Merck has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for V114, its 15-valent pneumococcal conjugate vaccine candidate.
The Merck vaccine candidate is intended for use in adults 18 years of age and older.
The pharma giant said that it is awaiting acceptance of the submissions from the two drug regulators.
Dr. Roy Baynes – Merck Research Laboratories senior vice president and head of global clinical development, chief medical officer said: “For more than a century, Merck inventors have developed vaccines that help tackle some of society’s biggest public health challenges, and that heritage is reflected today in our pneumococcal vaccine portfolio.
“These submissions for V114 help bring us closer to offering more options to help protect against pneumococcal disease.”
The regulatory applications seeking the approval of the V114 vaccine candidate contain results from phase 2 and phase 3 clinical studies in a range of adult populations. These include healthy adults and those at high risk, such as adults having chronic medical conditions, HIV adult patients, and those 65 years of age and older.
V114 had been granted FDA breakthrough therapy designation for the prevention of invasive pneumococcal disease in pediatric patients of six weeks to 18 years of age and adults aged 18 years and more.
According to Merck, the 15-valent pneumococcal conjugate vaccine candidate contains pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein. It includes the 22F and 33F serotypes, which are associated commonly with invasive pneumococcal disease in older adults across the world and are not contained in the pneumococcal conjugate vaccine, which is licensed currently for use in adults.