Health Canada approves extended use of Prevnar® 13 in adults 50 years and older

KIRKLAND, QC, Feb. 15, 2012 /CNW/ - Pfizer Canada Inc. is pleased to announce Health Canada's approval of the extended use of Prevnar^® 13 for active immunization for the prevention of invasive pneumococcal disease (IPD) (including sepsis, meningitis, bacteraemic pneumonia, pleural empyema and bacteraemia) in adults 50 years of age and older caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.¹  Prevnar^® 13 is a conjugate vaccine made from the purified polysaccharides of 13 different serotypes of S. pneumoniae individually conjugated to non-toxic diphtheria cross reactive material 197 (CRM197) protein. Prevnar^® 13 was first approved in December 2009 for use in children and infants from 6 weeks through 5 years of age for the active immunization against IPD caused by the serotypes of S. pneumoniae contained in the vaccine.

Older adults, and especially those with underlying medical conditions such as heart, liver or kidney disease, are at increased risk of invasive pneumococcal disease,² which can result in a loss of quality of life.³ 

"Adults should be more proactive when it comes to vaccines, especially for those that protect against some serious infectious diseases," says Dr. Karl Weiss, Professor of Medicine, Maisonneuve-Rosemont Hospital, Faculty of Medicine, Université de Montréal. "In Canada, we recognize the importance of immunization for infants and children, but the benefits for adults are not widely discussed." 

In addition to Canada, Prevnar^® 13 is also approved for use in adults 50 years of age and older in the United States, European Union, Australia, Mexico and more than 10 other countries.

ABOUT INVASIVE PNEUMOCOCCAL DISEASE (IPD)

Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus, which can infect people of all ages, although young children, older adults and individuals with certain chronic medical conditions are at an increased risk of infection. IPD occurs when bacteria invade parts of the body, such as the blood or spinal fluid, which are normally free from bacteria.

While less common than non-invasive pneumococcal disease, IPD is usually more severe, and it results in significant morbidity and mortality in older adults.  It includes bacteraemic pneumonia (lung inflammation with bacteria in the blood), bacteraemia (bacteria in the blood) and meningitis (inflammation of the tissues surrounding the brain and spinal cord).

In Canada, the incidence of invasive pneumococcal disease in adults, especially the elderly, has remained high ranging from 23 per 100,000 to 29.4 per 100,000.⁴

Increased risk factors for invasive pneumococcal disease include older age, underlying chronic conditions, including chronic lung diseases, chronic heart disease, chronic liver disease and cirrhosis, diabetes, alcoholisim and cigarette use, immunosuppressive conditions including HIV infection, hematologic malignancies, generalized malignancies, solid organ and bone marrow transplant recipients, sickle cell disease, functional or anatomic asplenia and long-term use of systemic corticosteroids or immunosuppressive drugs.⁵

ABOUT PREVNAR^® 13

Prevnar^® 13 was first approved for use in infants and young children in December 2009 in Canada and is now approved for such use in more than 100 countries worldwide. More than 400 million doses of Pfizer's pneumococcal conjugate vaccines for infants and children have been distributed worldwide, including approximately 9 million doses in Canada.

In clinical trials, Prevnar^® 13 demonstrated a functional antibody response in adults 50 years of age and older who had not previously been vaccinated with a pneumococcal polysaccharide vaccine, and in those who had been previously vaccinated, including those with chronic, stable co-morbidities such as chronic cardiovascular disease, diabetes mellitus, and chronic pulmonary disease.⁶

The most commonly reported solicited local and systemic adverse events in clinical trials with Prevnar^® 13 were redness, swelling and pain at the injection site, limitation of arm movement, decreased appetite, headache, diarrhea, chills, fatigue, rash and worsening of or new joint or muscle pain.

Prevnar^® 13 is to be administered as a single dose of 0.5 mL to adults 50 years and older, including those previously vaccinated with a pneumococcal polysaccharide vaccine.⁷

Regardless of prior pneumococcal vaccination status, if sequential administration of Prevnar^® 13 and pneumococcal polysaccharide vaccine is considered, Prevnar^® 13 should be given first.⁸

ABOUT PFIZER CANADA INC.

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical company. The company is one of the largest contributors to health research in Canada. Our diversified health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products.

Every day, Pfizer Canada employees work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. We apply science and our global resources to improve the health and well being of Canadians at every stage of life.

Our commitment is reflected in everything Pfizer does, from our disease awareness initiatives to our community partnerships, to our belief that it takes more than medication to be truly healthy. To learn more about Pfizer's More than Medication philosophy and programs, visit morethanmedication.ca. To learn more about Pfizer Canada, visit www.pfizer.ca.

REFERENCES

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¹ Prevnar 13 Canadian Product Monograph, Pfizer Canada Inc., January 13, 2012.
² Prevnar 13 Canadian Product Monograph, Pfizer Canada Inc., January 13, 2012.
³ Ontario Burden of Infectious Disease Report. http://www.ices.on.ca/file/ONBOIDS_FullReport_intra.pdf. Accessed January 31.
⁴ Prevnar 13 Canadian Product Monograph, Pfizer Canada Inc., January 13, 2012.
⁵ Prevnar 13 Canadian Product Monograph, Pfizer Canada Inc., January 13, 2012.
⁶ Prevnar 13 Canadian Product Monograph, Pfizer Canada Inc., January 13, 2012.
⁷ Prevnar 13 Canadian Product Monograph, Pfizer Canada Inc., January 13, 2012.
⁸ Prevnar 13 Canadian Product Monograph, Pfizer Canada Inc., January 13, 2012.

For further information:

Leah Olson
Pfizer Canada Inc.
[phone]
[email protected]

Ethan Pigott
beSPEAK Communications
[phone]
[email protected]