Phase 3 Study for 20-Valent Pneumococcal Vaccine Launched
Pfizer PF-06482077 is a pneumococcal disease vaccine candidate previously granted FDA Breakthrough designation
Pfizer Inc. announced the new serotypes included in its 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077.
PF-06482077 includes all of the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in adults in the U.S. and globally.
All 7 of the new serotypes included in 20vPnC are global causes of invasive pneumococcal disease and six of the seven serotypes (8, 10A, 11A, 15BC, 22F, and 33F) are associated with high case-fatality rates.
In addition, 4 of these serotypes (11A, 15B/C, 22F and 33F) are associated with antibiotic resistance5 and/or meningitis (10A, 15B/C, 22F and 33F).
PF-06482077 is 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.
Streptococcus pneumoniae is a gram-positive bacteria that cause a variety of infectious diseases, including invasive diseases such as bacteremia and meningitis, and infections of the respiratory tract says the Mayo Clinic.
More than 90 serotypes of Streptococcus pneumoniae have been identified. The serotypes responsible for disease vary with age and geographic location.
“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,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer.
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-naïve adults and adults with prior pneumococcal vaccination.
Additionally, Pfizer 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.
“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 Dr. Jansen in a press release.
Previously, on September 20, 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for 20vPnC for the prevention of invasive disease and pneumonia in adults age 18 years and older.
Additionally, in May 2017 the FDA granted Fast Track status for a pediatric indication for 20vPnC and clinical development is in progress.
And, the FDA previously granted Fast Track designation for 20vPnC in September 2017 for use in adults aged 18 years and older.
The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.