20 price pneumococcal vaccine! Pfizer 20vPnC receives FDA Priority Review: For ≥ 18-year-olds!

Dec 10, 2020 // -- Pfizer recently announced that the U.S. Food and Drug Administration (FDA) has accepted a 20-price pneumococcal polysaccharide binding vaccine (20vPnC) The Biological Products Licensing Application (BLA) for PF-06482077 will be reviewed as a priority for the vaccine for adults 18 years and older to prevent invasive diseases and pneumonia caused by streptococcus pneumoniae serotypes in the vaccine.
FDA has designated the target date for the Prescription Drug User Charge Act (PDUFA) of 20vPnC BLA as June 2021.
September 2018, the FDA granted 20vPnC a breakthrough drug (BTD) for the prevention of invasive diseases and pneumonia in adults 18 years and older.
September 2017 and May 2019, the FDA granted 20vPnC fast-track eligibility for adult and pediatric adaptations, respectively.
S. pneumoniae ,20vPnC regulatory document from Paramedicsworld .com) includes data from adult clinical projects, including Phases 1 and 2 trials, and 3 Phase 3 trials (NCT03760146, NCT03828617, NCT03835975), these trials assessed the safety and immunogenicity of 20vPnC to support regulatory approval for the prevention of Streptococcus pneumoniae-induced invasive diseases and Streptococcus pneumoniae pneumoniae in adults 18 years of age and older.
3 trial recruited more than 6,000 adult subjects aged 18 and over, including those aged 65 and over, as well as adults who had been vaccinated against pneumococcal bacteria and adults who had not been vaccinated against pneumococcal disease.
"The FDA's acceptance of our 20vPnC application is another important milestone in Pfizer's ongoing efforts to help protect the adult population from pneumococcal disease," said Dr. Kathrin U. Jansen, senior vice president and head of vaccine development at Pfizer.
if approved, 20vPnC will cover more serotonies that cause most pneumococcal disease than any other pneumococcal-binding vaccine currently licensed or currently in the late stages of clinical development.
importantly, 20vPnC has been shown to induce immune memory and provide protection and effectiveness for non-bacterial pneumonia, especially in the elderly.
" Pfizer's 20-price candidate vaccine 20vPnC includes 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and 7 new serotypes (8, 10A, 11A, 12F, 15BC, 22F and 33F).
the seven new serotypes were all global causes of invasive pneumococcal disease, of which 6 (8, 10A, 11A, 15BC, 22F and 33F) were associated with high death rates. 4 are associated with antibiotic resistance (11A, 15BC, 22F and 33F) and/or meningitis (10A, 15BC, 22F and 33F).
, pneumococcal pneumonia is expected to kill about 500,000 people and infect 30 million people a year in people aged 70 and over.
all, the 20 serotonies contained in 20vPnC together contribute to most of the pneumococcal disease that is currently endemic in the United States and around the world.
Prevnar 13 is an overweight pound pneumococcal vaccine listed by Pfizer that will have global sales of $5,847 million in 2019.
Prevnar 13 (Pye) has been approved: (1) for ≥18-year-old adults to prevent pneumococcal and invasive diseases caused by 13 serotypes of Streptococcus pneumoniae; Children (before 18th birthday) to prevent invasive diseases caused by 13 serotypes of streptococcus pneumoniae, and (3) for children between 6 weeks and 5 years of age (before 6th birthday) to prevent ear infections caused by 7 of the 13 serotypes of Streptococcus pneumoniae.
Prevnar 13 is not 100% effective and can only help prevent the 13 serotonies covered in the vaccine.
() original source: FDA accepts Pfizer's application for pneumoccal conjugate vaccine