Merck Submits Regulatory Applications for 15-Valent Pneumococcal Conjugate Vaccine V114 for Adults Aged 18 and Older in the U.S. and EU
Nov 24, 2020 02:25
CST Updated
02:25
MSD
Pharmaceutical R&D and Manufacturer
November 23, 2020 /BioValleyBIOON/ -- Merck & Co. recently announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the marketing authorization of the 15-valent pneumococcal conjugate vaccine V114 (15-valent), indicated for use in adults aged 18 years and older.
Globally, the incidence of pneumococcal disease in adults is on the rise, partly driven by pathogenic serotypes not covered by currently available pneumococcal conjugate vaccines.
V114 is an investigational 15-valent vaccine composed of pneumococcal polysaccharides from 15 serotypes conjugated to CRM197Carriercomposed of protein conjugates, including serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease worldwide but are not included in currently licensed pneumococcal conjugate vaccines for adults.
Pneumococcal Vaccine (Image source: firstcry.com)
Currently, V114 is in Phase III clinical development for the prevention of pneumococcal disease in adults and children. In January 2019, the United StatesFDAV114 has been granted Breakthrough Therapy Designation (BTD) for the prevention of invasive pneumococcal disease (IPD) caused by vaccine serotypes in infants, children, and adolescents aged 6 weeks to 18 years.
The regulatory submission for V114 includes results from Phase 2 and Phase 3 clinical studies conducted in various adult populations, including healthy adults and high-risk groups such as adults with chronic medical conditions, individuals living with HIV, and adults aged 65 years and older. In these studies,V114 met the primary immunogenicity endpoints and elicited robust immune responses against all 15 serotypes covered by the vaccine, including the V114-specific serotypes 22F and 33F.
Dr. Roy Baynes, Senior Vice President of MSD Research Laboratories, Global Head of Clinical Development, and Chief Medical Officer, stated, “For more than a century, Merck’s innovators have developed vaccines that help address some of society’s greatest public health challenges, a tradition that is reflected today in our pneumococcal vaccine portfolio. The submission of the regulatory application for V114 helps us provide more options to help prevent pneumococcal disease.”
Pneumococcal Pneumonia (Image source: bigstockphoto.com)
There are more than 90 different types of pneumococci, which affect adults differently from children. Pneumococcal serotypes not included in currently marketed conjugate vaccines (such as 22F and 33F) are commonly associated with invasive pneumococcal disease worldwide. Currently, in the United States, 13% of invasive pneumococcal diseases among adults aged 65 years and older are caused by serotypes 22F and 33F, while in Europe as a whole, these two serotypes account for 7%-12% of adult pneumococcal diseases.
Furthermore, serotype 3 remains one of the leading causes of invasive pneumococcal disease in both adults and children, despite its inclusion in currently available pneumococcal vaccines. In the United States, serotype 3 continues to cause 15% of invasive pneumococcal disease cases among adults aged 65 years and older; this proportion ranges from 12% to 18% among adults in European countries.
The Phase III clinical development program for V114 consists of 16 studiesClinical TrialsComposition, and the safety, tolerability, and immunogenicity of V1114 were studied in different populations (including healthy elderly individuals, healthy children, immunocompromised individuals, and individuals with certain chronic diseases). (Bioon.com)