Pfizer Announces Phase 3 Success for 20-Valent Pneumococcal Conjugate Vaccine in Adults, Plans BLA Submission by Year-End

Text | newborn

Recently, Pfizer announced the top-line results of a Phase III clinical study (NCT03760146) of its 20-valent pneumococcal conjugate vaccine (20vPnC), PF-06482077. This randomized, double-blind study enrolled a total of 3,880 adults aged 18 years and older with no prior history of pneumococcal vaccination. The study aimed to evaluate the immune response to 20vPnC in patients aged ≥60 years and compare it with the immune responses in control groups receiving either Prevnar 13 or PPSV23 (primary endpoint). The study also assessed the immune response to 20vPnC in adults aged 18–59 years (secondary endpoint) and characterized the safety profile of 20vPnC in all adults aged 18 years and older.

The results demonstrated that the study met its primary immunogenicity objective: one month after vaccination, in adults aged ≥60 years, 20vPnC showed non-inferior immunogenicity for all 20 serotypes compared to the 13 serotypes included in Prevnar 13 and to 6 of the 7 additional serotypes covered by PPSV23; for the remaining one of the 7 additional serotypes from PPSV23, non-inferiority was not met due to a small margin.

Regarding the secondary immunogenicity objectives, the immunogenicity of all 20 serotypes met the non-inferiority criteria in the 18–59-year and 60–64-year age groups. The safety objectives were met in the overall population aged ≥18 years, demonstrating that the safety and tolerability profile of 20vPnC was comparable to those of Prevnar 13 and PPSV23. Based on prior discussions with regulatory authorities, these data are expected to meet the criteria for regulatory approval. Pfizer plans to disclose the full results of this study in the future, pending completion of comprehensive analyses of the safety and immunogenicity data.

The pivotal Phase III adult program for 20vPnC comprises three clinical studies (NCT03760146, NCT03828617, and NCT03835975), which evaluated the efficacy and safety of 20vPnC in preventing invasive disease and pneumococcal pneumonia in adults aged 18 years and older. The three studies enrolled a total of more than 6,000 participants, including adults with or without a history of pneumococcal vaccination.

All three studies have been completed, and data from the remaining two studies will be released in the coming months. Pfizer has planned to submit a Biologics License Application (BLA) for the adult indication of 20vPnC to the U.S. FDA by the end of 2020.

Dr. Kathrin U. Jansen, Senior Vice President and Head of Vaccine Research and Development at Pfizer, stated: “The results of this pivotal study demonstrate that the 20vPnC vaccine has a safety profile similar to Prevnar 13 in preventing invasive pneumococcal disease and pneumonia, and may be equally efficacious as Prevnar 13, also providing protection against diseases caused by seven additional pneumococcal serotypes in adults aged 18 years or older.”

Globally, pneumococcal pneumonia causes 500,000 deaths and 30 million infections annually among individuals aged 70 years and older. Pfizer’s 20-valent pneumococcal conjugate vaccine (20vPnC) includes the 13 serotypes contained in Prevnar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as well as seven additional serotypes (8, 10A, 11A, 12F, 15BC, 22F, and 33F). These seven new serotypes are all global causes of invasive pneumococcal disease; six of them (8, 10A, 11A, 15BC, 22F, and 33F) are associated with high case-fatality rates, and four are linked to antibiotic resistance (11A, 15BC, 22F, and 33F) and/or meningitis (10A, 15BC, 22F, and 33F). In summary, the 20 serotypes included in 20vPnC collectively account for the majority of pneumococcal disease currently circulating among adults in the United States and worldwide.

In terms of regulatory status, in September 2018, the FDA granted Breakthrough Therapy designation to 20vPnC for the prevention of invasive disease and pneumonia in adults aged 18 years and older. In September 2017 and May 2019, the FDA granted Fast Track designation to 20vPnC for adult indications and pediatric indications, respectively.

Reference Source: Pfizer Announces Top-Line Results from Phase 3 Study of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults Aged 18 Years or Older