PFIZER ANNOUNCES SEROTYPES INCLUDED IN 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE CANDIDATE BEING INVESTIGATED FOR THE PREVENTION OF INVASIVE DISEASE AND PNEUMONIA IN ADULTS AGED 18 YEARS AND OLDER

发布时间： 2019-02-28 阅读：857次

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Pfizer Inc. (NYSE: PFE) announced today the new serotypes included in its 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes covered in the vaccine in adults aged 18 years and older. Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) plus 7 additional serotypes (8, 10A, 11A, 12F, 15BC, 22F and 33F).

Pfizer also announced that data from a Phase 2, proof-of-concept study of 20vPnC in adults have been accepted for oral presentation at the upcoming 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), which will take place in Amsterdam, Netherlands, from April 13-16, 2019. In addition, three Phase 3 trials (NCT03828617, NCT03835975 and NCT03760146) have been initiated for the purpose of evaluating 20vPnC in adults. Combined, these three trials will enroll more than 6,000 adult subjects, including populations of vaccine-na?ve adults and adults with prior pneumococcal vaccination.

“Pneumococcal disease burden remains a large unmet medical need in all age groups with changes in pneumococcal serotype prevalence observed globally, in part driven by antibiotic resistance,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We carefully monitored and evaluated the global pneumococcal epidemiology over time and selected the additional serotypes in the 20vPnC vaccine candidate with the intent, assuming successful development, to broaden global protection against pneumococcal disease beyond that afforded by existing pneumococcal conjugate vaccines.”

All seven of the new serotypes included in 20vPnC are global causes of invasive pneumococcal disease,1,2,3,4,5 and six of the seven serotypes (8, 10A, 11A, 15BC, 22F and 33F)6,7,8,9 are associated with high case-fatality rates. In addition, four of these serotypes (11A, 15B/C, 22F and 33F) are associated with antibiotic resistance5,10,11 and/or meningitis (10A, 15B/C, 22F and 33F).12,13

Together, all of the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in adults in the U.S. and globally.14,15,16,17,18

“Pneumococcal disease burden remains a large unmet medical need in all age groups with changes in pneumococcal serotype prevalence observed globally, in part driven by antibiotic resistance,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We carefully monitored and evaluated the global pneumococcal epidemiology over time and selected the additional serotypes in the 20vPnC vaccine candidate with the intent, assuming successful development, to broaden global protection against pneumococcal disease beyond that afforded by existing pneumococcal conjugate vaccines.”