Committee on Immunization (NACI) recommended pneumococcal vaccine for infants and children. Three years following the vaccine's introduction in Canada, there was a 93 per cent reduction in vaccine-type PD in some regions.(5) Prevnar (7-valent) is currently available in more than 100 countries and more than 300 million doses have been distributed worldwide, including approximately eight million doses in Canada. P

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