Vaccine Info

Pfizer 20vPnC 20-Valent Pneumococcal Vaccine

Authored by
Staff
Last reviewed
March 14, 2021

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 that 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 to prevent invasive disease and pneumonia in adults age 18 years or older. The FDA also granted Fast Track designation for 20vPnC in September 2017 for use in adults aged 18 years or older.

On December 8, 2020, Pfizer announced that the U.S. FDA accepted for priority review a Biologics License Application for its 20vPnC vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.

Kathrin U. Jansen, Ph.D., SVP and Head of Vaccine Research and Development, stated in a press release: “If approved, 20vPnC will cover more serotypes responsible for the majority of pneumococcal disease than any other pneumococcal conjugate vaccine currently licensed or currently in late-stage clinical development. Importantly, 20vPnC has shown to induce immune memory, which provides protection and efficacy against non-bacteremic pneumonia, particularly in older adults.”

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20vPnC (PF-06482077) Vaccine Indication

20vPnC (PF-06482077) is a 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate to prevent 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.

In May 2017, the FDA granted Fast Track status for a pediatric indication for 20vPnC.

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

February 26, 2021 - Pfizer Inc. announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. With the MAA acceptance, the formal review process by the EMA’s Committee for Medicinal Products for Human Use begins.

December 9, 2020 - Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. Additionally, the FDA put 20vPnC in the priority review fast lane, which means the FDA decision deadline is June 2021.

October 21, 2020 - Pfizer presents data from clinical trials for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older as well as the 20vPnC Phase 2 Infant Trial, which overall, the safety profile of a four-dose schedule of 20vPnC was consistent with 13vPnC given in the same schedule. The investigational vaccine demonstrated positive safety results and immune responses to 20 S. pneumoniae serotypes in adults and infants. Pfizer also submitted its biologics license application to the FDA for adults 18 years of age or older and awaits acceptance for review.

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 its 20-valent pneumococcal conjugate vaccine (20vPnC), the 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.

April 13, 2019 - Pfizer Inc. announced today the presentation of data from a Phase 2 study of 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 contained in the vaccine in adults aged 18 years and older. The presentation was delivered at the 29th European Congress of Clinical Microbiology and Infectious Diseases in Amsterdam, Netherlands.

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. We look forward to continuing our dialogue with the FDA so that we can accelerate the development program of the adult indication of Pfizer’s 20-valent next-generation pneumococcal vaccine candidate,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “There continues to be a global health need to protect against the potentially devastating effects of invasive pneumococcal disease and pneumonia caused by additional serotypes, and we are dedicated to continuing to build on our expertise in pneumococcal conjugate vaccines with this vaccine candidate.”

20vPnC (PF-06482077) Vaccine Clinical Trials

Clinical Trial NCT0438232620-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in 2000 Healthy Infants

Clinical Trial NCT04379713 20-valent Pneumococcal Conjugate Vaccine Safety Study in 1500 Healthy Infants

Approximately 3,500 infants will be enrolled in total for the 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. 

Clinical Trial NCT03512288Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in 460 Healthy Infants

Clinical Trial NCT04642079 - Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age

This Phase 3 study single-arm trial is designed to evaluate the safety and immunogenicity of 20vPnC in 800 healthy children 15 months through 17 years of age.

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.

Pfizer’s Phase 3 adult clinical program for 20vPnC, the vaccine candidate for preventing 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 adult trials have been completed, and the data for one remaining study will be reading out over the next few months.