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).
| 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 27 About 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).31 About 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:
SOURCE Pfizer Canada Inc. |
