PREVNAR 20 is the first conjugate vaccine indicated to help protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia cases.1 2 3 4 5 6 7
KIRKLAND, QC, July 21, 2022 /CNW/ – Pfizer Canada ULC announced today that PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is now available in Canada for the prevention of pneumonia and invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.8
Approved by Health Canada, PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD),9 10 11 12 13 and have been associated with high case-fatality rates,14 15 16 17 antibiotic resistance,18 19 20 and/or meningitis.21 22
“We are pleased to build on Pfizer’s legacy in the innovation and development of pneumococcal conjugate vaccines to help protect Canadians who are most at-risk of pneumococcal disease (PD),” said Fabien Paquette, Vaccines Canada Lead, Pfizer. “PREVNAR 20 is significant in our ongoing fight against pneumococcal disease, including pneumonia in adults, and helps protect against disease-causing serotypes that cause potentially serious respiratory infections. The approval of PREVNAR 20 is pivotal in adult vaccination as it meets a crucial need to expand coverage and protection to address the changing burden of disease.”
Streptococcus pneumoniae infections are a major cause of illness and death worldwide.23 In Canada, Streptococcus pneumoniae remains as a main cause of bacterial community-acquired pneumonia, with an increased risk in individuals with chronic medical conditions and age (65+). The overall case fatality rate of bacteremic pneumococcal pneumonia is 6.4% and is higher among adults 65+ (12%).24
PREVNAR 20 was approved on May 9, 2022. Health Canada’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. More than 6,000 adult subjects 18 years and older participated in the three Phase 3 trials, including adults 65 years of age and older, pneumococcal vaccine-naïve adults, and adults with prior pneumococcal vaccination.
“Pneumonia remains one of the most lethal infectious diseases in Canada. This vaccine broadens the protection against disease-causing serotypes that lead to Streptococcus pneumoniae infections and marks an important step forward in protecting the health of all Canadians, especially those at higher risk due to comorbidities, immunocompromising conditions, or older age ” said Dr. Angel Chu, Vice Chair of Immunize Canada and an infectious diseases physician at the Foothills Medical Centre in Calgary.
PREVNAR 20 builds on Pfizer’s legacy of more than two decades of experience in developing and supplying innovative pneumococcal conjugate vaccines.INDICATION FOR PREVNAR 20
PREVNAR 20 is indicated for active immunization for the prevention of pneumonia and invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.
Clinical efficacy for the prevention of pneumonia was studied with PREVNAR 13 for the shared serotypes, but not for the additional serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F.
PREVNAR 20 may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine.About Pneumonia
Pneumonia is generally defined based on how or where the disease is acquired. Community-acquired pneumonia (CAP) – pneumonia that is contracted outside of a healthcare setting – accounts for the vast majority of pneumonia cases and is a leading cause of death due to infection in the United States and Europe, with the death rate in older adults often exceeding 10%.25 26 27About Invasive Pneumococcal Disease (IPD)
Invasive pneumococcal disease (IPD) is an acute and serious communicable disease caused by the gram positive bacterium Streptococcus pneumoniae.28 IPD may lead to several syndromes including meningitis and bacteremia.29 In Canada, invasive pneumococcal disease (IPD) is more common in the winter and spring.30 S. pneumoniae can be spread by direct oral contact, respiratory droplets, or indirect contact with respiratory secretions of infected or colonized persons (e.g. sneezing, coughing or talking).31About PREVNAR 20™ in Canada
PREVNAR 20 is the first approved conjugate vaccine that helps protect Canadian adults ages 18 and over against the 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia cases.About Pfizer Canada
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world’s leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world’s best known and most prescribed medicines and vaccines. 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 we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.
For further information:
Corporate Affairs Canada
1-866-9PFIZER (1-866-973-4937)
corporate.affairs.canada@pfizer.com
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| 1 Centers for Disease Control and Prevention. Active Bacterial Core (ABCs) surveillance. National Center for Immunization and Respiratory Diseases. Atlanta, GA. |
| 2 Ladhani, SN, Collins S, Djennad A, et al. Rapid increase in non-vaccine serotypes causing invasive pneumococcal disease in England and Wales, 2000–17: a prospective national observational cohort study. Lancet Infect Dis. 2018;18(4):441-451. |
| 3 Menéndez R, España PP, Pérez-Trallero E, et al. The burden of PCV13 serotypes in hospitalized pneumococcal pneumonia in Spain using a novel urinary antigen detection test. CAPA study. Vaccine. 2017;35(39):5264-5270. |
| 4 Azzari C, Cortimiglia M, Nieddu F, et al. Pneumococcal serotype distribution in adults with invasive disease and in carrier children in Italy: Should we expect herd protection of adults through infants’ vaccination? Hum Vaccin Immunother. 2016;12(2):344-350. |
| 5 Pivlishi T. Impact of PCV13 on invasive pneumococcal disease (IPD) burden and the serotype distribution in the U.S. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. October 24th, 2018. |
| 6 European Centre for Disease Prevention and Control. Invasive pneumococcal disease. In: ECDC. Annual epidemiological report for 2016. Stockholm: ECDC; 2018. |
| 7 Beall B, Chochua S, Gertz RE Jr, et al. A population-based descriptive atlas of invasive pneumococcal strains recovered within the U.S. during 2015-2016. Front Microbiol. 2018;19(9). |
| 8 PREVNAR 20 Product Monograph, Accessed June 2022 |
| 9 Baisells E, Guillot L, Nair H, et al. Serotype distribution of Streptococcus pneumoniae causing invasive disease in children in the post-PCV era: A systematic review and meta-analysis. PlosOne. 2017;12(5): e0177113. |
| 10 Hausdorff W & Hanage W. Interim results of an ecological experiment – Conjugate Vaccination against the pneumococcus and serotype replacement. Hum Vaccin Immunother. 2016;12(2):358-374. |
| 11 Cohen R, Cohen J, Chalumeau M, et al. Impact of pneumococcal conjugate vaccines for children in high- and non-high income countries. Expert Rev Vaccines. 2017;16(6):625-640. |
| 12 Moore M, Link-Gelles R, Schaffner W, et al. Effect of use of 13-valent pneumococcal conjugate vaccine in children on invasive pneumococcal disease in children and adults in the USA: analysis of multisite, population-based surveillance. Lancet Infect Dis. 2015;15(3):301-309. |
| 13 Metcalf B, Gertz RE, Gladstone RA, et al. Strain features and distributions in pneumococci from children with invasive disease before and after 13-valent conjugate vaccine implementation in the USA. Clin Microbiol Infect. 2016;22(1):60. e9-60. e29. |
| 14 Oligbu G, Collins S, Sheppard CL, et al. Childhood Deaths Attributable to Invasive Pneumococcal Disease in England and Wales, 2006–2014. Clin Infect Dis. 2017;65(2):308-314. |
| 15 van Hoek, Andrews N, Waight PA, et al. Effect of Serotype on Focus and Mortality of Invasive Pneumococcal Disease: Coverage of Different Vaccines and Insight into Non-Vaccine Serotypes. PlosOne. 2012;7(7): e39150. |
| 16 Stanek R, Norton N, Mufson M. A 32-Years Study of the Impact of Pneumococcal Vaccines on Invasive Streptococcus pneumoniae Disease. Am J Med Sci. 2016;352(6):563-573. |
| 17 Harboe ZB, Thomsen RW, Riis A, et al. Pneumococcal Serotypes and Mortality following Invasive Pneumococcal Disease: A Population-Based Cohort Study. PlosOne. 2009;6(5): e 1000081. |
| 18 Azzari C, Cortimiglia M, Nieddu F, et al. Pneumococcal serotype distribution in adults with invasive disease and in carrier children in Italy: Should we expect herd protection of adults through infants’ vaccination? Hum Vaccin Immunother. 2016;12(2):344-350. |
| 19 Tomczyk S, Lynfield R, Schaffner W, et al. Prevention of Antibiotic-Nonsusceptible Invasive Pneumococcal Disease With the 13-Valent Pneumococcal Conjugate Vaccine. Clin Infect Dis. 2016;62(9):1119-1125. |
| 20 Mendes RE, Hollingsworth RC, Costello A, et al. Noninvasive Streptococcus pneumoniae Serotypes Recovered from Hospitalized Adult Patients in the United States in 2009 to 2012. Antimicrob Agents Chemother. 2015;59(9):5595-5601. |
| 21 Olarte L, Barson WJ, Lin PL, et al. Impact of the 13-valent pneumococcal conjugate vaccine on pneumococcal meningitis in US children. Clin Infect Dis. 2015;61(5):767-775. |
| 22 Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial Meningitis in the United States, 1998–2007. NEJM. 2011;364(21):2016-2025. |
| 23 Government of Canada, Pneumococcal vaccine: Canadian Immunization Guide, accessed April 13, 2022, Pneumococcal vaccine: Canadian Immunization Guide – Canada.ca |
| 24 LeBlanc JJ. Vaccine 2022;40:2635-2646 |
| 25 Gibson G, Loddenkemper R, Sibille Y, Lundbäck Bo, eds. Acute lower respiratory infections. European Lung White Book. Sheffield, United Kingdom: European Respiratory Society; 2013. Available at: https://www.erswhitebook.org/chapters/acute-lower-respiratory-infections/. Accessed April 5, 2021. Vaccines PP-PNR-GLB-0007 3 |
| 26 Restrepo MI, Faverio P, Anzueto A. Long-term prognosis in community-acquired pneumonia. Curr Opin Infect Dis. 2013;26(2):151-158. |
| 27 Ferreira-Coimbra J, Sarda C, Rello J. Burden of community-acquired pneumonia and unmet clinical needs. Adv Ther. 2020;37(4):1302-1318. |
| 28 Government of Canada, Invasive Pneumococcal Disease, accessed April 13, 2022, Invasive Pneumococcal Disease – Canada.ca |
| 29 Government of Canada, Invasive Pneumococcal Disease, accessed April 13, 2022, Invasive Pneumococcal Disease – Canada.ca |
| 30 Government of Canada, Invasive Pneumococcal Disease, accessed April 13, 2022, Invasive Pneumococcal Disease – Canada.ca |
| 31 Government of Canada, Invasive Pneumococcal Disease, accessed April 13, 2022, Invasive Pneumococcal Disease – Canada.ca |
SOURCE Pfizer Canada Inc.
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