Merck’s New Pneumococcal Vaccine Headed to Regulators by End of Year
Merck reported results from two more Phase III trials of V114, its 15-valent pneumococcal conjugate vaccine. V114 is made up of pneumococcal polysaccharides from 15 pneumococcal serotypes conjugated to a CRM197 carrier protein, which includes serotypes 22F and 33F. Both those serotypes are associated with invasive pneumococcal disease globally and are not otherwise in currently licensed conjugate vaccines for use in adults.
The two trials are PNEU-PATH and PNEU-DAY. PNEU-PATH evaluated V114 after administration of PNEUMOVAX 23 on year later in healthy adults 50 years of age or older. PNEUMOVAX 23 is a vaccine approved for people 50 years of age or older and people two years and younger who are at increased risk for pneumococcal disease. It immunized for pneumococcal disease caused by 23 serotypes.
In PNEU-PATH, immune responses after receiving PNEUMOVAX 23 were comparable to both vaccination groups for the 15 serotypes in V114. And at 30 days after vaccination with either V114 or PCV13, immune responses were comparable for both groups across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F.
PNEU-DAY is a Phase III trial that evaluated V114 after administration of PNEUMOVAX 23 six months later in adults between 18 and 49 years of age who are at increased risk for pneumococcal disease because of comorbidities, behavioral habits, or who live in an environment with increased risk of disease. V114 created immune responses comparable to PCF13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days after vaccination.
“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These data provide important information about the potential for V114 followed by PNEUMOVAX 23, a polysaccharide vaccine included in more than 90 percent of age-based adult pneumococcal immunization programs globally, to help protect healthy adults and adults who are at increased risk for pneumococcal disease.”
The company plans to present the data from the trials at a future scientific meeting. It also plans to apply to regulatory agencies before the end of the year, beginning with the U.S. Food and Drug Administration (FDA).
Pneumococcal disease is caused by the bacteria Streptococcus pneumoniae.There are more than 90 different types of the bacteria that can affect adults in a different way than children. The two strains, 22F and 33F, which are not in the currently licensed vaccine, are some of the most common that cause invasive pneumococcal disease around the world, including the U.S., in adults 65 years of age or older. Invasive pneumococcal disease from serotypes 22F and 33F are associated with more deaths and prolonged hospitalizations in adults. Also, adults with comorbidities like heart disease, diabetes or chronic obstructive pulmonary disease (COPD) are at higher risk for pneumococcal disease.
Pneumococcal disease, when it is confined to the lungs, is pneumococcal pneumonia, but can cause sinusitis and middle ear infection. Invasive pneumococcal illnesses include pneumococcal bacteria, a bloodstream infection, bacteremic pneumonia, and pneumococcal meningitis, when the infection spreads to the brain and spinal cord.