20vPnC (PF-06482077) Vaccine Description
Pfizer’s 20vPnC (PF-06482077) is a 20-Valent pneumococcal conjugate vaccine candidate to help protect adults from a substantial invasive pneumococcal disease and pneumonia burden.
Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).
On May 14, 2020, Pfizer announced a phase 3 study found 20vPnC's safety profile was similar to the Prevnar 13.
Previously, on September 20, 2018, Pfizer announced the U.S. FDA granted Breakthrough Therapy Designation for 20vPnC for the prevention of invasive disease and pneumonia in adults age 18 years or older. Also, the FDA had granted Fast Track designation for 20vPnC in September 2017 for use in adults aged 18 years or older.
To learn more, visit www.pfizer.com.
20vPnC (PF-06482077) Vaccine Indication
20vPnC (PF-06482077) is a 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults aged 18 years and older.
The 7 new serotypes included in 20vPnC are global causes of invasive pneumococcal disease (IPD) and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.
Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes in adults 70 years and older annually. Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the U.S. and globally.
20vPnC (PF-06482077) Vaccine Dosage
20vPnC (PF-06482077) is administered as an intramuscular injection.
20vPnC (PF-06482077) Vaccine News
June 1, 2020 - The first Global Pneumonia Forum: recommendations in the time of coronavirus.
May 14, 2020 - Pfizer Inc. announced top-line results from a second Phase 3 study, which described the safety and evaluated the consistency of immune responses elicited across three different lots of its 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC) candidate. In this study, the 20vPnC safety profile was similar to the Prevnar 13® (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) control group. This clinical lot consistency study is expected to satisfy licensure requirements for manufacturing consistency by the U.S. FDA and other countries’ regulatory agencies.
March 18, 2020 - Pfizer Inc. announced top-line results from a Phase 3 clinical trial which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate. Pfizer’s press release stated: The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in 20vPnC in adults 60 years of age and older at 1-month after vaccination, were met for all serotypes in common with licensed Prevnar 13, and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23).
September 9, 2019 - Pfizer Inc. announced positive preliminary results following administration of three doses in a four-dose series for a Proof-of-Concept Phase 2 study (B7471003) to assess safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes contained in the vaccine in healthy infants.
September 20, 2018 - “As the industry leader in pneumococcal conjugate vaccination, we are proud to start the Phase 3 trials of our third generation pneumococcal vaccine, which received Breakthrough Therapy Designation by the FDA in September 2018.”
20vPnC (PF-06482077) Vaccine Clinical Trials
Approximately 3,500 infants will be enrolled in total for these two studies. In both studies, infants will be vaccinated with either 20vPnC or Prevnar 13® (13vPnC) at 2, 4, 6, and 12-15 months of age, along with other routine infant vaccines according to the current CDC recommended schedule. Additional information can be found at www.clinicaltrials.gov under the identifiers NCT04382326 and NCT04379713. The results of the descriptive Phase 2 infant study with 20vPnC (NCT03512288) have been submitted for presentation at ID Week 2020.
In May 2017 the FDA granted Fast Track status for a pediatric indication for 20vPnC.1
Pfizer’s Phase 3 adult clinical program for 20vPnC includes three clinical trials (NCT03760146, NCT03828617, and NCT03835975) evaluating the vaccine candidate for the prevention of invasive disease and pneumococcal pneumonia in adults 18 years or older. Combined, these three trials have enrolled more than 6,000 adult subjects, including populations of vaccine-naïve adults and adults with prior pneumococcal vaccination.
All three trials have been completed and the data for one remaining study will be reading out over the next few months.
Clinical Trial NCT03835975: Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination (Recruiting)
- This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination
Clinical Trial NCT03760146: Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults (Active)
- A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Clinical Trial NCT03828617: Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults (Active)
- This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.