The US Food and Drug Administration (FDA) has accepted priority review of the Biologics License Application (BLA) of Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate, V114, for preventing invasive pneumococcal disease in adults.
The vaccine candidate has pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and also serotypes 22F and 33F.
The BLA and priority review status are backed by results from Phase II and Phase III clinical studies in the adult population. These include healthy adults and people at high risk, such as those with chronic medical conditions, HIV and aged 65 years and above.
Furthermore, additional studies in the BLA back V114’s usage in clinical settings, such as in co-administration with the quadrivalent influenza vaccine, as well as in sequential administration with PNEUMOVAX 23 and show identical performance among consecutive lots of V114.
Separately, a licensure application for V114 in adults is under review by the European Medicines Agency.
Merck Research Laboratories global clinical development senior vice-president and head, chief medical officer Dr Roy Baynes said: “Invasive pneumococcal disease in adults is on the rise in many countries, driven by highly-invasive serotypes including serotype 3, which is included in the currently licensed pneumococcal conjugate vaccine, as well as serotypes not included, such as serotypes 22F and 33F.
“Building on our nearly 40 years of experience with PNEUMOVAX 23, Pneumococcal Vaccine Polyvalent, we have developed V114 as another potentially important option to help protect more adults from invasive pneumococcal disease, especially those who are at increased risk.”
Merck noted that a Prescription Drug User Fee Act (PDUFA) target date of 18 July has been set for the application.
In 2019, Merck secured breakthrough designation from the US Food and Drug Administration (FDA) for its investigational 15-valent pneumococcal conjugate vaccine, V114.