Merck has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its V114 investigational 15-valent pneumococcal conjugate vaccine.
The breakthrough therapy designation has been granted for V114 to prevent invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients aged between six weeks and 18 years.
The V114 is also being developed to prevent IPD in adults, and both indications are currently being evaluated in phase 3 clinical trials.
The FDA’s decision was based on immunogenicity data from two studies, including study 005 and study 008.
Study 005 is a phase 1/2, multicentre, randomized and double-blind study designed to assess the safety, tolerability and immunogenicity profiles of four different lots of a new formulation of V114 in healthy adults and infants.
Study 008 is a proof of concept and phase 2 pediatric trial designed to verify the results from study 005 in a larger population of infants.
The V114 induced an immune response in infants for two disease-causing serotypes, including 22F and 33F, not incorporated in the currently available 13-valent pneumococcal conjugate vaccine. It also showed non-inferiority for the serotypes contained in both vaccines.
Merck Research Laboratories vaccine and infectious diseases clinical research head Dr Nicholas Kartsonis said: “We are pleased with the data on V114 compiled to date, and we look forward to working closely with the FDA on the subsequent development of this investigational vaccine.
“The goal of our program in pediatric patients remains focused on providing additional serotype coverage versus currently available vaccines, while at the same time maintaining a strong immune response across all serotypes in the vaccine.”
In October 2018, the FDA approved Merck’s human papillomavirus (HPV) 9-valent vaccine, Gardasil 9, to be used as treatment for women and men aged from 27 years to 45 years.
Merck’s supplemental application was approved to expand the use of Gardasil 9, which helps in preventing certain cancers and diseases caused by the nine HPV types covered by the vaccine.