Health Canada Approves Expanded Indication for Prevnar 13
KIRKLAND, QC, Aug. 5, 2015 /CNW/ - Prevnar® 13 (pneumococcal 13-valent conjugate vaccine) has received Health Canada's approval for active immunization of adults 18 years of age and older for the prevention of pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.1
"Pneumococcal pneumonia is a leading cause of hospitalization and can pose a serious health risk – particularly to older adults and those who are vulnerable to this infection," says Dr. Vivien Brown, Family Physician, University of Toronto, and Board Member of Immunize Canada. "The approval of this new indication for Prevnar 13 in Canada is great news for adults seeking added protection from this debilitating and potentially deadly disease."
Health Canada's approval of Prevnar 13's expanded indication is based on Pfizer's Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which evaluated the efficacy of immunization with Prevnar 13 to prevent a first episode of vaccine-type pneumococcal community-acquired pneumonia (CAP) in adults aged 65 and older.2
Streptococcus pneumoniae, also known as pneumococcus, is the most common bacterial cause of community-acquired pneumonia, and a major cause of illness and death worldwide.3,4 Pneumococcal pneumonia is considered non-invasive when bacteria cause infection in the lungs but are not detected in the blood concurrently, or invasive when bacteria also enter the bloodstream or another normally sterile site in the body.5 For every one case of invasive pneumococcal pneumonia in adults, there are an estimated three cases of non-invasive pneumococcal pneumonia.6 While non-invasive pneumococcal disease is more common, the invasive form is typically more severe.7
About Prevnar 13
Prevnar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including Canada. It is the most widely used pneumococcal conjugate vaccine (PCV) in the world, and more than 750 million doses of Prevnar 7-valent/Prevnar 13 have been distributed worldwide. In addition, Prevnar 13 is approved for use in adults 50 years of age and older in more than 100 countries, and is also approved in Canada, the US, European Union and other countries, for use in older children and adolescents aged 6 to 17 years.
About CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)
This study was a parallel-group, randomized, placebo-controlled, double-blind trial in which subjects aged 65 years and older were randomly assigned to receive a single dose of either Prevnar 13 or placebo.2 A total of 84,496 subjects were enrolled.2 The trial was conducted by Julius Clinical, an academic research organization affiliated with the University Medical Center Utrecht (UMCU) in the Netherlands. Fifty-nine sentinel hospitals were used for the surveillance of CAP and IPD.2
About Pfizer Canada Inc.
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world's best known and most prescribed medicines and vaccines. Historically, Pfizer Inc. has invested more than US $7 billion toward developing safe and effective medicines. At Pfizer, we're working together for a healthier world. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on Twitter (twitter.com/PfizerCA) or Facebook (facebook.com/Pfizer.Canada).
1 Prevnar 13 Product Monograph. July 2015.
2 Bonten MJM, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015;372:1114-1125.
3 World Health Organization. 23-valent pneumococcal polysaccharide vaccine: WHO position paper. Wkly Epidemiol Rec. 2008 Oct 17;83(42):373-384.
4 Blasi F, Mantero P, Santus P, Tarsia P. Understanding the burden of pneumococcal disease in adults. Clin Microbiol Infect. 2012:18(Suppl. 5):1-8.
5 Centers for Disease Control and Prevention. MMWR Recommendations and Reports. Prevention of pneumococcal disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP). 1997;46(RR-8):1-24.
6 Said MA, Johnson HL, Nonyane BAS, et al. Estimating the burden of pneumococcal disease among adults: a systematic review and meta-analysis of diagnostic techniques. PLoS ONE. 2013;8(4):e60273.
7 World Health Organization. Immunization, vaccines and biologicals. Pneumococcal vaccines. Available at: http://archives.who.int/vaccines/en/pneumococcus.shtml. Accessed October 20, 2014.
SOURCE Pfizer Canada Inc.