Published: May 09, 2019
By Mark Terry
Merck & Company announced that its investigational 15-valent pneumococcal conjugate vaccine was “noninferior” to a currently available 13-valent pneumococcal conjugate vaccine in healthy babies 6 to 12 weeks of age.
The Phase II study, called V114-008, met its primary endpoint, showing noninferiority for the 13 serotypes seen in both vaccines. V114 also caused an immune response in infants for two additional disease-causing serotypes, 22F and 33F, which aren’t in PCV13.
Pneumococcal disease is caused by Streptococcus pneumoniae, and includes non-invasive illnesses like pneumonia, sinusitis, and middle ear infection. It also causes invasive diseases such as bacteremia, bacteremic pneumonia, and meningitis. Everyone is at risk for pneumococcal disease, but the most vulnerable populations are children under the age of 2, adults 65 years and older, and people with suppressed immune systems or chronic diseases.
The U.S. Food and Drug Administration (FDA) granted V114 Breakthrough Therapy Designation in January 2019. That decision was in part due to data from this trial and another Phase I/II trial, V114-005.
“Children under the age of two are at increased risk for pneumococcal infection, which in some cases may lead to serious illnesses like pneumococcal pneumonia,” stated David Greenberg, study investigator and physician in the Pediatric Infectious Disease Unit of Sorokak University Medical Center in Beer-Sheva, Israel. “These Phase II data evaluating V114 in infants are encouraging and mark important progress to helping expand protection against pneumococcal disease for this vulnerable patient population.”
The company is studying V114 broadly, with 11 Phase III clinical trials evaluating the vaccine in adults, children, and immunocompromised patients.
Currently, the big competitor would be Pfizer’s Prevnar 13, which has raked in sales of $23 billion since 2015 and over $5.8 billion in 2018, although revenues have decreased because of a shrinking patient population. Merck’s V114 would appear to have an advantage by covering two additional serotypes, but Pfizer is also working on a follow-up vaccine.
In a January conference call, Roger M. Perlmutter, president of Merck Research Laboratories, responding to a question about V114, said, “I think there has been a tendency among some, looking at it from a distance, to say it’s really just a function of counting up the different specificities, whether you have 13 or 15 or 25. I mean, that’s sort of what matters. We’ve got a lot of experience in this business, having marketed Pneumovax for a long time.”
Perlmutter added, “And we know from the experience that our colleagues at Pfizer have had with Prevnar that what happens over time is that the epidemiology of pneumococcal disease does change in specific markets. And it becomes more important to ensure that you have appropriate immunity directed against particular serotypes. So I think the thing to watch, in addition to the number, is what is the extent of protection that really is achieved using immunogenicity as a surrogate for each one of those serotypes, and particularly the ones that are emerging and being, in essence, selected for by virtue of prevalent immunity for immunization.”
Which more simply stated means that having a vaccine for 15 serotypes instead of 13 only really makes a difference in the market if the vaccine really does a good job of offering protection for those two additional serotypes.
Perlmutter went on to say, “We’ve taken great pains in developing V114 to ensure that the most important serotypes are actually highly immunogenic in that conjugate, and that will have big advantages.”