15-price pneumonia vaccine! Mercedon V114 filed for listing in the U.S. and the European Union: ≥ 18-year-old adult population!

November 23, 2020 // -- Merck and Co recently announced that it has submitted a 15-price pneumococcal-binding vaccine V114 (15 price) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which is used in adult groups 18 years and older.
, pneumococcal disease is on the rise in adults, in part because it is driven by disease-caused serotonies that are not currently covered by pneumococcal-binding vaccines.
V114 is a 15-price vaccine in study that combines pneumococcal polysaccharides from 15 serotypes with CRM197 vector proteins, including 22F and 33F serotypes, which are commonly associated with invasive pneumococcal disease worldwide but are not included in the pneumococcal binding vaccine currently licensed for adult use.
vaccine (pictured from: firstcry.com) is currently being clinically developed in Phase III for the prevention of pneumococcal disease in adults and children.
In January 2019, the FDA granted V114 Breakthrough Drug Qualification (BTD) for the prevention of invasive pneumococcal disease (IPD) caused by vaccine serotypes in infants and adolescents between 6 weeks and 18 years of age.
V114 regulatory filings include the results of Phases 2 and 3 clinical studies of various adult populations, including healthy adults and high-risk groups such as adults with chronic diseases, people living with HIV and people over 65 years of age.
in these studies, V114 met the primary immunogenicity target and produced a strong immune response to all 15 serotypes covered by the vaccine, including V114-specific 22F and 33F serotypes.
"For more than a century, Mercado's inventors have developed vaccines that help address some of the greatest public health challenges in society, a tradition that is reflected today in our pneumococcal vaccine portfolio," said Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer of merca East Research Laboratory.
submission of the V114 regulatory application will help us provide more options to help prevent pneumococcal disease.
pneumococcal pneumonia (Photo: bigstockphoto.com) has more than 90 different types of pneumococcal bacteria, which affect adults differently than children.
pneumococcal serotypes (e.g. 22F and 33F) that are not included in the currently available combination vaccine are usually associated with invasive pneumococcal diseases worldwide.
Currently, 13 percent of invasive pneumococcal disease in adults 65 years of age and older in the United States is caused by serotypes 22F and 33F, while across Europe, these two serotypes cause adult pneumococcal diseases between 7% and 12%.
addition, serotype 3 remains one of the main causes of invasive pneumococcal disease in adults and children, although it is included in the pneumococcal vaccine currently available.
the United States, 15 percent of adults 65 years and older with invasive pneumococcal disease are still caused by serotype 3;
V114's Phase III clinical development project consists of 16 clinical trials that examine V1114's safety, tolerance, and immunogenicity in different populations, including healthy older people, healthy children, immunologically impaired people, and people with certain chronic diseases.
() Origin: Merck Applications for Licensure of V114, The Company's Investigational 15-Valent Pneumoccal Conjugate Vaccine, for Use in Adults to the U.S. FDA and European Medicines Agency