20 price pneumococcal vaccine! Pfizer announces positive results for the second study of the 20vPnC Adult Phase III program: Different batches of immunogenicity consistent!

2020 May 14 News /BioValleyBIOON / -Pfizer(Pfizer) recently announced 20 clinical study (NCT03828617) III of valent pneumococcal polysaccharide conjugate vaccine (20vPnC) PF-06482077 second top line resultsThis was a randomized, open-label study enrolled 1718 patients aged 18-49 years old, no history of adult pneumococcal vaccination is intended to describe and evaluate the safety of three different batches of the immune response to vaccination of 20vPnC consistencyresults showed that: three different batches 20vPnC vaccine to stimulate an immune response are consistent, to achieve the primary objective of the study immunogenicityIn this study, the safety and 20vPnC Prevnar13 (Pei children 13,13-valent pneumococcal conjugate vaccine [diphtheria CRM197 protein]) similar to the control groupThis clinical consistency lots study, is expected to meet the licensing requirements of the US Food and Drug Administration (
FDA) and other national regulatory authorities on the conformity of productionAfter thorough analysis of the safety and immunogenicity datato be completed, Pfizer plans to publish the full results of the study in the futurePfizer senior vice president and research director Drvaccine KathrinU.Jansen said: "We are excited about the progress 20vPnC adult development projects, because this is the study of this vaccine achieved positive top-line data of the second phase III trial these new data highlight the Pfizer strong tradition in the manufacture of highly complex biological products (such as pneumococcal conjugate vaccine) aspects of professional knowledge and successful experience proved to batch consistency help ensure that vaccine recipients receive the same level of protection to shut important, but no matter which one production batch"
Streptococcus pneumoniae (S.pneumoniae, pictures from paramedicsworld.com) March of this year, Pfizer announced the first phase III 20vPnC study (NCT03760146) positive top-line results This was a randomized, double-blind study enrolled 3,880 patients aged ≥18 years, adults without history of pneumococcal vaccination, the study assessed the 20vPnC induced ≥60 years in the elderly population in the immune response, and with Prevnar13 (Pei 13 children) or an immune response in the control group compared PPSV23 (primary endpoint) The study also assessed in a 20vPnC induced immune responses in adults aged 18-59 (secondary endpoint), and described in full safety 20vPnC ≥18 years in adults results show that the immunogenicity study met its primary objective: one month after vaccination, ≥60 years in the elderly population, 20vPnC for 20 kinds of serotypes immunogenicity Prevnar13 in all 13 serotypes of immunity immunogenicity and six serotypes immunogenic PPSV23 additional seven new serotypes has a non-inferiority, and PPSV23 additional seven new serotypes another serotype small amplitude differences were not immunogenic non-inferiority criterion Secondary objectives immunogenic, at 18-59 years of age, 60-64 years of age in all 20 serotypes of the immunogenic non-inferiority criterion reached In all ≥18 years population has met its safety target, display 20vPnC safety and tolerability and safety and tolerability of Prevnar13 and PPSV23 quite 20vPnC key Phase III projects include adult Phase III clinical study (NCT03760146, NCT03828617, NCT03835975) 3 items assessed the efficacy and safety of adults aged ≥18 20vPnC vaccine for the prevention of invasive pneumococcal disease and pneumonia 3 study enrolled more than 6000 cases of adults, including with or without a history of pneumococcal vaccination in adults 3 studies have been completed, one study (NCT03835975) the remaining data has not been announced, this study aimed to describe 20vPnC safety and immune response in the elderly population ≥65 years Pfizer has said it planned to submit Biologics License Application 20vPnC adult indication (BLA) to the US Food and Drug Administration (FDA) before the end of 2020 20 20vPnC Pfizer monovalent vaccine candidates included 13 serotypes (1,3,4,5,6A, 6B, 7F, 9V, 14,18C, 19A, 19F and 23F) Prevnar13 and contained seven new serotypes (8,10A, 11A, 12F, 15BC, 22F and 33F) These seven new global cause serotypes are invasive pneumococcal disease, including 6 (8,10A, 11A, 15BC, 22F and 33F) associated with high mortality, with four kinds of antibiotics
resistance (11A, 15BC, 22F and 33F), and / or meningitis (10A, 15BC, 22F and 33F) associated worldwide, pneumococcal pneumonia in the elderly population aged 70 and over are expected to result in approximately 50 million deaths, 30 million people infected each year All in all, 20vPnC contains 20 serotypes common led to the current global epidemic of the United States and most of pneumococcal disease regulation, in September 2018, the US FDA granted 20vPnC breakthrough drugs for the prevention of invasive disease in adults qualified for more than 18 years and pneumonia (BTD) September 2017 and May 2019, FDA were awarded 20vPnC Fast Track eligibility for adult and pediatric indications indications Prevnar13 (Pei children 13) is a super heavyweight Pfizer listed a pneumococcal vaccine, in 2019, global sales of the vaccine reached $ 5.847 billion Prevnar13 (Pei children 13) has been approved by: (1) ≥18 years for adults, and the prevention of invasive pneumococcal disease, a disease caused by the 13 serotypes of Streptococcus pneumoniae; (2) a 6 week -17 years old (before 18th birthday) children, the prevention of invasive disease caused by 13 kinds of serotypes of Streptococcus pneumoniae caused; (3) for children 6 weeks -5 years old (before the 6th birthday), serum 13 kinds of prevention seven kinds of ear type caused by Streptococcus pneumoniae infection Prevnar13 not 100% effective, can help prevent the 13 kinds of vaccine serotypes covered (Biovalley Bioon.com) ORIGINAL: PfizerAnnouncesPositiveTop-LineResultsFromPhase3LotConsistencyStudyof20-ValentPneumococcalConjugateVaccineinPneumococcalVaccine-NaiveAdults18Through49YearsofAge